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Summary of Contents for baxter TruLight 5000
- Page 1 Instructions for use TruLight 5000 / 3000 Surgical light Read the instructions for use carefully before using the ENGLISH product and keep them safe for future reference. en-US...
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- Page 3 +49 3671 586–0 Fax: +49 3671 586–41165 surgical@hillrom.com hillrom.com Baxter Medical Systems GmbH + Co. KG is a Baxter International Inc. company. The manufacturer is hereinafter referred to as Baxter. Technical Customer Service The contact details for the current Technical Customer Service hubs in the individual countries are listed on the Internet at www.hillrom.com.
- Page 4 TruLight 5000 / 3000 This page is intentionally blank. 7990005_030_05 – 2078240 – 2023-01-19...
- Page 5 © Baxter Medical Systems GmbH + Co. KG Reprinting, copying, or translating this document, in whole or in part, is forbidden without the express written permission of Baxter. All rights under copyright law are expressly reserved by Baxter. 7990005_030_05 – 2078240 – 2023-01-19...
- Page 6 TruLight 5000 / 3000 This page is intentionally blank. 7990005_030_05 – 2078240 – 2023-01-19...
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Page 7: Table Of Contents
Combination with other products from Baxter ........ - Page 8 TruLight 5000........
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Page 9: Usage Specifications
Usage specifications Usage specifications Normal use The surgical light system can have up to four support arms with up to three lamp heads. In addition to the lamp heads, other products can also be attached using a spring arm (e.g. VidiaPort spring arm with monitor holder and monitor). -
Page 10: Usage Environment
Usage specifications Usage environment DANGER Risk of explosion posed by anesthetics If high concentrations of flammable mixtures of anesthetic vapors with oxygen or nitrous oxide occur in the environment for use of the surgical light, there is a risk of ignition under certain conditions. -
Page 11: Safety
Safety Safety Combination with other products from Baxter Baxter offers a wide variety of products for further equipping of the surgical light. Not all products are available in all countries. Detailed information can be obtained from the relevant representative offices of Baxter, which are represented worldwide. -
Page 12: Combination With Products From Other Manufacturers
Baxter accepts no responsibility for the combination of the surgical light with third-party products. The guarantee/warranty for products from Baxter may become void in the event of combination with third-party products. Operator's responsibility... -
Page 13: Malfunction Caused By Other Devices
Safety Malfunction caused by other devices There are no known functional failures of the surgical light due to other devices. What to do in the event of a malfunction In the event of a failure of the electrical functions of the surgical light, the surgical light is to be disconnected from the power supply and the Technical Customer Service notified. -
Page 14: Position And Meaning
Safety 2.6.2 Position and meaning Information Meaning notice Note to the service technician for mounting the circlip on the spring arm (connection to the extension arm) Pull the mains power plug out of the socket before opening the housing. Manufacturer’s logo Follow the instructions for use Laser identification Class of the installed laser product for distance measurement... - Page 15 – Data Matrix Code – (01) Global Trade Item Number (GTIN) – (11) Date of manufacture (Year Month Day) – (21) Serial number – (240) Part number Baxter part number Serial number Medical product The device conforms to Regulation 2017/745/EU concerning medical devices.
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Page 16: Summary
Summary Summary The surgical light can be custom combined using various Baxter products. The approved products are listed in Chapter 2.1. Ceiling version of the surgical light (for example, Solo) Ceiling version of the surgical light on a ceiling-mounted supply unit (pedestal) -
Page 17: Description
Wall-mounted version (for example, Ceiling Duo) [17] Sterilizable handle [18] Ceiling conduit TruLight 5000 / 3000 Pendant: Light adjustment on the ceiling-mounted supply unit [19] Control panel at the wall control panel (Example TruLight 5x20) 7990005_030_05 – 2078240 – 2023-01-19... -
Page 18: Mobile Version
The functions available on the controls depend on the functional scope of the surgical light. [25] Transmission joint [26] Non-sterile side handle (illuminated for TruLight 5000) [27] Handle adapter (holder for the sterilizable handle) for TruLight 5x20 with ALC Plus (laser measuring unit) [28]... -
Page 19: Summary Of Control Modules
[25] Transmission joint [26] Non-sterile side handle (illuminated for TruLight 5000) [27] Handle adapter (holder for the sterilizable handle) [28] Spring arm type AC 2000 NRH (Version: Low room height) -
Page 20: Controls At The Trulight 3000 Lamp Head
Working distance indicator (3 steps from left to right: 80 cm/31.50 inch; 100 cm/ 39.37 inch; 120 cm/47.24 inch) 4.2.2 Controls at the TruLight 5000 lamp head [i2] Switching the surgical light function on and off [i3] Reducing the lighting intensity function... -
Page 21: Controls At The Trulight 5000 Comfort Strap
Description 4.2.3 Controls at the TruLight 5000 comfort strap The functions on the controls available for adjusting the lighting depend on the functional scope of the surgical light. The following overview is based on the maximum equipment level. [i1] Color temperature synchronization function (optional) -
Page 22: Wall Control Panel
The functional scope of the wall control panel corresponds to that of the controls on the surgical light. An exception to this is the Low Room Height version of the TruLight 5000 surgical light. Due to the design of the Low Room Height version, the controls on the lamp head have a more limited functional scope. -
Page 23: Setting Options
Setting options 4.5.1 Light field size The light field size function is only available for the TruLight 5000 surgical light. The light field size concerns the diameter of the light field. At constant working distance, the user may decide between a narrow and a wide light field, depending on the size of the wound field. -
Page 24: Color Temperature
5000 K in steps of 500 K. 4.5.6 Synchronization The function is only available for the TruLight 5000 surgical light. During synchronization, the color temperature for the surgical light on which the function was selected is transferred to the other surgical lights. -
Page 25: Illuminated Side Handles
Illuminated side handles The illuminated side handles on the lamp head are only available for the TruLight 5000 surgical light. The light system is available with the following options: – The side handle is permanently lit up (delivery state ex factory). -
Page 26: Use
After the handover, the surgical light must be cleaned and disinfected according to the hygiene directives and specifications of Baxter. The surgical light may only be used with the components and accessories approved by Baxter. - Page 27 Adhere to the maintenance recommendation to ensure the basic safety and major performance characteristics of the surgical light throughout its entire lifespan. Load limit: WARNING Crashing of support arm system The support arm system may not be exposed to additional stress. Overload may lead to significant malfunction.
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Page 28: Installation Of The Wall And Ceiling Versions
A functional test and visual inspection of the surgical light by personnel trained for this work by Baxter must be performed at least once a week and following a damage report by a user. -
Page 29: Selection Of Functions
Annual inspection The annual inspection should only be carried out by personnel who have been trained by Baxter in this work. The annual inspection includes a visual inspection and functional inspection of the surgical light considering the following inspection points. -
Page 30: Mobile Version
5.5.2 Mobile version WARNING Electric shock in the event of a short circuit • The mobile pedestal version (safety class I) may only be connected to a protective contact socket. Electrical earthing reduces the risk of electric shock in the event of an electrical short circuit. -
Page 31: Mobile Version
5.6.2 Mobile version Switch off the surgical light at the controls. Switch off the power adapter at the switch [35] (Position 0). Pull the plug [C] of the mains cable out of the socket. Pull the plug [A] out of the connection socket [34] on the power supply unit. -
Page 32: Moving The Mobile Pedestal Version
CAUTION Uncontrolled movement of the joint • If the spring arm moves up or down by itself, the spring strength will need to be re-adjusted. • The brake force needs to be readjusted if the lamp head does not stably remain in the set position. CAUTION Pinching hazard When swiveling the lamp head, do not place fingers between the... -
Page 33: Adjusting The Lighting
Switch off the surgical light on a control unit and disconnect it from the mains power. The power supply only needs to be disconnected when the surgical light is to be moved outside of its operating range. The operating range is determined by the length of the mains power cable. -
Page 34: Set Color Temperature
Switching on the Endo lighting intensity: Controls on the surgical light or a wall control panel: – Press the [i3] button until the Endo [a6] status indicator lights Switching off the Endo lighting intensity: Controls on the surgical light or a wall control panel: –... -
Page 35: Adjusting The Alc Plus (Adaptive Light Control Plus)
5.11.5 Adjusting the ALC Plus (Adaptive Light Control Plus) WARNING Damage to eyesight Prolonged visual contact with the laser beam might damage eyesight. • Do not look directly into the laser beam. • Always close, cover or protect the patient’s eyes (for example, with goggles - optical density at least 2 or designed according to safety class 6 EN 169). -
Page 36: Adjusting The Swivel Range Of The Spring Arm Up And Down
Adjusting the swivel range of the spring arm up and down The swivel range should only be set by personnel who have been trained by Baxter in this work. 5.12.1 Spring arm type AC 2000 NRH (Version: Low room height) Set the swivel range in such a way that collision with the ceiling or adjacent objects is not possible. -
Page 37: Adjusting The Spring Force
5.13 Adjusting the spring force The spring force should only be set by personnel who have been trained by Baxter in this work. 5.13.1 Spring arm type AC 2000 NRH (Version: Low room height) The weight of the lamp head is compensated by a spring installed in the spring arm. -
Page 38: Setting The Brake Force
Overview The braking force should only be set by personnel who have been trained by Baxter in this work. The joints are equipped with a friction brake. The friction brake acts on the pins of the support arm components by using friction from the setting screw. -
Page 39: Brake Force For The Transmission Joint
5.14.3 Brake force for the transmission joint Spring arm: Switch off the surgical light on a control unit and disconnect it from the mains power. Adjust the brake screw [A] with a slotted screw driver. The braking strength is raised by turning clockwise, and lowered by turning anti-clockwise. -
Page 40: Brake Force On The Lamp Head
5.14.4 Brake force on the lamp head Lamp head with standard handle: Switch off the surgical light on a control unit and disconnect it from the mains power. Remove the sterilizable handle from the handle adapter. Remove the grip attachment [A] (4 Allen screws M4x30 mm/ 1.18 inch). -
Page 41: Decommissioning
Lamp head, TruVidia HD camera: Switch off the surgical light on a control unit and disconnect it from the mains power. Pull the sterilizable handle off the camera. Remove the camera from the camera holder. Remove the cover of the handle attachment [A] (4 countersunk cross-headed screws). -
Page 42: Cleaning And Disinfection
Cleaning and disinfection Cleaning and disinfection WARNING Danger of electric shock Contact with live parts may result in electric shock. • Take the surgical light out of service before cleaning and disinfecting it. See information in Chapter 5.6. • Take all components connected to the surgical light (e.g. wall control panel, TruVidia HD camera) out of service before cleaning and disinfecting them. -
Page 43: Wipe-Down Disinfection
Only those agents or chemicals compatibility-tested and approved by Baxter may be used for cleaning and disinfecting. When using alternative cleaning agents and disinfectants, Baxter cannot confirm any material compatibility. Do not use agents that are not listed, otherwise functional components may be altered or damaged. -
Page 44: Recommended Disinfecting Agents
Moisten cloth with a little cleaning agent or disinfectant. Wipe surgical light only with a damp but not wet cloth. Recommended disinfecting agents Baxter recommends the following disinfecting agents for manual use: Manufacturer Product designation B. Braun Melsungen AG... -
Page 45: Troubleshooting
Troubleshooting Troubleshooting If an error recurs or cannot be resolved, take the device out of service and inform the Technical Customer Service of Baxter. Error Possible cause Correction Support arms The lamp head moves down or rises. The spring force in the spring Adjust the spring force. -
Page 46: Maintenance
The products must be repaired only by qualified service technicians. The contact details of service technicians can be obtained from the Technical Customer Service at Baxter. An electrical safety check must be carried out after each repair. 7990005_030_05 – 2078240 – 2023-01-19... -
Page 47: High-Wear Parts
Brake screws The brake screws may only be replaced by personnel that have been trained by Baxter in this kind of work. Brake screw at the extension arm (spring arm brake) 1378868 M10x1 mm/0.04 inch with 9 mm/0.35 inch length... -
Page 48: Disposal
If you have any questions about proper disposal, please contact the Technical Customer Service at Baxter, your local dealer, or the appropriate national authority. In addition to regional disposal, faulty or obsolete products can be returned to Baxter. -
Page 49: Technical Data
Technical data Technical data 12.1 Device data 12.1.1 TruLight 3000 Product designation TruLight 3300 3500 3510 Equipment Adaptive Light Control (ALC) TruVidia HD camera – – Side handles, not illuminated – – – Wall control panel Optional Optional Optional Electrical data Supply voltage at the power supply unit 100–240 V AC 100–240 V AC... -
Page 50: Trulight 5000
Light-emitting surface 1332 cm²/ 206.46 inch² 1892 cm²/ 293.26 inch² Weight of the light head (including comfort and 13.6 kg / 29.98 lbs 16.4 kg / 36.16 lbs central handles) 12.1.2 TruLight 5000 Product designation TruLight 5300 5310 5320 5500 5510... - Page 51 Technical data Lighting data TruLight All light technology values 53x0 55x0 maximum +/- 10% tolerance Light intensity with 1.0 m / 39.37 inch 140,000 lux 160,000 lux Dimmable from/to < 10% Endo; < 10% ENDO; 50% - 100% 50% - 100% Light field size can be varied by 16 cm - 30 cm / 16 cm - 30 cm /...
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Page 52: Support Arm System Swivel Ranges
Type Comfort strap – Lamp head TruLight 3000 Vertical: > 360° (without stop) Type Comfort strap – Lamp head of Vertical: < 420° (with end stop) TruLight 5000 Lamp head – Transmission joint 200° (-100°/+100°) 7990005_030_05 – 2078240 – 2023-01-19... - Page 53 Type Comfort strap – Lamp head TruLight 3000 Vertical: > 360° (without stop) Type Comfort strap – Lamp head of Vertical: < 420° (with end stop) TruLight 5000 Lamp head – Transmission joint 200° (-100°/+100°) 7990005_030_05 – 2078240 – 2023-01-19...
- Page 54 Technical data Joint Swivel range Type AC 2000 NRH wall-mounted version with spring arm (Version: Low room height) Wall bearing – Extension arm Horizontal: 200° Extension arm – Spring arm Horizontal: > 360° (without stop) Vertical: +20° to -40° Spring arm – Lamp head Horizontal: >...
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Page 55: Electromagnetic Compatibility
HF emissions in accordance with Class A The TruLight 5000 and the TruLight 3000 CISPR 11 system are intended for operation in facilities other than private homes, Harmonic emissions as per... - Page 56 Technical data Guidelines and manufacturer's declaration – electromagnetic immunity Guidelines and manufacturer's declaration – electromagnetic immunity The device has been designed for operation in one of the electromagnetic environments described below. The customer or user of the device should ensure that it is used in such an environment. The support arm system may not move unintentionally or cause interference.
- Page 57 Technical data Guidelines and manufacturer's declaration - electromagnetic immunity/portable and mobile radio units Portable and mobile radio units must not be used at a distance from the device, including cables, that is less than the recommended separation distance calculated according to the transmission frequency equation.
- Page 58 Technical data Immunity levels for RF fields of wireless communications equipment Table: Special frequencies Test Band Service Modulation Max. Distance Immunity frequency (MHz) power level (MHz) (V/m) 380 – 390 TETRA 400 Pulse modulation 18 Hz 1.8 430 – 470 GMRS 460 Pulse modulation FRS 460...
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Page 59: Svhc (Substance Of Very High Concern)
1907/2006, components contained in the products contain reportable substances in concentrations exceeding 0.1 mass percent. The list with the affected components is provided by Baxter upon request. The list can also be seen on the Internet at ois.hillrom.com/ois. 7990005_030_05 – 2078240 – 2023-01-19... -
Page 60: Product Certification
Regulation 2017/745/EU concerning medical devices, and is compliant with the version of this regulation in force at the time of product sale. Baxter declares the conformity of the surgical light with the essential safety and performance requirements according to Regulation 2017/745/EU concerning medical devices, Annex I. - Page 61 Product certification This page is intentionally left blank. 7990005_030_05 – 2078240 – 2023-01-19...
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