STARLED3 EVO+ Users Manual Rev 2013-01

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01

USER’S MANUAL - ENGLISH

Valid for the following versions : STARLED3 evo+/S (ceiling mounted) STARLED3 evo+/P (wall mounted) STARLED3 evo+/T (trolley mounted)

Date: 04/04/2012

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

INDEX 1. GENERAL INFORMATION 1.1 ATTENTION!! 1.2 FEATURES 1.3 CLASSIFICATION 1.4 USE PURPOSE 1.5 MANUFACTURER INFORMATION 1.6 INSPECTION UPON RECEIPT AND COMPLAINTS 1.7 ENVIRONMENTAL CONDITIONS 2. PARTS 2.1 LIGHT HEAD 2.2 WALL MOUNTED ARM 2.3 CEILING MOUNTED ARM 2.4 TROLLEY MOUNTED 3. START-UP 3.1 SAFETY ADVICE 3.2 VISUAL INSPECTION AND FUNCTIONING TEST BEFORE USE 3.3 INSTALLATION AND START-UP 3.4 WALL ARM ASSEMBLY 3.5 CEILING ARM ASSEMBLY 3.5.1 OPERATIONS ON THE SINGLE POLE 3.5.2 OPERATIONS ON THE DOUBLE POLE 3.5.3 OPERATIONS ON THE SPRING ARM 3.6 TROLLEY ASSEMBLY 3.7 LIGHT HEAD ASSEMBLY 4. USE 4.1 SWITCHING ON - SWITCHING OFF 4.2 I-SENSE CONTROL PANEL 4.3 I-SENSE CONTROLS 4.3.1 LIGHT INTENSITY ADJUSTMENT 4.3.2 LIGHT-UP (ENDOSCOPY) FUNCTION 4.3.3 SEL FUNCTION 4.4 FOCUS ADJUSTMENT 4.5 HANDLE 4.6 TROLLEY USE 5. MAINTENANCE 5.1 CLEANING AND DISINFECTION 5.2 HANDLE STERILIZATION 5.3 REGULAR CHECKS 5.4 LIGHT HEAD REPLACEMENT 6. MOVING 7. TECHNICAL FORM 7.1 ELECTRICAL FEATURES 7.2 LIGHT SOURCE TECHNICAL FEATURES 7.3 DIMENSIONS AND WEIGHTS 7.3.1 LIGHT HEAD 7.3.2 CEILING ARM 7.3.3 WALL ARM 7.3.4 TROLLEY 7.4 FURTHER DATA 8. DISPOSAL 9. COMPLAINTS 10. DECLARATION OF CONFORMITY 11. WARRANTY

5 5 5 5 5 5 6 6 6 6 7 7 7 8 8 8 8 9 9 9 9 9 9 11 12 12 12 12 12 13 13 14 14 14 15 15 15 15 15 16 17 17 17 18 18 18 18 18 18 19 19 20 21

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

1. GENERAL INFORMATION 1.1 Attention!! These instructions are together with the unit and must be always kept near the lamp to be looked up. This manual and its information are useful for a proper installation carried out by qualified personnel or by the authorized installer. Read carefully these instructions before use for a proper and correct utilization of the lamp according to their destination both for patient and operator safety.

1.2 Features STARLED3evo+ is a 3 lighted lamp which uses LEDs as new conception and high power light source. The use of this new technology enables to obtain an unparalleled quality of light with an excellent colour temperature and colour rendering index. Moreover, this technology can emit light without ultraviolet rays (dangerous for one’s health) and IR (infrared rays) responsible for the light flux heat. The easy to grip handle has a wide protection and a system to unlock it in a simple and practical way meeting the safety and hygiene requirements. This handle allows the focus adjustment . Compact dimensions and simplicity are other important features of STARLED3evo+. The microprocessors controlled functioning gives the maximum efficiency of the unit together with an intuitive and simple use of controls. The light head is mounted on a support and can be rotated, oriented and tilted in every direction.

1.3 Classification According to 93/42/CEE Directive – annex IX Short term medical device, active and non invasive destined to the local illumination of the patient. The device belongs to Class I according to the rule1. According to the general technical standard (EN 60601-1:2006-10 section 6) and particular technical standard (EN 60601-2-41:2009-12 § 201.6) Based on the kind of protection against electrical dangers: Class I device. Based on the kind of protection against water penetration: IP53. Based on the kind of use safety in the presence of combustible mixtures of anaesthetics with air, oxygen or nitrogen protoxide: device not suitable in the presence of the above mentioned substances. Based on the use conditions: device for continuous use.

1.4 Use Purpose According to the particular technical standard EN 60601-2-41:2009-12 MINOR SURGICAL LUMINAIRE (TREATMENT LUMINAIRE) single luminaire in the PATIENT ENVIRONMENT which is intended to support treatment and diagnosis which can be interrupted without any HAZARD for the PATIENT in case of failure of the light and to be used in operating rooms. REF.: EN 60601-2-41:2009-12 Par. 201.3

1.5 Manufacturer Information The manufacturer of the product is: ACEM S.p.A. Via della tecnica, 29 40050 Argelato - Bologna ITALY E-mail : [email protected] Web: www.acem.it Tel.: +39.051.721844 Fax: +39.051.721855

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

1.6 Inspection upon receipt and complaints It is suggested to inspect the product and/or accessories upon their receipt to check possible flaws or damages due to shipment. See the concerning chapter: Visual inspection and functioning test before use Complaints can be accepted only if suddenly communicated to the forwarding agent or representative. See concerning chapter: COMPLAINTS

1.7 Environmental conditions FUNCTIONNING TEMPERATURE RELATIVE HUMIDITY AIR PRESSURE

MIN. +10°C 30% 700 hPa

MAX. +40°C 75% 1060 hPa

MIN. -10°C 20% 700 hPa

MAX. +50°C 90% 1060 hPa

TRANSPORT/STORAGE TEMPERATURE RELATIVE HUMIDITY AIR PRESSURE

2. PARTS 2.1 Light head

2.2 Wall mounted arm

2.3 Ceiling mounted arm

2.4 Trolley mounted

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

3. START-UP 3.1 Safety advice The lamp is not suitable to be used in explosion risk areas. Use the lamp in proper premises only, built and equipped in conformity with the directions in force in point of safety (IEC 60364-7-710). Do not look frontally inside the lamp when it is turned on and do not insert reflecting objects during its functioning. Do not turn the light beam directly or indirectly into third parties eyes. Due to the high lighting power there is the potential danger of dazzlement. Do not put or hang objects on the head or arm of the lamp to avoid that they fall down on the operating area and even an unstable positioning of the lamp itself. Besides, this could damage the mechanical parts of the lamp too. The light head (above all in its superior part) must not be covered during functioning; this would block the thermal exchange with the environment and the lamp could get overheated. Avoid bumps of mobile arms and light head. With a strong bump the lamp can be damaged or paint pieces can split and fall down on the operating field.

3.2 Visual Inspection and functioning test before use A visual control must be carried out after installation: Mobile mechanical parts check Check the mechanical functioning of the lamp through orientation and rotation movements of the mobile mechanical parts. Check the handle functioning both inserting and releasing it. Check the focus adjustment by the handle Reflector check Visually check that there are no damages present on the light head, on the polycarbonate and light components inside these. In case of damage the lamp MUST NOT be switched on and MUST NOT be used until it is repaired. All LEDs of the light must be enlightened when the lamp is turned on. Control panel Touching the “Sel” control it is possible to select the reflectors use in all their combinations (3,2 or 1 only). Touching the “Endo” control it is possible to activate/deactivate the diffused ambient light function Moving your finger on the right or left side by touching the cursor in every of its points it is possible to increase or decrease the light intensity. This regulation must be confirmed by the correspondent variation on the LED bar.

3.3 Installation and start-up All ACEM lamps are provided with parts and components for installation and connection. STARLED3evo+ assembly and installation must be carried out according to assembly instructions and only by ACEM collaborators or by assembly companies authorized by ACEM itself. Wall or ceiling mounted lamps fixing must be carried out taking into consideration the net weights and the high torques as per ACEM assembly instructions “Ceiling fixing plate and spacer”. A non state-of-the-art lamp assembly can have as a consequence that it breaks off falling down and wounding mortally patient and personnel during its functioning. The electrical installation must comply with IEC 60364-7-710 directive requiring a protection with fuses as well as a magneto thermal switch for the simultaneous interruption on every pole of the lamp power supply. For more details information please refer to assembly instructions. The lamp is provided with integrated insulated and earthed plug (wall and ceiling mounted versions). Check that an earthed plug is available inside the operating area. The owner can put the lamp in operation only if the manufacturer or supplier: a) has checked it with a functioning test on its area of use. b) has trained the person in charge of its functioning according to use instructions. Attention ! The support arm contains the lamp connecting cable.

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

Do not carry out complete rotation (360°) around the vertical axe to avoid excessive torsions of the cable. It is suggested to find a “rest” position (referred to arm direction) during installation. For example, after the lamp has been positioned in its working area, you have to pass through the “rest” position for the following arm rotation.

3.4 Wall arm assembly Wall fixing height must be included between 170-210 cm. from the floor. Wall in the provided bracket leaving its two rods outside. Supply two dowels (type S4 or S5) to fix the power supply box, and make two holes on the wall at 65mm distance each other. Assemble the arm inserting the plate with two holes on the rods of the bracket and screw the supplied bolts being careful to keep the black plastic cover downwards. Proceed with mounting the power supply box on the wall, by fixing it through the mounting rings on the upper back of the box itself. Proceed with assembly of light head according to procedure as described in the relevant paragraph. ATTENTION: DO NOT REMOVE THE YELLOW SPLINE from the spring arm before having assembled the light head. It is suggested to keep the yellow spline to disinstall the unit if necessary.

3.5 Ceiling arm assembly The configuration of the arm is suitable for a wide range of ceilings heights, according to the length of the central pole. After unpacking, find the central pole to fix it on the ceiling. 3.5.1 Operations on the single pole Unscrew the screw on the white metallic ring near the flange. Remove both the above mentioned ring and the white plastic cover. Drill the 6 holes previously marked in the desired position keeping into consideration the arm width. Fix the pole to the ceiling with suitable dowels to the construction materials. Make the electrical connections: phase and neutral wire (blue and brown), earth (yellow/green) on the terminal block present on the flange. Position the white circular metallic cover on the flange. Insert the white plastic cover. Put the white ring with the screw against the cover and tight it so that the covering is properly fixed to the ceiling. Remove the Seeger and the brass washer situated on the inferior pole extremity. 3.5.2 Operations on the double pole Unscrew the screw on the white metallic ring near the flange. Drill the 6 holes previously marked in the desired position keeping into consideration the arm width. Fix the pole to the ceiling with suitable dowels to the construction materials. Make the electrical connections: phase and neutral wire (blue and brown), earth (yellow/green) on the terminal block present on the flange. Position the white circular metallic cover on the flange. Put the white ring with the screw against the cover and tight it so that the covering is properly fixed to the ceiling. Remove the Seeger and the brass washer situated on the inferior pole extremity. 3.5.3 Operations on the spring arm Unscrew the 2 hexagonal screws that block the white plastic cover at the arm extremity (where you can see a cable) and remove it from its seat. Insert the arm into the ceiling pole so that the white cover is positioned downwards. Put the brass washer and the seeger. Put the white plastic cover by fixing it with 2 screws. ATTENTION: DO NOT REMOVE THE YELLOW SPLINE from the spring arm before having assembled the light head. It is suggested to keep the yellow spline to disinstall the unit if necessary.

3.6 Trolley assembly The arms of the base are in-factory checked. However, to be sure that the wheels are perfectly on level and flat when you receive it, you should following the procedure described below:

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

Unscrew the 3 screws around the power supply box and lift the cover.

. Disconnect the 2 fastons of mains cable, connected to the main switch on the cover.

Disconnect the plug and the faston (G/Y, earth wire) of the cable from the switch to the power supply unit, on the power supply unit input. Remove temporary the cover. WHEELS ALIGNMENT CHECKING PROCEDURE Put the base on a perfectly smooth and flat surface. If the base is not on level, you can act on the arms, one at a time. For example, if an arm is "lifted" from the floor, slightly loosen the bolt near the center of the base and then press on the arm to align it with the other; then tighten back the bolt. Take the first portion of the pole (that with the cable output) and unscrew the bolt of the pole Put the pole on the base keeping the cable towards the back of the base. Be sure that the pin of the pole fit with the hole of the base and fix them. Put the PSU box round cover back on the pole. Reconnect the 2 fastons of the mains cable to the switch previously disconnected. Reconnect the plug and the faston to the power supply unit previously disconnected. Connect the cable coming out from the lower part of the pole, as follow: the white plug to its matching output connector on the board, and the Y/G wire faston to the earth connection on the other side of the board (together with the other Y/G wire).

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

Close the power supply box with the 3 screws. Insert the second portion of the pole into the first one being sure that the holes coincide and fix them. Get the spring arm. Remove the washer and the screws from the arm with an Allen key. Connect the 2 connectors of the pole and of the arm. It is not possible to make mistakes as there is one connecting way only. Insert the arm into the pole being sure that the hole on the back part of the pole coincides with that of the arm and check that the arm itself is parallel to the base. Make sure the arm is completely inserted into the pole. Insert the screw in the holes and tighten it with an Allen key. The arm is fixed. Proceed with assembly of light head according to the following procedure.

3.7 Light head assembly Unscrew the screw on the small blue plastic tube near the fixing pin. Rotate the small tube until its horizontal slit coincides with the internal one. Remove the metallic key. Put the light head pin in the small tube and insert the key in its seat. Rotate the small blue plastic tube once again and screw the screw in its original seat. Lever on the inferior part of the arm and remove the yellow spline positioned on its final part. Connect the plug to the socket and press the switch placed on the end of the small arm of the light head.

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

4. USE 4.1 Switching on - switching off In the wall mounted and trolley mounted configuration, a bipolar switch is positioned in the box containing the power supply section; this switch allows to disconnect the lamp from the mains.

4.2 I-sense Control panel STARLED3evo+ has an I-Sense touch control panel controlling all the functions of the lamp.

1 - Endo : ambient light function

2 – SEL: select light combinations

3 – stand-by

4 – Light intensity adjustment

The result is a diffused ambient light

4.3 I-SENSE Controls 4.3.1 Light intensity adjustment

The light intensity can be set directly by touching the cursor in every of its points. Moving your finger on the right or on the left side the light intensity proportionally increases or decreases.

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

4.3.2 Light-up (endoscopy) function The ENDO key is used to activate/deactivate a particular illumination of the lamp ideal for the endoscopic field. The ambient light that is given out is projected by the superior part of the light head and the intensity can be adjusted by the electronic touch panel ( refer to paragraph “light intensity adjustment”). The function is activated when the light flickers on the panel.

4.3.3 Sel Function Using the “Sel” control you can select sequentially the lights in all their combinations of 3, 2 or 1.

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

4.4 Focus adjustment The focus of the lamp can be adjusted from the handle. Rotating the handle clockwise the 3 lighting beams diverge, vice versa by rotating the handle anti-clockwise these will converge. This allows to obtain the widest range of regulation of the light field, and a working distance extension between 70-150 cm.

release focus adjustment

4.5 Handle The handle of STARLED3evo+ gives the lamp an excellent control. It is provided with quick release push button, positioned just under the protective collar, that enables to remove and sterilize it by assuring high sanitary safety standards. To insert it, it is enough to insert the handle in its fixing shaft completely – in case rotating it - until the blocking position between the two elements is found. To remove it, take the handle and press the release push button by pulling the handle toward yourself.

4.6 Trolley use The trolley is designed to offer an excellent stability during its use. However it is necessary to pay attention to its moving from an area to another one or to the obstacles on the way. Before moving it, it is necessary that the arm with the spring supporting the light head is fixed in the lowest position as possible and that the light head is in a vertical position (see picture 1), to avoid possible accidents. In such a position the system barycentre is lowered improving the trolley stability in case of difficult or sloping paths avoiding accident due to impacts at man’s height as the encumbrance is limited by the base of the trolley itself. The spring arm can move only vertically and is NOT designed to be rotated laterally anyway (angle). When moving the trolley, the base with its routing wheels useful for lateral movings must be free to move. The brakes (for the wheels provided with) must be used only when the trolley is still and need to be deactivated when it has to be moved again (for short wyas too).

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

5. MAINTENANCE 5.1 Cleaning and disinfection Always DISCONNECT the unit from the mains during cleaning and maintenance of the lamp. The surface can be easily cleaned by wiping with a damp cloth and using conventional cleaning agents. Use only neutral disinfectants (for example surface disinfectants) based on aldehyde, quaternary ammonium compounds, etc.. Do not pour liquids directly on the head light but rather wet a cloth with a small quantity of disinfectant to clean it.

5.2 Handle sterilization The exchangeable handle can be machine-processed with the same programs as approved for surgical instruments. The handle is thermostable and can be thermally disinfected at 93°C. The instructions provided by the manufacturer of your cleaning machine (washer-disinfector) and the manufacturers of the treatment agents used must be observed as well. Neutral or alkaline cleaning agents can be used for cleaning. The final rinse should be carried out with demineralised water to prevent spot and stains on handle surface. However, cleaners containing active chlorine should be avoided due to the chemical reaction between chlorine and plastic. Warning ! danger of handle damage danger ! The handle is suitable to be sterilized by steam sterilizer. Hot –air sterilizer must not be used, otherwise the handle would easily be destroyed. The handle is steam-sterilizable, using a fractionated vacuum process at 134°C (273.2°F) for 5 minutes or 121°C (249.8°F) for 20 minutes (e.g. a sterilizer complying with EN 285/ANSI/AAMI/ ISO 11134-1993 and ANSI/AAMI ST 46-1993, validated in accordance with EN 554/ISO 13683 requirements). To prevent permanent (plastic) deformation, the handle should be kept free from mechanical loads during sterilization. Useful life of the handles: The handles are subject to normal wear as a result of frequent sterilization. If fatigue is detected in the material (cracks or tears, discoloration), be sure to replace the handle.

5.3 Regular checks Is advisable to perform checking on a regular basis – at least once a year –to verify that the lamp is still safe and full featured, with the view of assuring safety and proper use of the product. Regular checking process include the following steps: • Check of functioning according to instruction manual. • Check mechanical damages which may alter the proper use • Check the proper functioning of joints and the tightening of brakes screws. • Visually check that there’s no damage to the paint and plastic parts. • Check the potential detachment of components.

5.4 Light head replacement Attention: all the operations below must be carried out after having previously disconnected the unit from the mains. NOTE:

light head replacement can be carried out only by authorized and specialized personnel who has acquainted with service manual.

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

6. MOVING If the lamp needs to be moved follow the below mentioned instructions: Attention!! The lamp contains delicate components sensitive to strong mechanical stresses. Thus, if some parts or the whole lamp needs to be moved, it is suggested to ask for ACEM SpA permission before operating. The non-compliance with the above mentioned procedure causes an immediate warranty period termination. Observe the following instructions in every case. Light head packing This is the most delicate part and this is the reason why it must be absolutely properly handled and protected both during disassembly and transport, by operating as follows: Put the handle in an envelope made of pluriball and close it with adhesive tape with the wording “fragile”. Put the head of the lamp and the fork in an envelope of pluriball and close it with adhesive tape with the wording “fragile”. Prepare a carton box (suitable for lamps), and fill it with 10 cm. of polystyrene into pieces. Put inside it: the light head The handle The documentation (user’s manual, report and so on) Fill the remaining empty part of the box with polystyrene into pieces and close it with adhesive tape with the wording “fragile”.

Column packing The column support is formed by four parts: the base, the column (2 parts) and the arm. Disassemble the trolley following backwards the instructions of the paragraph “Trolley Assembly” in this manual. Use a carton box (suitable for lamps) and put the base already packed with pluriball inside it. Close the box with adhesive tape. Use another box for the arm and the two portions of the pole by packing them with pluriball too. Close the box with adhesive tape. Put the forwarding stick-on label in the centre of the box and fill in it correctly.

Wall/ceiling arm packing There are no particular procedures to follow for the wall or ceiling mounted arms moving. After every packing procedure, emphasize on the boxes and/or structures to pay attention during transport and moving by using the adhesive tape with the wordings “FRAGILE” and “GLASS”.

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01

7. TECHNICAL FORM 7.1 Electrical features Tensione Di Rete all’ingresso del SMPSU Max power consumption Light head power supply Class (EN 60601-2-41)

100-240 VAC ±10% - 50/60 Hz 60 W 33 VDC I

7.2 Light source technical features Light Source Average life Power consumption Illuminance Ec @ 100 cm Light adjustment Lighting area surface

LEDs 50.000 h 55 W 130.000 lux from 130.000 to 10.000 lux 148 cm2

Colour temperature, CCT Colour rendering index, Ra

4.900 °K 95

IR irradiation UV irradiation Irradiation/illumination Ratio Luminous efficacy

0.026 W/m 2 0.022 W/m 2 0.356 mW/m *lux 243 lm/W

Light field dimension d50 @ 100 cm Light field dimension d10 @ 100 cm Focusable working distance Lighting depth L1+L2

10 - 17 cm 19 - 33 cm 70 - 150 cm. 82 cm

Remaining lighting as to Ec With standardized cylinder With one mask With two masks With standardized cylinder and one mask With standardized cylinder and two masks

99% 10% 48% 10% 47%

Note: all Photometric data are subject to 5% tolerance.

2

Date: 04/04/2012

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01

7.3 Dimensions and weights 7.3.1 Light head Light head weight Light head Diameter Max. overall light head rotation Reflector diameter

5,5 Kg 44 cm 52 cm 11 cm

7.3.2 Ceiling arm Single ceiling arm weight Vertical section height 1° section length 1° section rotation 2° section length 2° section rotation Vertical movement

12,5 Kg 60 cm 81 cm 360° 87 cm 360° 124 cm

7.3.3 Wall arm Wall arm weight Connection length 1° section length 1° section rotation 2° section length 2° section rotation Vertical movement

7,5 Kg 7 cm 81 cm 180° 87 cm 360° 124 cm

7.3.4 Trolley Weight Dimensions Jointed arm length Vertical movement

17 Kg 60x75x192 cm (LxDxH) 87 cm 124 cm

7.4 Further data External light reflector temperature IP protection class

45°C max. 53

Date: 04/04/2012

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

8. DISPOSAL At the end of its lifetime, the equipment must be disposed according to directives and procedures foreseen by the Law.

Directive 2002/96/EC

on waste electrical and electronic equipment (WEEE).

Directive 2002/95/EC

on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS).

According to the a.m. notice it is given that: It is forbidden to dispose WEEE as unsorted municipal waste. Collect such WEEE separately. When supplying a new product, distributors shall be responsible for ensuring that such waste can be returned at least free of charge on a one-to-one basis as long as the equipment is of equivalent type and has fulfilled the same functions as the supplied equipment. In other cases, the customer is bound to return the equipment to a reuse centres, treatment and recycling facilities. The equipment and its components, comply with RoHS directives on restriction of use of hazardous substances. There are not potential effect on the environment and human health as a result of the presence of hazardous substances in the equipment. The symbol:

Also reported on equipment label, means that it must be disposed separately. Penalties are applicable in case the equipment is disposed improperly or abusively to what is foreseen by the Law.

9. COMPLAINTS Complaints for possible damage during transport will be accepted only if communicated immediately to the seller or the forwarding agent.

In case of return of the product, use if possible, the original packing of the lamp and always specify the following data:

- Name and address of the owner - Serial number of the product - Defect description

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

10. DECLARATION OF CONFORMITY

DECLARATION of CONFORMITY

Manufacturer name Manufacturer address

: ACEM SpA : Via della tecnica, 29 - 40050 Argelato (Bologna) – ITALIA

Product type Product name Product class (MDD 93/42/EEC)

: Minor Surgical Luminaire : STARLED3 evo+ :I

The product complies with the requirements of the Medical Devices Directive 93/42/EEC, and with those of harmonized standards:

EN 60601-1:2006 “Medical electrical equipment. Part 1: General requirements for basic safety and essential performance”. EN 60601-2-41:2009 “Medical electrical equipment. Part 2: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis”.

Stamp and Gen. Manager Signature

MINOR SURGICAL LAMP

USER’S MANUAL

STARLED3 EVO+

Rev:2013-01 Date: 04/04/2012

11. WARRANTY

ACEM S.p.A. Via della tecnica, 29 40050 Argelato - Bologna – ITALY Tel.: +39 051.721844 (r.a.) – Fax: +39 051.721855

Validity 24 months ART.

: Minor surgical lamp

MOD.

: STARLED3 evo+

The warranty is valid for a period of 24 (twenty-four) months starting from the date of the purchase receipt and cannot be extended for the inactivity of the device due to repair. Thus the customer will have to communicate the working deficiency of the product to our seat within the aforesaid expiration, otherwise the right to make use of the warranty will be lost. Technical service under warranty is carried out by authorised technicians only. When the customer ask for repairing under manufacturer’s warranty this certificate together with the purchase receipt of the product proving its real place of origin will have to be shown. The warranty covers exclusively the breakdowns of the product determining its wrong working. The guaranteed product will have to carry the same serial number of that indicated on the certificate or it will be invalidated. Warranty means exclusively free repairing or replacement of components recognised as faulty in manufacturing or in material, labour included. Anyway, travelling, stay and/or transport expenses are in charge of the customer. Warranty cannot be enforced in case of damage due to carelessness, use or installation that do not correspond to the supplied directions, tampering with the product and/or warranty seal, damage due to accidental causes and/or to negligence by the buyer in particular as regards external parts. The warranty does not include parts that wear out after use, batteries (when supplied), cables, connectors, external parts and plastic bearings, that do not present manufacturing defects. After 24 (twenty-four) months from purchase warranty expires. In this case service will be carried out debiting the replaced parts and labour expenses according to rates in force or to formalities provided by after-sales service. For every contest the place of jurisdiction will be exclusively Bologna.