Stephan Staxel 3.5 User manual
Staxel 3.5
O2AIR Energy Supply Module
Operating Manual
Preface
Operating manual
This operating manual intends to provide clear answers to any questions
about how to use and care for S
TAXEL 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. S
TEPHAN 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 S
TAXEL 3.5,
if it is operated in conformity with the operating manual.
F. Stephan GmbH
- Medizintechnik Kirchstrasse 19
56412 Gackenbach
Subject to technical alterations.
as of: Januar 2006
version: V1.0
2 GA-602-0106V1.0-PAE-GB © F. Stephan GmbH
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Contents
Contents .....................................................................................................3
1 General 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
2 Safety instructions............................................................................11
2.1 Danger warnings....................................................................11
Contents
2.2 Warnings................................................................................12
3 Structure 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
4 Preparing 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
5 Test list.............................................................................................23
5.1 Test before starting the device every time .............................23
5.2 Test before every patient .......................................................23
6 Operation .........................................................................................25
6.1 Switching on..........................................................................25
6.2 Switching off .........................................................................25
6.3 Stopping the device ...............................................................25
7 Troubleshooting ...............................................................................27
8 Care and maintenance ......................................................................29
© F. Stephan GmbH GA-602-0106V1.0-PAE-GB 3
ContentsContents
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
9 List 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
1.1 Product combination
Combinations with other products can impair the performance and safety
of S
TAXEL 3.5.
TEPHAN GMBH rules out any warranty for unacceptable device
F. S
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 General information
1.2 Device name and manufacturer
TAXEL 3.5
Device name
Manufacturer
S
F. Stephan GmbH
- Medizintechnik Kirchstrasse 19
56412 Gackenbach
(+)49 (6439) 9125 – 0
(+)49 (6439) 9125 – 111
info@stephan-gmbh.com
www.stephan-gmbh.com
© F. Stephan GmbH GA-602-0106V1.0-PAE-GB 5
1 General information
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.
S
TAXEL 3.5 constantly generates oxygen from the ambient air and offers
an economic alternative to bottled or liquid oxygen.
S
TAXEL 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
Packaging
Return/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. S
TEPHAN 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.
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1.5 Introduction
German legislation
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.
1 General information
Warranty
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.
© F. Stephan GmbH GA-602-0106V1.0-PAE-GB 7
1 General information
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
O2 Oxygen
OG Upper limit
s seconds Unit of time
UG Lower limit
VAC Vacuum
Tab. 1: Abreviations and definitions
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1.7 Technical data
Ambient conditions
General
Operation Temperature 15 – 40 °C
Storage Temperature 5 – 60 °C
MPG class
1 General information
Rel. humidity 30 – 85 %
Air pressure 900 – 1060 hPa
Bring to room temperature before starting to
operate the device.
Rel. humidity 10 – 100 %
Air pressure 700 – 1060 hPa
Store in a protected, dust-free place protected
from moisture and frost
II b
Power supply
Specifications
Protection class
Inspection/maintenance
cycle
Dimensions (WxHxD)
Weight
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
O2 AIR
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
© F. Stephan GmbH GA-602-0106V1.0-PAE-GB 9
1 General information
Compressed air
compressor
Compressor for post-
compression
Flat fan
Parameters
Voltage
Motor speed/output
Capacitor
Voltage
Motor speed/output
Capacitor
Voltage
Motor speed
Input power
Noise level
Dimensions
Pressure gauge O
230 V / 50 Hz
1350 rpm / 435 Watt
15 μF
230 V / 50 Hz
1390 rpm / 435 Watt
15 μF
230 V / 50 Hz
2800 rpm
45 VA
48 dB
150 ∅ x 55 mm
0 – 6 bar
2
AIR 0 – 6 bar
VAC -1 – 0 bar
O
concentration
2
Monitoring
Flow [l/min] O2 concentration [%]
1 – 2 95
3 – 6 94
7 90
8 88
9 80
Tab. 2: Available O2 concentration 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
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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.
Danger
2 Safety instructions
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
Warning
Caution
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.
Danger
S
TAXEL 3.5 is not certified for use in explosion-risk areas.
Danger
© F. Stephan GmbH GA-602-0106V1.0-PAE-GB 11
2 Safety instructions
Danger
S
TAXEL 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.
Danger
Always disconnect the device from the mains immediately in any
dangerous situations or when technical faults occur.
Danger
2.2 Warnings
When moving the device, ensure that the wheel brakes have been
released and are applied again when set upright.
Warning
DIN EN 60601-1 resp. VDEO 0751-1 must be heeded in particular for
medical technical devices with electrical connection. Accordingly, these
Warning
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.
Warning
Only the authorized customer service of F. S
TEPHAN GMBH is allowed to
alter, modify, repair or open the device. This also includes replacing the
Warning
bacteria filter, intake filter and intake filter mat in accordance with the
operating manual. Use only spare parts from F. S
TEPHAN GMBH for
maintenance.
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3 Structure and description of functions
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)
© F. Stephan GmbH GA-602-0106V1.0-PAE-GB 13
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