Related Manuals for Gentherm STIHLER ELECTRONIC ASTODIA DIA100
Summary of Contents for Gentherm STIHLER ELECTRONIC ASTODIA DIA100
- Page 1 Instructions for Use ® ASTODIA Diaphanoscope DIA100 DIA120 DIA130 DIA140 STIHLER ELECTRONIC GmbH • 70771 Leinfelden - Echterdingen • Germany...
- Page 2 To be completed by the user: Serial number Registration number Equipment location Start-up date Manufacturer: STIHLER ELECTRONIC GmbH Gaussstrasse 4 70771 Leinfelden - Echterdingen GERMANY Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 www.stihlerelectronic.de E-Mail: info@stihlerelectronic.de © 2021 STIHLER ELECTRONIC GmbH STIHLER ELECTRONIC GmbH, Leinfelden - Echterdingen, declares in sole responsibility that this product conforms to the regulation (EU) 2017/745 on medical devices (MDR).
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Page 3: Table Of Contents
Contents 1 Introduction ........................4 1.1 I ................4 NFORMATION ON THESE INSTRUCTIONS 1.2 I ........................ 4 NTENDED USE 1.2.1 Intended medical indications..................... 4 1.2.2 Contraindications ......................4 1.2.3 Possible adverse effects ....................4 1.2.4 Intended patient group ...................... 4 1.2.5 Intended body part...................... -
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 Environment Of Use / Operation
1 Introduction ASTODIA Instructions for Use 1.2.7 Intended environment of use / operation • ASTODIA may only be used in professional healthcare facilities (e.g. hospital, emergency care, dialysis, etc.). • ASTODIA is not intended for home healthcare environment and for veterinary medicine. -
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
ASTODIA Instructions for Use 1 Introduction Batteries and rechargeable batteries are recoverable waste and should not be disposed of in domestic waste at the end of their service life. General recycling symbol Additional information Symbol for the permitted temperature range for storage and transport Symbol for the permitted moisture range for storage and transport Symbol for the permitted atmospheric pressure range for storage... -
Page 13: Liability
1 Introduction ASTODIA Instructions for Use 1.7 Liability The manufacturer shall be liable for the safety, reliability, and performance of the equipment only when all operating, servicing, and calibration procedures have been carried out by trained and qualified persons according to the procedures published by the manufacturer;... -
Page 14: Return Of A Used Product
ASTODIA Instructions for Use 1 Introduction 1.10 Return of a used product A report must be sent together with the equipment, detailing the precise reasons, circumstances, and, if known, the cause of the return. To prevent transportation damage, the equipment should be shipped either in the original packaging or in other, well-protected packaging. -
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 key on the lowest light level or with the on the second lowest light level. The device is, after of the LEDs flashed, preset to start with the red LED col- our as standard. -
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 response Device cannot be started Battery charge too low. Possible reasons ►Required Hand piece is not connected. Control unit or hand piece defect. tion(s) 1. Charge battery Required action(s) 2. -
Page 21: Servicing
6 Servicing ASTODIA Instructions for Use 6 Servicing 6.1 Preventative servicing ASTODIA does not require any preventative servicing. No service or maintenance shall be carried out while in use with a patient. 6.2 Periodic Safety Inspection At least every 24 months - and/or in accordance with the applicable regional and national regulations –... -
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 Chapter 4.2 Starting. •... -
Page 23: Technical Data
7 Technical data ASTODIA Instructions for Use 7 Technical data DIA120 DIA130 DIA140 Control Unit Hand piece Charger 100-240VAC ±10% Electrical connection 50-60Hz Nominal voltage 4.8 V Classification IPX0 IP4X (IEC/EN 60529) Isolation class II Protection class Classification Class I (EU) 2017/745 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 DIA120 1 piece hand piece DIA130 1 piece charger DIA140 1 pieces cable for DIA130 hand piece Instructions for Use Separate order piece control unit... -
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...