Dräger Polaris 600 Instructions For Use Manual
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Dräger Polaris 600 Instructions For Use Manual

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Instructions for use
Polaris 600
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Surgical light
Polaris 600

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Summary of Contents for Dräger Polaris 600

  • Page 1 Instructions for use Polaris 600 Surgical light WARNING To properly use this medical device, Polaris 600 read and comply with these instructions for use.
  • Page 2 This page has been left blank intentionally. Instructions for use Polaris 600...

  • Page 3: Table Of Contents

    ............57 Polaris 100 light (configuration example) ..19 Replacing the battery in the Polaris 600 remote Polaris 600 light with sterilizable handle E ..20 control for MedView camera......58 Polaris 600 light with sterilizable handle E and Troubleshooting..........
  • Page 4 Ambient conditions .......... 84 Technical light data ......... 84 Electrical data..........86 Mechanical data ..........87 MedView camera..........87 Polaris 600 remote control for MedView camera ............88 Wireless video transmission ......88 Combination with system components .... 90 Operating options ..........90 Classifications ..........

  • Page 5: Information Regarding The Instructions For Use

    The following web page lists the local contact persons: www.draeger.com Trademarks Trademarks owned by Dräger Trademark ® Polaris The following web page provides a list of the countries in which the trademarks are registered: www.draeger.com/trademarks Instructions for use Polaris 600...

  • Page 6: Safety Information Definitions

    Description of target groups Task Requirement The target groups may only perform the following Reprocessing Specialist knowledge in the tasks if they meet the corresponding requirements. reprocessing of medical devices Instructions for use Polaris 600...

  • Page 7: Abbreviations And Symbols

    Training in service activities nance" section) on this product Dräger recommends arranging a service contract with DrägerService. Abbreviations and symbols Explanations can be found in the sections "Abbreviations" and "Symbols" in chapter "Overview". Instructions for use Polaris 600...

  • Page 8: Safety-Related Information

    For correct use of a Polaris 100 or 200 light in combination with the Polaris 600 light, read Strictly follow these instructions for use and observe the Polaris 100/200 instructions for use.
  • Page 9 Device combinations that are approved by Dräger meet the requirements of the following standards: – IEC 60601-1, 3rd edition (general safety requirements, device combinations, software- controlled functions) – IEC 60601-1-2 (electromagnetic compatibility) Instructions for use Polaris 600...
  • Page 10 "EMC declaration" (page 82). essential performance of this device is This device can be affected by other electrical fulfilled. devices. – Maintain an adequate distance between this device and other medical electrical equipment. Instructions for use Polaris 600...
  • Page 11 Instructions for use must be kept accessible to the user. Training Training for users is available via the Dräger organization responsible (see www.draeger.com). Functional safety The essential performance of lights consists in: – illumination of the operating field, Instructions for use Polaris 600...

  • Page 12: Product-Specific Safety Information

    Make sure that a switching element to individual lights, see "Setting the disconnect all poles of the supply is fitted illuminance" on page 42. before installing the light. The required switching element is part of the Dräger mains connection component. Instructions for use Polaris 600...
  • Page 13 IEC 60601-1:1988 (or later) or IEC 60950-1 Compatibility of displays standards. WARNING Risk due to incompatible displays The displays used in combination with a Polaris light system must be approved for use in the patient environment according to IEC 60601-1. Instructions for use Polaris 600...
  • Page 14 Dräger could void the user’s authority to operate the equipment. This medical device includes radio equipment in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.draeger.com/doc-radio Instructions for use Polaris 600...

  • Page 15: Application

    The Polaris 600 light system is classified as a Single light surgical light system in accordance with IEC As a single light, the Polaris 600 light is intended to 60601-2-41 and is intended to be used for the local be used as a surgical or examination light in...

  • Page 16: Environments Of Use

    Description Light Color temperature The Polaris 600 light is certified and approved as a The color temperature can be adjusted in 4 steps, surgical light. The Polaris 600 light uses LED which the surgeon can select depending on tissue bulbs.

  • Page 17: Overview

    Overview Overview Multimedia system with 2 Polaris 600 lights (configuration example) A Ceiling cover B IR receiver for Polaris 600 remote control for MedView camera Instructions for use Polaris 600...
  • Page 18 G Display spring arm H Light spring arm Gimbal mounting J Light control panel K Polaris 600 light L Polaris 600 light with MedView camera and radio transmitter M Display mount (24 inch to 32 inch) with radio receiver N Display...

  • Page 19: Light System With A Polaris 600 And A Polaris 100 Light (Configuration Example)

    Overview Light system with a Polaris 600 and a Polaris 100 light (configuration example) A Ceiling cover G Light control panel B Ceiling tube H Sterilizable handle C Central axis Polaris 600 light D Light swivel arm J Polaris 100 light...

  • Page 20: Polaris 600 Light With Sterilizable Handle E

    B Integrated handle C Light control panel D Sterilizable handle E E Lens with LED F Bottom glass Polaris 600 light with sterilizable handle E and MedView camera A Gimbal mounting B Integrated handle C Light control panel D Sterilizable handle E...

  • Page 21: Light Control Panel

    Reduce illuminance key: Increase illuminance key: Set color temperature key: Set light field diameter key: Switch ambient light (Endo light) on/off – For further information on controlling the lighting, see "Operation" on page 35. Instructions for use Polaris 600...

  • Page 22: Medview Camera (Option)

    MedView camera (option) The MedView camera is permanently installed in the light head. It is located in a segment next to the LED bulbs. Polaris 600 remote control for MedView camera key: MedView camera on/standby key: Zoom out video image (Wide)

  • Page 23: Wall-Mounted Control Panel For 2 Polaris 600 Lights And A Medview Camera (Configuration Example)

    Overview Wall-mounted control panel for 2 Polaris 600 lights and a MedView camera (configuration example) For a Polaris 600 light with MedView camera, the camera control area is on the right-hand side of the shared wall-mounted control panel. Light control area...

  • Page 24: Or Panel (Option)

    Overview OR panel (option) The OR panel is a messaging and operating panel. It is used for operating a Polaris 600 light system in operating rooms and for displaying operational and error messages. Polaris 600 control interface (option) The Polaris 600 control interface is an interface...

  • Page 25: Symbols

    Use by: YYYY-MM-DD Expiration date The product is a medical device (CE conformity assessment pro- cedure) Quantity Storage temperature Relative humidity Ambient pressure Part number Lot number Serial number Revision index Protect from moisture Instructions for use Polaris 600...

  • Page 26: Operating Concept

    Operating concept Operating concept Operating controls and their functions on the Polaris 600 light This table is applicable to light systems consisting of Polaris 600 lights, with or without a MedView camera. This table shows which control elements can be used to make which settings for the functions.

  • Page 27: Operating Controls And Their Functions On The Polaris 600 And Polaris 100/200 Light System

    Operating concept Operating controls and their functions on the Polaris 600 and Polaris 100/200 light system This table is applicable to light systems consisting of Polaris 600 lights, with or without a MedView camera, and Polaris 100/200 lights. This table shows which control elements can be used to make which settings for the functions.

  • Page 28: Sterilizable Handle E

    Operating concept Polaris 600 remote control for MedView camera Light field diameter – Illuminance – Color temperature – Synchronization – Ambient light (Endo light) – MedView camera Sterilizable handle E illuminance and the light field diameter. NOTE The sterilizable handle E will lose its functionality...

  • Page 29: Wall-Mounted Control Panel (Option)

    The wall-mounted control panel can incorporate up to 3 light control panels. Optionally it can include a camera control panel. The keys on the wall-mounted control panel are pressure-sensitive, i.e., a certain pressure must be applied by the finger. Instructions for use Polaris 600...

  • Page 30: Color Assignment Of The Lights To The Wall-Mounted Control Panel

    – The uppermost light control panel on the wall- mounted control panel and the associated color are always assigned to the uppermost light on the arm system. Instructions for use Polaris 600...

  • Page 31: Assembly And Preparation

    NOTE partially. Sterilizable handles are supplied by Dräger in a non-sterile state. WARNING Checking the Polaris 600 remote control for Risk of infection MedView camera Personnel and patient may become infected  Press any key on the remote control. by a non-sterile handle.

  • Page 32: Fitting The Handle

    – Status LED does not light up: the battery is replaced immediately, see "Replacing the completely discharged or is defective. To battery in the Polaris 600 remote control for reestablish the function of the remote control, MedView camera" on page 58.
  • Page 33 The handle must be checked for secure attachment after it has been fitted to the inner handle. – To remove the handle, see "Disassembly" on page 67. Instructions for use Polaris 600...
  • Page 34 If the inner handle is not free from damage, it may damage the disposable handle. – To remove the disposable handle, see The inner handle must be free from damage. "Disassembly" on page 67. Instructions for use Polaris 600...

  • Page 35: Operation

    Do not hang heavy loads on the arm system (e.g., leaning body weight). The mechanism The light head is held at its new position. of the arm system may be damaged, which may compromise the correct positioning of the arm system. Instructions for use Polaris 600...
  • Page 36 The non-sterile integrated handle is located at the edge of the light head. 1 Take hold of the integrated handle (A) and use it to position the light. The light head is held at its new position. Instructions for use Polaris 600...

  • Page 37: Positioning A Light System

    Position the light so that the light field is not – The main surgical light (A) is positioned directed towards the unprotected eyes of the laterally above the surgeon's shoulder to patient. ensure that the operating field (B) is fully illuminated. Instructions for use Polaris 600...

  • Page 38: Positioning The Medview Camera

    LED bulbs. times.  The optimum distance between the MedView camera (from the bottom glass of the light) and the operating field is 90 cm to 130 cm (35.43 in to 51.18 in). Instructions for use Polaris 600...

  • Page 39: Status Leds

    The light is in standby mode. The light is not being supplied with power. – The status LED (A) is lit orange. There is a light system fault, see "Fault – Cause – Remedy" on page 60. Instructions for use Polaris 600...

  • Page 40: Switching The Light On And Off

    Risk of patient injury Synchronization function is activated, the When the Synchronization function is activated, selected Polaris 600 light sends a request to all the the wound site may be heated to an other Polaris 600 lights in the light system. The unacceptable level if the light fields overlap.
  • Page 41 When the Synchronization function is activated on the wall-mounted control panel, the panel sends a request to all Polaris 600 lights to set the color temperature and the illuminance to specific values. The color temperature and the illuminance are then set on the Polaris 600 lights in accordance with the request.

  • Page 42: Setting The Illuminance

    Restriction when a Polaris 600 light is to trace back whether the command originated combined with Polaris 100/200 lights from the selected Polaris 600 light or from the wall- mounted control panel. In particular, the Polaris The Polaris 100/200 light does not receive any...
  • Page 43 Only one finger at a time must touch the operating section. 2 When the key (A) is pressed twice, the next LED (C) of the LED indicator lights up with half brightness. Instructions for use Polaris 600...
  • Page 44  The change in the illuminance is shown by the LED indicator (B). – For further information on illuminance, see "Technical light data" on page 84.  The change in the illuminance is shown by the LED indicator (B). Instructions for use Polaris 600...
  • Page 45 – If the maximum level of illuminance from one light is required, the illuminance from the other lights must be reduced. The light fields from the individual lights should not overlap if possible. Instructions for use Polaris 600...
  • Page 46 1120 W/m Polaris 200 (B) Polaris 600 (A) Acceptable 1160 W/m Polaris 200 (B) Polaris 600 (A) Acceptable 1060 W/m Polaris 100 (B) Polaris 600 (A) Polaris 600 (B) Acceptable 1800 W/m Polaris 600 (C) Instructions for use Polaris 600...
  • Page 47 Polaris 200 (B) Acceptable 1620 W/m Polaris 100 (C) 1) When all lights in the light combination are set to maximum illuminance 2) Maximum permissible total irradiance according to IEC 60601-2-41 corresponds to 1000 W/m Instructions for use Polaris 600...

  • Page 48: Color Temperature Function

    5600 K – The color temperature when the light is switched on is the same as the color temperature set before the light was switched off. 1 Press the key (A). The color temperature is increased. Instructions for use Polaris 600...

  • Page 49: Light Field Diameter Function

    NOTE The operating section of the sterilizable handle E must be dry to guarantee proper operability. 1 Press the key (A). The light field diameter is increased by one step. Instructions for use Polaris 600...
  • Page 50 3 The change in the light field diameter is shown by the LED indicator (B).  If the largest light field diameter has been reached, double-tapping again will reset the light field diameter to its smallest size. Instructions for use Polaris 600...

  • Page 51: Ambient Light Mode (Endo Light)

    Polaris 600 lights can be individually switched to the Ambient light mode. This deactivates the Synchronization function on a light. When a Polaris 600 light in the light system is in the Ambient light mode, the key on this light is deactivated.

  • Page 52: Operating The Medview Camera Using The Wall-Mounted Control Panel

    Operation Operating the MedView camera using the wall-mounted control panel For a Polaris 600 light with MedView camera, the Switching the MedView camera off camera control area is on the right-hand side of the shared wall-mounted control panel. Switching the MedView camera on ...
  • Page 53 3 The change in the image detail is shown by the LED indicator (C). The status LED (B) is not lit. The larger the image detail becomes, the more LEDs light up. The smaller the image detail becomes, the fewer LEDs light up. Instructions for use Polaris 600...
  • Page 54 4 The change in the exposure is shown by the LED indicator (C). The lighter the video image becomes, the more LEDs light up. The darker the video image becomes, the fewer LEDs light up. Instructions for use Polaris 600...
  • Page 55 3 Press the key (B). NOTE The camera focuses on a closer object. The Manual focus function must be activated if the current focus setting is to be maintained without continuous automatic focusing taking place. Instructions for use Polaris 600...
  • Page 56 The white balance for the camera takes place automatically, i.e., the camera adjusts itself automatically to the color temperature of the Polaris 600 light. NOTE The MedView camera adjusts itself automatically to the color temperature selected for the Polaris 600 light. Instructions for use Polaris 600...

  • Page 57: Operating The Medview Camera By Means Of The Polaris 600 Remote Control For Medview Camera

    Operation Operating the MedView camera by means of the Polaris 600 remote control for MedView camera Operating the remote control Positioning the remote control The keys on the remote control are identical to the keys in the camera control area on the right-hand side of the wall-mounted control panel.

  • Page 58: Replacing The Battery In The Polaris 600 Remote Control For Medview Camera

    Operation Replacing the battery in the Polaris 600 remote control for MedView camera The remote control requires 9-volt batteries of the type 6LR61, 6F22, or 1604D. The operating time of the remote control depends on the capacity of the battery used and is approximately 1 year for the factory-supplied battery.
  • Page 59 7 Close the cover. 8 Close the housing flap. 9 Perform a functional test, see "Checking for operational readiness before each use" on page 31. 10 Dispose of the old battery appropriately. 11 Charge rechargeable batteries as required. Instructions for use Polaris 600...

  • Page 60: Troubleshooting

    The LEDs on the mains connection component are numbered and indicate the status of the light system. Supply mains Emergency power Output voltage Initialize in progress Contact service Initialize system System number A System number B Instructions for use Polaris 600...
  • Page 61 Electronics fault Notify Dräger- Communication with the light system is Service Notify DrägerSer- disrupted vice (Contact ser- Flashing yellow Light system is not initialized Perform initial- vice) ization according to assembly instructions or notify Dräger- Service Instructions for use Polaris 600...
  • Page 62 LEDs on the light control panel and on the wall-mounted control panel The description of this function applies to both the light control panel and the wall-mounted control panel. Only the light control panel is shown in the illustrations. Instructions for use Polaris 600...
  • Page 63 Light is in standby mode Continuously white Light is in ambient light mode No remedial action nec- Status LED (D) on the light control (Endo light) essary panel Continuously orange on the wall-mounted control panel Instructions for use Polaris 600...
  • Page 64 Troubleshooting Polaris 600 remote control for MedView camera Fault Cause Remedy Remote control is not within the reception range of the IR Aim the remote control at receiver the IR receiver, see "Operating the MedView camera by means of the Polaris 600 remote con- trol for MedView camera"...
  • Page 65 4 Set the on/off switch on the radio receiver to I.  The connection will be reestablished. This procedure takes up to 30 seconds Video image is Unknown Notify DrägerService not displayed and cannot be rees- tablished Instructions for use Polaris 600...

  • Page 66: Reprocessing

    To avoid the risk of infections for hospital staff and patients, always clean and disinfect the device after each use. NOTE Do not use abrasive cleaners for cleaning. NOTE Strictly follow the disinfectant manufacturer's instructions for use! Instructions for use Polaris 600...

  • Page 67: Disassembly

    1 Take hold of the handle section and press the pulling. locking mechanism (A). 2 Keep the locking mechanism pressed and turn the handle counterclockwise (B) until the markers (C) line up. 1 Take hold of the handle (A). Instructions for use Polaris 600...
  • Page 68 The locking mechanism is intended to ensure single use of the disposable handle and is unusable after it has been pulled. 4 Pull the disposable handle (E) down to remove Instructions for use Polaris 600...

  • Page 69: Service Life Of The Handle

    The handle can undergo up to 300 reprocessing cycles. After that, it must be disposed of. NOTE Cleaning methods based on alkaline agents (pH values >10) can increase material wear to the handle and thus shorten its service life. Instructions for use Polaris 600...

  • Page 70: Overview Of Reprocessing Procedures

    Concentration: 3 % not resistant to certain components of surface Contact time: 15 minutes disinfectants. Machine reprocessing It is essential to follow the instructions in this chapter. Machine cleaning: ® – Neodisher MediClean forte by Dr. Weigert Instructions for use Polaris 600...
  • Page 71 1 Immerse items in disinfectant. delamination). 2 After the contact time has elapsed, rinse items If signs of external wear occur, replace the thoroughly under running water until affected accessory. disinfectant residues are no longer discernible. Instructions for use Polaris 600...

  • Page 72: Materials Used In The Light

    Integrated handle Polyamide (PA) Seals Silicone Light control panel Polyamide (PA), polyester foil Bottom glass Polycarbonate (PC) Polaris 600 remote control for Aluminum, pow- MedView camera der coating, Sterilizable handle E Polyetherimide polyester foil (PEI) Sterilizable handle Polyetherimide (PEI)

  • Page 73: Maintenance

    Regular inspections must be carried out according to the following specifications and at the stated intervals. Technical documentation is available on request. WARNING Risk of electric shock Disconnect all electrical connections from the power supplies before carrying out any work. Instructions for use Polaris 600...
  • Page 74 Every 2 years Check the horizontal and system sonnel vertical joints of the arm system for free movement and regrease them if nec- essary. Check the height stop of the arm system and read- just if necessary. Instructions for use Polaris 600...
  • Page 75 Check for paint damage and cracks in plastic parts. Check whether all plastic parts are present and in the correct position. Perform functional and visual inspection. Instructions for use Polaris 600...

  • Page 76: Preventive Maintenance

    (minimum material thick- ness and minimum length) and replace if necessary. Repair It is recommended that only original parts from Dräger are used and that the parts are replaced by Dräger. Instructions for use Polaris 600...

  • Page 77: Adjusting The Arm System

    Use an Allen key (size 5 mm) for this.  Turn the set screw clockwise to adjust the stop  Turn the set screw clockwise to increase the downwards. spring force.  Turn the set screw counterclockwise to decrease the spring force. Instructions for use Polaris 600...
  • Page 78 NOTE Set the braking force as low as possible and as high as necessary. 1 Adjust the braking force of the joint using the set screw (A). Use an Allen key (size 4 mm). Instructions for use Polaris 600...

  • Page 79: Locking Segment Of The Spring Arm

    2 Check the dimensions of the locking segment (minimum material thickness and minimum length) and replace if necessary. 3 Grease the locking segment and the gimbal mounting journal. 4 Fit the device to the spring arm. Instructions for use Polaris 600...

  • Page 80: Acceptance And Handover

    A written record of the handover is filed for reference. The users are instructed on the use of the system. Polaris 600 remote control for MedView camera It may be necessary to change the room address if MedView cameras are operated by remote control in adjacent operating rooms which are only separated by a pane of glass.

  • Page 81: Disposal

    Republic of Germany observe the applicable national laws and regulations for battery disposal. Disposal of accessories Dispose of the following articles in accordance with – Sterilizable handle the hospital's hygiene regulations: – Dräger disposable handle – Sterilizable handle E Instructions for use Polaris 600...

  • Page 82: Technical Data

    (for which CISPR 11 Class B is normally required), this equipment might not offer adequate protection to radio- frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment. Instructions for use Polaris 600...
  • Page 83 To ensure that the full functional integrity of this device is not compromised, there must be a separation distance of at least 1.0 m (3.3 ft) between this device and wireless high-frequency communication equipment. Instructions for use Polaris 600...

  • Page 84: Ambient Conditions

    Light field diameter at a distance of 1 m (39.37 in) 190 mm (7.48 in) 240 mm (9.45 in) 120 mm (7.72 in) 135 mm (5.31 in) Depth of illumination L1+L2 (20 %) 1300 mm (51.18 in) 1300 mm (51.18 in) Instructions for use Polaris 600...
  • Page 85 1) Light settings (1 m (39.37 in) distance to light-emitting surface): Central color temperature set to 4400 K and light field diameter set to "Small". 2) The maximum total irradiance is attained at a distance of 91 cm (35.83 in). Instructions for use Polaris 600...

  • Page 86: Electrical Data

    Light in standby mode 35 VA Maximum connected load Light head Max. 240 VA Display spring arm Max. 800 VA Total rated power of all LED bulbs 70 W Power supply for the light head 24 V Instructions for use Polaris 600...

  • Page 87: Mechanical Data

    Auto shutter Minimum illuminance 100 lx Signal/Noise ratio 50 dB White balance Automatic adjustment to the color temperature of the Polaris 600 light Freeze frame Focus Autofocus (AF) Manual focus Power supply 12 V, from the light head Power consumption <15 W...

  • Page 88: Polaris 600 Remote Control For Medview Camera

    78 mm x 46 mm x 49 mm (3.07 in x 1.81 in x 1.93 in) Weight <250 g (0.55 lb) All details are subject to manufacturing tolerances. Polaris 600 remote control for MedView camera Signal transmission Infrared radiation Range Max. 7 m (275.60 in)
  • Page 89 (4.53 in x 3.66 in x 0.91 in) (without power plug) 130 mm x 93 mm x 23 mm (5.12 in x 3.66 in x 0.91 in) (with power plug) Weight including power supply unit 300 g (0.66 lb) Instructions for use Polaris 600...

  • Page 90: Combination With System Components

    Integrated handle (at the light head) Non-sterile Light control panel (on the gimbal mounting) Non-sterile Wall-mounted control panel Non-sterile Polaris 600 remote control for MedView camera Non-sterile Classifications Protection class according to IEC 60601-1 Mains connection component Protection class 1...
  • Page 91 Requirements for special installations or locations - Medical locations European medical device classification for the Class I Polaris 600 light system UMDNS code for the Polaris 600 light system 12-282 European medical device classification for the Class Is Dräger Polaris disposable handle UMDNS code for the Dräger Polaris disposable...

  • Page 92: List Of Accessories

    Handle adapter (optional) for disposable sleeves for lights, manufacturer Covidien For MedView camera Polaris 600 remote control for MedView camera G36182 1) The Dräger Polaris disposable handle is expected to be available in selected countries from the beginning of 2019.

  • Page 93: Index

    Polaris 600 control interface ....24 Polaris 600 remote control ....22 Positioning a light, non-sterile .
  • Page 94 Zoom ....... . . 53 Instructions for use Polaris 600...
  • Page 95 This page has been left blank intentionally. Instructions for use Polaris 600...
  • Page 96 These instructions for use are provided for customer information only and will only be updated or exchanged upon customer request. (Polaris 600 light system) (Dräger Polaris disposable handle) (Radio transmitter) Manufacturer Drägerwerk AG & Co. KGaA Moislinger Allee 53 –...

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