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

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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

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.

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

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

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

3.1 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

3.2 Controls and display elements

Fig. 2: Controls and display elements

1 Mains switch "On/Off" for O

2 Operating hours counter for O

3 Pressure gauge for O

pressure display

2

and AIR

2

and AIR generation

2

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 O

and AIR generation

2

10 Visual alarm for failure of electronic components or switching valves

11 Visual alarm for overheating

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3.3 Rear view

3 Structure and description of functions

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

3.4 Right-hand side view

Fig. 4: Right-hand side view

1 O

outlet 2 AIR outlet

2

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3.5 Left-hand side view

3 Structure and description of functions

Fig. 5: Left-hand side view

1 O

outlet 3 VAC outlet

2

2 AIR outlet

®

4 Preparing for operation

4.1 Erecting the device

S

TAXEL 3.5 with rollers

S

Caution

TAXEL 3.5 is supplied on rollers.

The front rollers of the device are equipped with parking brakes to prevent any unintended movement of S

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.

TAXEL 3.5.

4 Preparing for operation

Information

S

TAXEL 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.

4 Preparing for operation

R

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 O

and

2

AI

The outlets for O 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

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

S

TAXEL 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 O 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.

and AIR are on the two sides of STAXEL 3.5. The

2

and AIR on the front of

2

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 O

and AIR on the front of the device.

2

When in use, S

TAXEL 3.5 can only have max. 4 user-accessible auxiliary

power sockets.

Warning

20 GA-602-0106V1.0-PAE-GB © F. Stephan GmbH

®

Warning

4 Preparing for operation

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

Mains failure also means failure of the auxiliary power sockets,

®

f

5 Test list

All relevant tests must be carried out before using the device. The staff carrying out the test must have exact knowledge of the operating manual.

Prerequisites for the

test

5.1 Test before starting the device every time

Check pressure

The device is completely assembled and connected up.

 Remove all tubes from the connections

 Visually check the pressure gauge for O

 All pressure must be in the correct range ( > 3 bar ).

and AIR

2

Check condition o

device

 Check the device for any signs of damage

 Check the mains lead and electrical devices for any external signs of

damage

 Visually check the LEDs

5.2 Test before every patient

concentration

2

Danger

 Check O

 Visually check the pressure gauge for O

All pressure must be in the correct range ( > 3 bar )

The device must not be used if it fails any of the tests!

and AIR

2

®

6 Operation

6.1 Switching on

Only switch the device on if it is not pressurized!

1. Switch on the mains switch "On/Off" for O2 and AIR on the front of the device.

2. S

TAXEL 3.5 starts to generate oxygen and compressed air

3. The pressure in the corresponding pressure gauges for oxygen and compressed air on the front panel increases to 3.5 bar.

6 Operation

4. Switch on the mains switch "On/Off" for VAC on the front of the device.

5. S

TAXEL 3.5 starts to generate vacuum.

6.2 Switching off

1. Switch off the mains switch "On/Off" for O the device.

2. Pressure is released from the tanks.

3. Switch off the mains switch "On/Off" for VAC on the front of the device.

6.3 Stopping the device

1. Switch off the mains switch "On/Off" for O the device.

and AIR on the front of

2

and AIR on the front of

2

2. Pressure is released from the tanks.

3. Switch off the mains switch "On/Off" for VAC on the front of the device.

4. Remove all tubes from the connections.

5. Disconnect the device from the mains.

®

7 Troubleshooting

Fault Cause Remedy

No pressure for O2 and compressed air, acoustic alarm

Initial pressure of O2 or compressed air falls below 2.5 bar, acoustic alarm

Red LED "Visual overheating alarm" (Fig. 2) on, the device stops working

 No power supply

 Fuse defect

 Fine filter clogged

 Gas consumption too high

 Compressor defect

 Tube leaks

 STAX EL 3.5 overheated

 Insufficient air flow to cool

the capacitor

 Check power supply

 Replace fuse

 Replace fine filter

 Reduce gas consumption

 Inform F. S

customer service

 Replace filter mat

 Check that fan works

properly, replace if necessary

7 Troubleshooting

TEPHAN GMBH

Red LED "Visual alarm for failure of electronic component or switching valves« (Fig. 2) is on

O2 concentration falls below minimum value

Tab. 4: Troubleshooting

 Valves not switching correctly

 Electronic component defect

 Compressor defect

 Supply tube torn off

 Balance of pressure between

the two absorber tanks no longer balanced

 Outdated absorber tanks

 Inform F. S

TEPHAN GMBH

customer service

 Readjust absorber

 Flow too high

 Replace absorber tanks

®

8 Care and maintenance

8.1 Disinfection and sterilisation

As with operation of the device, it must only be cleaned and disinfected by instructed members of staff.

Caution

Proceed with routine cleaning at regular intervals according to the local hospital routine.

All disposable parts must be disposed of in an environment-friendly manner according to the local hospital routine.

8 Care and maintenance

Caution

All instrument and surface disinfectants based on alcohol and aldehyde may be used.

Do not use deoxygenating or dechlorinating disinfectants or disinfectants containing phenol or its derivatives.

Amino derivatives can damage soft plastics (tubes).

All used disinfectants must be certified in accordance with relevant environmental legislation.

Always comply with the regulations for handling cleaning agents and disinfectants issued by the Professional Association.

When using cleaning agents and disinfectants, pay attention to correct concentrations and reaction times as otherwise damage to the materials cannot be ruled out.

When using effective substances other than those stated, please contact the manufacturer of the disinfectant to obtain compatibility confirmation.

Caution

8 Care and maintenance

8.1.1 Device housing, gas connections, mains lead

Cleaning

Procedure

 Wiping disinfection

1. Wipe down the surfaces with ready made-up disinfectant solution (surface disinfectant).

2. The cloth should be no more than damp.

3. No moisture must be allowed to penetrate in the device.

8.2 Safety checks

Safety checks are to be carried out every twelve months by the manufacturer or the authorized customer service for F. S

8.3 Maintenance

For reasons of device safety, it is advisable to proceed with maintenance of S

TAXEL 3.5 after every approx. 1000 operating hours but at least every

twelve months together with the safety checks.

TEPHAN GMBH.

Maintenance is to be carried out by the authorized customer service for F. S

TEPHAN GMBH.

After 10,000 operating hours, arrange for a general overhaul to be carried out by the authorized customer service for F. S

Only use spare parts from F. S

TEPHAN GMBH for maintenance.

TEPHAN GMBH.

®

8.3.1 Filter unit

Fig. 6: Exploded drawing intake filter

8 Care and maintenance

Changing the bacteria

filter

1 Holder 4 Intake filter

2 3-ply bacteria filter 5 Housing flange

3 Stainless steel fine sieve 6 Tube for housing flange

The bacteria filter for room air must be replaced and the intake filter mat cleaned every 10 days or after every 250 operating hours. Please note that these intervals can be drastically reduced depending on the contamination levels in the ambient air.

At the beginning, please check the condition of the bacteria filter every 23 days to reduce the changing intervals if necessary. The bacteria filter must be changed when it goes gray.

1. Pull the holder out of the housing flange.

2. Remove the 3-ply bacteria filter and replace with a new bacteria filter (in S

TAXEL 3.5 spare parts set).

3. Replace the holder again.

Check the intake filter integrated in the intake filter housing every time after changing the 3-ply bacteria filter. If the bacteria filter is changed too late, the intake filter can become clogged with dust particles so that the air supply to the compressors is drastically reduced. This can result in a rapid fall in the O

concentration of STAXEL 3.5.

2

8 Care and maintenance

Changing the intake

filter

1. Pull the holder out of the housing flange.

2. Remove the 3-ply bacteria filter.

3. Remove the stainless steel fine sieve.

4. Unscrew the intake filter and screw in a new one (in S spare parts set).

5. Put the stainless steel fine sieve in again.

6. Insert the 3-ply bacteria filter.

7. Put the holder back in again.

The intake filter cannot be cleaned!

TAXEL 3.5

®

9 List of accessories

Pos. Designation Art. No. Quantity (ea)

1 Fuses 8 A ( T ) 1 804 60 026 2

2 Fuses 1.25 A ( T ) 1 804 60 004 2

3 3-ply bacteria ultra-fine filter 1 600 60 115 6

4 Intake filter mat 1 600 61 123 6

5 Intake silencer & bacteria

filter

6 O ring 4.47 x 1.78 EPDM 1 950 60 031 10

7 Filter insert for moisture

filter

9 List of accessories

1 600 40 046 6

1 925 60 362 3

Tab. 5: List of accessories

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10 Guarantee

The manufacturer F. S the date of purchase.

Any intervention in the device or repairs must only be carried out by F. S

TEPHAN GMBH or an authorized expert. Otherwise the guarantee

becomes null and void.

The guarantee also becomes null and void if the device is handled incorrectly.

10 Guarantee

TEPHAN GMBH grants a 24 month guarantee from

®

11 List of illustrations

Fig. 1: Front view.................................................................................... 13

Fig. 2: Controls and display elements ..................................................... 14

Fig. 3: Rear view..................................................................................... 15

Fig. 4: Right-hand side view ................................................................... 16

Fig. 5: Left-hand side view ..................................................................... 17

Fig. 6: Exploded drawing intake filter .................................................... 31

11 List of illustrations

®

12 List of tables

Tab. 1: Abreviations and definitions......................................................... 8

Tab. 2: Available O2 concentration at corresponding flow ..................... 10

Tab. 3: Alarm limits ................................................................................ 10

Tab. 4: Troubleshooting .......................................................................... 27

Tab. 5: List of accessories....................................................................... 33

12 List of tables

®

13 Notes

F. Stephan GmbH

- Medizintechnik Kirchstrasse 19

56412 Gackenbach

 (+)49 (6439) 9125 – 0  (+)49 (6439) 9125 – 111  info@stephan-gmbh.com  www.stephan-gmbh.com

Stephan Staxel 3.5 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1.1 Product combination

1 General information

1.2 Device name and manufacturer

1.3 Proper use

1.4 Packaging and waste disposal

1.5 Introduction

1.6 Abbreviations and definitions

1.7 Technical data

2 Safety instructions

2.1 Danger warnings

2.2 Warnings

3 Structure and description of functions

3.1 Front view

3.2 Controls and display elements

3.3 Rear view

3.4 Right-hand side view

3.5 Left-hand side view

4.1 Erecting the device

4 Preparing for operation

4.2 Connecting to the gas and power supply

4.2.1 Gas supply

4.2.2 Power supply

5 Test list

5.1 Test before starting the device every time

5.2 Test before every patient

6 Operation

6.1 Switching on

6.2 Switching off

6.3 Stopping the device

7 Troubleshooting

8.1 Disinfection and sterilisation

8 Care and maintenance

8.1.1 Device housing, gas connections, mains lead

8.2 Safety checks

8.3 Maintenance

8.3.1 Filter unit

9 List of accessories

10 Guarantee

11 List of illustrations

12 List of tables

13 Notes