Stephan STAXEL 3,5 Manual de usuario

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
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
Tabla de contenidos
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