STIHLER ELECTRONIC ASTODIA DIA100 Instructions For Use Manual Download Page 2

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To be completed by the user:

Serial number

Registration number

Equipment location

Start-up date

Manufacturer: STIHLER ELECTRONIC GmbH

Julius-Hoelder-Strasse 36

70597 Stuttgart

GERMANY

Tel. +49 (0) 711-720670

Fax +49 (0) 711-7206757

www.stihlerelectronic.de

E-Mail: [email protected]

STIHLER ELECTRONIC GmbH, Stuttgart, declares in sole responsibility that

this product conforms to EC Directive 93/42/EEC on medical devices.

Summary of Contents for ASTODIA DIA100

Page 1: ...Instructions for Use ASTODIA Diaphanoscope STIHLER ELECTRONIC GmbH 70597 Stuttgart Germany Part no 0811 7200 12 Rev 07 02 2020 ...

Page 2: ...NIC GmbH 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 ...

Page 3: ... 1 10 Service information 14 1 12 Incident reporting 14 2 Product description 15 2 1 Introduction 15 2 2 Technical Description 15 2 3 Components of ASTODIA 16 3 Installation 17 3 1 Initial start up 17 4 Start up 17 4 1 Preparation for use 17 4 2 Starting 17 4 3 End operation 18 4 4 Charging the batteries 18 4 5 Cleaning and disinfecting 19 5 Troubleshooting 20 Device cannot be started 20 Batteries...

Page 4: ... Diaphanoscope ASTODIA serves for searching blood vessels and helps identify structures filled with air or fluid deep under the skin surface 1 2 2 Intended medical indications It serves for the translumination of the biological tissue to visualize its structures e g in the over extentioned neonatal wrist joint of the dorsopalmar to punctuate the radial and ulnar arteries while they are visible and...

Page 5: ...fessional healthcare facilities e g hospital emergency care dialysis including HF surgical equipment etc ASTODIA is not intended for home healthcare environment ASTODIA is reusable but requires cleaning disinfection between the applica tions Appropriate medical hygienic factors must be applied for the use of ASTODIA ASTODIA must not be used in an environment at risk of explosion or in the present ...

Page 6: ... 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 CAUTION Describes a dangerous situation which when not avoided can lead to mild to moderate injuries NOTICE Describes a warning relating to material damage ...

Page 7: ...s procedures other than those published are carried out during operation servicing or repeated inspections Operating and servicing personnel must be appropriately trained and medi cally qualified ASTODIA does not contain any parts the user can repair Therefore do not attempt to repair ASTODIA yourself Contact your local sales point Do not use ASTODIA until the following error conditions have been ...

Page 8: ... necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including peri...

Page 9: ...s quickly reversible and does not cause tissue lesions ASTODIA may not be used several times on a fixed point on the surface of the skin Once ASTODIA has been switched on the red and yellow LEDs of the hand piece each flash three times functional testing ASTODIA may only be used after the LEDs have flashed If the LEDs do not flash as described ASTODIA must be serviced before being used again The e...

Page 10: ...a ble in liquid Do not disinfect the system using steam e g in autoclaves hot air or thermo chemical cleaning solutions The customer is responsible for the proper packaging and labelling of returns The operator should not use any cleaning or decontamination methods other than those recommended by the manufacturer The essential performance can be lost or degraded due to EM disturbances ...

Page 11: ...rt 1 IPX 0 This symbol indicates following IEC EN 60529 that this device does not have specific protection against humidity Observe the instructions for use General warning danger symbol REF Reference part number SN Serial number Year of manufacture Manufacturer This symbol on the control unit indicates that this device complies with the requirements of the Medical Devices Directive 93 42 ECC of 1...

Page 12: ...l standard Electro magnetic compatibility Requirements and tests ASTODIA complies with the requirements of the Class I regulation 10 of the Medical Device Directive 93 42 ECC 1 6 Guarantee conditions The guarantee period is 12 months During this guarantee period the manufactur er will repair or replace free of charge all defects caused as a result of material or manufacturing errors Other damage i...

Page 13: ...a suitable location in accordance with the instructions for use On request STIHLER ELECTRONIC GmbH will provide service instructions that will allow properly trained and qualified persons to repair the parts of the equip ment that the manufacturer has designated as reparable The provision of technical documents or spare parts is not an authorisation from the manufacturer to open or repair the equi...

Page 14: ... use and before you return the equipment for repairs NOTICE 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 GmbHTel 49 0 711 720670 Julius Hoelder Strasse 36 Fax 49 0 711 7206757 70597 Stuttgart www stihlerelectronic de GERMANY E Mail in...

Page 15: ...used for the transillumination of thin limbs e g wrist joint and for the quick identification of a pneumothorax or a hy drocele in the field of paediatrics neonatology The extremely bright light of the used high performance diodes is adjustable in 9 steps or infinitely variable The special yellow coloured light visualizes the vessel structures particularly well as it is required for venipuncture T...

Page 16: ...nd Piece SN DH05000 Two high performance diodes of different wave lengths yellow and red provide for a wide field of application The round and edge free design allows the transillumi nation also on positions which are difficult to access 2b Hand Piece SN DH05000 3 Charger The intelligent charging management ensures that the integrated batteries work for a long time 4 Switch key Switch key for LED ...

Page 17: ...DIA connect the hand piece with the interface of the control unit Make sure that the plug of the connection cable for the ASTODIA handpiece is fully plugged in If the plug is not completely plugged in the function of the handpiece is lim ited e g only the yellow LED lights up 4 2 Starting CAUTION Risk of injury In case ASTODIA starts directly after switch on in the highest light level and a change...

Page 18: ...ly switch over to the next lower level after 2 minutes 3 If the unit is switched on for about 5 minutes and no key is actuated during this time it will automatically switch off to save the battery power 4 If the battery power is low the LED which is working at that time will start flashing This warning can be suppressed for 5 minutes by shortly pressing any button This can be repeated until the ba...

Page 19: ...t 3 Only disinfect the control unit and the hand piece with a disinfectant on the basis of alcohol or with one of the recommended disinfectants List of approved ready to use disinfectants Disinfectant Manufacturer Aniosurf ND Premium Laboratoires ANIOS Bacillol Plus BODE Chemie GmbH BIGUAMED PERFEKT N Desomed Dr Trippen GmbH Incidin Plus Ecolab Healthcare Incidin Rapid Ecolab Healthcare Meliseptol...

Page 20: ... Control unit or hand piece defect Required action s for resetting 1 Charge battery 2 Connect the hand piece 3 Send the control unit and the hand piece to the local dealer Batteries cannot be charged Device response Batteries cannot be charged Possible reasons Required ac tion s Charger defect Batteries defect Required action s for resetting 1 Replace charger 2 Return the charger and get it repair...

Page 21: ...ty of the ASTODIA charger 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 6 2 1 Visual inspection Check the following components for completeness and visible damages before each application Charger Housing of the control un...

Page 22: ...m light intensity see Chapter4 2 Starting Watch the LED and measure I the time until the ASTODIA automatically reduces the maximum light in tensity by one level This time must be 2 minutes 10 s II the time until the ASTODIA automatically switches off completely This time must be 5 minutes 30 s 6 2 4 Electrical Test The charger has to be checked once a year according to the applicable national safe...

Page 23: ... level Charging time Approx 3 hours Essential performance according to IEC EN 60601 1 Control of the brightness of the LEDs of the hand piece in different stages Automatically switch over If the device is constantly operated with the highest light level it will automatically switch over to the next lower level after 2 minutes Colour LED Red 620 640 nm Yellow 584 597 nm Illumination intensity At le...

Page 24: ...ce 1 piece charger 1 piece Instructions for Use Separate order 1 piece control unit DIA120 1 piece hand piece with exchangeable cable DIA130 1 piece cable for DIA 130 hand piece hand piece SN DH05000 with exchangeable cable 1607 0001 1 piece charger DIA140 1 piece Operating instructions English 0811 7200 12 We reserve the right to modify design and technical data without notice ...

Page 25: ...customer or user of the ASTODIA should assure that it is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guid ance Electrostatic discharge ESD IEC EN 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air in compliance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 E...

Page 26: ...ment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ASTODIA is used exceeds the applicable RF compliance level above the ASTODIA should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ASTODIA b Over the f...

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