Dürr Technik SICOLAB med User manual

SICOLAB med
Installation and operating instructions
1018100100L02

1907V005
EN
0297

1018100100L02 1907V005 1
8.2 Information regarding the pres-
sure vessel . . . . . . . . . . . . . . . . . . 18
8.3 Pressure tank . . . . . . . . . . . . . . . . 18
8.4 Instructions for use for the pres-
sure vessel (explanation by Be-
hälter-Werk Burgau GmbH) . . . . . . 19
9 Commissioning. . . . . . . . . . . . . . . . . . . 20
9.1 Remove the packaging . . . . . . . . . 20
9.2 Unit with castors . . . . . . . . . . . . . . 20
9.3 Establishing the compressed air
connection . . . . . . . . . . . . . . . . . . 20
9.4 Condensate . . . . . . . . . . . . . . . . . 21
9.5 Electrical installation . . . . . . . . . . . 21
9.6 Overtemperature protection . . . . . 22
Usage
10 Operation . . . . . . . . . . . . . . . . . . . . . . . 23
10.1 On/Off switch . . . . . . . . . . . . . . . . 23
10.2 Manual venting . . . . . . . . . . . . . . . 23
10.3 Unit with castors . . . . . . . . . . . . . . 23
11 Maintenance. . . . . . . . . . . . . . . . . . . . . 24
11.1 Maintenance schedule . . . . . . . . . 24
11.2 Disinfecting and cleaning the sur-
faces . . . . . . . . . . . . . . . . . . . . . . 25
Troubleshooting
12 Tips for operators and service techni-
cians. . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Appendix
13 Information about EMC in accord-
ance with EN 60601-1-2 . . . . . . . . . . . . 28
13.1 General notes . . . . . . . . . . . . . . . . 28
13.2 Abbreviations . . . . . . . . . . . . . . . . 28
13.3 Guidelines and manufacturer's in-
formation . . . . . . . . . . . . . . . . . . . 28
EN
Contents
Important information
1 About this document . . . . . . . . . . . . . . . 3
1.1 Warnings and symbols . . . . . . . . . . 3
1.2 Copyright information . . . . . . . . . . . 4
2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended use. . . . . . . . . . . . . . . . . . 4
2.2 Improper use . . . . . . . . . . . . . . . . . 4
2.3 General safety information. . . . . . . . 4
2.4 Specialist personnel . . . . . . . . . . . . 5
2.5 Electrical safety. . . . . . . . . . . . . . . . 5
2.6 Essential performance character-
istics. . . . . . . . . . . . . . . . . . . . . . . . 5
2.7 Notification requirement of seri-
ous incidents . . . . . . . . . . . . . . . . . 5
2.8 Only use original parts. . . . . . . . . . . 5
2.9 Transportation and storage . . . . . . . 6
2.10 Disposal . . . . . . . . . . . . . . . . . . . . . 6
Product description
3 Overview. . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Scope of delivery . . . . . . . . . . . . . . 7
3.2 Spare parts and accessories. . . . . . 7
4 Technical data . . . . . . . . . . . . . . . . . . . . 8
4.1 Basic data . . . . . . . . . . . . . . . . . . . 8
4.2 Variants. . . . . . . . . . . . . . . . . . . . . . 9
4.3 Declaration of conformity . . . . . . . 10
5 Operation . . . . . . . . . . . . . . . . . . . . . . . 11
5.1 Unit details . . . . . . . . . . . . . . . . . . 11
5.2 Pneumatics plan . . . . . . . . . . . . . . 12
5.3 Main air supply . . . . . . . . . . . . . . . 13
5.4 Standby mode . . . . . . . . . . . . . . . 13
5.5 Device label . . . . . . . . . . . . . . . . . 14
6 Type plate. . . . . . . . . . . . . . . . . . . . . . . 16
Assembly
7 Tools required. . . . . . . . . . . . . . . . . . . . 17
8 Requirements . . . . . . . . . . . . . . . . . . . . 17
8.1 Installation/setup room . . . . . . . . . 17

2 1018100100L02 1907V005
Contents
Contact
14 Addresses . . . . . . . . . . . . . . . . . . . . . . 32
14.1 Returns / Repairs . . . . . . . . . . . . . 32
14.2 To order spare parts . . . . . . . . . . . 32
14.3 Service . . . . . . . . . . . . . . . . . . . . . 32
14.4 Addresses worldwide . . . . . . . . . . 32
EN

1018100100L02 1907V005 3
The signal word differentiates between four
levels of danger:
– DANGER
Immediate danger of severe injury or death
– WARNING
Possible danger of severe injury or death
– CAUTION
Risk of minor injuries
– NOTICE
Risk of extensive material/property damage
Other symbols
These symbols are used in the document and
on or in the unit:
Note, e.g. specific instructions regarding
efficient and cost-effective use of the unit.
Refer to Operating Instructions.
0297 CE labelling with the number of the noti-
fied body
Manufacturer
Date of manufacture
Order number
Serial number
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Disconnect all power from the unit.
Protective ground connection
Air
Weight
Recycling
Orange warning LED "Temperature too
high"
1 About this document
These installation and operating instructions
represent a part of the unit. They correspond to
the relevant version of the unit and the status of
technology valid at the time of its market launch.
In the event that the instructions and
notes in these installation and operating
instructions for are not observed, Dürr
Technik accepts no warranty or liability of
any kind for the safe operation and relia-
ble function of the units.
This translation was prepared to the best of our
knowledge. The original German language ver-
sion of the manual is the definitive version. Dürr
Technik is not liable for translation errors.
1.1 Warnings and symbols
Warnings
The warnings in this document are intended to
draw your attention to possible injury to persons
or damage to machinery.
The following warning symbols are used:
General warning symbol
Warning – dangerous high voltage
Warning – hot surfaces
Warning - automatic start-up of the unit
The warnings are structured as follows:
Description of the type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
iFollow these measures to avoid the
danger.
Important information
EN

4 1018100100L02 1907V005
Important information
2 Safety
Dürr Technik has developed and constructed
the units in such a way that danger is to a large
extent excluded if the units are used as intend-
ed. Nevertheless, residual risks can remain.
You should therefore observe the following
notes.
2.1 Intended use
The unit is designed to provide compressed air
for the supply of a respirator.
The unit aspirates ambient air. The aspirated
ambient air must be suitable for the ventilation
of patients and must not contain any harmful
substances.
The compressed air generated by the unit is de-
livered directly to a ventilator. The unit can be
used either as a replacement unit in standby
mode or directly as the main air supply for a
ventilator.
If the unit is used to supply air to life-sustaining
ventilators, an adequate replacement supply
must be provided as a backup in case of a de-
fect on the unit
.
2.2 Improper use
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer ac-
cepts no liability for damage resulting from such
use. In such cases, the user/operator will bear
the sole risk.
WARNING
Danger of explosion from the ignition
of flammable materials
iDo not operate the unit in any rooms
containing flammable mixtures.
2.3 General safety information
iWhen operating this unit, always observe all
directives, laws, and other rules and regula-
tions applicable at the site of operation.
iCheck the function and state of the unit prior
to each use.
iDo not convert or modify the unit.
iComply with the specifications of the Installa-
tion and Operating Instructions.
AC current
Green control LED "Unit ready for opera-
tion"
Compressed air intake in bar / psi
Compressed air outlet in bar / psi
I
O
On / off switch in position "I": switch unit
on
OIOn / off switch in position "O": switch
unit off
Fuses
Tool Allen wrench
Tool Hexagon wrench
Nm
Tool Torque wrench
1.2 Copyright information
All names of circuits, processes, names, soft-
ware programs and units used in this document
are protected by copyright.
The reprinting of the installation and operating
instructions, even in extracts, is only permitted
with the written permission of Dürr Technik.
EN

1018100100L02 1907V005 5
Important information
Installation and repairs
iAlways arrange for any assembly work, read-
justments, alterations, extensions, and repairs
to be performed by Dürr Technik or by per-
sonnel authorised and trained by Dürr Tech-
nik. Qualified personnel are defined as those
trained by Dürr Technik; who are familiar with
the unit technology; and are aware of the dan-
gers presented by the unit.
2.5 Electrical safety
iObserve and comply with all the relevant elec-
trical safety regulations when working on the
unit.
iReplace any damaged cables or plugs imme-
diately.
2.6 Essential performance charac-
teristics
The SICOLAB med unit does not have any es-
sential performance characteristics in accord-
ance with EN/IEC 60601-1 section 4.3. The unit
is classified as not life-sustaining. An adequate
replacement supply must be provided for the
supply of a life-sustaining ventilator.
2.7 Notification requirement of seri-
ous incidents
The user / patient is required to report to the
manufacturer and the competent authority of
the Member State, in which the user and/or pa-
tient is established, any serious incident that has
occurred in relation to the device.
2.8 Only use original parts
iOnly use accessories and special accessories
that are specified or approved by Dürr Tech-
nik.
iOnly use original working and spare parts.
iEnsure that the unit operator has access to
the Installation and Operating Instructions at
all times.
Should the user connect additional units
to the respiratory air compressor, the re-
sulting system is a medical device sys-
tem.
It is the responsibility of the user to make
sure that the medical device system
meets the requirements of IEC 60601-1.
WARNING
The supply pressure of life-sustaining
ventilators is too low.
Should the respiratory air compressor
supply the respirator unit with an insuffi-
cient amount of compressed air, this
can result in a pressure drop in the ven-
tilator and insufficient air supply to the
patient.
iThe ventilator must have a suitable
alarm signal.
WARNING
Malfunction of the device due to
portable and mobile RF communica-
tion units (electromagnetic interfer-
ence)
Portable and mobile RF communication
units (including antennae cable and ex-
ternal antennae) generate electromag-
netic fields. This can result in malfunc-
tion of the unit.
iKeep a minimum distance of 30 cm
between the unit (including power
cord) and RF communication unit /
accessories.
2.4 Specialist personnel
Operation
Unit operators must ensure safe and correct
handling based on their training and knowledge.
iInstruct or have every operator instructed in
the handling of the unit.
EN

6 1018100100L02 1907V005
Important information
Ambient conditions during storage and
transport
Ambient conditions during storage and
transport
temperature °C -20 to +70
Rel. humidity %0 to 99
Air pressure hPa 100 to 1100
Please refer to the labels on the packaging pad-
ding.
2.10 Disposal
Unit
The unit must be disposed of properly.
Within the European Union, the unit must
be disposed of in accordance with EU
Directive 2012/19/EU (WEEE).
iPlease contact Dürr Technik if you have any
questions regarding the proper disposal of the
unit.
Packaging
Dispose of the packaging material in an
environmentally responsible manner.
– Note current disposal routes.
– Keep the packing materials out of the reach
of children.
WARNING
Risk of explosion of the pressure
vessel and pressure hoses
The unit is pressurised and may explode
if you do not comply with the notice.
iThe pressure vessel and the pressure
hoses must be vented before they are
stored or transported.
iProtect the unit from moisture during
transportation.
iAlways transport the unit in an upright
position.
Dürr Technik accepts no liability for dam-
age resulting from the use of non-ap-
proved accessories, special accessories
or any working parts or spare parts other
than original parts.
The use of non-approved accessories,
special accessories or non-genuine
working parts / spare parts (e.g.power
cord) can have a negative effect on the
electrical safety and EMC.
2.9 Transportation and storage
The original packaging provides optimum pro-
tection for the unit during transport.
Dürr Technik will not accept any respon-
sibility or liability for damage occurring
during transport due to the use of incor-
rect packaging, even where the unit is
still under guarantee.
– Only transport the unit in its original packag-
ing.
– Keep the packing materials out of the reach
of children.
The unit may be stored in its original packaging
– in warm, dry and dust-free rooms;
– protected from contaminants.
If possible, retain the packaging material.
EN

1018100100L02 1907V005 7
3 Overview
3.1 Scope of delivery
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
Product name . . . . . . . . . . . . . Article number
SICOLAB med . . . . . . . . . . . . . . . . 1018xxxxxx
Power cord
Installation and Operating
Instructions. . . . . . . . . . . . . . . . . . 1018100100
3.2 Spare parts and accessories
Unit feet . . . . . . . . . . . . . . . . . . . . 1018100132
Castors. . . . . . . . . . . . . . . . . . . . . 1018100126
Trolley . . . . . . . . . . . . . . . . . . . . . . 1018100070
Product description
EN

8 1018100100L02 1907V005
Product description
4 Technical data
4.1 Basic data
Electrical data Basic unit
Nominal pressure bar / MPa 3 / 0.3
General data
Pressure vessel volume L 3
Delivery quantity at 3 bar (0.3 MPa) l/min 30
Duty cycle %100
Operating pressure, max. bars Max. 5
Switch-on/cut-off pressure(on standby) bars 2.7 ±0.2 to 3.2 ±0.2
Supply pressure (standby mode) bars 2.7 - 6
Safety pressure PS bars 8
Type of protection IP IP20
Continuous flow -min. 30 L/min at 3.0 bar (the continuous
flow depends on the ambient pressure.
The actual minimum flow decreases at
the ratio of ambient pressure/1013
mbar.)
Peak flow 180 L/min for max. 0.8 sec .
Dew point reduction at operating pres-
sure
5°C at ambient temperature at ≥ 30
L/min. and max. ambient temperature of
40 °C.
15°C at ambient temperature at 15
L/min. and max. ambient temperature of
40 °C
Air quality Dust- and oil-free compressed air
Sub-micro filter µm ≤ 0.3
Noise level (at nominal pressure) dB (A) 47
Weight kg 40
Dimensions (L x W x H) mm 348 x 515 x 440
Ambient conditions during ongoing
operation
temperature °C +5 to +40
Air pressure hPa 500 to 1060
Rel. humidity %0 - 95
Classification
Medical Devices Directive (93/42/EEC) Class IIb
EN

1018100100L02 1907V005 9
Product description
4.2 Variants
Nominal voltage
V
Electrical fre-
quency
Hz
Nominal current
A
Output
P1 (kW)
Fuses
IEC 127-2/V
Units without transformer
220-240 50 2.2 -T4H250V
Units with transformer
220-230 60 2.4 -T4H250V
115-120 50 or 60 4.7 -T8H250V
127 50 or 60 4.2 -T8H250V
110 50 or 60 4.8 -T8H250V
100 50 or 60 5.4 -T8H250V
EN

10 1018100100L02 1907V005
Product description
4.3 Declaration of conformity
Manufacturer's name: Dürr Technik GmbH & Co. KG
Manufacturer's address:
Pleidelsheimer Straße 30
D-74321 Bietigheim-Bissingen
Reference number: 1018
Article designation: SICOLAB med
From the serial number: H400000
We hereby declare that the product described above conforms to the requirements of the valid ver-
sion of the Medical Devices Directive 93/42/EEC.
The device fulfills the requirements of the following pertinent directives:
- Simple pressure vessel directive 2014/29/EU
- RoHS directive 2011/65/EU
The company Dürr Technik GmbH & Co. KG bears the sole responsibility for issuing the declaration of
conformity.
The conformity assessment procedure was performed in accordance with Appendix II and included
the participation of the notified body, DQS Medizinprodukte GmbH, August-Schanz-Str. 21, D-60433
Frankfurt a.M. (identification number 0297).
This declaration applies to products placed on the market until 6 May 2024.
Bietigheim-Bissingen, 29/04/2019
Andreas Ripsam Proof of signature in the
Executive Board of Dürr Technik Original document held by Dürr Technik
EN

1018100100L02 1907V005 11
Product description
4
5
6
7
8
9
14
10
11
12
13
4 Filter mat
5 On/off switch
6 Power connection socket
7 Fuses
8 Operating time counter
9 Type plate
10 Compressed air supply1) of the ventilator
(max. 5 bar)
11 Connection2) for central compressed air
supply (supply pressure) in standby mode
(2.7 - 6 bar)
12 Cooling air vents
13 Unit feet / castors
14 Strain relief (for cables)
1)Available versions: NIST connection; DISS con-
nection; quick coupling NW 7.2
2)Available versions: NIST connection; DISS con-
nection; G1/4" internal thread
5 Operation
If the unit is to be used as the main source of
air supply for a ventilator, the pressure hose
(not included in the scope of delivery) must be
connected to the compressed air supply (10) of
the unit and must be connected to the ventila-
tor.
If the unit is used in standby mode, an addi-
tional pressure hose with connector (not includ-
ed in the scope of delivery) needs to be con-
nected to connector (11) of the unit and the wall
outlet of the central compressed air system. In
standby mode, the unit monitors the pressure in
the central compressed air system:
If the pressure drops below 2.7 ±0.2 bar, the
unit automatically takes over the supply of com-
pressed air to the ventilator connected to it. If
the pressure in the central compressed air sys-
tem rises above 3.2 ±0.2 bar again, the unit
switches off its supply and remains in standby
mode.
5.1 Unit details
1
2
3
1 Green control LED "Unit ready for opera-
tion"
2 Orange warning LED "Temperature too
high"
3 Cover of the unit
EN

12 1018100100L02 1907V005
Product description
5.2 Pneumatics plan
20 21 22 23 26a 24
25
26
28
29
30
10
31
32
11
4
27
X
4 Filter mat (aspiration)
10 Compressed air connection for the ventilator
11 Connector for central compressed air supply in standby mode
20 Air intake filter
21 Regulating valve
22 Compressor unit
23 Cooler
24 Sub-micro filter 0.3 µm
25 Condensate separator
26 Membrane dryer
26a Fine filter 5 µm
27 Throttle nozzle
28 Check Valve
29 Pressure vessel
30 Safety Valve
31 Check Valve
32 Pressure switch
X only required for standby mode
EN

1018100100L02 1907V005 13
Product description
5.3 Main air supply
Ambient air is aspirated via the air intake filter on the regulating valve, compacted in the compressor
and cooled in the cooler.
The compacted air is cleaned in the pre-filter, the condensate is separated in the condensate separa-
tor and discharged.
In the downstream membrane dryer, the air is dehumidified to a dew point of at least 5°C below am-
bient temperature.
The dehumidified air is guided via the throttle nozzle and check valve to the pressure vessel.
The dehumidified air is removed from the ventilator via the compressed air connection.
5.4 Standby mode
In standby mode, the ventilator is supplied from the central compressed air supply via the connection
(11) with non-return valve. The compressor is in standby.
If the pressure in the central supply drops below 2.7 ±0.2 bar, the pressure switch switches the com-
pressor on.
If the pressure in the central supply rises to 3.2 ±0.2 bar, the pressure switch switches the compres-
sor off again.
The safety valve protects from excessively high pressure from the central supply.
The regulating valve is pressurised with the container pressure and regulates the generation of com-
pressed air as a function of the volume removed.
The air from the central compressed air supply is not processed any further by the unit. It is
necessary to use medical-grade compressed air free of hazardous substances and suitable for
ventilation.
EN

14 1018100100L02 1907V005
Product description
5.5 Device label
1 Medium
2 Supply pressure (max. 6 bar)
3 Compressed air input symbol
EN

1018100100L02 1907V005 15
Product description
1 Medium
2 Operating pressure (max. 5 bar)
3 Compressed air outlet symbol
EN

16 1018100100L02 1907V005
Product description
6 Type plate
The type plate is located on the rear of the unit.
nom. 40 Kg (88 lbs)
medium:
0297
2017-08-23
Date of manufacture
Duerr Technik GmbH&Co.KG
Pleidelsheimer Str. 30
74321 Bietigheim-Bissingen
Made in Germany
1018101001 DSKJ-0000
REF SN

1018101001DSKJ-0000 IP: 20
5x20mm IEC 127-2/V
T4H250V
V ~220-230 Hz 60
A 2,4
REF Order number
SN Serial number
EN

1018100100L02 1907V005 17
8 Requirements
8.1 Installation/setup room
The room chosen for set up must fulfil the fol-
lowing requirements:
– Closed, dry, well-ventilated room.
– Should not be a purpose-made room (e.g.
boiler room or wet room).
– Set up the unit on a clean, level and sufficient-
ly stable surface (take the weight of the unit
into account).
– Set up or install the unit so that the type plate
can be easily read and the unit is easily acces-
sible for operation and maintenance.
– Set up the units so that the socket to which
the units is connected is easily accessible.
– Room temperature: +5°Cto +40°C.
– Ensure that there is sufficient distance to the
wall so that the air can flow in and out without
any obstruction.
The air is filtered when it is sucked in.
This does not alter the composition of
the air. The source of the air taken in
should be free of any harmful substances
(e.g. do not draw in air from an under-
ground garage or directly next to a suc-
tion machine).
NOTICE
Risk of overheating due to insuffi-
cient ventilation
The units generates heat. Possibility of
heat damage and/or reduced service life
of the unit.
iDo not cover the unit.
iAir must be able to flow in and out un-
obstructed.
iVentilation openings must be suffi-
ciently large.
iInstalled units may require an inde-
pendent ventilation system in unfa-
vourable cases.
The unit must only be operated on a stable,
even base. The unit must not be used as a
climbing aid. Danger of breakage!
7 Tools required
–
Nm
Torque wrench
– Hexagon keySW12
– Allen wrench SW 3
Assembly
EN

18 1018100100L02 1907V005
Assembly
8.2 Information regarding the pressure vessel
The owner must comply with the national directives.
The container of the unit is smaller than 250 bar L. Therefore, EU countries do not require a periodic
safety inspection.
Those operating the device outside the EU must check the valid national directives pertaining to the
container inspection and implement them if necessary.
8.3 Pressure tank
Pressure vessels from Behälter-Werk Burgau GmbH are installed in the unit.
The instructions for use given below apply to the following pressure vessel type:
Type Pressure1) Vessel2) APP3) c4) Remark5)
316033/0834100014 PS 10 bars V 3 L Ac = 1.0 mm 2
For serial number and build year refer to the labelling on the vessel.
1)Pressure Maximum operating pressure PS in bar
2)Vessel Vessel volume V in litres
3)Application (APP) A = Pressure vessel for compressors
4)Corrosion allowance c in mm
Maximum tempera-
ture
+100°C
Minimum temperature -10°C
Medium Air/nitrogen
5)Remark 2:
The vessel is capable of sustained operation within a pressure fluctuation
range of
2.0 bar (20% PS)
EN