Summary of Contents for Hill-Rom Trumpf Medical TruLight 5000
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Instruction manual TruLight 5000/3000 lighting system Read the instruction manual before using the product and store for later reference. Englisch en-GB...
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Thank you very much for buying the new TruLight 5000/3000 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 applies to the TruLight 5000 and TruLight 3000 lighting systems: •...
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How to contact us Manufacturer and distributor TRUMPF Medizin Systeme GmbH + Co. KG Carl–Zeiss–Straße 7–9 07318 Saalfeld Germany www.trumpfmedical.com Telephone: +49 3671 586-0 Fax: +49 3671 586-41165 E-mail: info@trumpfmedical.com Technical Customer Service TRUMPF Medizin Systeme GmbH + Co. KG Carl–Zeiss–Straße 7–9 07318 Saalfeld Germany...
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Notes relating to this documentation Copyright and property rights All rights reserved. This instruction manual is protected by copyright. Copyright • Any use not currently regulated by law must be approved in writing by TRUMPF Medizin Systeme GmbH + Co. KG, hereinafter referred to as Trumpf Medical.
Table of Content Important information regarding safe use ..............10 Details for the identification of the system ....................10 Details for identification of the instruction manual..................10 Designation of groups of individuals....................... 10 1.3.1 Operator .....................................10 1.3.2 User.....................................10 1.3.3 Specialist personnel ................................10 Information for operators..........................
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Table of Content 4.1.4 Position of the laser marking ..............................25 Description of devices and functions................26 Description of the ceiling-mounted version ....................26 5.1.1 Implementation of the ceiling-mounted version........................26 5.1.2 Components of the ceiling-mounted version ........................26 5.1.3 Camera on light head, optional ............................26 5.1.4 Size of the light heads .................................26 5.1.5...
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Table of Content 8.9.1 Non-sterile setting of the light intensity at the control panel ....................54 8.9.2 Set the light intensity in the sterile area using the Sterile Light Control (SLC) ..............55 8.9.3 Setting the light intensity to the working distance in the non-sterile area with Adaptive Light Control (ALC)....56 8.9.4 Adjusting the light intensity with Adaptive Light Control plus (ALC plus) ................57 8.9.5...
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Table of Content 12.7.3 Adjusting the braking force for the spring arm........................75 12.7.4 Adjusting the brake of the convenience bracket on AC 3000.....................75 12.7.5 Adjusting the brake force of the cardan joint rod ......................76 12.7.6 Setting the braking force of the cardan joint axle on the standard light head..............77 12.7.7 Setting the braking force on the light head SLC / ALC plus....................78 12.7.8 Setting the cardan joint axis braking force on the standard light head with camera............79 Consumables ......................
Important information regarding safe use Details for the identification of the system This instruction manual is solely intended for systems with rating plates that show the following information: – TruLight single 4038110 System identification – TruLight mobile 4038120 – TruLight wall 4038130 –...
Important information regarding safe use • The device may only be operated, cleaned, disinfected and maintained by qualified personnel. 1.4.1 Initial commissioning This instruction manual is only valid after successful initial operation by the operator Scope or an installer authorised by the manufacturer. •...
Important information regarding safe use Delivery Before installation, check the delivered components for completeness and for any possible transportation damage. • To check the delivery, unpack all components and carry out visual inspection. • The components can be identified on the basis of the order number on the delivery note and / or the order-specific dimension sheet.
Important information regarding safe use CE mark: This device is a Class I medical device as defined by the European Medical Device Directive (MDD). UL marking: device has been tested by Underwriter Laboratories Inc. for the USA and UL mark Canada with regard to electric shock and fire hazard as well as mechanical hazards.
Important information regarding safe use Surgical lighting system A surgical lighting system consists of two or multiple small surgical lamps and is Definition: Surgical lighting system usable without restrictions. 1.8.5 Special features The light heads provide high light intensity to ensure good visual conditions for the High light intensity surgeon.
Important information regarding safe use 1.10 Combination with other medical devices • The system can be combined with medical devices from other manufacturers Observe the instruction manuals of (e.g. monitoring systems). The operation of the devices is described in the combined medical devices relevant instruction manual.
Safety instructions Structure of the safety instructions in this instruction manual Important information is shown in this instruction manual by means of symbols and signal words. 2.1.1 Indicating risk of injury Signal words such as DANGER, WARNING or CAUTION indicate the severity of the hazard.
Safety instructions Risk of pinching: warns of pinching the fingers in the device. Damage to surfaces: warns against damages to surfaces caused by unsuitable cleaning agents and disinfectants. Symbols on the device CE conformity mark: certifies that the device complies with the European Medical Device Directive (MDD).
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Safety instructions BF/CF Class application components No BF or CF Class application components in accordance with IEC 60601-1 may be directly connected to the support arm systems of the lighting system. WARNING Electric shock The lighting system may only be connected to an appropriately earthed power supply with protective conductors in order to avoid the risk of an electric shock.
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Safety instructions Contact with laser beams WARNING Damage to vision Direct contact with the laser beam may cause damage to vision: • Do not look directly into the laser beam • Protect the patient's eyes: The patient's eyes must be closed or protected as necessary (e.g. with safety goggles with an optical density of at least 2 or designed according to protection level 6 EN169).
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Safety instructions • Only position the light head by using the sterile handle or the non- sterile handles (outer handles). Cleaning and disinfection WARNING Improperly used cleaning agents or disinfectants can pose a risk for patients or damage products If the following information and instructions are not observed or complied with, this may result in a risk of contamination or infection for the patient or damage to the product.
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Safety instructions done by an authorised hospital technician or a person with equivalent qualification. Deinstallation for service purposes WARNING The spring arm may bounce up When the light head/flat screen is removed before moving the spring arm to the top-most limit stop position, the spring arm will shoot up and can cause severe injuries: •...
The technology of the lighting system The light head The light head has a wide range of new functions that allow for ergonomic control using the control panel on the light head or using the optional wall-mounted control panel. The light heads are fitted with illuminated, non-sterile handles (outer handles). The Operating modes of the non-sterile following operating modes are available: handles (optional)
The technology of the lighting system The LED light source The light system is a future-proof light equipped with LEDs (Light Emitting Diodes). LEDs have a very high service life, unlike conventional halogen or discharge lights. Service life Further advantages of the LEDs are that they generate less heat by not emitting IR Low heat generation (infrared) radiation and cause less tissue damage by not emitting UV (ultraviolet) radiation.
Identification of the lighting system Use of serial numbers Figure 1 A light system is identified by its rating plate and serial numbers. • The ra ng plate ① contains the specific device data and also the main serial number. The main serial number identifies a complete device order-specifically.
Identification of the lighting system 4.1.3 Position of the serial numbers Figure 2 on the mobile stand version C: Mobile stand version • The ra ng plate ① with the main serial number is on one side of the power adapter housing.
Description of devices and functions Description of the ceiling- Figure 3 mounted version 5.1.1 Implementation of the ceiling- mounted version Different models of the ceiling-mounted version of the lighting system are available: • A: Surgical light as single light with a small light head on the AC 2000 type spring arm •...
Description of devices and functions 5.1.5 Rotation / swivel ranges of the Figure 4 ceiling-mounted version The horizontally rotatable boom ② together with the horizontal and vertically adjustable spring arm ③ or ⑦ facilitate stable posi oning of the light head ⑤ within the activity range of the support arm system.
Description of devices and functions • Hinge E, light head on cardan joint light head: Swivel movement (200°). The swivelling ranges of the support arms are adjustable (see Chpt. 12). Description of the wall- Figure 5 mounted version 5.2.1 Implementation of the wall- mounted version Different models of the wall-mounted version of the lighting system are available:...
Description of devices and functions 5.2.4 Rotary / swivel movement of Figure 6 the wall-mounted version The horizontally rotatable boom ② together with the horizontal and vertically adjustable spring arm ③ facilitate stable posi oning of the light head ⑤ within the ac vity range of the support arm system.
Description of devices and functions Description of mobile stand Figure 7 version 5.3.1 Implementation of the mobile stand version The mobile stand version is available as an single light equipped with an AC 2000 LCH type spring arm. 5.3.2 Components of the mobile stand version The mobile stand version consists of: •...
Description of devices and functions 5.3.5 Rotating / swivel movement of Figure 8 the mobile stand version The stand base ⑤ with castors facilitates unrestricted mobility. The horizontally and vertically adjustable AC 2000 LCH (Low Ceiling Height) type spring arm ③ on the stand rod ④...
Description of devices and functions Functional specifications of Figure 9 the light head 5.4.1 Positioning the light head Sterile positioning The light head can be positioned with complete sterility using the sterile handle: • sterile handle, standard version ④, • sterile handle with function: Sterile Light Control (SLC) ⑥.
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Description of devices and functions TruLight 3000 can be fitted with an optional wall-mounted control panel ⑩. TruLight 3000, wall-mounted control panel ⑪ The wall-mounted control panel has the same range of functions as the corresponding control panel on the light head. –...
Description of devices and functions 5.4.3 Controlling the light intensity Figure 10 Non-sterile setting of the light intensity The light intensity is set at the Light ③ control panel. • A: for TruLight 3000 ① at the control panel ② for the light head or the op onal wall-mounted control panel ④, •...
Description of devices and functions 5.4.4 Sterile Light Control (SLC) Figure 11 function, optional Sterile setting of the light intensity With the optional sterile handle ② with Sterile Light Control (SLC), the light intensity of the TruLight 5000 ⑤ lamp can be adjusted with complete sterility.
Description of devices and functions 5.4.5 Adaptive Light Control (ALC) Figure 12 function, optional Non-sterile adjustment of the light control The Adaptive Light Control (ALC) function allows lighting settings of the two light types TruLight 3000 and TruLight 5000 to be manually adjusted to the new working distance, if the position of the light head to the wound area is changed.
Description of devices and functions 5.4.6 Adaptive Light Control plus Figure 13 (ALC plus) function, optional The light model TruLight 5000 can be optionally fitted with the Adaptive Light Control plus (ALC plus) function. Alongside the basic ALC func on ⑤, the ALC plus function can automatically control various LED groups of the light modules depending on the distance of the light head...
Description of devices and functions 5.4.7 Controlling the light field Figure 14 The TruLight 5000 light model is equipped with a function for setting the size of the light field ③: • Narrow light field, Ø 16 cm at 1 m distance, for a short distance of the light head from the wound area, •...
Description of devices and functions 5.4.8 Controlling the colour Figure 15 temperature (optional) The TruLight 5000 light models are equipped with a functionality for variable colour temperature ③. The value of the colour temperature can be manually adjusted in the range from 3500 K up to 5000 K in steps of 500 K.
Description of devices and functions 5.4.9 Synchronisation of the colour Figure 16 temperature The TruLight 5000 light models ① are equipped with a functionality for colour temperature synchronisa on ③. For operating table lighting systems which consist of several lamps, the TruLight 5000 allows the synchronisation of the colour temperature of the individual light heads.
Commissioning Checking the lighting systems Figure 17 For all versions of the lighting system, a function test and a visual inspection should be carried out before use, or at least once per week. WARNING Contamination and infection hazard for patients Loose or damaged parts may fall into wounds.
Commissioning Positioning of the lighting systems Figure 18 The positioning function of the lighting system is safe to operate. Pinching injuries during positioning may nevertheless occur. CAUTION Risk of jamming When rotating the light head, the distance between the cardan joint and the lighting module reduces: •...
Commissioning 6.2.2 Positioning the cover-mounted / Figure 19 wall-mounted version Ceiling-mounted version of single light A: Surgical light as single light with a light head on the AC 2000 type spring arm • The best possible mobility of the support arms is a "V-type arrangement".
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Commissioning Figure 20 Wall-mounted version single light C: Surgical light as single light with a light head on an AC 2000 or AC 2000 LCH (Low Ceiling Height) type spring arm. • The best possible mobility of the support arms is a "V-type arrangement”.
Commissioning Positioning the mobile stand version Figure 21 The mobile stand version has a high tilting stability. The following, basic precautions must nevertheless be considered when positioning the mobile stand version. ATTENTION Tilting of the stand The tilting stability of the mobile stand version can be at risk due to objects lying on the floor, uneven floors or the mains cable: •...
Commissioning 6.3.1 Connecting the mobile stand version to the Figure 22 mains The power supply of the mobile stand version is established by a mains cable ⑥ with an IEC connector ③ and a safety connector ⑤. WARNING Electric shock There is a risk of electric shock in the event of contact with damaged electrical components:...
Decommissioning Switching off the ceiling- and wall- Figure 23 mounted version Disconnecting the power to the lighting system • Switch off the operating theatre master switch. → The lighting system is disconnected from the power supply. Switch off the mobile stand version Switching the mobile stand version to a current-free state •...
Operation Working rules The safety instructions must be read and adhered to when using the lighting system Compliance with safety instructions to ensure that it is safely handled and to prevent harm to the patient. Preparatory measures Measures that should be considered before using the lighting system. Checking the lighting system A function test and a visual inspection should be carried out before use, or at least Function test / visual inspection...
Operation Measures to take when using the lighting system Measures that should be considered while using the lighting system. WARNING Risk of damage to vision due to high intensity illumination In the event of surgery in the field of vision of the patient, the high intensity of illumination by the light heads may cause damage to vision: •...
Operation Attaching the sterile handle Figure 24 Sterile handle standard version • A: Push the sterile handle ④ onto the handle adapter ① and press it upward un l the ball latch ② engages audibly in the hole ③. • Check the firm attachment of the sterile handle. Sterile Light Control (SLC) handle, optional •...
Operation Control panels of the lighting system Figure 25 The control panels for the lighting functions area equipped with various control elements, depending on the scope of functions of the particular light. A: TruLight 3000 • Control panel ① on the light head, •...
Operation Switching the light head on/off Figure 26 The lighting system is switched on in two stages: • Switch the power supply of the lighting system to standby, • Switch on the light head Switch the power supply to Standby Ceiling-mounted and wall-mounted versions: •...
Operation Setting the size of the light field Figure 27 The TruLight 5000 light model is equipped with a function for setting the size of the light field ③: • Narrow light field for a short distance of the light head from the wound area, •...
Operation Setting the light intensity Figure 28 Working distance Position the light head with the sterile handle or the outer non-sterile outer handles at a working distance of 70 cm–150 cm from the wound area. CAUTION High light intensities with overlapping fields of illumination When working with overlapping fields of illumination, high light intensities may accelerate tiring of the eyes.
Operation 8.9.2 Set the light intensity in the sterile area using Figure 29 the Sterile Light Control (SLC) The light intensity can be set in the sterile area for the light model TruLight 5x20 ①. The sterile handle ② with Sterile Light Control func on can be used to set light intensity with simple finger movements ④.
Operation 8.9.3 Setting the light intensity to the working distance in the non- Figure 30 sterile area with Adaptive Light Control (ALC) The Adaptive Light Control (ALC ) function automatically adapts the light intensity when the position of the light head is changed relative to the wound area. Three distance levels can be selected with the ALC func on ①: –...
Operation 8.9.4 Adjusting the light intensity with Adaptive Light Control plus (ALC plus) Adaptive Light Control plus (ALC plus) has the same functionality as Adaptive Light Control (ALC), but also enables the targeted electronic control of various LEDs in order to achieve optimum illumination of the wound area. ...
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Operation Figure 31 Fine positioning Adaptive Light Control Plus (ALC plus) To use Adaptive Light Control plus (ALC plus), point the light head precisely at the wound area ④ using the sterile handle ②. Activating the ALC plus function: 1. Press the key ⑥ Auto. →...
Operation 8.9.5 Setting colour temperature Figure 32 Only the light models TruLight 5000 have the Adjustable Color Temperature function (optional). The value of the colour temperature can be manually adjusted in the range from 3500 K up to 5000 K in steps of 500 K. The colour temperature is set in the non-sterile area on the control panels ①...
Cleaning and disinfection Regular cleaning and disinfection with suitable cleaning or disinfection agents is necessary for the safe use of the surgical light. WARNING Electric shock Touching live components may result in an electric shock. • Disconnect the device before cleaning and disinfection: •...
Cleaning and disinfection • It is essential that the hygiene instructions of the operator are observed. Cleaning and disinfection 9.1.1 General Cleaning and disinfection of the surgical lights may only be performed by a hygiene Performed by hygiene specialist staff specialist or a person instructed by the hygiene specialist.
Cleaning and disinfection 1. Disconnect the power supply from the mains. Cleaning procedure 2. Allow the light head to cool down. Only clean or disinfect the light head when it is cold. 3. Moisten a cloth with a drop of cleaning or disinfecting agent. Clean the surgical light with the damp but not wet cloth.
Sterilising handles of surgical lights The handles are made of heat- and impact-resistant polyphenylene sulfone (PPSU) Material plastic. NOTE Warranty claim Failure to comply with the sterilisation requirements will render any warranty claim null and void. No warranty is accepted for damage, which is due to the use of unsuitable sterilisation methods.
1 0 Sterilising handles of surgical lights A machine-based procedure (disinfector) according to DIN EN ISO 15883-1 is to be used for cleaning/disinfection. The effectiveness of the method used must be accepted in principle (e.g. be included in the list of the disinfectants and procedures checked and approved by the Robert Koch-Institute / DGHM) and must be validated in principle.
1 0 Sterilising handles of surgical lights Steam sterilisation at 135 °C (275 °F): • Sterilisation time = 3 minutes, • Drying time = at least 16 minutes 10.3.3 Sterilisation packaging The handles are placed in a suitable sterilisation packaging (disposable sterilisation packaging, e.g.
Inspections, maintenance and repairs All devices are subject to wear and tear over time. The safety and function of the device must therefore be inspected after regular inspection and maintenance intervals. Repeat inspections must be carried out according to the specific national regulations.
1 1 Inspections, maintenance and repairs 11.3 Maintenance every two years The device must only be serviced by the Trumpf Medical Customer Service, or Maintenance every two years authorised partners. The tests must be carried out every 2 years by qualified experts in accordance with the service manual.
Adjustments 12.1 Setting spring arm swivel range type Figure 33 AC 2000 LCH The vertical swivel movement may only be adjusted within the range of +30° (upwards) and -45° (downwards). The swivel range can be set so that the collision with the ceiling or with bordering objects can be avoided (the swivel range can be restricted down to the horizontal level).
1 2 Adjustments 12.2 Setting spring arm swivel range type Figure 34 AC 2000 and type AC 3000 The vertical swivel movement may only be adjusted within the range of +45° (upwards) and -50° (downwards). The swivel range can be set so that the collision with the ceiling or with bordering objects can be avoided (the swivel range can be restricted down to the horizontal level).
1 2 Adjustments 12.3 Setting spring arm swivel range type Figure 35 AC 5000 The vertical swivel movement may only be adjusted within the range of +40° (upwards) and -40° (downwards). The swivel range can be set so that the collision with the ceiling or with bordering objects can be avoided (the swivel range can be restricted down to the horizontal level).
1 2 Adjustments 12.4 Setting spring arm spring force type Figure 36 AC 2000 LCH The weight of the light head is compensated by a spring which is installed in the spring arm. The spring force must be adjusted when the spring arm with the light head does not reliably stop at the height position selected after a swivel movement.
1 2 Adjustments 12.5 Setting spring arm spring force type Figure 37 AC 2000 and type AC 3000 The weight of the light head is compensated by a spring which is installed in the spring arm. The spring force must be adjusted when the spring arm with the light head does not reliably stop at the height position selected after a swivel movement.
1 2 Adjustments 12.6 Setting the spring arm spring force type Figure 38 AC 5000 The weight of the light head is compensated by a spring which is installed in the spring arm. The spring force must be adjusted when the spring arm with the light head does not reliably stop at the height position selected after a swivel movement.
1 2 Adjustments 12.7 Adjusting the brake force of the friction Figure 39 brakes If the boom, spring arm, convenience bracket or the light head do not remain stable in the position to which they are rotated, the braking force of the friction brake must be adjusted. The friction brake acts through the friction force of the adjustment screw (slot-head screw (3)) on the relevant pin of the support arm components.
1 2 Adjustments 12.7.3 Adjusting the braking force for the spring arm Figure 40 Adjusting friction brake B: 1. Adjust brake screw ① with a suitable slot-head screwdriver: Reducing the braking force • Turn the adjustment screw to the left (anti-clockwise). Increasing the braking force •...
1 2 Adjustments 12.7.5 Adjusting the brake force of the cardan joint Figure 41 Light head on the convenience bracket Adjusting the friction brake D of the light head on the convenience bracket: 1. Adjust brake screw ① with a suitable slot-head screwdriver: Reducing the braking force •...
1 2 Adjustments 12.7.6 Setting the braking force of the cardan joint Figure 43 axle on the standard light head Adjusting the friction brake E for the light head on the handle attachment. If the friction brake can no longer be adjusted, an internal brake strip must be replaced by a service technician.
1 2 Adjustments 12.7.7 Setting the braking force on the light head Figure 44 SLC / ALC plus Adjusting the friction brake E for the light head on the handle attachment. If the friction brake can no longer be adjusted, an internal brake strip must be replaced by a service technician.
1 2 Adjustments 12.7.8 Setting the cardan joint axis braking force on Figure 45 the standard light head with camera Adjusting the friction brake E for the light head on the handle attachment. If the friction brake can no longer be adjusted, an internal brake strip must be replaced by a service technician.
Troubleshooting NOTE Recurrent faults If a fault reoccurs or cannot be remedied, put the device out of service and contact Trumpf Medical Customer Service. Causes of faults and fault removal Error Possible cause Remedy Chapter Suspension / mobility Light head drops / rises Spring force in spring arm is Adjusting the spring force Chpt.
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1 5 Technical data TruLight 5000 lighting system technical data Product designation TruLight 53x0 TruLight 55x0 Light intensity at 1.0 m 140,000 lux 160,000 lux Dimmable from/to < 10% Endo; < 10 % Endo; 40 %–100 % 40 %–100 % Variable light field size due to changes 16 cm - 30 cm 16 cm - 30 cm...
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1 5 Technical data Mechanical data, 5xxxx light models Mechanical data TruLight 53x0 TruLight 55x0 Light head diameter 640 mm 730 mm Distribution area of the light head 2100 cm 3100 cm Light-emitting surface area 1332 cm 1892 cm Weight of the light heads (incl. convenience and central bracket) 13.9 kg 17.2 kg Performance specifications, Laser 5520/5320...
1 5 Technical data 15.3 EMC information EMC notes WARNING Operate the device only with the stated accessories. The device may only be operated with the accessories stated in the accompanying documents. Operation with accessories, converters or cables other than those stated in the accompanying documents can lead to increased EMC emissions or reduced interference immunity of the device and with it to improper use.
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1 5 Technical data Guidelines and manufacturer's declaration - electromagnetic immunity The lighting system is intended for use in the environment specified below. The customer or user of the device should ensure that it is operated in one of the environments as described. The support arm system may not execute any unintentional movements in cases of interference.
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1 5 Technical data Guidelines and manufacturer declaration - immunity to electromagnetic interference / portable and mobile radio devices Portable and mobile RF communication device should be used no closer to any part of the insulating lighting system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended safety distance: Immunity test IEC 60601 test level...
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1 5 Technical data Immunity level of RF fields from wireless communication device Table: Special frequencies Test Band Service Modulation max. Distance Immunity Frequenc (MHz) power level (V/ y (MHz) 380 – 390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460 Pulse modulation FM ±5 FRS 460...
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1 5 Technical data Controlled RF interference variables The lighting system is intended for use in an electromagnetic environment where the RF disturbances are monitored. To prevent electromagnetic interference, maintain a minimum distance between the portable and mobile HF communications devices (transmitters) and the above-mentioned device according to the maximum output power of the communications equipment, as recommended below.
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