Hill-Rom Trumpf Medical iLED 7 страница 1 Скачать руководство пользователя

Страница: 1 / 133

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

Содержание Trumpf Medical iLED 7

Страница 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 ...

Страница 2: ......

Страница 3: ...ponents iLED 7 lighting systems Designed as a single surgical light with a lamp head in ceiling mounted or mobile version Designed as a surgical lighting system with a combination of two to three surgical lights in ceiling mounted version Control system for the iLED 7 lighting system External control units Control and WallControl Panel TruRemote operating software The operation of the optional cam...

Страница 4: ...or TRUMPF Medizin Systeme GmbH Co KG in order to facilitate easier reading Technical Customer Service The contact details for the current Technical Customer Service hubs in the individual countries can be found on the Internet at www trumpfmedical com Technical customer service is used as a synonym for Trumpf Medical Customer service and for technicians authorized by Trumpf Medical and trained ser...

Страница 5: ...g system 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 Document number 55000 00004_030_01 Material number 2070134 Date of publication 01 04 2018 ...

Страница 6: ...ra system instruction manual DE 55000 00030 2022461 RH interface converter iLED 7 DE EN 55000 00029 2068523 EPC iLED 7 DE EN 55000 00038 2025701 SM iLED 7 DE 55000 00006 2015531 IA iLED 7 DE 55000 00005 1971385 VidiaPort holder Duo instruction manual 55000 00033 1836570 VidiaPort holder Single instruction manual 55000 00033 1836569 ...

Страница 7: ...aPort 2000 iLED 7 VidiaPort 5000 VidiaPort 3000 iLED 7 VidiaPort 2000 VidiaPort 3000 iLED 7 VidiaPort 3000 VidiaPort 3000 iLED 7 VidiaPort 5000 VidiaPort 5000 iLED 7 VidiaPort 2000 VidiaPort 5000 iLED 7 VidiaPort 3000 VidiaPort 5000 iLED 7 VidiaPort 5000 iLED 7 iLED 7 iLED 7 VidiaPort 2000 iLED 7 iLED 7 iLED 7 VidiaPort 3000 iLED 7 iLED 7 iLED 7 VidiaPort 5000 VidiaPort 2000 iLED 7 iLED 7 iLED 7 V...

Страница 8: ... Systeme GmbH Co KG TRUMPF Medizin Systeme GmbH Co KG accepts no liability for any damage arising from the non permitted use of the information set out in these instructions by other persons or companies iLED is a registered trademark of TRUMPF Medizin Systeme GmbH Co KG TruVidia is a registered trademark of TRUMPF Medizin Systeme GmbH Co KG Modifications and translations Modifications to the devi...

Страница 9: ...r of liability 28 2 2 4 Maintenance and Repair 28 2 2 5 Service life of all components in the iLED 7 lighting system 29 2 2 6 Date of production 29 2 3 Delivery 29 2 3 1 Damage in transit 29 2 3 2 Address for returns 29 2 4 Notes for users 29 2 4 1 Training on the device 30 2 4 2 Information and inspection commitment of the user 30 2 5 Compliance 30 2 5 1 Marking 30 2 5 2 Standards and directives ...

Страница 10: ...erile positioning of the lamp head 50 6 5 Sterile positioning of the lamp head 50 6 6 Non sterile operation on the operating element 50 6 6 1 States of the operating element 51 6 7 Non sterile operation with TruRemote operating software 51 6 8 Control sequence 52 6 9 Sterile operation with the hand grip 52 6 9 1 Sterile Light Control SLC optional use 52 7 Commissioning 54 7 1 Checking the lighting...

Страница 11: ...4 4 Setting the color temperature 77 9 4 5 Lamp head synchronization Sync 78 10 Operating the OR light with the TruRemote operating software 79 10 1 Introduction 79 10 1 1 Conditions for operation 79 10 2 Operating the Control WallControl Panel 80 10 2 1 Unlocking the Control WallControl Panel 80 10 2 2 Energy saving mode 80 10 2 3 Operating safety 80 10 3 Adjusting the settings hospital technicia...

Страница 12: ...n 101 12 1 1 Defective or damaged devices or accessories 101 12 2 Annual visual inspection 102 12 3 Two year maintenance 103 13 Adjustments 104 13 1 Introduction 104 13 2 Adjusting the swivel range of the mobile pedestal version s spring arm 104 13 2 1 Disconnect the mobile pedestal version 104 13 2 2 Adjusting the swivel range 104 13 3 Setting the swivel ranges of the spring arm support arm syste...

Страница 13: ... 00004_030_01 2070134 2018 01 04 16 2 Device data 114 16 3 EMC information 117 16 3 1 iLED 7 lighting system 118 16 3 2 WallControl Panel 124 17 List of components 130 17 1 iLED 7 components and accessories 130 ...

Страница 14: ...ication of additional information NOTE provides additional information and useful tips for the safe and efficient use of the device DANGER WARNING CAUTION ATTENTION NOTE In the safety information the signal words are located in the title field with the color background They follow a specific hierarchy and in conjunction with the warning symbol indicate the severity of the hazard or the type of inf...

Страница 15: ...otes CE conformity marking shows the device s conformity with the guidelines of the European Medical Device Directive MDD Follow the instruction manual refers to this instruction manual UL mark device tested by Underwriter Laboratories Inc for use in the USA and Canada UL cUL classification with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 1st Edition 04...

Страница 16: ...ence in residential buildings The user must take appropriate measures accordingly National restrictions This device is suitable for use without restriction in homes and offices in all EU countries and in other countries in which EU Directive 2014 53 EU applies Exceptions Country Restriction Reason comment Bulgaria None For outdoor operation and for public purposes a permit is generally required Fr...

Страница 17: ...tact the dealer or an experienced radio TV engineer Canada IC ID Trumpf Medical Wi fi module 8407A RS9113DB IC ID interface converter 4908B SDMAN This device complies with the FCC regulations according to Part 15 and the license free RSS standards from Industry Canada Operation is subject to the following two conditions 1 This device must not cause any harmful interference 2 This device must be ab...

Страница 18: ...for industrial commercial and medical applications Qatar The iLED 7 lighting system produced and configured for Qatar is limited in the production facility exclusively to the use of the 2 4 GHz band 2400 2435 MHz Singapore Complies with IMDA standards N1312 17 United Arab Emirates TRA REGISTERED No ER54166 17 Jordan TRC SS 2017 101 Philippines ESD 1714802C Pakistan TAC No 9 405 2017 Japan The main...

Страница 19: ...structions Location requirements Gas explosions due to anesthetics The lighting system is not suitable for use in environments containing high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide If such high concentrations of flammable mixtures of anesthetics with oxygen or nitrous oxide occur in the device s environment there is a risk of ignition under certain cond...

Страница 20: ...light for operations involving the patient s field of vision under anesthesia with open eyes Do not look directly into the light aperture Overlapping fields of illumination of several lamp heads Tissue damage to the patient Overlapping fields of illumination of several lamp heads with high lighting intensities can cause tissue damage With the early onset of tissue dehydration Separate the overlapp...

Страница 21: ...stomer Service The replacement of the bulb or repairs to the lighting system must only be carried out by Technical Customer Service Additional loads Support arm system crashing Overloading may cause the support arm system or the end device to become detached from the fixture and to fall to the ground The maximum load capacity specified in the technical data must not be exceeded Swivel motion of th...

Страница 22: ...rol device Do not use the Control WallControl Panel for findings or diagnosis Do not use the Control over the area of the operation During medical use do not use the non sterile Control over the sterile operation area as otherwise contamination or danger of infection may result for the patient Only use the Control in a sterile disposable sleeve In a sterile environment only use the Control in a st...

Страница 23: ...ing the Control can only be charged on the Dock desk and the Control must be charged on the Dock desk every 1 5 days at the latest the Dock desk can only be used to charge the Control Other devices may not be charged on the Dock desk Booting up the system The processing unit in the lamp head requires around one minute to start up After this the system is fully ready for use and operation Basic fun...

Страница 24: ...ger of contamination of the patient or injury to the user Only use the Control with the bumper and in accordance with the proper use Malfunctions of the system or the control devices If the Control does not work or does not work correctly take the following steps On the lamp head control element actuate the relevant button and activate safe mode in order to interrupt communication WLAN with the Co...

Страница 25: ...ng 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 Risk to the patient or danger of material damage from incorrectly used cleaning agents or disinfectants Non compliance with the specifications and d...

Страница 26: ...with Adjustments Performing settings The manufacturer guarantees the safety and proper function of the system only under the condition that settings are performed by an authorized hospital technician or by a person with comparable qualifications Dismantlement for service Sudden release of spring arm If the lamp head flat screen for video display is disassembled without first having put the spring ...

Страница 27: ...ob and recognize the potential hazards involved on the basis of their professional experience and instruction in the safety relevant regulations be able to demonstrate the appropriate certificate for classification as qualified staff e g medical technician certified by Trumpf Medical or Trumpf Medical sales staff in countries in which jobs in the medical technical field require certification 2 2 I...

Страница 28: ...ability Disclaimer of liability The Trumpf Medical product warranty requires that The device is used exclusively as prescribed for its proper use and is operated and maintained as stipulated in this instruction manual Only original spare parts and accessories authorized by Trumpf Medical are used No structural alterations are made to the device Checks and maintenance work are carried out at the sp...

Страница 29: ...mmediately In case of damage in transit or shortages a damage report including the following information must be forwarded to Trumpf Medical Accompanying documents Damage report providing information on the damage and or faults Main serial number of the device system or serial numbers of the damaged components Order number as specified on the shipping note and or order specific dimension sheet Nam...

Страница 30: ...l service department or from Trumpf Medical 2 5 Compliance 2 5 1 Marking Compliance The manufacturer declares the compliance of this product with the fundamental requirements as defined in Appendix I to 93 42 EEC and a complete quality assurance system as detailed in Appendix VII CE mark This device is a Class I medical device in accordance with the directive specified above and as defined in Appe...

Страница 31: ...electronic products for electrical measurement control and laboratory devices EN 301489 1 EN 301489 17 FCCprovisionsaspertherequirementsoftheFCCProvisionsandRegulations setoutin47 CFRChapter 1 Sections 2 Edition 1 10 13 and15 Edition 1 10 13 The following sub sections apply Sub section 15 2 5 3 Internationally applied standards UL 60601 1 ANSI AAMI ES60601 1 CAN CSA C22 2 No 60601 1 IEC 60601 1 20...

Страница 32: ...n in explosive areas The system must not be used near strong magnetic fields The system is not suitable for use in rooms or areas with flammable mixtures of anesthetics with air oxygen or nitrous oxide N20 If such high concentrations of flammable mixtures of anesthetic vapors with oxygen or nitrous oxide occur in the environment of the device there is a risk of ignition under certain conditions In...

Страница 33: ...ows third party integrators to integrate the iLED 7 surgical light into their system and control selected functions The iLED 7 RS 232 interface converts wire mediated RS 232 signals into wireless TCP IP signals This ultimately allows the user to wirelessly adjust the settings of the iLED 7 surgical light via the third party system A WallControl Panel is required for the integration of the iLED 7 R...

Страница 34: ...0 m above sea level applies 2 6 2 Ambient conditions for storage Ambient temperature Surgical light 20 C to 40 C A maximum storage temperature of 60 C applies for the lamp head Relative humidity 5 to 95 Atmospheric pressure 500 hPa to 1060 hPa 2 7 Combination with other medical devices The lighting system can be equipped with medical products of other manufacturers which are approved according to ...

Страница 35: ...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 The device complies with the requirements of standard EN 50581 and the 2011 65 EU RoHS Directive on the restricted use of certain hazardous substances in electrical and electronic equipment ...

Страница 36: ...ontrol of various LED groups to ensure optimal illumination of the wound area ALC plus automatically ensures a consistent lighting intensity and higher lighting power If the lamp head is moved during the surgery the movement detector automatically measures the distance of the light from the wound area This allows precise adjustment of the lighting at all times ALC plus can be disabled in the Contr...

Страница 37: ...ote operating software features an intuitively operated graphical user interface with clearly structured function areas and distinctive icons displays and buttons The clear and easy to learn operation of the various functions allows an excellent level of process safety and the easy integration of all operating room staff in the operation process TruVidia Wireless camera system optional The optiona...

Страница 38: ...ontrol screen Control Light portable tablet unit with touchscreen WallControl Panel Tablet unit with touchscreen permanently installed on a wall LED Abbreviation for Light Emitting Diode Icon Pictogram OP Operation WLAN Abbreviation for Wireless Local Area Network SLC Abbreviation for Sterile Light Control Sync Synchronization function IR Abbreviation for infrared ALC Abbreviation for Adaptive Lig...

Страница 39: ...separate serial numbers and thus enables the delivery of suitable spare parts by Technical Customer Service IP class The serial numbers identify the individual components of a device The production date of the device 5 1 1 Position of the serial numbers on the ceiling mounted version A Ceiling mounted version The device label with the main serial number on the topmost extension arm The serial numb...

Страница 40: ...ing system 55000 00004_030_01 2070134 2018 01 04 40 Figure 2 Sensor recognition Designates the class of the installed laser product for distance measurement according to IEC 60825 1 Edition 2 2007 03 and IEC 60825 1 Edition 3 2014 ...

Страница 41: ...umbers of the individual components are marked on the Spring arm bracket Lamp head Stand foot 5 1 3 Position of the sensor detection laser C Lamp head with Automatic Adaptive Light Control plus ALC plus function Sensor detection is attached in the area of the mounting on the housing of the lamp head SN 123456789 REF 4047020 2017 11 29 Carl Zeiss Straße 7 9 07318 Saalfeld Made in Germany TRUMPF Med...

Страница 42: ... number of the Dock Desk is located on the underside of the housing 5 2 Scope of delivery iLED 7 Lamp head iLED 7 with video camera connection and control element Control welded in tablet unit with bumper and or optional WallControl Panel Dock desk with power pack cable TruRemote operating software installed on Control WallControl Panel RS 232 interface iLED 7 optional with Device label Serial num...

Страница 43: ...amera system The lamp head can be mounted with or without a comfort bracket and bracket onto various support arm systems as a ceiling mounted version or mobile pedestal version Dock desk The Dock desk is placed in the non sterile area and is used as a storage location and charging station for the non sterile Control The Control is placed exactly onto the shape of the Dock desk and is then charged ...

Страница 44: ...me It is either secured with the frame onto the wall or integrated into a recess in the wall The WallControl Panel is directly connected to the hospital s power supply and does not need to be charged The WallControl Panel can be disinfected but not sterilized See Chapter 11 5 Figure 6 6 1 2 TruRemote operating software All of the functions and settings can be operated adjusted using the graphical ...

Страница 45: ...le light on spring arm AC 2000 B Surgical light system in combination with multiple lamp heads on spring arm AC 2000 6 2 2 Components of the ceiling mounted version The lighting system comprises Ceiling paneling Ceiling pipe Extension arm Spring arm AC 2000 Comfort bracket and bracket iLED 7 lamp head 6 2 3 Optional camera on the lamp head The lamp head can be equipped with an optional camera see ...

Страница 46: ...ufficient distance to adjacent walls or objects the following rotating swiveling motions can be carried out at the articulations with the support arms Spring arm type AC 2000 Articulation A extension arm on the ceiling pipe Full horizontal rotational movement 360 Articulation B spring arm type AC 2000 on the extension arm Horizontal rotational movement 360 Vertical swivel movement in the range fro...

Страница 47: ...ion B spring arm type AC 2000 NRT on the extension arm Full horizontal rotational movement 360 Vertical swivel movement in the range from 30 to 45 Articulation D bracket on spring arm type AC 2000 NRH Full vertical rotational movement 360 Articulation E lamp head on bracket Full vertical rotational movement 360 The swivel ranges of the support arms can be adjusted by the technical personnel see Ch...

Страница 48: ...bracket AC 2000 NRH spring arm Stand rod Power pack housing with mains cable the power pack housing contains the components of the electrical supply Stand foot with 4 casters 2 of which have a locking mechanism 6 3 3 Power supply to the mobile pedestal version The power supply to the mobile pedestal version is established at the power pack housing Through the mains cable with the IEC plug for conn...

Страница 49: ... range of action The rotational joints on the bracket allow precise alignment of the lamp head with the wound area Provided that there is sufficient distance to adjacent walls or objects the following rotating swiveling motions can be carried out at the articulations A spring arm on the stand rod Horizontal rotational movement in the range from 10 to 10 Vertical swivel movement in the range from 3...

Страница 50: ...horizontal slider and the Sterile Light Control SLC function 6 6 Non sterile operation on the operating element The following functions can be set on the non sterile operating element on the lamp head Surgical light on off Lighting intensity Safe mode On Off Switch for switching the surgical light on and off Lighting intensity The lighting intensity of the lamp head can be adjusted using 5 levels ...

Страница 51: ... TruRemote operating software The TruRemote operating software which is installed on the external Control and WallControl Panel operating units contains the graphical user interface for the control of up to three iLED 7 lights a TruVidia Wireless video camera in one operating room The control of the TruVidia Wireless video camera is described in a separate instruction manual The following function...

Страница 52: ...ation area as well as in the image of the device and in the corre sponding control areas or operating options See Chapter 10 4 3 The user always sees the current setting of the surgical light on the Control WallControl Panel if the corresponding control screen is open Figure 14 6 9 Sterile operation with the hand grip One of the following functions can be set in a sterile manner with simple finger...

Страница 53: ...f the device and its functions 55000 00004_030_01 2070134 2018 01 04 53 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 NOTE ...

Страница 54: ...ng system components must be checked for the following points prior to each use Loose parts on the comfort bracket bracket or on the lamp head Visible damage particularly on the Cover panels Cover plates of the internal and external LED ring 3D sensor Operating element Sterile hand grips Secure positioning of the sterile hand grips Regular function check Before every use of the surgical light chec...

Страница 55: ... lighting system should not be used near strong magnetic fields Figure 16 7 2 Positioning the lighting system Positioning the lighting system is safe and reliable Despite this pinching injuries can occur when the lighting system is being positioned Pinch hazard When the lamp head is being swiveled the distance between the two brackets or the lower bracket and the lamp head reduces When swiveling t...

Страница 56: ...ollisions with other objects or adjacent walls Before adjusting the height check that there is sufficient ceiling clearance and ensure that there are no other objects positioned above the lamp head 7 2 2 Positioning the ceiling mounted version Single light ceiling mounted version A Surgical light as a single light with a lamp head on the AC 2000 spring arm Ⴇ The best possible mobility of the suppo...

Страница 57: ...inst tipping can be endangered by rolling over objects on the floor uneven flooring or mains cables Always move the pedestal with the lamp head pointing in the direction of travel to its place of use Do not roll over any objects lying on the floor uneven flooring or mains cables To move the pedestal disconnect the mains cable plug from the socket and coil the mains cable on the power pack housing ...

Страница 58: ...mp head facing forwards Ⴇ If there are steps uneven flooring etc keep a particularly firm grip of the pedestal and spring arm surgical light and carefully overcome the obstacle 3 After positioning the mobile pedestal version lock the brakes on the two front casters 4 Position the lamp head using the sterile hand grip at a working distance of 70 to 150 cm from the wound area 5 Connect the mobile pe...

Страница 59: ...electric shock in the event of an electrical short circuit The mobile pedestal version protection class I may only be connected to a properly earthed protective contact socket 1 Check that the mains voltage matches the details specified on the device label If in doubt ask the responsible power supply company or a qualified electrician 2 Route the mains cable so that no trip hazards can occur and n...

Страница 60: ...switch on the underside of the power pack housing i e by moving it to position 0 2 Disconnect the mains cable from the earthed socket Ⴇ The mobile lighting system is switched off 3 Coil the mains cable around the power pack housing 4 Park the mobile pedestal version in a storage location with suitable ambient conditions see Chapter 2 6 2 5 Fix the front two casters in position with the locking mec...

Страница 61: ...ower supply via a power pack The power pack is equipped with a special flanged plug for connection to the Dock desk and a power pack with a plug for connection to a socket 1 Plug the flanged plug into the corresponding socket on the Dock desk according to the white marking 2 Thread the mains cable into the three cable holders and guide it out of the cable opening on the Dock desk 3 Plug the mains ...

Страница 62: ...age V and maximum current A information are not the same the mains unit must not be connected to the power supply Figure 23 7 4 3 Replacing the Dock desk power pack 1 Pull the mains unit adapter out of the power socket 2 Unthread the mains cable from the cable opening and the three cable holders 3 Pull the flanged plug out of the socket on the Dock desk 4 Clearly label the power pack e g Faulty an...

Страница 63: ...n the adjacent corner of the bumper diagonally outwards over the corner of the welded in tablet unit 3 Pull down another corner of the bumper diagonally outwards over the corner of the welded in tablet unit and remove the tablet unit from the bumper B Putting on the bumper 1 Slide the welded in tablet unit from above into one corner of the bumper 2 Slip the edge of the adjacent corner of the bumpe...

Страница 64: ...hold the On Off switch until the Apple logo is displayed A few seconds later the Unlock screen appears Control standby Briefly pressing the On Off switch sets the Control WallControl Panel to standby Unlocking the Control WallControl Panel After switching on activating the Control WallControl Panel must be unlocked before the TruRemote operating software can be started To do this move the Unlock s...

Страница 65: ...ged on the Dock desk every 1 5 days at the latest 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 Correct function of the operating unit including the TruRemote operating software 7 6 Inspections 7 6 1 Befor...

Страница 66: ...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 See Chapter 2 5 4 ...

Страница 67: ...e and obtain replacements Cleaning and disinfection 2 See Chapter 11 Charging the Control 3 Place the Control on the Dock desk and charge it fully Before every operation 1 Activate the Control WallControl Panel and operating page of the iLED 7 TruRemote operating software Function test 2 Check the function of the Control WallControl Panel 3 Check the function of all operating pages of the TruRemot...

Страница 68: ...edestal version If the plugs or mains cable are damaged the lighting system must not be connected to the power supply Take the device out of service and label it FAULTY Taking the lighting system out of operation If functional defects or damage occur that impair the operational safety of the lighting system the device must be taken out of service Disconnect the lighting system from the power suppl...

Страница 69: ...the patient s eyes the patient s eyes must be closed or protected The performance of operations or procedures other than those specified in this instructions manual may lead to hazardous radiation effects by the sensor Complications due to charge balancing To avoid complications due to electrostatic charge balancing between device parts and patients the user must not touch the light and the patien...

Страница 70: ... 2 Align the grip adapter camera or camera so that the arrangement of the three bayonet pins and the two centering pins of the mount are aligned with the shut off openings in the base plate of the lamp head alignment of the camera plug connector then also matches up 3 Connect the grip adapter or camera to the mount on the lamp head Ⴇ To secure it in place slide the locking device of the bayonet lo...

Страница 71: ... sterile hand grip Grip adapter only 4 Slide the cover metal ring onto the grip adapter and the mount of the lamp head Ⴇ Ensure that the plastic catch on the mount is correctly engaged in the securing hole on the cover 5 Push the sterile hand grip onto the camera so that the locking lever of the camera audibly engages in the securing hole of the hand grip 6 If necessary adjust the braking force on...

Страница 72: ...n Grip adapter only 3 Press the plastic catch on the mount in and pull the cover off the hand grip Grip adapter and camera 4 Hold the lamp head still 5 Slide the bayonet lock downwards into position so that the three shut off openings on the base plate are released 6 Remove the grip adapter or camera from the mount on the lamp head Camera only 7 Carefully set down the camera 8 If necessary adjust ...

Страница 73: ...Slide the standard sterile hand grip or Sterile Light Control SLC hand grip onto the camera or slide the grip adapter so that the locking lever of the camera grip adapter audibly engages in the hand grip s securing hole 2 Check that the sterile hand grip is securely in place 8 4 4 Removing the sterile hand grip camera grip adapter Push the locking lever of the camera grip adapter in and pull off t...

Страница 74: ...e to the hospital s power supply 2 Switch on the power pack by moving the switch to position I see Chapter 7 3 3 Ⴇ The power supply to the mobile lighting system is set to standby 9 1 2 Switching on the lamp head 1 Press button ON OFF on the operating element of the lamp head Ⴇ The light illuminates with the default setting or the last lighting intensity set depending on which option was set durin...

Страница 75: ...ng the lighting intensity High lighting intensity with overlapping fields of illumination When working with overlapping fields of illumination from multiple lamp heads high levels of intensity can accelerate eye fatigue and tissue dehydration Reduce the lighting intensity of the lamp heads The lighting intensity of the lamp head can be adjusted using 5 levels ENDO 30 50 80 100 Increase the lightin...

Страница 76: ...econds Ⴇ LED goes out 2 To restore the connection with the Control press button again Ⴇ LED lights up Ⴇ The light can again be operating using the Control Effects of safe mode Safe mode disconnects the communication connection WLAN to the Control and restarts the internal processing unit Shadow management ALC plus Sync and SLC functions are disabled and the light is switched to its default setting...

Страница 77: ...d illumination of the wound area If the lamp head is repositioned during surgery the distance of the lamp head to the wound area is automatically determined and the field of illumination and lighting intensity are adapted optimized accordingly To set the ALC plus function 9 4 2 Diameter of the field of illumination For distances of 0 8 to 1 3 meters commonly used in everyday surgical settings thre...

Страница 78: ... concentrate e g during operations carried out at night There are four color temperatures available 3500 4000 4500 and 5000 K 9 4 5 Lamp head synchronization Sync When this function is activated the following situations are set synchronously for all lamp heads in the system max three lamp heads Lighting intensity Field of illumination size Color temperature ALC plus status Shadow management status...

Страница 79: ...ynchronize all lights to the settings of the light currently being used Sync The scope of the synchronization function can be set by the hospital technician together with activation of the one click screen See Chapter 10 3 10 1 1 Conditions for operation A device can only be operated if it is switched on and connected to the power supply In addition it must be licensed for the operating room recog...

Страница 80: ...ontrol Panel After switching on activating the Control WallControl Panel must be unlocked before the TruRemote operating software can be started To do this slide the Unlock slider to the right on the touchscreen This function of the Control WallControl Panel cannot be switched off 10 2 2 Energy saving mode The Control WallControl Panel darkens after around one to two minutes if the screen is not u...

Страница 81: ...red with the number pad or Tap the Cancel button and end the process 10 3 2 Changing the room name 1 Tap the Room name field Ⴇ The keyboard appears 2 Change the room name 3 Tap the Main button Ⴇ The change is saved Ⴇ If necessary log in for further adjustments 10 3 3 Defining the scope of synchronization The Synchronization Sync function sets the values of the lights being used currently on all of...

Страница 82: ...nstead of the operating screen so that all settings can be changed on a single page 1 To activate the one click screen function tap the One click setting field Ⴇ A tick appears in the field Ⴇ Next time a light s control screen is opened it is displayed 2 To deactivate the one click screen function tap the One click setting field Ⴇ The tick disappears and field is empty Ⴇ Next time a light s contro...

Страница 83: ...nnected to another Trumpf Medical surgical light not iLED 7 the TruVidia Wireless control screen appears See the separate TruVidia Wireless camera system instructions for use 10 4 1 Graphical user interface of the iLED 7 surgical light The graphical user interface of the iLED 7 is comprised of four different screen types A control screen for each iLED 7 surgical light An optional one click screen ...

Страница 84: ...connected Status indicator Charge status and icon of the Control 3 4 1 2 7 56 8 Video OP 1 Icon Meaning Signal strength 0 no connection device is switched off Signal strength 1 many sources of interference are present line of sight connection between the camera and receiver is interrupted Signal strength 2 sources of interference are present line of sight connection between the camera and receiver...

Страница 85: ...intensity Color temperature Size of the field of illumination ALC plus active not active status With each change of the settings options the light image adapts to the modified selection Information area with the current settings for brightness color temperature field of illumination and ALC plus in written form Settings options for settings areas Action bar to with the following functions Switch t...

Страница 86: ...re 39 The one click screen has a similar structure to the control screen but here instead of the stylized light image all of the settings options for the settings ranges are displayed This allows the surgical lights to be operated more quickly It therefore shows the current settings of the surgical light as a highlight in the respective image icon 1 ...

Страница 87: ... device in the quick access bar Ⴇ The selected control screen is displayed 10 5 2 Opening the settings screen 1 To call up the settings screen tap the Settings icon Ⴇ The settings screen is displayed 10 6 Calling the control screens from a settings screen 1 To call up a control screen on a settings screen tap the Main icon Ⴇ The control screen of the last surgical light selected is displayed 2 To ...

Страница 88: ... move the slider to the right to position I Ⴇ The image of the light illuminates and shows the last settings which were used in the settings area the settings options and the information area 10 7 2 Switching off the light 1 To switch the light off move the slider to the left to position 0 Ⴇ The image of the light no longer illuminates the Information area is empty the settings options disappear a...

Страница 89: ...10 Operating the OR light with the TruRemote operating software 55000 00004_030_01 2070134 2018 01 04 89 Figure 42 ...

Страница 90: ...ure Four color variants 3500 4000 4500 5000 K Field of illumination Three settings versions Narrow medium wide ALC plus On Off 3 Select the settings option by tapping it Ⴇ The change to the settings option is indicated visually in the image of the light and in text form in the information area 10 7 4 Activating shadow management 1 Tap the Shadow button Ⴇ The light adjusts automatically to what is ...

Страница 91: ...ll Endo is selected or if this is selected during the synchronization process a feedback window appears asking whether all lights really are to be set to the Endo lighting intensity 2 Tap the OK or Cancel button as necessary 10 7 6 Switching all lights on 1 Tap the All on button Ⴇ All surgical lights present are switched on 10 7 7 Switch all lights off 1 Tap the All off button Ⴇ A feedback window ...

Страница 92: ...lect the settings area required by tapping the icon Ⴇ The settings areas are Lighting intensity Five setting levels Endo 30 50 80 and 100 Color temperature Four color variants 3500 4000 4500 5000 K Field of illumination Three setting versions Narrow medium wide ALC plus On Off Or execute point 3 directly 3 Select the settings option by tapping the corresponding icons in the individual settings opt...

Страница 93: ...itch off the main switch in the operating room Ⴇ The lighting system is disconnected from the mains Mobile pedestal version 1 Switch off the power pack by moving the switch to position 0 See Chapter 7 3 4 2 Disconnect the mains cable from the earthed socket Ⴇ The mobile lighting system is switched off Improperly used cleaning or disinfecting agents can endanger patients or damage products Non comp...

Страница 94: ... Medical as Cleaning supplement disinfection sterilization surgical lights 11 3 Cleaning and disinfection of the surgical lighting system 11 3 1 General To be performed by hygiene specialists Only a hygiene specialists or those instructed by them may clean and disinfect the OR lights Use only approved cleaning and disinfecting agents Only those agents or chemicals compatibility tested and approved...

Страница 95: ...crobiological effect The fluid does not need to remain on the surface Avoid build up Applying too much fluid to the surface during disinfection leaves behind residue This can lead to incorrect measurements especially on the sensor cover plate To prevent build up of disinfectant residue a mild all purpose cleaner should be used for regular cleaning Clean at least once per month The regularity of cl...

Страница 96: ...y After wiping with disinfectant wait until the disinfecting agent is completely dry Ensure that the room is adequately ventilated 11 4 Sterilization of OR light hand grips Material The hand grips are made of polyphenylsulfone PPSU a heat resistant shock resistant plastic Warranty Non compliance with sterilization specifications voids all warranty claims No liability is assumed for damage caused b...

Страница 97: ...Rinse off the cleaning agent thoroughly with faucet water Disinfecting Use a wipe down or spray disinfectant Trumpf Medical recommends products with an alcohol or aldehyde base that are approved by the manufacturer for use on PPSU 1 Disinfect the sterilizable hand grip 2 Check the sterilizable hand grip for material damage cracks or deformations and replace damaged hand grips 3 Check that the cove...

Страница 98: ... on the rinsing device danger of scratching Sterilize sterilizable hand grips individually in packaging suitable for steam sterilization The sterilization packaging has to be large enough for the hand grip without placing any tension on the seal If sterilizing more than one hand grip in one sterilization cycle do not exceed the maximum load of the sterilizer a Steam sterilization at 132 C 270 F St...

Страница 99: ...lean and disinfect the components of the device wipe them with a damp but not wet cloth Dose cleaning agent disinfectant such that no fluid flows into the joints or openings of the device Use surface disinfectants only in the concentration specified by the manufacturer Use only disinfectants approved by the manufacturer for use on the following materials Polycarbonate PC polyamide PA acrylonitrile...

Страница 100: ...nfection is used as the disinfection method Wipe with moist cloth only To clean and disinfect the components of the device wipe them with a damp but not wet cloth Apply only a thin liquid film wipe and leave behind only a thin cohesive film of moisture This moist film has sufficient microbiological effect The fluid does not need to remain on the surface Avoid build up Applying too much fluid to th...

Страница 101: ...l Customer Service Inspection before and after use The user is required to check the device for visible damage before and after every use This can be integrated into the cleaning procedure for example The following damage must be reported to the operator s technical personnel Loose parts on the lighting system Visible damage to the lighting system particularly on the cover plate of the lamp head a...

Страница 102: ...personnel If there is damage or a fault notify Technical Customer Service Faulty devices or accessories Defective devices and function units must be immediately marked clearly and removed from operation 12 2 Annual visual inspection Annual visual inspection A visual inspection of the entire lighting system must be performed by qualified operator personnel once a year In particular the following de...

Страница 103: ...nt must be tested as regards the following Maintenance Electrical safety inspection with the testing specifications for performance of the electrical repeat inspection being available from Trumpf Medical Shorter maintenance intervals After 10 years in operation the functional inspection on the lighting system must be repeated once a year Documentation in accordance with Medical Devices Operators O...

Страница 104: ... the earthed socket Ⴇ The mobile lighting system is switched off 2 Ensure that the power plug is safeguarded against being inadvertently plugged in again 13 2 2 Adjusting the swivel range Removing the cover panels 1 Carefully press in the two halves of the cover panel at the six clips using a compatible slotted screwdriver and unlock them 2 Remove the halves of the cover panel Adjusting the swivel...

Страница 105: ...the ceiling or other components are ruled out the swivel range can be restricted up to the horizontal level 13 3 1 Adjusting the swivel range 1 Insert the hexagon wrench size 5 into the setting screw in the adjustment opening 2 Pull the spring arm down to relieve the setting screw Reducing the swivel range Turn the setting screw clockwise to the right Extending the swivel range Turn the setting sc...

Страница 106: ... system is switched off 2 Ensure that the power plug is safeguarded against being inadvertently plugged in again All versions 3 Insert the hexagon wrench size 5 into the setting screw in the adjustment opening 4 Position the spring arm approximately 10 relative to the horizontal in order to relieve the setting screw in the spring arm 13 4 1 Ceiling mounted version To reduce the spring force Turn t...

Страница 107: ... are designed as slotted screws No other type of screw should be loosened 13 5 1 Disconnecting the lighting system Ceiling mounted version 1 Switch off the main switch in the operating room Ⴇ The lighting system is disconnected from the mains 2 Ensure that the main switch is safeguarded against being inadvertently switched back on Mobile pedestal version 1 Switch off the power pack by moving the s...

Страница 108: ...or the spring arm Adjust the friction brake B 1 Adjust the brake screw using a suitable slotted screwdriver Reduce the braking force Turn the setting screw anti clockwise to the left Increase the braking force Turn the setting screw clockwise to the right 2 Check the function of the braking force Brake screw type 1378857 1 B B ...

Страница 109: ...crew anti clockwise to the left Increase the braking force Turn the setting screw clockwise to the right 2 Check the function of the braking force Brake screw type 4025239 Adjust the friction brake D for the bracket lamp head 1 Adjust the brake screw using a suitable slotted screwdriver Reduce the braking force Turn the setting screw anti clockwise to the left Increase the braking force Turn the s...

Страница 110: ...on brake D for the lamp heads on the spring arm AC 2000 NRH Adjusting the brake force 1 Adjust the brake screw on both sides using a suitable slotted screwdriver Reduce the braking force Turn the setting screw anti clockwise to the left Increase the braking force Turn the setting screw clockwise to the right Check the function of the braking force Brake screw type 1378866 D AC 2000 NRH LCH 1 2 ...

Страница 111: ...rew on spring arm AC 2000 NRH M12 x 1 mm with 2 mm length two pieces 1378866 Slotted brake screw on extension arm extension arm brake M12 x 1 mm with 30 mm length two pieces 1378864 Slotted brake screw on extension arm spring arm brake M12 x 1 mm with 16 mm length two pieces 1378857 Slotted brake screw on comfort bracket M10 x 1 mm with 11 mm length two pieces 4025239 External components Chapter R...

Страница 112: ...rease the brightness Chapter 9 2 Uneven field of illumination Lamp head is outside the work area Position the lamp head Chapter 7 2 Chapter 7 3 1 Shock impact on the light Switch the lamp head off and on again Chapter 9 1 The light does not illuminate The main switch in the operating room is switched off Switch the main switch on The lamp head has been switched off at the control element Press the...

Страница 113: ...ent color temperatures in the field of illumination The color temperature is only set on one light Switch on the Sync function See Chapter 10 7 5 Operation Control The light cannot be operated with the Control Fault in the WLAN connection Control lighting intensity using the control element on the lamp head Sterilizable hand grip Hand grips are damaged or exhibit cracks The end of their useful lif...

Страница 114: ...perwork can lead to increased EMC transmissions or reduced resistance of the device to interference Designation Equipment Sterile Light Control SLC Optional Adaptive Light Control Plus ALC plus Automatic shadow management available for max two lights in one system Designation Values Lamp head IP40 Axis system IP20 Control IP67 WallControl Panel IP42 Designation Values Supply voltage on the power s...

Страница 115: ...ith one shade 92 147 200 lux Residual lighting intensity with two shades 68 108 800 lux Residual lighting intensity with lens barrel 98 156 800 lux Residual lighting intensity with lens barrel and one shade 91 145 600 lux Residual lighting intensity with lens barrel and two shades 66 105 600 lux Illumination depth L1 L2 at 20 Ec EN ISO 60601 2 41 2nd Edition 1930 mm with ALC plus Illumination dept...

Страница 116: ...emitting surface 1996 cm2 Area of the lamp head aperture 200 cm2 Weight of the lamp head including comfort and quarter brackets approx 15 5 kg Designation Values Max output power 108 mW Wavelength 860 nm Designation Values Wireless communication and mobile radio IEEE 802 11a 802 11b 802 11g 802 11n Data rate 802 11b 1 2 5 5 11 Mbps 802 11g 6 9 12 18 24 36 48 54 Mbps 802 11n MCS0 up to MCS7 with an...

Страница 117: ... basic safety in relation to EMC over the expected operational service life The properties of this device determined by emissions allow its use in the industrial sector and in hospitals CISPR 11 Class A When used in domestic situations for which CISPR 11 normally Class B is required this device may not provide adequate protection from radio services The user must if necessary take remedial measure...

Страница 118: ... 7 lighting system should ensure that it is operated in such an environment Emissions measurements Compliance ELECTROMAGNETIC ENVIRONMENT guidelines HF emissions in accordance with CISPR 11 Group 1 The iLED 7 lighting system uses HF energy only for its internal FUNCTIONING Therefore its HF emissions levels are very low and it is improbable that neighboring devices would be affected by interference...

Страница 119: ...l business or hospital environment Impulse voltages surges in accordance with EN IEC 61000 4 5 1 kV outer conductor outer conductor voltage 2 kV outer conductor ground voltage 1 kV outer conductor outer conductor voltage 2 kV outer conductor ground voltage The supply voltage quality should correspond to that in a typical business or hospital environment Voltage dips short inter ruptions and voltag...

Страница 120: ...owing 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 Interference immunity test EN IEC 60601 1 test level Compliance level Static electricity discharge ESD according to EN IEC 61000 4 2 8 kV contact discharge 15 kV air discharge 8 kV contact discharge 15 kV air disch...

Страница 121: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a is less than the COMPLIANCE LEVEL b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 For 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines might not be applicable in all situations The propagation of electromagnetic waves is ...

Страница 122: ... ISM industrial scientific and medical between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3 MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 2...

Страница 123: ...nications equipment transmitters and the iLED 7 lighting system as recommended below in accordance with the communications equipment s maximum output Rated output of the transmitter W Separation distance according to transmission frequency m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 1 1 10 100 0 12 0 38 1 2 3 8 12 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 2...

Страница 124: ...n environment Emissions measurements Compliance ELECTROMAGNETIC ENVIRONMENT guidelines HF emissions in accordance with CISPR 11 Group 1 The WallControl Panel iLED 7 control system uses HF energy only for its internal FUNCTIONING Therefore its HF emissions levels are very low and it is improbable that neighboring devices would be affected by interference HF emissions in accordance with CISPR 11 Cla...

Страница 125: ... for power lines 1 kV for input and output lines 100 kHz repeat frequency 2 kV for power lines 1 kV for input and output lines 100 kHz repeat frequency The supply voltage quality should correspond to that in a typical business or hospital environment Impulse voltages surges in accordance with EN IEC 61000 4 5 1 kV outer conductor outer conductor voltage 2 kV outer conductor ground voltage 1 kV out...

Страница 126: ...ich corresponds to a professional healthcare facility for healthcare WARNING NOTE Interference immunity test EN IEC 60601 1 test level Compliance level Conducted HF disturbance variables as per EN IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V In the ISM band between 0 15 MHz and 80 MHz a 3 V 0 15 MHz 80 MHz 6 V In the ISM band between 0 15 MHz and 80 MHz a Radiated HF disturbance variables as per EN IEC 6...

Страница 127: ... FRS 460 Pulse modulation FM 5 kHz variation 1 kHz sine 2 0 3 28 720 704 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 75 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 24...

Страница 128: ... recommended below in accordance with the communications equipment s maximum output Rated output of the transmitter W Separation distance according to transmission frequency m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 1 1 10 100 0 12 0 38 1 2 3 8 12 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 23 For transmitters whose maximum rated power is not indicated in t...

Страница 129: ... 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 Table WLAN properties NOTE Bandwidth 20 MHz or 40 MHz Frequencies 2412 MHz 2484 MHz 4920 MHz 5825 MHz Modulation OFDM with BPSK QPSK 16 QAM and 64 QAM 802 11b with CCK and DSSS Wi Fi transmission power 18 dBm for 802 11b DSS...

Страница 130: ...s 3f ZA 700 850 1000 STOP 3p STOP 1470969 Axis 2f ZA 1000 1150 STOP 3p 1470997 Axis 2f ZA 1000 1150 3p STOP 1470999 Axis 1f ZA 1000 3p 1471346 Axis 2f ZA 850 1000 STOP 7P 1529528 Axis 1f ZA 700 3p 1561452 Axis 1f SlimLine 750 3p AC2 1622050 Axis 1f ZA 1750 3p 1622052 Axis 2f ZA 1600 1750 Stop 3p 1623198 Axis 1f ZA 1600 3p 1623236 Axis 2f ZA 1450 1600 Stop 3p 1623250 Axis 2f ZA 1450 1600 3p 3p 1623...

Страница 131: ...1583966 Disposable hand grip adapter 2066135 iLED 7 standard hand grip adapter TL 2065945 SLC hand grip cpl 2065726 Sterilizable ALC hand grip pack of 3 1660214 Sterilizable central hand grip pack of 3 4025708 Sterilizable camera grip pack of 3 4025709 Control bumper 1835271 Control bumper pack 3 pcs 1887193 SteriTablet 240x340 mm 1881617 FA AC2000 stop 3 5 7 kg 1471018 FA AC2000 stop 6 11 kg 1471...

Страница 132: ...r 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 26 HD FSN medical display 1844095 24 FSN medical display 1975566 32 High Bright LED medical display 2068217 ...

Страница 133: ...d 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 Australia TRUMPF Med Australia Singapore TRUMPF Pte Ltd Medical Division China TRUMPF Medical Systems Ltd United Arab Emirates TRUMPF...

Результаты поиска

Содержание Trumpf Medical iLED 7

Отзывы:

Похожие инструкции для Trumpf Medical iLED 7

Бренды по названию

Популярные бренды

Hill-Rom Trumpf Medical iLED 7, Инструкция по эксплуатации

Результаты поиска

Содержание Trumpf Medical iLED 7

Отзывы:

Похожие инструкции для Trumpf Medical iLED 7

Бренды по названию

Популярные бренды