Changes and innovations

Leon / Leon plus

Homecare
Pneumologie

Der Mensch im Mittelpunkt. Neonatologie

Anästhesie
Intensivbeatmung
Schlafdiagnostik
Service
Patientenbetreuung
 Changes to the device

Juli 17 2
Changes to the PCB`s
• Nearly all the boards from Leon and Leon plus have had an increase in
their revision in the last years, some are due to improvements, but most
are because of termination of electronic components.

• The parts are all backward compatible to the older units.

• If several parts are required (for example the power supply) you will
receive from us a complete backward compatible module / service kit.

• ! The version of the adapter board and the controller board are
monitored by the device. This means that the devices need the current
software to recognise the newest boards!

Juli 17 3
Changes to the PCB`s
Here is an example from a new and old Controller board / NET-DCU /
Backlight inverter

Juli 17 4
Changes to the front modules

• We had many changes to the front module in the past 10 years, here
just an excerpt:

• Smooth front without visible frame

• Change of symbols due to normative requirements
• Change from LCD to LED display

• For the exchange you will always get a complete backward

compatible set.

Juli 17 5
Changes to the front modules
Old New

The old screen is easy to recognize with the “window sill”. If you have such a system
with a broken touch or screen, it must be upgraded with a new flat module.

Juli 17 6
IEC 30601 3rd edition

3rd edition is on everyone's

lips and everyone who
works with medical
products is talking about it
but:

Juli 17 7
What is IEC 30601 3rd edition?

The EN 30901 3rd edition is a normative requirement which specifies what

conditions medical units must comply. Only those who adhere to this standard may
produce for the market.

The first draft of the 3rd edition was 2005, this replaces the 2nd from 1988. Now we
have to manufacture our anesthesia devices according to this new standard, so the
Hardware and Software on all units, since 2017, will have the requested changes.

Because of this standard we also had to make changes to the software. For the
country's all over the world who want this standard, we have the 3rd edition
software 3.11.x and for all the other's we have 3.10.x

The European EN and Canadian CSA versions of the standard are identical to the
IEC standard.

Juli 17 8
Differences in the software version
• Depending on the age of the Leon / Leon plus and the built in net-dcu,
we maintain different software versions. 3.5.xx for older units, 3.10.xx
and 3.11.xx for the newer ones.

• In older units, produced before 2012, the NET-DCU version is 5.2.

The highest software version for these units is 3.5.xx.

• Since 2012, units were produced with the NET-DCU 9.0 or 9.2, each
of the software versions will run on these.
• All 3 software versions are maintained. This means that if we adjust
revisions or if there is a safety-relevant change, we change this in all 3
versions.

Juli 17 9
Differences in the software version
3`rd edition NET-DCU 9/9.2 NET-DCU 5.2
NET-DCU 9/9.2

• Feature 3.11.x 3.10.x 3.5.x

• Patient Safe 3rd / /
• Neg. pressure (up to -10mbar) 3rd / /
• Alarm message aPat Paw < 0 (bis -10mbar) 3rd / /
• Alarm message atF 55 Patientsafe 3rd / /
• Symbols UI 3rd / /
• Setting of the alarm volume is not possible with red alarms 3rd / /
• HuL-Bus 0.0.5 X / /
• Battery runtime > 100 min X / /
• Warning for reboot > 24h X / /
• HL7 X X /
• Settings optional / individually resettable X X /
• O2 absorption X X /
• 3 ml MV in Neo mode X X /
• light for writing desk available Leon plus X X /
• HLM FG =0 Liters possible. X X /
• Econometers X X /
• MON Mode X X /
• IBW X X /
• Alarm setting MV to 0 possible X X X
• Safety Flow active in Standby X X X
• NeoMode license X X X
• cmH2O in mbar X X X
• System test with open FG-Outlet not possible. X X X

Juli 17 10
Visible changes for 3rd edition
Any labeling on the outside of the device has been replaced by symbols.

Juli 17 11
Visible changes for 3rd edition

Juli 17 12
Visible changes for 3rd edition

Juli 17 13
Visible changes for 3rd edition

Juli 17 14
Visible changes for 3rd edition
The symbols on the patient module have also been adapted to the
normative standard

Juli 17 15
Internal changes for 3rd edition
In the gas return of the Aion there is a filter installed, this must be replaced
once a year

!Attention!
• The Filter has a flow direction, clear is inlet, blue is outlet.
• It is not necessary to retrofit the filter during maintenance, it must only be
replaced if it is already present in the device.

Juli 17 16
Internal changes for 3rd edition
The grounding had to be adapted in some places

Juli 17 17
Changes to Rotameter block - Leon

!Here is the old version!

• Pipes > 1 l/min in l/min

< 1 l/min in ml/min

• Ratio on "internal system“ is

Controlled. If the N2O spindle
is rotated, the O2 spindle does not rotate
with it.

Juli 17 18
Changes to Rotameter block - Leon

!This is the New Version for 3rd edition!

• All pipes in l/min

• Ratio controlled by spindle. If the

N2O spindle is turned on alone, the
O2 spindle also rotates.

Juli 17 19
Changes to Generator module - Leon plus
In the event of a fault, we exchange parts, not the complete module.

1. Propellant gas mixer Leon / Leon plus

0208750v2hul200
2
2. Holder O2 Cell
silver: 0208760 blue: 0208760a
3. Fresh gas mixer Leon plus
1 3 0208751-1

4. Circuit board mixer Leon plus

4 0208751-2v01

Juli 17 20
Changes to the oxygen cell holder - Leon plus
New P/N:0208760a Old P/N: 0208760

-The new blue holder has a new differential pressure measurement with a sintered
disc inside, this has higher accuracy than the old version with a metal disc. To use
this measurement you must install the highest SW-Version 3.10 x or 3.11.x, for this
you will need a new Monitor Pic (see next page)
- New units (since 2017) are all delivered with the blue version.
- Both parts are available as a spare part.

Juli 17 21
Changes to Monitor Pic Controller - Leon plus

Juli 17 22
Changes to Generator module - Leon plus
This means summarized:

For a Software Update to 3.10.x or 3.11.x from an older version, a new

monitor pic controller is required and must be ordered as hardware.

For units with the silver O2 Cell holder you need the Version 5.5.1

Only after exchange from the silver to the blue version, you need
Version 5.5.3
Please note: If the blue version is already installed, you will have the
5.5.3 inside and you don’t need a new pic controller.

P/N: for 5.5.1 0170512hul551

P/N for 5.5.3 0170512hul553

If you are from China: For your country we have a special version,
please contact us before you want to order a pic controller.

Juli 17 23
Single use CO2 Absorber`s manufactured by LM

0209411/6 0209410/6

Juli 17 24
Changes to the Patient module
The first version of patient module,V1, had 3 slide valves. The third was
designed for an open system option and was never in use.

Juli 17 25
Changes to the Patient module
The next patient modules are merely without the check valve for the
open system.

Juli 17 26
Changes to the Patient module
The version V3 has only 2 slide valves to switch between mechanical and
manual ventilation.V3 is also designed for the dishwasher rack.

Juli 17 27
Dishwasher for the patient module

• New patient modules V3

have cleaning
connections. If you want
to use them, you will
need a special rack for
the dishwasher.

• This rack is an option,

cleaning is still possible
without this frame.

Juli 17 28
Changes to the Patient module
On version V4 the hand ventilation bag and the gas return from the gas analyser
inside the module, are at a different locations.

Juli 17 29
Changes to the Patient module
Also new is that the excess diaphragm is mounted from the outside.

Juli 17 30
Stronger Springs for the slide valves
• Diameter of old spring 1 mm
• Diameter of new spring 1.25 mm Old spring New spring
• P/N for the new spring is 0209585
• In the past, it could happen that the
grease on the valves is washed away
during cleaning, this caused errors
during the system test. With the new
spring`s and an increase of the pressure
for the slide valves (200mbar higher
than before, max.1,4 bar) this problem
is now solved.
• The springs are part of the annual
maintenance kit from 2017 and will be
included for 2 years, then all in the field
have to be exchanged.

Juli 17 31
New APL-valve to decrease the noise during
hand ventilation

Juli 17 32
 New APL-valve to decrease the noise during
hand ventilation
• The new version is easy to recognize from the outside by the
straight corrugated grip surface.
• In addition, the designation V2 can be seen in the article number.
New Old

Juli 17 33
New fixation of the peep-membrane

• P/N for the conversation kit is

0209198bg
• It could be that after the
cleaning the peep is no longer
accurately controlled because
the membrane was clamped in New Old
the holder. With this
construction, clamping of the
membrane is no longer
possible.

Juli 17 34
New fixation of the peep-membrane
The new version is easy to recognize from the outside on the straight
corrugated grip surface

New Old

Juli 17 35
New Peep-membrane
• The P/N from the new peep membrane is 0209109hul200bg
• The new one is easy to differentiate due to the changed colour, the
new version is blue.
• The membrane is 100% identical to the old one. The reason for the
colour change is only that we have a new injection mould for the
production.
New Old

Juli 17 36
New inspection glass
The new glass has more ripples on the outside, so it is better to grip
and turn.

New Old

Juli 17 37
6 years or 20.000 hours maintenance Patient module

! The excess diaphragm, since 2016, is no longer inside

the maintenance kit and does not need to be replaced in
the future!

The reason is that after exchanging this we had many

problems in the past with it not passing the system test.
This is because it has not been fitted accurately enough.
Long-term tests have resulted that the lifetime is much
longer than 6 years.

Juli 17 38
Gas measurement
The Artema Aion 02 and Aion 03 have been discontinued since mid-2017.
They have been replaced by the successor products, Aion Platinum and
Aion Argentum.

Old New

Juli 17 39
Gas measurement
The Aion Platinum with an integrated Servomex
paramagnetic sensor will replace the Aion 03
with Servomex. ( Premium class and Standard
on Leon plus)

The Aion Argentum combined with Oxima cell

or KE 25 will replace the Aion 02 (middle class
and standard on Leon)

Juli 17 40
Gas measurement
Aion 02 and 03 will continue to be available as a spare part, so if you are
having a problem with your gas measurement you don`t have to upgrade
your unit with another gas measurement.

The new Aion is only installed in new units manufactured after 08-2017.

Juli 17 41
The End…….

Thank you, for your attention.

Juli 17 42