Please carefully read each step of the procedure that is to be carried out
before beginning the servicing of the unit. Always use the correct tools
and the indicated measuring instruments. Any non-compliance with the
instructions and/or recommendation found in this technical
documentation can lead to a malfunctioning of the equipment or damage
to it.
Use only original replacement parts as supplied by F. S
TEPHAN GMBH,
and that are listed in the Replacement Parts List.
This technical documentation is not to be used in place of the operating
instructions. Each operation and handling of the equipment requires exact
knowledge and observance of the operating instructions. This equipment
is only to be used for the stipulated application.
F. Stephan GmbH
F. Stephan GmbH
- Medizintechnik -
- Medizintechnik Kirchstrasse 19
Kirchstrasse 19
56412 Gackenbach, Germany
56412 Gackenbach, Germany
Subject to technical changes. Subject to technical changes.
Stand: April 1999 Status: April 1999
Version: V1.2
The manufacturer grants a 24-month warrant effective from the date of
purchaser.
Any modification or repair work carried out on the equipment may only
be done by F. S
Otherwise the warranty becomes invalidated.
In validation of the warranty can also arise through improper handling
and opertion of the equipment.
TEPHAN GMBH or an authorized technical team.
Claims
Warranty claims that can be attributed to improper operation, insufficient
care and maintenance shall not be honored by the manufacturer.
The manufacturer guarantees only for the safety and reliable operation of
the equipment only if the operating and servicing instructions are strictly
adhered to.
2.1 Check of the plug-in gas couplings O2, N2O, AIR
for:
correct color coding
correct fit in the gas socket
external damage
2.2 Check of the gas connection tubes O2, N2O, AIR,
for:
correct connection of the plug-in gas coupling
correct connection to the screw joint of the connecting thread
correct color coding
external damages
2.3 Check of the screw joints of the connecting
threads O
, N2O, AIR for:
2
Tightness
correct color coding of the individual types of gas
damage to the thread
he gas-mixing unit serves as proportioning device for medical gases
T
(e.g. oxygen, nitrous oxide and compressed air).The desired gases can be
mixed in any relation by means of the proportioning valves below the
flowmeter tubes. The types of gas can be clearly recognized on the
control knobs.
To prevent conf
usion, the control knob of the regulating valve for oxygen
differs haptically from the two other valves. Inadvertent shift of the
settings is avoided by a special twisting-prevention device.
he proportioning valves (control knobs) permit a continuous flow, when
T
they are rotated counterclockwise. The measuring area for O
consists of
2
two flowmeter tubes, so that an exact proportioning is guaranteed.
The high precision flowmeter tube (at the left) indicates the measuring
range from 0 to 2 l/min, the "rough" flowmeter tube (at the right)
indicates the flow quantities from 2 to 15 l/min.
Reading line is the upper edge of the float. Graduation of the lower scale
parts of the measuring tubes (AIR/N
Because the dimensions of the lateral parts of the GME 2/3 can be altered
optionally, the use of flowmeter tubes of other manufacturers (e.g. Rota,
KDG and others) is possible.
O) is more closely stepped.
2
Fig. 2: Gas Mixing Unit
3.1.1 O2-Flush
Depressing the O
-flush-button effects a quick oxygen supply
2
(approximately 50 l/min) directly to the outlet for fresh gas ( not via the
vaporizer for anaesthetic agent).
Releasing the O
-flush-button effects return to the initial position.
2
3.1.2 AIR / N2O-Change-Over
The AIR/N
knobs (AIR/N
possible. The appropriate proportioning of the gases is carried out by
means of the regulating valves O
In case of a decrease of pressure in the supply system (oxygen
lower than 2,8 bar ) an audible alarm sounds for at least 7 seconds.
No muting is possible.
O-change-over-switch is situated below the respective control
If pressure of oxygen further decreases to approximately 2 bar,the portion
of N
O is also reduced proportionally to the portion of oxygen. In case of
2
a total failure of oxygen supply, the flow of N
The readiness for service of the apparatus can only be restored by
providing the prescribed pressure of oxygen of at least 2 bar at the
connection with the supply system.
Check setting wheel and stop for performance
Check indication of filling level for damage
Check drain screw for easy running and tightness
Check performance of safety filling socket for performance
Check locking device of vaporizer
Verify concentration values of the vaporizer with the help of a testing
device for anaesthetic gases
maximum admissible tolerance in accordance with DIN 13252: +/-
20% of the set value or 0,2 Vol % absolute, always the higher value of
the two.
4.2 Vaporizer holding device
Check sealing valves for tightness
Exchange O-rings
Check for firm fit
Performance test of the high-pressure gauges for N
Check of the connections for supply cylinders
Check of correct coding of threads
Check of the packings of the supply cylinders
Check screw joints and pipe installations for tightness and damages
Check housing for damages
Check attached components for firm fit
The circle system together with the patient forms a closed cycle, into
which fresh gas is fed via the fresh gas pipe line. Excess gas escapes
through the excess gas valve (10)from the cycle and is removed from the
field of activity of the anaesthetist by means of the suction system for
anaesthetic gas (13).During the inspiration phase, the gas contained in the
system is transported to the patients' lungs by effecting pressure,
produced either by the respirator or by manual operation of a respiratory
bag. The consequent PRESSURE RELIEF in the system during the
expiration phase and the increase of pressure in the lungs due to the
elasticity of the thorax makes the gas flow back out of the lungs. Thereby
it is the task of the inspiration valve (1) and the expiration valve (7) to
permit the flow of gas only in one direction and so to establish the cycle.
Prior to reaching the patient again, CO
(2). Humidity and heat given off by the patient are fed back to him in
such a semi-closed system, which prevents desiccation and excessive
cooling of the airways. The fresh gas feeder is located on the lower end of
the holding tube. The adjustability of elevation and the possible
swivelling stand for a good adaptation to the local conditions of the
operating theatre. The respiratory pressure gauge(3), which can be
slipped onto the holding device of the circle system, has a measuring
range from - 10 to 100 mbar. It can be replaced by a blind plug.
is removed in the two absorbers
2
6 Circle System
As a standard, a mechanic volumeter (9) is installed below the expiration
valve, which measures all expiratory values of respiratory volume. The
measuring of O
in accordance with DGAI, is carried out by means of a polarographic cell
(by Clark) (1) at the head of the inspiration valve. Moreover, the circle
system is provided with connection tapers in accordance with ISO
respectively DIN 13 252, so that corrugated tubes for the ventilation of
adults as well as tube systems for infants can be used. The excess valve
(10) serves to carry off spent respiratory gases. It can be operated in four
different adjustments.
The valve is completely closed. This setting is necessary for operation in
respirator mode. In this mode, the spent respiratory gases are evacuated
via the ejector on the patient component during the expiration phase.
6.1.2 Pressure Range from 5mbar to 50mbar
This setting is used to limit the maximum pressure during manual
ventilation. When the set pressure is reached, the valve evacuates.
6.1.3 Spontaneous Respiration
During spontaneous respiration of the patient under light anaesthesia, the
valve closes in the inspiration phase, the patient now breathes the fresh
gas provided by the apparatus. In the expiration phase, the valve opens
and evacuates the system until ambient pressure is reached.
This setting is to be used in case of assisted ventilation with the patient
triggering the respiration and the respirator deepening the respiration.
Aside of that, it is possible to switch to SP briefly in case of manual
ventilation in the pressure range of 5 to 50 mbar to evacuate an overfilled
respiratory bag.
6.1.4 VOL (volume-controlled ventilation)
With the valve setting VOL, the circle system is closed automatically to
guarantee supply of the patient with the desired respiratory working
volume. Spent and excess respiratory gases escape from the valve at the
end of the expiration phase. During the expiration phase, pressure in the
system never rises above 1,5 mbar.
Check performance of inspiration- and expiration valve and contact
surfaces of the valves for damages
Check tapers and taper seats for damages
Check absorber for damages and tightness
Check performance of respiratory pressure gauge
Check setting values and performance of the Berner-valve
Check fresh-gas-feed for passage of flow and tightness
Check tube system, Y - piece and mask
In the course of semi-annual servicing, all packings and O-rings must
Do not use in the application described above. You will destroy the
manometer.
Prior to putting the apparatus into service, it must be verified, that the O
flush-valve closes immediately and automatically after the key has been
released. For this test, the flush-key must be depressed briefly. When
released, it must return immediately to its initial position.
7.3 Air / N2O-Change Over (Basic setting)
O
- proportioning valve closed
2
N
O-proportioning valve set at 3 l/min
2
Proportioning valve for AIR set at 3 l/min
Change-over-switch in "N
Suction system for anaesthetic gas connected
O
-monitor calibrated and in operation
2
7.3.1 Execution of the Test
O" – position
2
-
2
The flowmeter tube for N
O must indicate 3 l/min, while the
2
flowmeter tube for compressed air must give a reading of zero. The
O
-monitor indicates ca. 0% O2 ( after a brief delay ).
2
When changing over from N
O to AIR (Change-over-switch)
2
without altering the settings of the proportioning valves
the float of the N
O-flowmeter tube must return to zero, while in
2
parallel the reading of the flowmeter tube for compressed air must
rise to 3 l/min. As a confirmation, the O
21 % O
7.4 Check of types of gas and test of the safety
devices
(Nitrous oxide blocking and O
Apparatus in operating mode
Suction system for anaesthetic gas connected
Spindles of all proportioning valves opened to 3 l/min
Change-over-switch for AIR/N
7.4.1 Execution of the Test
Separate angular plug for O
The flow of oxygen must decrease continuously
-failure-alarm)
2
O in N2O-position
2
from supply system
2
The O
-failure alarm sounds, when line pressure reaches approximately
2
2,8 bar
When pressure further decreases to approximately 2 bar, the nitrous-
oxide-blocking must set in and lower the N
oxygen flow, until, with the system completely emptied, both volume
flows have decreased to zero.
Oxygen supply is restored by inserting the angular O
When the N
O-supply is interrupted, only the N2O-flow drops to zero
2
After restoring of the nitrous-oxide-supply, finally change over to AIR
and separate this gas from the supply pipe line. Here as well the flow of
O must drop to zero.
N
2
7.4.2 Proportioning Valves
When the proportioning valves are closed, the respective floats of the
corresponding flowmeter tubes must move back to the zero position. If
this is not the case, a leakage of the respective spindle exists, which must
be eliminated by the service technician.
O flow in parallel to the
2
-plug.
2
When carrying out this test, do not forget to change over from N
Fig. 5: Y – piece, feed line for control gas, rspiratory pressure gauge
1 y – piece
2 respiratory pressure gauge
3 feed line for control gas
7.5.1 Basic setting
Flow-regulating valves on flowmeter unit closed
Pressure-regulating valve in position CL
Remove mask from Y – piece
Slip feed line for control gas (3) onto the Y - piece, so that the circle
While observing the respiratory pressure gauge (2), the zero-position
of which has been verified beforehand, cautiously open the flowregulating valve for oxygen, until the pressure gauge comes to a
standstill at constantly 60 mbar.
Read off the quantity of escaping gas at the corresponding flowmeter
tube
If leakage is less than 250 ml/min, the circle system is sufficiently
tight for operation
If the value of 250 ml/min is exceeded, the following items must be
checked:
Tightness of connecting tapers
Tightness of screw joints
Packings and O – rings
7 Performance Test
Corrugated tubes for damages
If after a repeated tightness test the inadmissibly large leakage could
not be eliminated, the service department must be notified.
7.6 Test of the pressure-regulating valve
Fig. 6: Y – piece, feed line for control gas, rspiratory pressure gauge
1 y – piece
2 rspiratory pressure gauge
3 feed line for control gas
7.6.1 Basic setting
Circle system in operating mode
Calibrate respiratory pressure gauge
Remove mask from y - piece
Slip feed line for control gas (3) onto the Y - piece (1), so that the
circle system forms a closed space.
7.6.2 Execution of the Test
Fig. 7: Pressure regulating valve
Adjust the flow of oxygen to 5 l/min
Cover the values imprinted on the pressure regulating valve and
control them by means of the respiratory pressure gauge.
Do not go beyond 50 mbar, otherwise there is danger of overload.
Tolerance: +/- 5 mbar
If tolerance limits are exceeded, exchange of the valve is necessary.
®
7 Performance Test
7.7 Test of inspiration-and expiration valve
Fig. 8: Test of inspiration-and expiration valve
7.7.1 Basic setting
Circle system in operating mode
Remove mask from Y – piece
Connect the Y - piece with a test lung
Adjust fresh gas flow to 2 l/min
Limit pressure regulating valve to 35 mbar
+/- 10 % of the respective terminal value of the scale.
In case of integrated high precision measuring range
+/- 10 % of the terminal value of this measuring range (under
standard conditions of 20
o
C and 1,013 bar)
10.5 O2-Failure alarm
Trigger pressure: 2,8 bar
Duration of audible alarm: 7 seconds
N
O - Blocking Trigger pressure: 2,0 bar
2
10.6 Technical Data Circle System
Volume of the complete circle
system with 2 absorbers and tubes: ca. 3 l
Weight: ca. 5,5 kg
Length: 330 mm
Height: 800 mm
6 Corrugated tube 1 m 1 952 60 011
7 Expiration valve 1 155 61 005
8 Y - piece 1 155 60 035
9 Mechanical volumemeter Haloscale 1 155 60 040
10 Pressure regulating valve 0 to 50 mbar 1 155 60 006
11 Flat packing 33 X 21 X 2 1 951 60 004
12 Flat packing 29 X 21 X 1,5 1 951 60 003
13 Adapter for suction system anaesthetic gas 1 155 60 036
14 Tube for suction system 1 m 1 952 60 016
15 Plug for suction system for anaesthetic gas 1 155 60 037
16 Corrugated tube 1,5 m 1 952 60 012
17 Respiratory bag 2 liter, without reinforcement 1 952 60 013
18 ISO - adapter A 1 155 60 038
19 ISO - adapter I 1 155 60 039
20 Flat packing 1 951 40 007
Tab. 3: spare parts circle system
11.1.1 Semi-annual servicing circle system
Item Designation Article No.
11 Flat packing 33 X 21 X 2 1 951 60 004
12 Flat packing 29 X 21 X 1,5 1 951 60 003
20 Flat packing 1 951 40 007
Tab. 4: List of parts for exchange on the occasion of semi-annual
3 O-ring 34,5 x 3,5 1 155 60 023
5 O-ring 34,5 x 3,5 1 155 60 023
10 O-ring 9 x 2 1 950 60 005
Tab. 10: List of parts for exchange on the occasion of semi-annual
After removing the packing sets (1) and (5),the end plugs (2) and (4) can
be pulled out of the flowmeter tube with the help of a pair of pincers and
the float can be taken out.
The floats, together with the corresponding flowmeter tubes, form a
calibrated system, so that an interchanging must be avoided by all means.
Now the flowmeter tube can be rinsed first with soap suds and then with
clear water.The completely dry tube can be re-installed. After the
plexiglass hood has also been cleaned, the cover of the flowmeter tube
can be screwed up again.
In accordance with MedGV (Ordinance on medical appliances), medicotechnical appliances must undergo an inspection in regular intervals of
time.
This inspection must be carried out only by authorized persons (service
technicians) of the supplier of the appliance.
Periodical maintenance generally is semi-annual.
Best guarantee is a service contract, providing for a semi-annual rhythm
of inspections with automatic exchange of the working parts.
13 Servicing
If servicing is carried out by unexperienced, unauthorized persons, the
liability of the manufacturer for safe performance of the apparatus
automatically becomes void.
Herewith we confirm the orderly execution of the semi-annual servicing
in accordance with the service instructions on hand, based on the
regulations of the MedGV.
Herewith we confirm the acceptance of the serviced inhalation apparatus
ARTEC. Performance of the apparatus and the observance of the
prescribed safety regulations have been verified by us.