Staxel 3.5 O2-Air Supply System Operating Manual

Operating Manual

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Staxel 3.5 O2 AIR 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 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.

F. Stephan GmbH - Medizintechnik Kirchstrasse 19 56412 Gackenbach Subject to technical alterations.

as of:

Januar 2006

version:

V1.0

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Contents

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

Safety instructions...11 2.1

Danger warnings...11

2.2

Warnings...12

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

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

Test list...23 5.1

Test before starting the device every time ...23

5.2

Test before every patient ...23

Operation ...25 6.1

Switching on ...25

6.2

Switching off ...25

6.3

Stopping the device ...25

Troubleshooting ...27

Care and maintenance ...29

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ContentsContents 8.1

Disinfection and sterilisation ...29 8.1.1

8.2

Safety checks ...30

8.3

Maintenance...30 8.3.1

Device housing, gas connections, mains lead ...30

Filter unit ...31

List of accessories ...33

Guarantee ...35

List of illustrations ...37

List of tables...39

Notes ...41

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General information

1.1

Product combination

General information

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 Device name

STAXEL 3.5

Manufacturer

F. Stephan GmbH - Medizintechnik Kirchstrasse 19 56412 Gackenbach (+)49 (6439) 9125 – 0 (+)49 (6439) 9125 – 111 [email protected] www.stephan-gmbh.com

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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. 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 Packaging

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).

Return/disposal

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.

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1.5

General information

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.

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.

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General information

1.6 Abbrevations

Abbreviations and definitions Definition

Meaning

AIR

Medical compresed air

bar

Unit of measurement for compressed air

DIN

German standardization institute

European standard

Flow

Volume flow

LED

Light Emitting Diode

min

minutes

Unit of time

Oxygen

Upper limit

seconds

Unit of time

Lower limit

VAC

Vacuum Tab. 1: Abreviations and definitions

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1.7

General information

Technical data

Ambient conditions

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

General

Power supply

MPG class

II b

Protection class

I type B as per DIN EN 60601-1 :March 1996

Inspection/maintenance cycle

annual

Dimensions (WxHxD)

610 x 820 x 680 mm

Weight

122 kg

Mains

Connection

230 V AC 50 – 60 Hz

Input power

Device fuses

2 x 8 AT 2 x 1.25 AT

Specifications

Absorber unit

Pressure

2.2 bar

Changeover cycle

11 s

Flushing time

AIR

System pressure

5.2 bar

Output pressure

3.8 bar

Consumption

6 l/min

8 l/min

Max. consumption

7 l/min

13 l/min

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General information

Compressed air compressor

Compressor for postcompression

Flat fan

Parameters

O2 concentration

Voltage

230 V / 50 Hz

Motor speed/output

1350 rpm / 435 Watt

Capacitor

15 μF

Voltage

230 V / 50 Hz

Motor speed/output

1390 rpm / 435 Watt

Capacitor

15 μF

Voltage

230 V / 50 Hz

Motor speed

2800 rpm

Input power

45 VA

Noise level

48 dB

Dimensions

150 ∅ x 55 mm

Pressure gauge

O2 AIR VAC

Flow [l/min]

O2 concentration [%]

1–2

3–6

0 – 6 bar 0 – 6 bar -1 – 0 bar

Tab. 2: Available O2 concentration at corresponding flow Monitoring

Parameter

Unit

Pressure sensor

bar

2.5

5.5

Temperature sensor

°C

Pressure relief valve

bar

5,5

Tab. 3: Alarm limits Alarm

visual, acoustic

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Safety instructions

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

Warning

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. Caution

2.1

Danger warnings

The device must be operated according to the instructions in this operating manual. Danger

STAXEL 3.5 is not certified for use in explosion-risk areas. Danger

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Safety instructions

Danger

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. 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

Warning

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. Warning

Warning

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.

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Structure and description of functions

3.1

Front view

Fig. 1: Front view

Controls and display elements

Housing jacket

Handles

Rollers (4, 2 can be fixed)

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Structure and description of functions

3.2

Controls and display elements

Fig. 2: Controls and display elements 1

Mains switch "On/Off" for O2 and AIR

Operating hours counter for O2 and AIR generation

Pressure gauge for O2 pressure display

Pressure gauge for AIR pressure display

Pressure gauge for VAC pressure display

Knob for regulating the vacuum

Mains switch "On/Off" for VAC

Fuse for VAC generation

Fuse for O2 and AIR generation

10 Visual alarm for failure of electronic components or switching valves 11 Visual alarm for overheating

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3.3

Structure and description of functions

Rear view

Fig. 3: Rear view

Intake filter mat

Membrane dryer

Power sockets (230 V AC)

Acoustic alarm

Connection lead

Water separator

Filter

Filter unit

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Structure and description of functions

3.4

Right-hand side view

Fig. 4: Right-hand side view 1

O2 outlet

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AIR outlet

3.5

Structure and description of functions

Left-hand side view

Fig. 5: Left-hand side view

O2 outlet

AIR outlet

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VAC outlet

Preparing for operation

4.1

Erecting the device

STAXEL 3.5 with rollers

Preparing for operation

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.

Caution Information

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.

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Preparing for operation

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.

Connections for O2 and AIR

The outlets for O2 and 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.

Connection for VAC

4.2.2

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.

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 O2 and 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

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 O2 and AIR on the front of the device.

When in use, STAXEL 3.5 can only have max. 4 user-accessible auxiliary power sockets. Warning

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Preparing for operation

No not connect any further multiple power sockets, e.g. socketa dapters, to the auxiliary power sockets. Warning

Mains failure also means failure of the auxiliary power sockets, Warning

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Air Oxygen Supply Units

Staxel 3.5 O2-Air Supply System Operating Manual