ASTODIA Instructions for Use Rev 07

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]

© 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.

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 ...5 1.2.7 Intended environment of use / operation ...5

1.3 Important safety information ...6 1.3.1 Dangers...7 1.3.2 Warnings ...7 1.3.3 Caution information ...9 1.3.4 Notices ...10

1.4 Symbols ...11 1.5 Conformity with international standards ...12 1.6 Guarantee conditions...12 1.7 Liability...13 1.8 Disposal of the equipment ...13 1.9 Return of a used product ...14 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 cannot be charged ...20 6 Servicing ...21 6.1 Preventative servicing...21 6.2 Periodic Safety Inspection ...21 6.2.1 Visual inspection ...21 6.2.2 Check the function of the yellow and the red LED ...21 6.2.3 Check the functioning of the reduction of the maximum light intensity and the automatic switching off ...22 6.2.4 Electrical Test ...22

7 Technical data ...23 8 Ordering information...24 9 Guidelines and manufacturer’s declaration ...25

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 using this product. Failure to follow the instructions for use can result in damage to the product or to other property and/or personal injury. These instructions contain important information on the safe use of ASTODIA. Fully read the instructions for use, including the warning and caution information, before you use ASTODIA. Failure to follow the warnings, cautions, and information on use can result in death or severe injury to the patient. ASTODIA consists of a control unit DIA120, a hand piece DIA130 and a charger DIA140. These instructions for use are directed towards trained healthcare personnel and persons in medical professions.

1.2 Specification of the application 1.2.1 Intended use The 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 for the quick identification of a pneumothorax or a hydrocele in the field of paediatrics/neonatology. Two high-performance light-emitting diodes of different wave length (yellow and red) are used for a wide range of applications. The thermal load for the transilluminated tissue is minimized and regulated by an electronic control unit. 1.2.3 Contraindications Contraindications for the transillumination of tissue using visible light are not known for the intended use. 1.2.4 Possible adverse effects In normal use, no adverse effects arising from ASTODIA are to be expected. 1.2.5 Intended patient group Paediatrics and preferably for premature babies and neonates.

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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.). • ASTODIA is not intended for home healthcare environment. • ASTODIA is reusable, but requires cleaning / disinfection between the applications. • 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 of flammable anesthetics.

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

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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 documentation that came with the medical device. Failure to observe the instructions, including warnings and safety information, can result in incorrect handling, patient injury, user injury, medical personnel injury, damage to the device, or material damage. • Operate and service this equipment only in accordance with the procedures described in these instructions and with the applicable standards, rules, and guidelines. The manufacturer shall not be responsible for the safety of users or patients if any actions/procedures other than those published are carried out during operation, servicing, or repeated inspections. • Operating and servicing personnel must be appropriately trained and medically 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 remedied through appropriate corrective action: - Damaged or worn cables, plugs, or device box. - Damaged casing, damaged or loose control panel. - A system that has been exposed to mechanical impact or liquid ingress into internal electronic system components • Only persons authorised and qualified by the manufacturer may perform repairs to the equipment. • To prevent the risk of an electric shock, strictly use a charger approved by the manufacturer. • Modifications to ASTODIA are not permitted. WARNING Risk of infection! Clean and disinfect the equipment after every use and before you return the equipment for repairs.

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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! • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is 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 peripherals such as antenna cables and external antennas) should not be used at a distance less than 30 cm (12 inches) to any part, including cables of the device specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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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 responsibility 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! • Due to its high light intensity this device may not be used in close vicinity to the patient's eyes. • If the ASTODIA control unit is being charged, a safety distance of at least 1.5 m has to be kept. • In case of continuous use at maximum intensity to a fixed point on the surface of the skin, temperatures of up to 48 ºC can be reached within a period ≤ 2 minutes even when device is being used in the intended use. Due to the small surface area and short amount of time, this should not be classed as a critical issue (see IEC/EN 60601-1). The slight redness that can be seen after use is 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 essential performance can be lost or degraded due to EM disturbances. CAUTION Risk of radio interference! • According to Standard IEC/EN 60601-1-2, medical electrical equipment requires special precautionary measures in regard to electromagnetic compatibility (EMC). Install and operate medical equipment according to the EMC information listed in the accompanying documentation. Portable and mobile RF communication equipment may have an impact on medical electrical equipment. • This equipment/system can produce radio interference and can interfere with the operation of equipment in close proximity. It may be necessary to take appropriate corrective action, such as a new direction, a new configuration of ASTODIA, or shielding.

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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 cable 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.

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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. This symbol states that this device is a Type BF applied part to standards IEC/EN 60601-1 and VDE 0750 Part 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 14 June 1993. Warning of optical radiation. Do not aim LED directly at the eyes! Electrical devices are recoverable waste and should not be disposed of in domestic waste at the end of their service life. Batteries and rechargeable batteries are recoverable waste and should not be disposed of in domestic waste at the end of their service life. 11

ASTODIA Instructions for Use

1 Introduction

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 and transport Transport with the arrows pointing up Keep dry Fragile, protect against impacts Medical Device

1.5 Conformity with international standards Standard IEC/EN 60601-1 IEC/EN 60601-1-2

Title

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic 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 manufacturer will repair or replace free of charge all defects caused as a result of material or manufacturing errors. Other damage is not subject to this guarantee. The guarantee does not include cases of misuse or incorrect handling, use of force, or damage caused by normal wear and tear. This applies also to changes undertaken by persons who are not authorised by the manufacturer and to modifications to the original condition. 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.

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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; when only original spare parts have been used to replace components as needed; when the assembly and completion of repairs have been carried out only by authorised persons or an authorised service centre; when the electrical installations satisfy the locally applicable regulations and the IEC/EN requirements; and when the equipment is used for its intended purpose and at 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 equipment 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 equipment.

1.8 Disposal of the equipment Electrical devices are recoverable waste and should not be disposed of in domestic waste at the end of their service life. Please follow the local rules for the disposal 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. Follow the national regulations on the disposal of medical products.

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ASTODIA Instructions for Use

1 Introduction

1.9 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. WARNING Risk of infection! Clean and disinfect the equipment after every 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 following: 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: [email protected]

1.11 Incident reporting All serious incidents relating to the product should be reported to the manufacturer and the competent authority of the Member State in which the user is established.

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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. Until now, cold light sources with fibre-optical light cables have been used for this purpose. Nowadays, however, the light emitting diodes (LED) are more often applied. Because of its design, the ASTODIA is particularly suitable for the patient-specific application on small premature babies.

2.2 Technical Description ASTODIA consists of a control unit, a hand piece and a charger. Its light in the visible spectrum (yellow/red) is used for the transillumination of thin limbs (e.g. wrist joint) and for the quick identification of a pneumothorax or a hydrocele 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. The red light ensures a continuous, extensive and deep transillumination, which is required for visualizing the pneumothorax or for diagnosing the hydroceles. The common interface on the control unit is designed for charging the integrated batteries as well as for the electrical connection of the hand piece cable. This avoids using and charging of the device at the same time. This way, the charger, when it is charging the device, cannot be seen as a medical device in the sense of the Medical Devices Directive provided the distance to the patient (min. 1. 5 m) is kept.

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ASTODIA Instructions for Use

2 Product description

2.3 Components of ASTODIA 2a

1

5

2b

3

6

4

Fig. 1 Components of ASTODIA

No. Designation 1

2a 2b 3 4 5 6

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Control unit

Description

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. Hand Piece Two high-performance diodes of different wave lengths (SN < DH05000) (yellow and red) provide for a wide field of application. The round and edge-free design allows the transillumiHand Piece nation also on positions which are difficult to access. (SN ≥ DH05000) Charger The intelligent charging management ensures that the integrated batteries work for a long time. Switch key for LED-colours - press shortly Switch key OFF button - press and hold (ca. 1 s) Reduce the light intensity Key "-" Switching on the device Increase the light intensity Key "+" Switching on the device

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 manufacturer. Charging is complete when the LED on the charger lights up green or alternately with a short flash of the yellow LED and the green LED. Prior to first use, perform the following inspections: Visual inspection (see Section 6.2.1 Visual Inspection)

4 Start-up

Read each section before you use ASTODIA.

4.1 Preparation for use To apply the ASTODIA 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 limited; 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 of the highest level is not possible - then do not use ASTODIA! • Due to its high light intensity this device may not be used in close vicinity to the patient's eyes. • 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. 17

ASTODIA Instructions for Use

1

4 Start-up

Start the device directly with the keys or on the lowest light level. The device is, after of the LEDs flashed, preset to start with the red LED colour as standard. Infinitely variable light intensity is set by pressing and holding (for at least 0.5 s) the / key. If you press the button for a short time, you can change the light intensity. The colour changes from RED to YELLOW and vice versa by pressing this key

. The transillumination effect can significantly be improved if you dim the surrounding light.

2 3 4

If the device is constantly operated with the highest light level, it will automatically switch over to the next lower level after 2 minutes. 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. 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 battery voltage reaches a critical value and the device automatically switches off.

4.3 End operation Switch the device off by pressing and holding the key

(for about 1 s).

4.4 Charging the batteries To charge the integrated batteries only use the charger provided with the basic equipment and follow exactly the instructions of the charger. WARNING Risk of electric shock! During charging, the device shall not be in the patient environment.

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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. Clean and disinfect the control unit and the hand piece, if necessary, or when it is polluted as follows: 1. Clean all surfaces using a soft cloth/cotton swab and a mild soap solution. 2. Disinfect the control unit and the hand piece using a recommended disinfectant. 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 Aniosurf ND Premium Bacillol Plus BIGUAMED PERFEKT N ® Incidin Plus Incidin Rapid Meliseptol Foam pure Meliseptol Wipes sensitive Mikrobac forte Mikrozid AF liquid ® Super Sani-Cloth Terralin protect

Manufacturer Laboratoires ANIOS BODE Chemie GmbH Desomed-Dr.Trippen GmbH Ecolab Healthcare Ecolab Healthcare B. Braun Melsungen AG B. Braun Melsungen AG Paul Hartmann AG Schülke & Mayr GmbH Ecolab Healthcare Schülke & Mayr

Follow the specific instructions for use. NOTICE The operator should not use any cleaning or decontamination methods other than those recommended by the manufacturer.

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ASTODIA Instructions for Use

5 Troubleshooting

5 Troubleshooting Device cannot be started Device cannot be started Device response Battery charge too low. Possible reasons ►Required ac- Hand piece is not connected. Control unit or hand piece defect. tion(s) 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 Batteries cannot be charged Device response Charger defect. Possible reasons ►Required ac- Batteries defect. tion(s) Required action(s) 1. Replace charger 2. Return the charger and get it repaired for resetting 3. Replace batteries

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