Photonic ATO ML 600 B Operation And Installation Instruction

Mobile stand, ceiling mount and wall mount models
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INSTRUCTIONS FOR
OPERATION AND INSTALLATION
MINOR SURGICAL LIGHTS:
ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K
MOBILE STAND, CEILING MOUNT and
WALL MOUNT MODELS
As of: March 8, 2021
Version: V10.1
Doc: PT- 1
CE MARK
Class I medical device in compliance
with the regulation MDR 2017/745/EU

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  • Page 1 INSTRUCTIONS FOR OPERATION AND INSTALLATION MINOR SURGICAL LIGHTS: ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K MOBILE STAND, CEILING MOUNT and WALL MOUNT MODELS As of: March 8, 2021 Version: V10.1 Doc: PT- 1 CE MARK...
  • Page 3 Dear Customer, Congratulations on the purchase of your new ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K minor surgical light from Photonic Optische Geräte GmbH & Co KG. Our simple operating concept allows for intuitive handling using both the control panel on the housing and the detachable handle.
  • Page 4: Table Of Contents

    Operation ..........................1 Check Before Each Use ....................1 Operation of the Lamp Head ..................1 3.2.1 Operation of the ATO ML 600 B | ML 1000 B Lamp Head ........2 3.2.2 Quick Start via Sterilizable Handle ................2 3.2.3 Operation of the ATO ML 1000 K Lamp Head ............
  • Page 5 Measures in the Event of Malfunctions or Changes in Performance ....... 46 12.6 Inspection Plan for the Lamp Head and Associated ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K Holding System ................... 46 13 ATO ML 600 B | ATO ML 1000 K Reference Numbers ............48...
  • Page 6 SYMBOLS IN THE INSTRUCTIONS FOR OPERATION AND INSTALLATION SYMBOL MEANING WARNING Non-observance may result in serious or even fatal injury CAUTION Failure to do so may result in minor to moderate injury or damage to property NOTE Gives application tips and useful information FOLLOW THE OPERATING INSTRUCTIONS Read the operating instructions carefully before using the support system for the first time.
  • Page 7 SPRINGING OPEN OF THE SPRING ARM Warns of the sudden springing open of the spring arm when disassembling the end device. TIPPING HAZARD The support arm system, especially the mobile stand version, is only designed to support the weight of the light head. If additional weight is added, the unit may tip over, potentially hitting people and causing serious injury.
  • Page 8: Safety Instructions

    SAFETY INSTRUCTIONS Please observe the operating instructions when handling the light! The light is a class I medical device according to EU 2017/745. Surroundings: This device is not intended for operation in potentially explosive areas! • Do not use in oxygen-enriched areas! •...
  • Page 9: Brief Description

    These operating instructions (including the operating instructions for the support systems) are intended for health care professionals who use, clean, disinfect and sterilize the ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K minor surgical lights. The installation instructions for the holding systems are intended for qual- ified and trained technical personnel.
  • Page 10: Versions

    VERSIONS The ATO ML 600B, ATO ML 1000B and ATO ML 1000K minor surgical lights are offered in combination with the corresponding support arm systems in the following versions: Mobile stand: ATO ML 600B / ML 1000B / ML 1000K with ATO ACSwing mobile stand Wall mount: ATO ML 600B / ML 1000B / ML 1000K with ATO ACSwing wall mount Ceiling mount: ATO ML 600B / ML 1000B / ML 1000K with ATO ACSwing ceiling mount 200/400/600/800/1000 viii...
  • Page 11: Operation

    The blue "sterile handle" (the assembly consists of a sterilizable handle and clip) for the ATO ML 600 B | ML 1000 B | ML 1000 K is not supplied sterile and must be disinfected and sterilized before first use as described in Chapter 4.
  • Page 12: Operation Of The Ato Ml 600 B | Ml 1000 B Lamp Head

    Sterilizable handle with quick start and brightness control Figure 1: Schematic representation of the ATO ML 600 B | ATO ML 1000 B lamp head. 3.2.2 QUICK START VIA STERILIZABLE HANDLE For time-critical applications (e.g., trauma room), the light can be turned on with a slight twist of the sterilizable handle.
  • Page 13: Operation Of The Ato Ml 1000 K Lamp Head

    3.2.3 OPERATION OF THE ATO ML 1000 K LAMP HEAD The controls for switching on and off (button A), color temperature selection (button B) and for brightness control (buttons C and D) are integrated into the top of the lamp head. The handle allows you to adjust the luminosity by turning the handle.
  • Page 14: Working Areas Of The Support Systems

    WORKING AREAS OF THE SUPPORT SYSTEMS 3.3.1 MOBILE STAND MODEL bis zu 35 °+5° Use of the mobile stand in conjunction with the lamp head allows 360° rotation around the horizontal axis. The swivel arm of the stand support is mounted vertically and enables a rotation of 60° around the vertical axis via the swivel joint.
  • Page 15 Figure 4: Schematic representation of the mobile stand Only use the stand support on a level and solid surface. Once the stand support has been positioned, lock both stand rollers using the brakes.
  • Page 16: Ceiling Mount Model

    3.3.2 CEILING MOUNT MODEL The arms of the ceiling mount are mounted vertically and allow a rotation of 2 x 360° around the vertical axis via the swivel joints. 185 mm 1100 mm Figure 5: Schematic diagram of ceiling attachment...
  • Page 17: Wall Mount Model

    3.3.3 WALL MOUNT MODEL 1100 mm Figure 6: Schematic diagram of wall mount The arms of the wall mount are mounted vertically and allow a rotation of 360° between the arms and 180° on the wall around the vertical axis via the swivel joints. Do not attach any additional loads to the lamp head or stand/support.
  • Page 18: Safety Functions

    SAFETY FUNCTIONS The ATO ML 600 B │ ATO ML 1000B | ATO ML 1000 K minor surgical lights have built-in safety functions to protect the user and patient during operation. PROTECTION AGAINST OVERHEATING In the event that the circuit board overheats (T > 75°C), the light will switch to an emergency lighting mode, with maximum illuminance limited to 40,000 lx.
  • Page 19: Equipotential Bonding Cunductor

    EQUIPOTENTIAL BONDING CONDUCTOR An equipotential bonding conductor is an additional conductor (accessory; not included in the scope of delivery) that establishes a direct connection between the electrical unit and the equipotential bonding busbar of the elec- trical installation. The mobile light on a mobile stand as well as the wall-mounted lights have a PE connection on the housing of the mobile stand or on the wall mount, respectively, so that possible potential differences that can occur as voltage sources are avoided in the patient environment - including in connection with parallel use of other units.
  • Page 20: Reprocessing Of Sterile Accessories

    STERILIZABLE HANDLE (ALSO "STERILE HANDLE") The ATO ML 600 B | ML 1000B | ML 1000 K lights are equipped with a blue sterilizable handle (sterile handle) as standard. The removable handle is steam sterilizable up to 134 °C.
  • Page 21: Sterilization

    STERILIZATION Sterilization may only be performed on handles that have already been cleaned and disinfected. The sterilization of the blue sterile handle has been validated with the following mechanical procedure and parameters: Table 2: Sterilization Sterile handle packaged in paper/laminate Sterilizer class B LISA 522, serial number 08-0794, W&H company Sterilization process: Fractionated pre-vacuum process Temperature: 134 °C...
  • Page 22: Cleaning/Desinfection

    Please observe the general safety instructions according to Chap. 5.1. DISINFECTION PROCESS The standardized disinfection procedure for the ATO ML 600 B and ATO ML 1000 K light system is wipe disinfec- tion. Hygiene guidelines and corresponding safety measures for the disinfection processes to be used must be defined by the operator WARNING –...
  • Page 23: Maintenance

    MAINTENANCE Medical devices must be subjected to regular maintenance and testing cycles. This is fundamental for compliance with safety concerns. The manufacturer of the medical device is responsible for defining regular safety measures. The operator is re- sponsible for implementing these defined measures. Always switch the light to standby mode and disconnect the power plug or disconnect the light from the power supply before carrying out any maintenance or inspection work.
  • Page 24: Disposal

    DISPOSAL The light may be operated for a maximum of 10 years after initial commissioning. The unit should then be taken out of service and disinfected and cleaned for disposal. Therefore, for proper disposal, contact an approved dis- posal company. For proper disposal of the system, please contact an authorized disposal company. Do NOT disassemble the spring arms and articulated joints.
  • Page 25: Mounting Of The Lamp Head

    MOUNTING THE LAMP HEAD 10.1 LAMP HEAD ASSEMBLY Accessories: Fuse element Figure 11: Accessory lamp head...
  • Page 26 MOUNT LAMP HEAD CAUTION – DAMAGE TO THE UNIT After mounting the lamp head, perform a tilt test according to DIN EN 60601-1. Figure 12: Tilt test of mobile stand...
  • Page 27: Mobile Stand Assembly

    10.2 MOBILE STAND ASSEMBLY 10.2.1 MOUNT ROLLERS WARNING – STATIC CHARGE If the PE cable is not fitted, the stand unit may become statically charged and discharged onto patients. Mount the PE cable CAUTION Always attach the braked rollers diagonally, otherwise there is a risk of tipping/slipping. Figure 13: Rollers Figure 14: Brakes Ring...
  • Page 28: Mount Stand Tube

    10.2.2 MOUNT STAND TUBE CAUTION – DAMAGE TO THE UNIT Without engaging the nose lock and then screwing the stand tube, the stand will fall over. Engage nose lock and tighten screw with spring washer. Take the roller base as described in the previous chapter and mount the stand tube as follows: Unscrew the screw with spring washer from the roller foot.
  • Page 29: Disassemble & Assemble Spring Arm / Safety Ring Correctly

    Check for secure seating. Screw in the screw with spring washer again and tighten it firmly. Press plastic half rings with sealing ring into the stand base. Tighten the Phillips screw and check that it is se- curely seated. 10.2.3 DISASSEMBLE & ASSEMBLE SPRING ARM / SAFETY RING CORRECTLY Figure 15: Accessory spring arm Accessories included: washer (left);...
  • Page 30 Use of circlip pliers with over-expansion guard (See "Figure 21") The illustration shows an example of circlip pliers with over-expansion guard①. The over-expansion guard prevents over-expansion of the circlip. The circlip must not be dismantled without circlip pliers with over-expansion guard①. •...
  • Page 31 Acoustic test (See "Figure 22") – The circlip① must audibly engage in the groove on the trunnion. Figure 22: Acoustic test Visual inspection (See "Figure 23") – The washer Ø39 mm② must be mounted under the circlip①. – The circlip① must not be non-circular. –...
  • Page 32 Unscrew the Phillips screw. Remove the cover cap to the front and upwards. Insert spring arm pin. Push in as far as it will go.
  • Page 33 5. Place the washer and secure it with the circlip. The circlip must fit into the groove of the trunnion. This should be checked. 6. Establish electrical plug connection. 7. Carefully insert the connection into the tube. Put on the cover cap. Screw the cover cap with the Phillips screw.
  • Page 34: Adjust Spring Force

    10.2.4 ADJUST SPRING FORCE Like any technical component, springs are subject to natural wear. Thus, the spring force may decrease after longer operation and must be readjusted. Adjust the spring force so that the spring arm with end unit remains in any desired position. CAUTION - DESTRUCTION OF THE SPRING ARM The spring force is adjusted in the upper end position.
  • Page 35: Replacing Fuses

    10.2.5 REPLACING FUSES WARNING - ELECTRIC SHOCK For all maintenance work, disconnect the unit from the power supply, pull out the power plug and secure the unit from being switched on again. CAUTION – DAMAGE TO THE UNIT Only the specified fuses (see Technical Data p.41) may be used. Loosen the Phillips screw, but do not unscrew it completely.
  • Page 36 Push the clamping ring, seal and housing downwards. Tighten the Phillips screw.
  • Page 37: Mounting The Wall Fixture And Ceiling Fixture

    DECLARATION OF ACCEPTANCE: This is to certify that the load-bearing wall/ceiling and anchorage for the ATO ML 600 B and ML 1000 K minor sur- gical lights are secure and load-bearing.
  • Page 38: Choice Of Fasteners

    11.1 CHOICE OF FASTENERS • The person responsible for the installation is responsible for the safe selection of the fasteners and the safe execution of the fastening. • For lightweight walls, we recommend fastening with a counter-plate (not included in delivery). WARNING - LOAD DATA: •...
  • Page 39 Loosen the side screws on the plastic cover. Remove the lower plastic cover. Remove the upper plastic cover. Mark according to the drilling template. Drill two holes according to the specifications of the manufacturer of the fastener . Insert fasteners flush. NOTE: Do not proceed with installation until the binder has cured.
  • Page 40 MOUNTING WALL MOUNT Attach the two-pole connection terminal (with lever) so that there is a connection terminal on each of the white and black ends of the cable. Open the folding ferrite and place the cable in one half. Close the folding ferrite. Fasten the plug-in power supply cable to the wall bracket with a strain relief clamp.
  • Page 41 MOUNTING WALL MOUNT Unscrew the Phillips screw and pull the cover cap forward and remove it upward. Slide the upper plastic cover part over the extension arm and the plug-in power supply cable. Push the cable of the extension arm through the trunnion and insert the extension arm with spring arm onto the trunnion of the wall bear- ing.
  • Page 42 MOUNTING WALL MOUNT Push the upper plastic cover part back up and put it on. Screw the green-yellow cable from the extension arm, as well as the green-yellow cable from the PE connection in the cover flap to the wall bearing bracket. Insert the bend protection sleeve from the plug-in power supply unit into the recess.
  • Page 43: Mounting The Ceiling Fixture

    11.3 MOUNTING THE CEILING FIXTURE 11.3.1 MOUNTING CEILING PANEL WARNING: ELECTRIC SHOCK Disconnect the on-site power supply from the mains and secure it against being switched on again. In addition to the basic module, there are supplementary modules, e.g. for bridging larger distances between the suspended ceiling and the solid ceiling.
  • Page 44: Mounting Extension Arm With Spring Arm

    11.3.2 MOUNTING EXTENSION ARM WITH SPRING ARM CEILING MOUNTING: MOUNT SPRING ARM Unscrew the Phillips screw. Remove the plug. Push the extension arm with the spring arm onto the trunnion of the spacer tube. CAUTION - RISK OF INJURY Without the washer and tab washer in place, the circlip can loosen.
  • Page 45: Replacing The Fuse Of The Ceiling Mount

    CEILING MOUNTING: MOUNT SPRING ARM Put on the washer. Apply the tab washer. Insert the tab washer into the hole and slide the washer over the tube. Pick up circlip with collet Mount circlip. Check that the extension arm with spring arm is securely seated.
  • Page 46 3. Remove and replace the defective fuse. 4. Insert new fuse. 5. Push the canopy back up and tighten the three setscrews with a screwdriver.
  • Page 47: Adjust Spring Force

    11.4 ADJUST SPRING FORCE Like any technical component, springs are subject to natural wear. Thus, the spring force may decrease after longer operation and must be readjusted. Adjust the spring force so that the spring arm with end unit remains in any desired position.
  • Page 48: Drilling Template

    11.5 DRILLING TEMPLATE...
  • Page 49: Data

    Service life of medical device [years] Table 3.1: Photometric data according to DIN EN 60601-2-41 for ATO ML 600 B. All measurements were made at a working distance of 1000 mm. The technical data are subject to certain fluctuations. For technical production rea- sons, the actual values may differ slightly from the above values.
  • Page 50 ATO ML 1000 B Maximum central illuminance level [lx]. 100,000 Illuminated field diameter [mm] 140/210 Illuminance level distribution ≥ 0.66 Illumination depth 60% [mm] ≥ 1070 Color rendering index ≥ 95 Color temperature 4000 Standard dimming range between 10,000 lx and Electronic brightness control on the handle 100,000 lx in ten levels, with five levels visualized on the handle.
  • Page 51 ATO ML 1000K Maximum central illuminance level [lx]. 100,000 Illuminated field diameter [mm] 140/210 Illuminance level distribution ≥ 0.67 Illumination depth 60% [mm] ≥ 1020 Color rendering index ≥ 95 Color temperature 3500 -5000 between 3500 K and 5000 K in six steps in "MIX" mode (60,000 lx) Electronic color temperature control on lamp head 4300 K in "FULL"...
  • Page 52: Electrical And Other Technical Data

    12.2 ELECTRICAL AND OTHER TECHNICAL DATA LAMP HEAD ATO ML 600 B ATO ML 1000 B | 1000 K 24V DC ± 10 % Rated voltage 24V DC ± 10 % 1.4 A @ 24 V Rated current 1.0 A @ 24 V...
  • Page 53: Electromagnetic Compatibility

    GUIDELINES AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMISSIONS The ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K minor surgical lights are intended for use in an ELECTROMAGNETIC EN- VIRONMENT as specified below. The user should ensure that the units can be operated in such an environment.
  • Page 54 Please note that the ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K minor surgical lights will go out in the event of a power failure or mains volt- age drop. If uninterrupted illumination is required, connect the lights to a power outlet with an emergency power function.
  • Page 55: Immunity To High-Frequency Electromagnetic Fields In The Direct Vicinity Of Wireless Communication Devices

    IN THE VICINITY OF WIRELESS COMMUNICATIONS DEVICES The ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K small surgical light is intended for use in an electromagnetic environment where RF interference are controlled. The customer or user of the light can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the light, depending on the output power of the communication device, as indicated below.
  • Page 56: Measures In The Event Of Malfunctions Or Changes In Performance

    AC power and discontinue fixture operation. Contact your dealer or our service centers for inspection and repair of the device. 12.6 INSPECTION PLAN FOR THE LAMP HEAD AND ASSOCIATED ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K HOLDING SYSTEM System data: Supplier...
  • Page 57 Electrical test leakage current** Confirmation of the inspections performed 1st year 6th year Date Signature/Stamp Date Signature/Stamp 2nd year 7th year Date Signature/Stamp Date Signature/Stamp 3rd year 8th year Date Signature/Stamp Date Signature/Stamp 4th year 9th year Date Signature/Stamp Date Signature/Stamp 5th year 10th year...
  • Page 58: Ato Ml 600 B | Ato Ml 1000 K Reference Numbers

    ATO ACSwing 600 ceiling mount 4530.0706.XX ATO ACSwing 400 ceiling mount 4530.0704.XX ATO ACSwing 200 ceiling mount 4530.0702.XX Table 6: Reference numbers for the sets of ATO ML 600 B | ATO ML 1000 B | ATO ML 1000 K models...
  • Page 59 Edition 08.03.2021 Doc.No.: 4500-18-001 (a) Photonic Optische Geräte GmbH & Co KG 1160 Vienna, Seeböckgasse 59 Austria Tel.: +43-1-486 56 91-0 Fax: +43-1-486 56 91- 33 office@photonic.at www.photonic.at...

This manual is also suitable for:

Ato ml 1000bAto ml 1000 k

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