Stephan STAXEL 3,5 User manual

Staxel 3.5
O2AIR Energy Supply Module
Operating Manual

Preface
2 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
This operating manual intends to provide clear answers to any questions
about how to use and care for STAXEL 3.5.
This operating manual does not contain any instructions for repairs and
installation.
In the event of any faults during operation, please contact the authorized
customer service of F. STEPHAN GMBH or the authorized dealer who
delivered the device to you and provided you with the initial instructions
on how the device functions and how to operate it.
The manufacturer only warrants the safety and reliability of STAXEL 3.5,
if it is operated in conformity with the operating manual.
Operating manual
F. Stephan GmbH
- Medizintechnik -
Kirchstrasse 19
56412 Gackenbach
Subject to technical alterations.
as of: Januar 2006
version: V1.0

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Contents
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 3
Contents
Contents .....................................................................................................3
1General information ...........................................................................5
1.1 Product combination................................................................5
1.2 Device name and manufacturer ...............................................5
1.3 Proper use ................................................................................6
1.4 Packaging and waste disposal..................................................6
1.5 Introduction .............................................................................7
1.6 Abbreviations and definitions..................................................8
1.7 Technical data..........................................................................9
2Safety instructions............................................................................11
2.1 Danger warnings....................................................................11
2.2 Warnings................................................................................12
3Structure and description of functions .............................................13
3.1 Front view..............................................................................13
3.2 Controls and display elements...............................................14
3.3 Rear view...............................................................................15
3.4 Right-hand side view .............................................................16
3.5 Left-hand side view ...............................................................17
4Preparing for operation ....................................................................19
4.1 Erecting the device ................................................................19
4.2 Connecting to the gas and power supply ...............................20
4.2.1 Gas supply .................................................................20
4.2.2 Power supply .............................................................20
5Test list.............................................................................................23
5.1 Test before starting the device every time .............................23
5.2 Test before every patient .......................................................23
6Operation .........................................................................................25
6.1 Switching on..........................................................................25
6.2 Switching off .........................................................................25
6.3 Stopping the device ...............................................................25
7Troubleshooting ...............................................................................27
8Care and maintenance ......................................................................29

ContentsContents
4 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
8.1 Disinfection and sterilisation .................................................29
8.1.1 Device housing, gas connections, mains lead ...........30
8.2 Safety checks .........................................................................30
8.3 Maintenance...........................................................................30
8.3.1 Filter unit...................................................................31
9List of accessories............................................................................33
10 Guarantee .........................................................................................35
11 List of illustrations ...........................................................................37
12 List of tables.....................................................................................39
13 Notes ...............................................................................................41

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1 General information
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 5
1 General information
1.1 Product combination
Combinations with other products can impair the performance and safety
of STAXEL 3.5.
F. STEPHAN GMBH rules out any warranty for unacceptable device
combinations operating with products not approved by the manufacturer
or products without certified compatibility.
Only use the accessories stated in chapter 9 on page 35.
1.2 Device name and manufacturer
STAXEL 3.5
F. Stephan GmbH
- Medizintechnik -
Kirchstrasse 19
56412 Gackenbach
(+)49 (6439) 9125 – 0
(+)49 (6439) 9125 – 111
[email protected]
www.stephan-gmbh.com
Device name
Manufacturer

1 General information
6 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
1.3 Proper use
Oxygen concentrators provide a safe source of oxygenated air for patients
needing it. These devices increase the level of oxygen by filtering out the
nitrogen from the ambient air.
STAXEL 3.5 constantly generates oxygen from the ambient air and offers
an economic alternative to bottled or liquid oxygen.
STAXEL 3.5 is used to generate oxygen and to produce compressed air
and vacuum; it is designed primarily for operating ventilation and
anesthesia systems.
Other combinations are also available on request or order.
1.4 Packaging and waste disposal
The device packaging consists essentially of recyclable or reusable
materials.
The carton packaging can be reused or disposed of as used paper.
The wrapping consists of CFC-free padding which can be disposed of
together with the foil as recyclable plastic waste (in Germany: yellow
trash can).
F. STEPHAN GMBH guarantees that used devices from our company can
be returned free of charge and disposed of correctly, thus making a
contribution to the environment.
Packaging
Return/disposal

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1 General information
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 7
1.5 Introduction
The Medical Devices Law (MPG), the Medical Devices Operator
Ordinance (MPBetreibV) and the Law on Technical Working Equipment
stipulate that the operator's attention must be drawn to the following:
 The device must only be operated by skilled staff who must have
an exact knowledge of the operating manual.
 Only use the device for the intended purpose described in the
operating manual.
 Read the operating manual through carefully and comply with its
instructions, because lasting safety for patient and user is only
warranted when the device is operated perfectly.
 The operating manual must be kept constantly available at the
place of use.
 Faulty care and operation can cause work stoppages and
accidents.
The manufacturer does not accept any warranty claims resulting from
incorrect operation or inadequate care and maintenance.
The manufacturer only guarantees the safety and reliability of the device
if it is operated in compliance with the operating manual.
German legislation
Warranty

1 General information
8 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
1.6 Abbreviations and definitions
Abbrevations Definition Meaning
AIR Medical compresed air
bar Unit of measurement for compressed
air
DIN German standardization institute
EN European standard
Flow Volume flow
LED Light Emitting Diode
min minutes Unit of time
O2Oxygen
OG Upper limit
s seconds Unit of time
UG Lower limit
VAC Vacuum
Tab. 1: Abreviations and definitions

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1 General information
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 9
1.7 Technical data
Operation Temperature 15 – 40 °C
Rel. humidity 30 – 85 %
Air pressure 900 – 1060 hPa
Bring to room temperature before starting to
operate the device.
Storage Temperature 5 – 60 °C
Rel. humidity 10 – 100 %
Air pressure 700 – 1060 hPa
Store in a protected, dust-free place protected
from moisture and frost
MPG class
Protection class
Inspection/maintenance
cycle
Dimensions (WxHxD)
Weight
II b
I type B as per DIN EN 60601-1 :March 1996
annual
610 x 820 x 680 mm
122 kg
Mains Connection 230 V AC
50 – 60 Hz
Input power 6 A
Device fuses 2 x 8 AT
2 x 1.25 AT
Absorber unit Pressure 2.2 bar
Changeover cycle 11 s
Flushing time 2 s
O2AIR
System pressure 5.2 bar 5.2 bar
Output pressure 3.8 bar 3.8 bar
Consumption 6 l/min 8 l/min
Max. consumption 7 l/min 13 l/min
Ambient conditions
General
Power supply
Specifications

1 General information
10 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
Voltage
Motor speed/output
Capacitor
230 V / 50 Hz
1350 rpm / 435 Watt
15 μF
Voltage
Motor speed/output
Capacitor
230 V / 50 Hz
1390 rpm / 435 Watt
15 μF
Voltage
Motor speed
Input power
Noise level
Dimensions
230 V / 50 Hz
2800 rpm
45 VA
48 dB
150 ∅x 55 mm
Pressure gauge O20 – 6 bar
AIR 0 – 6 bar
VAC -1 – 0 bar
Flow [l/min] O2concentration [%]
1 – 2 95
3 – 6 94
7 90
8 88
9 80
Tab. 2: Available O2concentration at corresponding flow
Parameter Unit UG OG
Pressure sensor bar 2.5 5.5
Temperature sensor °C 45
Pressure relief valve bar 5,5
Tab. 3: Alarm limits
Alarm visual, acoustic
Compressed air
compressor
Compressor for post-
compression
Flat fan
Parameters
O2concentration
Monitoring

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2 Safety instructions
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 11
2 Safety instructions
Refers to instructions drawing attention to important facts.
The following safety instructions are repeated at relevant points in the
operating manual and must always be heeded.
Refers to dangers which, if not heeded, can result in life-threatening
injuries to the patient and/or operator.
Refers to warnings which, if not heeded, can result in malfunctions,
damage or defects in the device, which can possibly also put the patient at
danger.
Refers to precautions which, if not heeded, can result in damage to the
device and its accessories.
2.1 Danger warnings
The device must be operated according to the instructions in this
operating manual.
STAXEL 3.5 is not certified for use in explosion-risk areas.
Danger
Warning
Caution
Danger
Danger

2 Safety instructions
12 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
STAXEL 3.5 must not be operated in the vicinity of naked flames or
glowing objects, given the increased explosion risk from the
concentration of pure oxygen in the device.
The device must not be used when damaged. Disconnect from the mains.
Always disconnect the device from the mains immediately in any
dangerous situations or when technical faults occur.
2.2 Warnings
When moving the device, ensure that the wheel brakes have been
released and are applied again when set upright.
DIN EN 60601-1 resp. VDEO 0751-1 must be heeded in particular for
medical technical devices with electrical connection. Accordingly, these
devices must only be repaired by the manufacturer or an entity explicitly
authorized for this purpose by the manufacturer.
The provisions of DIN EN 60601-1 must be heeded when connecting
external electrical devices.
Only the authorized customer service of F. STEPHAN GMBH is allowed to
alter, modify, repair or open the device. This also includes replacing the
bacteria filter, intake filter and intake filter mat in accordance with the
operating manual. Use only spare parts from F. STEPHAN GMBH for
maintenance.
Danger
Danger
Danger
Warning
Warning
Warning
Warning

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3 Structure and description of functions
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 13
3 Structure and description of functions
3.1 Front view
Fig. 1: Front view
1 Controls and display elements 3 Housing jacket
2 Handles 4 Rollers (4, 2 can be fixed)

3 Structure and description of functions
14 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
3.2 Controls and display elements
Fig. 2: Controls and display elements
1 Mains switch "On/Off" for O2and AIR
2 Operating hours counter for O2and AIR generation
3 Pressure gauge for O2 pressure display
4 Pressure gauge for AIR pressure display
5 Pressure gauge for VAC pressure display
6 Knob for regulating the vacuum
7 Mains switch "On/Off" for VAC
8 Fuse for VAC generation
9 Fuse for O2and AIR generation
10 Visual alarm for failure of electronic components or switching valves
11 Visual alarm for overheating

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3 Structure and description of functions
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 15
3.3 Rear view
Fig. 3: Rear view
1 Intake filter mat 5 Membrane dryer
2 Power sockets (230 V AC) 6 Acoustic alarm
3 Connection lead 7 Water separator
4 Filter 8 Filter unit

3 Structure and description of functions
16 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
3.4 Right-hand side view
Fig. 4: Right-hand side view
1 O2outlet 2 AIR outlet

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3 Structure and description of functions
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 17
3.5 Left-hand side view
Fig. 5: Left-hand side view
1 O2outlet 3 VAC outlet
2 AIR outlet

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4 Preparing for operation
©F. Stephan GmbH GA-602-0106V1.0-PAE-GB 19
4 Preparing for operation
4.1 Erecting the device
STAXEL 3.5 is supplied on rollers.
The front rollers of the device are equipped with parking brakes to
prevent any unintended movement of STAXEL 3.5.
Press lightly on the brake lever to activate the parking brake by blocking
the rollers. Lift the brake lever with the tip of your foot to release the
parking brake again.
When moving the device, ensure that the wheel brakes have been
released and are applied again when set upright.
STAXEL 3.5 must only be erected and operated in dry, well-ventilated
rooms with low dust levels. Moist or wet environments can drastically
impair the functioning of the device. Ensure in particular that there are no
containers filled with water or similar in the immediate vicinity.
When choosing the site for erecting the device, make sure there is easy
access for operation, cleaning and maintenance.
The ambient temperature should never exceed +40° C. For relative
humidity levels exceeding 70%, it is advisable to operate the device only
in air-conditioned rooms.
The air intake grids on the back of the device must not be covered or any
objects placed on them.
There should be spacing of at least 10 cm to the wall at the rear of the
device.
STAXEL 3.5 with rollers
Caution
Information

4 Preparing for operation
20 GA-602-0106V1.0-PAE-GB ©F. Stephan GmbH
4.2 Connecting to the gas and power supply
4.2.1 Gas supply
Check the pressure gauge on the front to see whether there is sufficient
pressure. The needle must show more than 3 bar.
The outlets for O2and AIR are on the two sides of STAXEL 3.5. The
connections are quick-release couplings which lock automatically when
connected.
To pull the tube out of the connection, at the same time press the
unlocking pin on top of the connection.
The outlet for vacuum is on the right of the device. The connection is a
1/8" tube nozzle. Simply insert the tube to the intake unit.
4.2.2 Power supply
STAXEL 3.5 runs on 230 V AC.
1. Connect the mains lead at the rear of the device to the power socket
on the wall.
2. Switch on the power switch "On/Off" for O2and AIR on the front of
the device. The switch lights up green.
3. Switch the power switch "On/Off" for VAC on the front of the device.
The switch lights up green.
Electrical accessories can be connected to the 4 auxiliary power sockets.
The auxiliary power sockets are switched on with the mains switch
"On/Off" for O2and AIR on the front of the device.
When in use, STAXEL 3.5 can only have max. 4 user-accessible auxiliary
power sockets.
Connections for O2and
AI
R
Connection for VAC
Electrical accessories
Warning