Hill-Rom Trumpf Medical iLED 7 Instruction Manual
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Hill-Rom Trumpf Medical iLED 7 Instruction Manual

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Instruction Manual
iLED® 7 Lighting system
Read the instruction manual carefully before using the product and keep it safe for future refer-
ence.
ENGLISH
en-US

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  • Page 1 Instruction Manual iLED® 7 Lighting system Read the instruction manual carefully before using the product and keep it safe for future refer- ence. ENGLISH en-US...
  • Page 3 Thank you very much for purchasing the new iLED® 7 lighting system. Please read through this instruction manual carefully and ensure adherence to all safety instructions and requirements regarding the operation and care of the device. This instruction manual is valid for the following components: iLED®...
  • Page 4 How to contact us Manufacturer and distributor TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 07318 Saalfeld Germany Phone: +49 3671 586-0 Fax: +49 3671 586-41165 info@trumpfmedical.com www.trumpfmedical.com Below, Trumpf Medical is used as a synonym for TRUMPF Medizin Systeme GmbH + Co.
  • Page 5 Information about the document Original instruction manual for the iLED® 7 lighting system Document number: 55000-00004_030_01 Material number: 2070134 Date of publication: 01/04/2018 This information can be found in the footer of each page and is binding for the validity of the instruction manual. It must not be removed, regardless of the type of publication (in printed form, electronic form or excerpt form).
  • Page 6 Validity Supporting documents Designation Document number Material no. TruVidia® Wireless camera 55000-00030 2022461 system instruction manual DE RH interface converter 55000-00029 2068523 iLED® 7 DE / EN EPC iLED® 7 DE / EN 55000-00038 2025701 SM iLED® 7 DE 55000-00006 2015531 IA iLED®...
  • Page 7 Validity Designator / rating Type Item No. This document applies to the following sales units: iLED® 7 iLED® 7 single 4068110 For the position of the serial numbers, see Chapter 5.1. iLED® 7 / mobile iLED® 7 mobile 4068120 iLED® 7 / iLED® 7 iLED®...
  • Page 8 Information regarding this document Original instruction manual This instruction manual can be found in PDF form on the CD enclosed with the system from Trumpf Medical. Please contact Trumpf Medical Customer on CD Service if you need to request a replacement CD. Keep the instruction manual with For reference purposes, a printout of this instruction manual must be kept in an easily accessible location, near the system.

  • Page 9: Table Of Contents

    Table of contents Safety instructions ..................... 14 Structure of the safety information in this instruction manual ..............14 1.1.1 Identification of physical harm ............................14 1.1.2 Warnings of damage to property............................14 1.1.3 Identification of additional information ..........................14 Graphic symbols used in the safety instructions ....................15 Graphic symbols on the device ........................15 1.3.1 General notes..................................
  • Page 10 5.1.1 Position of the serial numbers on the ceiling-mounted version..................39 5.1.2 Position of the serial numbers on the mobile pedestal version ..................41 5.1.3 Position of the sensor detection (laser)..........................41 5.1.4 Position of the serial numbers on the Control........................42 5.1.5 Position of the serial numbers on the WallControl Panel....................
  • Page 11 Daily use of the surgical lighting system ..............67 Introduction ..............................67 Work rules...............................67 Prescribed steps ..............................67 User-specific configuration ..........................70 8.4.1 Coupling the grip adapter / camera........................... 70 8.4.2 Decoupling the grip adapter / camera..........................72 8.4.3 Fitting the sterile hand grip (camera / grip adapter) ......................73 8.4.4 Removing the sterile hand grip (camera / grip adapter) ....................
  • Page 12 10.7.4 Activating shadow management ............................90 10.7.5 Synchronizing all lights............................... 91 10.7.6 Switching all lights on................................. 91 10.7.7 Switch all lights off ................................91 10.7.8 Setting all lights to Endo lighting intensity......................... 91 10.7.9 Operating the one-click screen ............................92 Cleaning, disinfection and sterilization................
  • Page 13 16.2 Device data ..............................114 16.3 EMC information............................117 16.3.1 iLED® 7 lighting system ..............................118 16.3.2 WallControl Panel ................................124 List of components....................130 17.1 iLED® 7 components and accessories ......................130 55000-00004_030_01 – 2070134 – 2018-01-04...

  • Page 14: Safety Instructions

    1 Safety instructions Structure of the safety information in this instruction manual Important notes in this instruction manual are marked with graphic symbols and signal words. Signal word DANGER In the safety information, the signal words are WARNING located in the title field with the color CAUTION background.

  • Page 15: Graphic Symbols Used In The Safety Instructions

    1 Safety instructions Graphic symbols used in the safety instructions warns of the ignition of explosive mixtures of gases Gas explosion: warns of electric shock which can lead to severe injury or even Electric shock: death warns of the risk of the spring arm suddenly Sudden release of spring arm: jumping up when dismantling the lamp head/flat screen warns of the risk of the lighting system suddenly...

  • Page 16: Radio Identification

    1 Safety instructions IP40 Protection class of the lamp head through the housing according to IP code: EN 60529:1991+A1:2000+A2:2013 First digit "4" = protected against solid foreign bodies with a diameter of 1.0 mm and greater Second digit "0" = no protection against water Designates the class of the installed laser product for Sensor identification: distance measurement according to IEC 60825-1, Edition 2.0 (2007-03) and...
  • Page 17 1 Safety instructions FCC ID Trumpf Medical Wi-fi module: XF6-RS9113DB FCC ID interface converter: N6C-SDMAN This device has been tested and complies with the thresholds for digital devices of class B according to Part 15 of the FCC provisions. These thresholds are intended to ensure adequate protection from interference with domestic use.

  • Page 18: Pictograms On The Packaging

    1 Safety instructions The use of low-frequency electrical equipment must impair neither flight safety nor legal communication. If radio interference occurs, the use of the device must be stopped immediately and the cause of the interference remedied before use of the device may continue. Legal communication includes radio transmission in accordance with the Telecommunications Act.

  • Page 19: Overview Of The Most Important Safety Instructions

    1 Safety instructions Displays the permissible moisture range for the storage or Moisture limit: transport of the package. The upper or lower limit must not be exceeded. Displays the permissible atmospheric pressure Atmospheric pressure limit: range for the storage or transport of the package. The upper or lower limit must not be exceeded.
  • Page 20 1 Safety instructions Electrostatic charge balancing  WARNING Complications due to charge balancing To avoid complications due to electrostatic charge balancing between metallic device parts and the patient, the user must not touch the surgical light, the Control or the Dock desk and the patient at the same time.
  • Page 21 1 Safety instructions Photobiological safety (eye safety) The surgical light is classified in risk group 2 (medium risk) according to the IEC 62471 standard and therefore extends beyond the “Free group”. The risk to the retina from blue light (400 nm to 780 nm) occurs when the thresholds of risk group 2 relating to retinal danger are significantly exceeded by blue light.
  • Page 22 1 Safety instructions Installation / replacement  WARNING Installation only by Technical Customer Service The iLED® 7 lighting system may only be installed by Technical Customer Service since otherwise the correct function of the iLED® 7 cannot be guaranteed. Replacement of components by Technical Customer Service All connected components must only be replaced by Technical Customer Service.
  • Page 23 1 Safety instructions Check room allocation Before using the Control / WallControl Panel, ensure that the Control / WallControl Panel is allocated to the correct room, since otherwise damage or danger can occur to the user and patient. • Check the room allocation in the status bar of the TruRemote operating software.
  • Page 24 1 Safety instructions Software  WARNING Only use the original software from Trumpf Medical Do not use any software other than the original software from Trumpf Medical, as this can impair the safety, effectiveness and functionality of the system and can therefore lead to increased risk for the user and the patient.
  • Page 25 1 Safety instructions Handling sterile, disposable sleeves Sterile, disposable sleeves must not be damaged and must not be reused or used after the expiry of the maximum storage period. • Replace sterile disposable sleeves after use or if they become damaged.
  • Page 26 1 Safety instructions Polycarbonate (PC), polyamide (PA), acrylonitrile-butadiene- styrene copolymer (ABS), polystyrene (PS), polyurethane (PUR), polyphenylsulfone (PPSU), polyvinyl chloride (PVC), polybutylene terephthalate (PBT), and silicones. • In the event of increased build-up of surface disinfectant, conduct a thorough basic cleaning. •...

  • Page 27: Important Information For Safe Use

    2 Important information for safe use Groups of individuals This instruction manual refers to the following groups of individuals: • Operators • Users • Qualified staff 2.1.1 Operators An operator (e.g. medical office, hospital, etc.) is any individual person or legal entity that owns and operates the device or on whose behalf the device is operated.

  • Page 28: Availability Of The Instruction Manual

    2 Important information for safe use • Prior to its first use, the device must be thoroughly cleaned and disinfected. • Once the device has been released for operation, the instructions in this instruction manual are binding for the user. 2.2.2 Availability of the instruction manual Duty to supply information...

  • Page 29: Service Life Of All Components In The Iled® 7 Lighting System

    2 Important information for safe use 2.2.5 Service life of all components in the iLED® 7 lighting system Component Service life Lamp head Ten years Axis system Ten years Preassembly set Ten years Control Two years WallControl Panel Five years Dock desk Ten years 2.2.6...

  • Page 30: Training On The Device

    2 Important information for safe use 2.4.1 Training on the device Training All user training must be hands-on at the device and carried out by qualified staff of the operator or the installation engineer authorized by the manufacturer. • On completion of the training, it must be documented that the user has understood the special operating measures required for correct use of the device for its proper use.

  • Page 31: Internationally Applied Standards

    2 Important information for safe use • EN 60601-1-2 • EN 60601-2-41 • EN 17764 • EN 0825-1 / IEC 60825 • EN 62471 / IEC 62471 • EN 60950 RoHS • DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND THE COUNCIL dated June 8, 2011 on the restriction of use of certain hazardous substances in electrical and electronic equipment •...

  • Page 32: Improper Use

    2 Important information for safe use • The color temperature must be adjustable and the adjustment method optimally selectable Any use exceeding the conditions specified above shall be considered as improper use. The user or operator is exclusively responsible for any damage arising from incorrect use.

  • Page 33: Special Conditions

    2 Important information for safe use Definition: Surgical light system A surgical light system consists of two or more surgical lights and is therefore failure-safe. It can be used without restriction within the scope of its correct use. Operation The surgical lights can be operated in two ways •...

  • Page 34: Ambient Conditions For Operation And Storage

    2 Important information for safe use • Max. output 108 mW The output was measured with an ambient light of 200 lux on a white screen which fills the camera’s field of view at a distance of 20 cm. • Wavelength 860 nm Ambient conditions for operation and storage Different ambient conditions apply for the operation and interim storage of the device.

  • Page 35: Disposal

    2 Important information for safe use Disposal • The system must be disposed of at a suitable disposal point for the recycling of electrical and electronic devices in accordance with the requirements of Directive WEEE II 2012/19/EU and country-specific regulations. RoHS compliance •...

  • Page 36: The Technology Of The Lighting System

    3 The technology of the lighting system The lamp head The iLED® 7 surgical light features settings for lighting intensity, color temperature, field of illumination size, shadow management and synchronization (Sync), as well as the automatic Adaptive Light Control plus (ALC plus) function.

  • Page 37: The Led Illuminant

    3 The technology of the lighting system Sterile hand grip with Sterile Light Using the horizontal slider on the sterile hand grip of the light or TruVidia® Wireless camera, the lighting intensity (without Endo function), color Control (SLC) (optional) temperature and size of the illumination field can be controlled in a sterile manner.

  • Page 38: Overview Of Abbreviations And Terms

    4 Overview of abbreviations and terms The following technical terms and abbreviations are used in this instruction manual: Abbreviation for application (TruRemote control software) Control element Control panel membrane at the operating lamp Touchscreen Touch-sensitive control screen Control Light, portable tablet unit with touchscreen WallControl Panel Tablet unit with touchscreen permanently installed on a wall Abbreviation for Light Emitting Diode...

  • Page 39: Identification Of The Lighting System

    5 Identification of the lighting system Use of serial numbers Figure 1 A lighting system is identified through its T RUMPF Medizin S ysteme GmbH + Co . KG Carl-Zeiss-Straße 7-9 07318 Saalfeld device label and serial numbers. Made in Germany •...
  • Page 40 5 Identification of the lighting system Designates the class of the installed Figure 2 Sensor recognition: laser product for distance measurement according to IEC 60825-1, Edition 2 (2007-03) and IEC 60825-1, Edition 3 (2014). 55000-00004_030_01 – 2070134 – 2018-01-04...

  • Page 41: Position Of The Serial Numbers On The Mobile Pedestal Version

    5 Identification of the lighting system 5.1.2 Position of the serial numbers on the Figure 3 mobile pedestal version Mobile pedestal version • The device label ① with the main serial number on the side of the power pack housing. •...

  • Page 42: Position Of The Serial Numbers On The Control

    5 Identification of the lighting system 5.1.4 Position of the serial numbers on the Figure 4 Control T RUMPF Medizin S ysteme GmbH + Co . KG 07318 Saalfeld Carl-Zeiss-Straße 7-9 The device label ① / ③ with the serial number ② of Made in Germany the control is located on the back.

  • Page 43: Description Of The Device And Its Functions

    6 Description of the device and its functions Components of the iLED® 7 lighting Figure 5 system The lighting system consists of the following components: Hardware • iLED® 7 lamp head ② with video camera connection and integrated operating element ① •...

  • Page 44: Truremote Operating Software

    6 Description of the device and its functions The tablet unit and the bumper can be disinfected but not sterilized. WallControl Panel The WallControl Panel ⑥ comprises a tablet unit with a high-resolution touchscreen, which is built into a sturdy frame.

  • Page 45: Ceiling-Mounted Version

    6 Description of the device and its functions Ceiling-mounted version Figure 7 6.2.1 Ceiling-mounted version designs The lighting system is available in various designs as a ceiling-mounted version: Surgical light as a single light on spring arm AC 2000. Surgical light system in combination with multiple lamp heads on spring arm AC 2000.

  • Page 46: Rotational / Swivel Range Of The Ceiling-Mounted Version

    6 Description of the device and its functions 6.2.4 Rotational / swivel range of Figure 8 the ceiling-mounted version The horizontally rotating extension arm ②, together with the horizontally and ② vertically adjustable spring arm ③, ① allows stable positioning of the lamp head ⑥...
  • Page 47 6 Description of the device and its functions Spring arm type AC 2000 NRH Figure 9 • Articulation - extension arm ② on the ceiling pipe ①: ② – Full horizontal rotational ① movement > 360° • Articulation - spring arm type +30°...

  • Page 48: Mobile Pedestal Version

    6 Description of the device and its functions Mobile pedestal version Figure 10 6.3.1 Designs of the mobile pedestal version The mobile pedestal version is designed as a single light and equipped with an AC 2000 NRH spring arm. NOTE The mobile pedestal version of the iLED®...

  • Page 49: Rotational / Swivel Movements Of The Mobile Pedestal Version

    6 Description of the device and its functions 6.3.4 Rotational / swivel Figure 11 movements of the mobile pedestal version 20° (-10° / +10°) The mobile stand foot ⑥ ensures unlimited mobility. The horizontally and vertically adjustable AC 2000 NRH spring arm (low room height) ④...

  • Page 50: Non-Sterile Positioning Of The Lamp Head

    6 Description of the device and its functions Non-sterile positioning of the lamp head The lamp head can be positioned in a non- sterile manner via the housing ① and at the brackets ②. In order not to impair the function of the 3D sensor ③, this is not suitable as a touchpoint for repositioning.

  • Page 51: States Of The Operating Element

    6 Description of the device and its functions management and SLC functions are deactivated and the PC is restarted. The status LED lights up once the surgical light is in normal operating mode. In safe mode, the status LED does not light up. 6.6.1 States of the operating element Figure 13...

  • Page 52: Control Sequence

    6 Description of the device and its functions Control sequence The Control / WallControl Panel is secondary in priority to the operating element, i.e. if an operating element and the Control / WallControl Panel are operated simultaneously, only the control inputs from the operating element will be actioned.
  • Page 53 6 Description of the device and its functions NOTE Assignment of the hand grip At the customer's request, the functions can also be assigned differently. Safe mode In safe mode, SLC is disabled. 55000-00004_030_01 – 2070134 – 2018-01-04...

  • Page 54: Commissioning

    7 Commissioning Checking the lighting system Figure 15 Each lighting system must be subjected to a function check before use or at least once a week, and to a visual inspection by the operator's technical personnel.  WARNING Risk of contamination and infection of the patient Loose or damaged parts are at risk of falling into wounds.

  • Page 55: Positioning The Lighting System

    7 Commissioning with damaged electrical components of the mobile pedestal version: • If the plugs ⑦ / ⑧ or mains cables ⑨ are damaged, do not connect the stand to the power supply. • If the damage mentioned above or further damage occurs, the light is no longer safe to operate: - Label the lighting system as FAULTY!

  • Page 56: Risk Of Collision While Positioning

    7 Commissioning 7.2.1 Risk of collision while Figure 17 positioning The lighting system features impact- resistant housing parts and surface coatings. Despite this, collisions can cause AC 2000 damage to the lighting system. ATTENTION Damage to the lamp head The lamp head’s swivel range can be restricted by other components or adjacent walls.

  • Page 57: Taking The Ceiling-Mounted Version Out Of Service

    7 Commissioning 7.2.3 Taking the ceiling-mounted version out of service 1. Disconnect the lighting system from the power by switching off the main switch in the operating room. The lighting system is disconnected from the mains. Commissioning the mobile pedestal version 7.3.1 Positioning the mobile pedestal version...

  • Page 58: Positioning The Pedestal

    7 Commissioning • To release the locking mechanism ⑧, push the two front casters ⑦ upwards. Figure 19 7.3.2 Positioning the pedestal 1. Release the locks on the front two casters. 2. Grip the pedestal on the stand rod ③, hold the spring arm in place and move to the place of use with the lamp head ①...

  • Page 59: Connecting The Mobile Pedestal Version To The Mains Power Supply

    7 Commissioning 7.3.3 Connecting the mobile pedestal version to Figure 20 the mains power supply The mobile pedestal version is supplied with power via a mains cable ⑥ with an IEC plug ③ and an earthed plug ⑤.  WARNING Electric shock hazard There is a risk of electric shock when in contact with damaged...

  • Page 60: Taking The Mobile Pedestal Version Out Of Service

    7 Commissioning 7.3.4 Taking the mobile pedestal version out of Figure 21 service 1. Disconnect the mobile pedestal version from the power supply by switching off the ON / OFF switch on the underside of the power pack housing ②, i.e. by moving it to position 2.

  • Page 61: Dock Desk

    7 Commissioning Dock desk 7.4.1 Selecting the location of the Dock desk The Dock desk ① must stand on a straight, level surface • stand in a location in which neither the Dock desk • ① nor the Control lying on it can inadvertently be knocked down.

  • Page 62: Replacing The Dock Desk Power Pack

    7 Commissioning  WARNING Checking the mains power supply • Before connecting to the mains power supply, check that the voltage values of the power supply correspond with the information shown on the device label of the Dock desk. • If the voltage (V) and maximum current (A) information are not the same, the mains unit must not be connected to the power supply.

  • Page 63: Control / Wallcontrol Panel

    7 Commissioning Control / WallControl Panel 7.5.1 Removing bumpers / putting bumpers on the Control Figure 24 NOTE The bumper is a wear part with a maximum service life of six months. • Bumpers must be replaced when damaged or after their service life has expired.

  • Page 64: Charging The Control

    7 Commissioning 7.5.2 Charging the Control Figure 25 The underside ③ of the Control ① fits the Dock desk ④ perfectly. 1. Place the Control ① on the Dock desk ④. A signal sounds and the Control ① is charged automatically.

  • Page 65: Inspections

    7 Commissioning NOTE Storing the Control Place the non-sterile Control on the Dock desk in the non-sterile area. Use of the Control while charging The Control can be used while charging, i.e. while it is on the Dock desk. The Control is not responding If the Control has switched off and cannot be activated, the batteries may be discharged.

  • Page 66: Handing Over Of The Organization System

    7 Commissioning Handing over of the organization system Handover and training After checking the installation, the lighting system is handed over to the operator's responsible operating personnel through hands-on training on the system's devices. After training has been completed, it must be documented that the operating personnel understand the operation of the system in line with its proper use.

  • Page 67: Daily Use Of The Surgical Lighting System

    8 Daily use of the surgical lighting system Introduction Various steps must be carried out before and after every use of the surgical lighting system. These include: • Prescribed steps • User-specific configuration Work rules Follow the safety information For the safe operation of the lighting system and to protect yourself and patients from harm, the safety information set out in Chapter 1 must be read and complied with whenever the lighting system is used.
  • Page 68 8 Daily use of the surgical lighting system Do not use damaged Controls in medical settings • Take the Control out of service. • Do not position a non-sterile Control over the sterile operation area during medical use. • Replace damaged devices or parts (bumpers, Dock desk or power pack/cable) immediately.
  • Page 69 8 Daily use of the surgical lighting system  CAUTION Impairment of vision After prolonged direct visual contact with the sensor, the eyesight may be damaged: • Do not look directly into the sensor. • Protect the patient's eyes - the patient’s eyes must be closed or protected.

  • Page 70: User-Specific Configuration

    8 Daily use of the surgical lighting system User-specific configuration Figure 26 8.4.1 Coupling the grip adapter / camera 1. Slide the locking device of the bayonet lock downwards into position ⑪ so that the three shut-off openings ⑫ of the base plate ⑬ are released.
  • Page 71 8 Daily use of the surgical lighting system ATTENTION Check the secure position of the grip adapter / camera After locking the bayonet lock, make sure to check that the grip adapter / camera is securely in place on the mount. Only use the grip adapter / camera with the sterile hand grip! Grip adapter only:...

  • Page 72: Decoupling The Grip Adapter / Camera

    8 Daily use of the surgical lighting system 8.4.2 Decoupling the grip adapter / Figure 27 camera 1. Before removing the grip adapter ⑱ / camera ⑯, remove the sterile hand grip (see Chapter 8.4.4). 2. Press the locking lever ⑮ of the grip adapter ⑱/ camera ⑯...

  • Page 73: Fitting The Sterile Hand Grip (Camera / Grip Adapter)

    8 Daily use of the surgical lighting system The camera connection must always be covered by a camera or grip adapter. 8.4.3 Fitting the sterile hand grip Figure 28 (camera / grip adapter) 1. Slide the standard sterile hand grip ④...

  • Page 74: Operating The Or Light Directly On The Operating Element

    9 Operating the OR light directly on the operating element Switching the lamp head on / Figure 29 9.1.1 Putting the power supply in standby mode Ceiling-mounted version 1. Switch on the main switch in the operating room. The power supply to the lighting system is set to standby.

  • Page 75: Disconnecting The Lighting System

    9 Operating the OR light directly on the operating element 9.1.4 Disconnecting the lighting system Ceiling-mounted version 1. Switch off the main switch in the operating room. The lighting system is disconnected from the mains. No LEDs remain lit up on the operating element. Mobile pedestal version 1.

  • Page 76: Activating And Deactivating The Radio Connection / Safe Mode

    9 Operating the OR light directly on the operating element corresponding LED ② of the current level set lights up. Activating and deactivating Figure 31 the radio connection / safe mode 1. To interrupt the connection with the Control, for example in the event of a malfunction, press button ①...

  • Page 77: Adjusting The Lighting Intensity In A Sterile Manner With The Sterile Light Control (Slc)

    9 Operating the OR light directly on the operating element 9.3.1 Adjusting the lighting intensity in a sterile Figure 32 manner with the Sterile Light Control (SLC) Below the collar ① of the sterile hand grip ② is a touch sensor ③, with which the preset function, e.g.

  • Page 78: Lamp Head Synchronization (Sync)

    9 Operating the OR light directly on the operating element The user can make contrasts as visible as possible by changing the color temperature. At the same time, a higher color temperature allows low- fatigue working and supports the ability to concentrate, e.g. during operations carried out at night.

  • Page 79: Operating The Or Light With The Truremote Operating Software

    10 Operating the OR light with the TruRemote operating software 10.1 Introduction The following functions are available: • Setting the setting ranges of one surgical light on one operating screen • Setting the setting ranges of all surgical lights on one operating screen (one-click screen) •...

  • Page 80: Operating The Control / Wallcontrol Panel

    10 Operating the OR light with the TruRemote operating software 10.2 Operating the Control / WallControl Panel Installation / replacement  WARNING Check room allocation Before using the Control / WallControl Panel, ensure that the Control / WallControl Panel is allocated to the correct room, since otherwise damage or danger can occur to the user and patient.

  • Page 81: Adjusting The Settings (Hospital Technicians Only)

    10 Operating the OR light with the TruRemote operating software 10.3 Adjusting the settings (hospital Figure 34 technicians only) 10.3.1 Opening the settings screen 1. To call up the settings screen ③ from a control screen, tap the icon. Settings The settings screen is displayed.

  • Page 82: Enabling / Disabling The One Click Screen

    10 Operating the OR light with the TruRemote operating software The change is saved. If necessary, log in for further adjustments! Figure 35- Partial repetition Fig. 30 NOTE Making the settings for each Control The Sync settings areas must be defined individually for each Control / WallControl Panel used in the operating room.

  • Page 83: Structure Of The Truremote Operating Software

    10 Operating the OR light with the TruRemote operating software 10.4 Structure of the TruRemote operating Figure 36 software If an iLED® 7 surgical light is connected, the control screen of the iLED® 7 surgical light ① always opens when an external operating unit is switched on. The quick-access bar can be used to open the control screen of the TruVidia®...

  • Page 84: Screen Structure - All Screen Types

    10 Operating the OR light with the TruRemote operating software 10.4.2 Screen structure - all screen types Figure 37 Status bar All screens have a status bar ⑥ at the top with important general information, displays and functions: • Location (e.g. operating room 1) ② •...

  • Page 85: Screen Structure - Control Screen

    10 Operating the OR light with the TruRemote operating software 10.4.3 Screen structure - control screen Figure 38 The control screen ③ is divided up into the following areas: • Quick-access bar ① - a click on the icon opens the control screen for one surgical light or for the TruVidia®...

  • Page 86: Screen Structure - One-Click Screen

    10 Operating the OR light with the TruRemote operating software 10.4.4 Screen structure - One-click screen The one click screen has a similar structure to the control Figure 39 screen, but here instead of the stylized light image, all of the settings options for the settings ranges ①...

  • Page 87: Calling Up Other Screens From A Control Screen

    10 Operating the OR light with the TruRemote operating software 10.5 Calling up other screens from a control Figure 40 screen After starting the operating software, the iLED® 7 control screen ② of the first surgical light ④ (if multiple are present) is displayed. 10.5.1 Opening other control screens 1.

  • Page 88: Operating The Light

    10 Operating the OR light with the TruRemote operating software 10.7 Operating the light Figure 41 10.7.1 Switching on the light The light can only be operated if it is switched on. 1. To switch the light on, move the slider ⑥ to the right to position I.
  • Page 89 10 Operating the OR light with the TruRemote operating software Figure 42 ① ② ③ ⑤ ④ ⑥ ⑦ ⑨ ⑧ ⑫ ⑪ ⑩ 55000-00004_030_01 – 2070134 – 2018-01-04...

  • Page 90: Adjusting The Light

    10 Operating the OR light with the TruRemote operating software 10.7.3 Adjusting the light 1. Switch on the light as described in Chapter 9.1. The image of the light illuminates and the information area shows the last setting in writing. 2.

  • Page 91: Synchronizing All Lights

    10 Operating the OR light with the TruRemote operating software 10.7.5 Synchronizing all lights 1. Tap the ⑪ button. Figure 43 Sync On all lights, the settings ranges specified on the settings screen are adjusted to the values of the surgical light currently being used.

  • Page 92: Operating The One-Click Screen

    10 Operating the OR light with the TruRemote operating software 10.7.9 Operating the one-click screen The one-click screen ① displays all settings areas ③ and their settings options ②. 1. Switching on the lights, see Chapter 9.1. Figure 44 The last settings are displayed in the settings options ②...

  • Page 93: Cleaning, Disinfection And Sterilization

    11 Cleaning, disinfection and sterilization 11.1 General For the safe operation of the surgical lights, it is essential to regularly clean and disinfect them with suitable cleaning agents and disinfectants.  WARNING Switching off the power supply Contact with live parts may result in an electric shock. •...

  • Page 94: Recommended Disinfecting Agents

    11 Cleaning, disinfection and sterilization styrene copolymer (ABS), polystyrene (PS), polyurethane (PUR), polyphenylsulfone (PPSU), polyvinyl chloride (PVC), polybutylene terephthalate (PBT), and silicones. • In the event of increased build-up of surface disinfectant, conduct a thorough basic cleaning. • To avoid damage to surfaces: Do not use sharp, pointed or abrasive objects Do not use abrasives or agents that strip away material Do not use solvents, gasoline, paint thinners, or alkaline, acidic or...

  • Page 95: Wipe-Down Disinfection

    11 Cleaning, disinfection and sterilization cleaning disinfectant. Disinfection can take place once all the visible contaminants have been removed. Wipe-down disinfection only Use only a wipe-down disinfectant to disinfect the device. Disinfection using UV light or steam is prohibited. NOTE Warranty Non-compliance with cleaning and disinfection specifications voids all warranty claims.

  • Page 96: Sterilization Of Or Light Hand Grips

    11 Cleaning, disinfection and sterilization • Completely disconnect the electrical installations in the room, where possible, and ensure that no switching can take place while disinfecting, especially automatically. • After wiping with disinfectant, wait until the disinfecting agent is completely dry. •...

  • Page 97: Preparation

    11 Cleaning, disinfection and sterilization 11.4.1 Preparation • Remove heavy soil on the sterilizable hand grip immediately after use (within 2 hours). • For later cleaning, store the sterilizable hand grip in a retaining device where the soil will remain moist. •...

  • Page 98: Sterilization

    11 Cleaning, disinfection and sterilization Interim rinsing 20 - 24 °C 60 s Disinfecting 93 °C 300 s Drying 100 °C 25 min 11.4.3 Sterilization General instructions • Sterilization processes must be validated according to EN ISO 17665-1 and EN ISO 17665-2; •...

  • Page 99: Cleaning, Disinfection And Sterilization Of External Control Units

    11 Cleaning, disinfection and sterilization deformations and replace damaged hand grips. 4. Check that the cover plate (if present) is seated securely and replace the sterilizable hand grip if necessary. 11.5 Cleaning, disinfection and sterilization of external control units For the safe operation of the Control, WallControl Panel, bumper and the Dock desk, it is essential to clean and disinfect the hardware components regularly with suitable cleaning agents or disinfectants.

  • Page 100: General

    11 Cleaning, disinfection and sterilization 11.5.2 General Use only approved cleaning and Only those agents or chemicals compatibility-tested and approved by Trumpf Medical may be used for cleaning and disinfecting as specified in disinfecting agents Chapter 11.2. Do not use agents that are not listed, otherwise functional components may be altered or damaged.

  • Page 101: Inspections And Maintenance

    12 Inspections and maintenance  WARNING Do not carry out any maintenance work during surgery or while the device is in use All equipment is subject to wear over time. As a result, the safety and proper functioning of your device must be checked at regular inspection and maintenance intervals.

  • Page 102: Annual Visual Inspection

    12 Inspections and maintenance Operating safety For safety reasons, check the components of the Control for the following prior to every use: • The Dock desk is secure • The Control is adequately charged • Visible damage, especially abrasion of the plastic surfaces or loose parts •...

  • Page 103: Two-Year Maintenance

    12 Inspections and maintenance • Visual inspection for collision damage • Visual inspection for cracks in the area of the welded joints • Test the Safe mode button regularly. 12.3 Two-year maintenance Two-year maintenance The device must only be maintained by Technical Customer Service. The inspections must be carried out at least every two years.

  • Page 104: Adjustments

    13 Adjustments 13.1 Introduction Figure 45 Adjustments should only be made by the operator’s trained technical personnel and only following suitable hospital engineer training provided by Trumpf Medical. 13.2 Adjusting the swivel range of the mobile pedestal version’s spring arm The vertical swivel movement can be adjusted in a range from +30°...

  • Page 105: Setting The Swivel Ranges Of The Spring Arm Support Arm System

    13 Adjustments 13.3 Setting the swivel ranges of the spring Figure 46 arm support arm system The vertical swivel movement can be adjusted in a range from +45° (upwards) to -50° (downwards). Adjust the swivel range in such a manner that collisions with the AC 2000 ceiling or other components are ruled out (the swivel range can be restricted up to the horizontal level).

  • Page 106: Setting The Spring Force Of The Spring Arm

    13 Adjustments 13.4 Setting the spring force of the spring arm Figure 47 The weight of the lamp head is compensated by a spring installed in the spring arm. If the spring arm with the lamp head does not remain stable in the selected height position during a swivel movement, the spring force needs to be readjusted.

  • Page 107: Setting The Braking Force Of The Support Arm System Friction Brakes

    13 Adjustments 13.5 Setting the braking force of the support Figure 48 arm system friction brakes If the extension arm, spring arm, comfort bracket, ¼ bracket or lamp head do not remain stable in the set swivel position during a swivel movement, the braking force of the friction brake needs to be readjusted.

  • Page 108: Setting The Braking Force For The Spring Arm

    13 Adjustments Brake screw type: 1378864 13.5.3 Setting the braking force for the spring arm Figure 49 Adjust the friction brake 1. Adjust the brake screw ① using a suitable slotted screwdriver: Reduce the braking force • Turn the setting screw anti-clockwise, to the left. Increase the braking force •...

  • Page 109: Setting The Braking Force For The Lamp Head On The Comfort Bracket Or ¼ Bracket

    13 Adjustments 13.5.4 Setting the braking force for the lamp head Figure 50 on the comfort bracket or ¼ bracket Adjust the friction brake for the comfort bracket 1. Adjust the brake screw ② using a suitable slotted screwdriver: Reduce the braking force •...
  • Page 110 13 Adjustments 13.6 Setting the friction brake of the spring Figure 51 arms (mobile pedestal version, NRH of the AC 2000 NRH / LCH ceiling-mounted systems) Adjust the friction brake for the lamp heads on the spring arm AC 2000 NRH: Adjusting the brake force 1.

  • Page 111: High-Wear Parts

    14 High-wear parts Hand grips, brake screws and external components Wear parts should only be replaced by the operator’s trained technical personnel and only following suitable hospital engineer training provided by Trumpf Medical. Hand grips Chapter # (article / material number) Sterilizable hand grip for lamp head;...

  • Page 112: Troubleshooting

    15 Troubleshooting NOTE Error repetition If an error recurs or cannot be resolved, take the device out of service and notify Technical Customer Service Causes and remedies Error Possible cause Remedy Chapter Mounting / mobility Lamp head falls / rises Spring force in the spring Adjust the spring force Chapter 13.5.3...
  • Page 113 15 Troubleshooting Automatic distance Failure of the sensor or 1. Disable the ALC plus detection does not work repeatedly incorrect function using the Control measurements 2. Disable the ALC plus function using safe mode (press the button on the lamp head) or 3.

  • Page 114: Technical Data

    16 Technical data 16.1 Equipment of the surgical light Designation Equipment Sterile Light Control (SLC) Optional  Adaptive Light Control Plus (ALC plus)  Automatic shadow management (available for max. two lights in one system) 16.2 Device data IP classification according to IEC 60529 Designation Values Lamp head...
  • Page 115 16 Technical data Light technology data Designation Values Central lighting intensity at 0.8 / 1.0 / 1.3 m distance 160,000 lux Dimmable from/to < 10% Endo, 30% - 100% Field of illumination size variable by changing the distance 16 cm - 30 cm Focusable field of illumination size Narrow Medium...
  • Page 116 16 Technical data Mechanical Data Designation Values Diameter of the lamp head 710 mm Flow surface of the lamp head 3300 cm Light-emitting surface 1996 cm Area of the lamp head aperture 200 cm Weight of the lamp head (including comfort and quarter approx.

  • Page 117: Emc Information

    16 Technical data 16.3 EMC information EMC notes  WARNING Only operate the device with the specified accessories The device must only be operated with the accessories specified in the accompanying paperwork. Operation with accessories, converters or cables other than those specified in the accompanying paperwork can lead to increased EMC transmissions or reduced resistance of the device to interference and therefore to incorrect operation.

  • Page 118: Iled® 7 Lighting System

    16 Technical data 16.3.1 iLED® 7 lighting system NOTE Do not stack the device with or next to other devices The iLED® 7 lighting system must not be arranged in a stacked manner immediately next to or with other devices. Key features The key feature is the provision of illumination and limitation of the energy over the operative field.
  • Page 119 16 Technical data Guidelines and manufacturer's declaration - electromagnetic immunity Guidelines and manufacturer's declaration - ELECTROMAGNETIC IMMUNITY The iLED® 7 lighting system has been designed for operation in one of the ELECTROMAGNETIC ENVIRONMENTS described below. The customer or user of the iLED® 7 lighting system should ensure that it is operated in such an environment.
  • Page 120 16 Technical data The iLED® 7 lighting system satisfies the following EN / IEC 60601-1-2:2014 test level with the specified compliance levels; the customer or user of the iLED® 7 lighting system should ensure that it is being used in such an environment.
  • Page 121 16 Technical data Guidelines and manufacturer's declaration - ELECTROMAGNETIC IMMUNITY The iLED® 7 lighting system has been designed for operation in one of the ELECTROMAGNETIC ENVIRONMENTS described below. The customer or user of the iLED® 7 lighting system should ensure that it is operated in such an environment.
  • Page 122 16 Technical data The iLED® 7 lighting system satisfies the following EN / IEC 60601-1-2:2014 test level with the specified compliance levels; the customer or user of the iLED® 7 lighting system should ensure that it is being used in such an environment.
  • Page 123 16 Technical data 2450 2400 – Bluetooth Pulse modulation 217 Hz 2 2570 WLAN 802.11 b/g/n RFID 2450 LTE band 7 5240 5100 – WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 5800 5500 5785 Controlled HF disturbance variables Recommended separation distances between portable and mobile HF communication devices and the The iLED®...

  • Page 124: Wallcontrol Panel

    16 Technical data The table below can be subject to country-specific restrictions. Table: WLAN properties Bandwidth 20 MHz or 40 MHz Frequencies 2412 MHz – 2484 MHz 4910 MHz – 5825 MHz Modulation OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and DSSS Transmission power 18 dBm 16.3.2 WallControl Panel...
  • Page 125 16 Technical data Guidelines and manufacturer's declaration - electromagnetic immunity NOTE Avoid environments with electromagnetic fields and interference stronger than those listed below Guidelines and manufacturer's declaration - ELECTROMAGNETIC IMMUNITY The WallControl Panel (iLED® 7 control system) has been designed for operation in one of the ELECTROMAGNETIC ENVIRONMENTS described below.
  • Page 126 16 Technical data Guidelines and manufacturer's declaration - electromagnetic immunity / portable and mobile radio units  WARNING Distance for portable RF communications equipment and its peripherals Portable and mobile radio units must not be used at a distance from the WallControl Panel (iLED® 7 control system), including cables, less than the recommended protection ratio calculated on the basis of the transmission frequency equation.
  • Page 127 16 Technical data Immunity levels for RF fields of wireless communications equipment Table: Special frequencies Test Band Service Modulation max. Distance Immunity Fre- (MHz) Power level (V/m) quency (MHz) 380 – 390 TETRA 400 Pulse modulation 18 Hz 1.8 430 – 470 GMRS 460 Pulse modulation FM FRS 460...
  • Page 128 16 Technical data Controlled HF disturbance variables Recommended separation distances between portable and mobile HF communication devices and the WallControl Panel The WallControl Panel (iLED® 7 control system) has been designed for operation in an ELECTROMAGNETIC ENVIRONMENT in which radiated HF disturbance variables are controlled. The customer or user of the WallControl Panel (iLED®...
  • Page 129 16 Technical data EMC-relevant wireless properties of the WallControl Panel (iLED® 7 control system) NOTE Interference caused by other devices The WallControl Panel (iLED® 7 control system) can experience interference from other devices, even if these devices comply with the CISPR-defined transmission requirements applicable to them. The table below can be subject to country-specific restrictions.

  • Page 130: List Of Components

    17 List of components 17.1 iLED® 7 components and accessories Accessories – TruVidia® Wireless Video Camera 1940442 – TruVidia® Wireless Receiver 1940747 – WallControl -Preinstall Set FLUSH 1956143 – WallControl -Preinstall Set SURFACE 1956144 – WallControl-Universal Front Interf. 1956146 – Control incl. bumper 1992609 –...
  • Page 131 17 List of components – Axis 3f ZA 850/1000/1150, STOP/3p/STOP 0386854 – Axis 2f ZA 1000/1150, 3p/3p 0387058 – FA AC2000 3p, 12-18kg 1471010 – FA AC2000 NRH 3p, 12-18kg 1471012 – FA AC2000 NRH mobile 3p 12-18kg 0384021 – iLED® 7 ¼ bracket compact cpl. 1987401 –...
  • Page 132 17 List of components – VidiaPort adapter cpl 2020629 – GTP8 adapter VidiaPort 2000 0377609 – GTP8 adapter VidiaPort 3000 0377610 – E-OT25B05 Portegra2 radiation protector 76x60 2005395 – E-OT54B01 Portegra2 radiation protector 78x90 2005442 – 19" FSN medical display 1812820 –...
  • Page 133 TRUMPF Medizin Systeme GmbH + Co. KG Head office Carl-Zeiss-Straße 7–9 07318 Saalfeld Germany Phone: +49 3671 586–0 Fax: +49 3671 586-41105 Branch offices France TRUMPF Systèmes Médicaux United Kingdom TRUMPF Medical Systems Ltd. Italy TRUMPF MED ITALIA s.r.l. United States of America TRUMPF Medical Systems, Inc.

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