Related Manuals for STIHLER ELECTRONIC ASTODIA DIA100
Summary of Contents for STIHLER ELECTRONIC ASTODIA DIA100
- Page 1 Instructions for Use ® ASTODIA Diaphanoscope STIHLER ELECTRONIC GmbH • 70597 Stuttgart • Germany...
- Page 2 Julius-Hoelder-Strasse 36 70597 Stuttgart GERMANY Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 www.stihlerelectronic.de E-Mail: info@stihlerelectronic.de © 2019 STIHLER ELECTRONIC GmbH STIHLER ELECTRONIC GmbH, Stuttgart, declares in sole responsibility that this product conforms to EC Directive 93/42/EEC on medical devices.
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Page 3: Table Of Contents
Contents 1 Introduction ........................4 1.1 Information on these instructions ................. 4 1.2 Specification of the application ..................4 1.2.1 Intended use........................4 1.2.2 Intended medical indications..................... 4 1.2.3 Contraindications ......................4 1.2.4 Possible adverse effects ....................4 1.2.5 Intended patient group ...................... 4 1.2.6 Intended user profile ...................... -
Page 4: Introduction
ASTODIA Instructions for Use 1 Introduction 1 Introduction 1.1 Information on these instructions It is imperative that you read these instructions for use before us- ing this product. Failure to follow the instructions for use can re- sult in damage to the product or to other property and/or personal injury. -
Page 5: Intended User Profile
1 Introduction ASTODIA Instructions for Use 1.2.6 Intended user profile Medical staff (e.g., doctor, nurse, nurse, service personnel, medical technician). 1.2.7 Intended environment of use / operation • ASTODIA may only be used in professional healthcare facilities (e.g. hospital, emergency care, dialysis, including HF surgical equipment, etc.). •... -
Page 6: Important Safety Information
ASTODIA Instructions for Use 1 Introduction 1.3 Important safety information These instructions for use define and refer to the following safety information. DANGER Describes a maximum risk from a situation which, when not avoided, can lead directly to severe or fatal injuries. WARNING Describes a dangerous situation which, when not avoided, can lead to severe or fatal injuries. -
Page 7: Dangers
1 Introduction ASTODIA Instructions for Use 1.3.1 Dangers DANGER Explosion hazard! Do not use the ASTODIA diaphanoscope in an explosion-hazard environment or in the presence of flammable anaesthetics. 1.3.2 Warnings WARNING Risk of injury! • Read and observe all instructions, stickers, and accompanying documenta- tion that came with the medical device. - Page 8 ASTODIA Instructions for Use 1 Introduction WARNING Risk of electric shock! • All electrical installations must conform to the applicable electrical standards and the specifications defined by the manufacturer. • During charging, the device shall not be in the patient environment. WARNING Risk of radio interference! •...
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Page 9: Caution Information
1 Introduction ASTODIA Instructions for Use 1.3.3 Caution information CAUTION Risk of injury! • The use of the ASTODIA diaphanoscope must be carried out under the re- sponsibility of a physician. • In case ASTODIA starts directly after switch on in the highest light level and a change of the highest level is not possible - then do not use ASTODIA! •... -
Page 10: Notices
ASTODIA Instructions for Use 1 Introduction 1.3.4 Notices NOTICE • Actions to avoid damaging the diaphanoscope: - Do not immerse the control unit and/or the connector for the connection ca- ble in liquid. - Do not disinfect the system using steam (e.g., in autoclaves), hot air, or thermo-chemical cleaning solutions. -
Page 11: Symbols
1 Introduction ASTODIA Instructions for Use 1.4 Symbols Symbols and indications on the control panel Switch key for LED-colours - press shortly OFF button - press and hold (ca. 1 s) ON button Reduce the light intensity ON button Increase the light intensity Where applicable, these symbols appear at the appropriate location on the patient warming system, on the packaging, on the identification plate, or in the accompanying documentation. -
Page 12: Conformity With International Standards
If the equipment is damaged during the guarantee period, send the cleaned equipment to the nearest sales point or directly to STIHLER ELECTRONIC GmbH. The sender is responsible for any transport and packaging costs. -
Page 13: Liability
Please follow the local rules for the dis- posal of used products, or send the cleaned and disinfected equipment with a corresponding note to STIHLER ELECTRONIC GmbH or your closest sales point. This will ensure the most cost efficient and proper disposal of your old equipment. -
Page 14: Return Of A Used Product
The customer is responsible for the proper packaging and labelling of returns. 1.10 Service information For service or technical support, please contact your local sales point or the fol- lowing: STIHLER ELECTRONIC GmbH Tel. +49 (0) 711-720670 Julius-Hoelder-Strasse 36 Fax +49 (0) 711-7206757 70597 Stuttgart www.stihlerelectronic.de GERMANY E-Mail: info@stihlerelectronic.de... -
Page 15: Product Description
2 Product description ASTODIA Instructions for Use 2 Product description 2.1 Introduction The method of transillumination or Diaphanoscopy has been used in the field of paediatrics and especially of neonatology for decades. It is used to identify a pneumothorax or a hydrocele quickly and to visualize vessels in limbs during a puncture. -
Page 16: Components Of Astodia
ASTODIA Instructions for Use 2 Product description 2.3 Components of ASTODIA Fig. 1 Components of ASTODIA No. Designation Description Control unit It includes the complete electronic circuitry and the power supply of the unit. The interface, which is used for the charger and the hand piece ensures that the patient is only treated without galvanic connection to the power mains. -
Page 17: Installation
3 Installation ASTODIA Instructions for Use 3 Installation 3.1 Initial start-up Before you put the device into operation, charge the integrated batteries. To do this, use the belonging charger which is to plug into the interface of the control unit. WARNING Risk of injury! To prevent the risk of an electric shock, strictly use a charger approved by the... -
Page 18: End Operation
ASTODIA Instructions for Use 4 Start-up Start the device directly with the keys on the lowest light level. The device is, after of the LEDs flashed, preset to start with the red LED col- our as standard. Infinitely variable light intensity is set by pressing and holding (for at least 0.5 s) the key. -
Page 19: Cleaning And Disinfecting
4 Start-up ASTODIA Instructions for Use 4.5 Cleaning and disinfecting NOTICE Actions to avoid damaging the diaphanoscope: - Do not immerse the control unit and/or the connector for the connection cable in liquid. - Do not disinfect the system using steam (e.g., in autoclaves), hot air, or thermo-chemical cleaning solutions. -
Page 20: Troubleshooting
ASTODIA Instructions for Use 5 Troubleshooting 5 Troubleshooting Device cannot be started Device cannot be started Device response Battery charge too low. Possible reasons Hand piece is not connected. ►Required Control unit or hand piece defect. tion(s) 1. Charge battery Required action(s) 2. -
Page 21: Servicing
All tests of the periodic safety inspection have to be passed! If one of the tests does not pass, the ASTODIA has to be sent to the local dealer or to STIHLER ELECTRONIC GmbH for repair (see Chapter 1.9 Return of a used product). -
Page 22: Check The Functioning Of The Reduction Of The Maximum Light Intensity And The Automatic Switching Off
ASTODIA Instructions for Use 6 Servicing 6.2.3 Check the functioning of the reduction of the maximum light intensity and the automatic switching off • Switch on the ASTODIA on the control unit and set the maximum light intensity - see Chapter4.2 Starting. •... -
Page 23: Technical Data
7 Technical data ASTODIA Instructions for Use 7 Technical data DIA120 DIA130 DIA140 Control Unit Hand piece Charger Electrical connection 100-240VAC ±10% 50-60Hz Nominal voltage 4,8 V Classification IPX0 IP4X (IEC/EN 60529) Isolation class II Protection class Classification Class I (MDD 93/42/EEC) Code UMDNS 14-130... -
Page 24: Ordering Information
ASTODIA Instructions for Use 8 Ordering information 8 Ordering information Item Part no.: ASTODIA DIA100 completely packaged consisting of: 1 piece control unit 1 piece hand piece 1 piece charger 1 piece Instructions for Use Separate order piece control unit DIA120 piece hand piece DIA130... -
Page 25: Guidelines And Manufacturer's Declaration
9 Guidelines and manufacturer’s declaration ASTODIA Instructions for Use 9 Guidelines and manufacturer’s declaration Guidance and manufacturer's declaration - electromagnetic emissions ASTODIA is intended for use in the electromagnetic environment specified below. The customer or user of the ASTODIA should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance... - Page 26 ASTODIA Instructions for Use 9 Guidelines and manufacturer’s declaration Guidance and manufacturer's declaration - electromagnetic immunity The ASTODIA is intended for use in the electromagnetic environment specified below. The customer or user of the ASTODIA should assure that it is used in such an environment. Immunity test Test level Compliance...
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