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Summary of Contents for Skytron DoVera DM520
- Page 1 Operation Manual [English] Light System DoVera DM520...
- Page 2 Titelseite Text Thank you very much Thank you very much for purchasing this SKYTRON product. Please read this Operation Manual very carefully, abide by the safety notices and observe all operating and cleaning requirements. For which appliances does this manual apply?
- Page 3 Any other use than that regulated by law must be approved in writing by SKYTRON. • SKYTRON does not take any liability for or in relation to the misuse of this information in the prohibited manner by any person or company.
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Page 4: System Overview
Titel Bildseite ohne Strich System overview Light System DoVera DM520 Versions of the pendant system 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... - Page 5 OR light with double yoke is used to illuminate the sur- gical surface. It can optionally be equipped with a camera. Monitor Carrier The monitor carrier is used to support and position a flat screen. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 6 Titelseite Text 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
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Page 7: Functional Description
The product label is attached to the top side of the spring arm For more detailed information on how to adjust the brake force, please contact your local SKYTRON representative. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... - Page 8 Titel Bildseite ohne Strich System overview Versions of the OR lights Version of the Monitor Carrier 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
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Page 9: Device Description
① External yoke, ② Internal yoke, ③ Light head, ④ Function control keyboard, ⑤ Sterilizable handle. monitor carrier ① Supporting tube, ② Monitor carrier, ③ Vesa interface, ④ Vesa adapter plate. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 10: Table Of Contents
3 Maximum Payload and structural alterations of the Light System 4 Initial and Repeated Commissioning and Handover 5 Cleaning and Disinfection Safety instructions of Cleaning and Disinfection Cleaning Disinfection Handle sterilization 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... - Page 11 9 Operation Positioning the monitor carrier 9.1.1 Swivelling the monitor carrier 9.1.2 Adjusting the height of the monitor carrier Part 5: Technical Data 10 Technical Data of the Light System DoVera DM520 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 12 Titelseite Text 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
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Page 13: Part 1: General Information
Titelseite Text Part 1: General Information 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 14: Important Information For Safe Use
This Operation Manual is intended solely for devices with the manufacturer's product label bearing the following information: Device identification – Type designation: Light System DoVera DM520 How to identify the Operation Manual Make sure you are • To ensure that you always have the latest version of these Operation Manual, every... -
Page 15: Notes For The Operator
• For safety reasons, any operator actions or interventions exceeding this scope may only be carried out by SKYTRON or companies authorized by SKYTRON. As a pre- requisite for the authorization of a company, its service technicians must have suc- cessfully participated in technical training organized by SKYTRON. -
Page 16: Notes For The User
1.5.1 Instruction on the appliance Instruction • The instruction must be carried out on the appliance immediately by SKYTRON, by a company authorized by SKYTRON. • On completion of the instruction, an in service-form will be created and signed in order to document that the user has understood the special operator control actions required for normal use. -
Page 17: Intended Purpose
• The combination of any other SKYTRON product with the light system must be approved by SKYTRON. If applicable, the conformity assessment must be repeated. 1.6.2 Contraindications •... -
Page 18: Safety Instructions
Risk of parts falling off: warns of parts falling off while carrying out mounting or dismantling work underneath the pendant system. Sudden release of spring arm: warns that the spring arm may jump up suddenly while dismantling an adaption or an end device. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 19: Description Of Graphic Symbols Possibly Used On The Appliance And The Package
Ambient temperature: indicates the permissible ambient temperature values in a range +60°C (140 F) ° from -15°C (5°F) to +60°C (140°F) for transport and storage. -15°C ( F) 5° 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 20: Information On The Product Label
2019-10-15 GTIN (01)10841736113858 • The Light System DoVera DM520 product label is located on the Made in USA right side of the lowest extension arm. Ondal Medical Systems Inc., 540 Eastpark Court, Suite A - Sandston, VA 23150 USA Global Trade Item Number •... -
Page 21: Overview Of The Most Important Safety Instructions
• The emitted light is stable and of adequate intensity; • The swinging arm maintains its position; • The light head maintains its Position; • The light head shows no signs of physical damage and operates prop- erly. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 22: Mounting / Dismantling
WARNING Risk of parts falling off During all uninstallation and installation work, it must be ensured that no person is in the area underneath the light system. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 23: Cleaning And Disinfection
Observe the protective measures: • Observe the hygiene regulations. • Adhere to the disinfectant manufacturer's instructions. • Perform surface disinfection every working day and in case of contam- ination. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 24: Incorrect Use
• Avoid collisions between the arms of the light system as well as collisi- ons between the light system and nearby equipment or walls. • The use of after market, non-SKYTRON accessories or parts such as disposable handles may fall off the light. Ensure that only SKYTRON / DoVera genuine parts and accessories are utilized. -
Page 25: Proper Use Of Oxygen
The end of the useful life for the light system is 10 years under normal operating con- ditions, service parts are available for this period. • Please contact your SKYTRON authorized representative for disposal of the light system products or parts in accordance with current environmental regulations for medical products. -
Page 26: Maximum Payload And Structural Alterations Of The Light System
For this reason, structural alterations to the light system, including the replacement of the spring arms, adaptions and end devices, may only be carried out by SKYTRON service technicians and authorized service personnel. 1567030, Edition 2020-04, Version 1... -
Page 27: Initial And Repeated Commissioning And Handover
For commissioning following installation, proper initial commissioning must be car- ried out for the entire light system by an authorized SKYTRON representative. The following points must be observed during handover to the operator: The light system must not be handed over and commissioned to the operator until it has been tested. -
Page 28: Cleaning And Disinfection
(dishwashing product) if required. 2. Afterwards, carefully wipe the surfaces dry with a clean cloth. 3. Avoid directly spraying fluids onto the camera and the wall control. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 29: Disinfection
Surface disinfection of surfaces using UV-C radiation devices can cause damage to the transparent screen of the OR light. It can lead to a permature aging. • DO NOT place the UV-C device directly under the OR light. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 30: Handle Sterilization
When placing in the autoclave, make sure the open side of the handpieces is turned down- wards. The handpieces must be free and not burdened by other material being sterilized. Damaged handpieces must no longer be used. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 31: Part 2: Light System Dovera Dm520
Titelseite Text Part 2: Light System DoVera DM520 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 32: Operation
Hold your finger or thumb on the circle to rapidly change the intensity. The lowered circle ⑦ decreases the intensity. The raised circle⑧ increas- es the intensity. The light intensity can be adjusted without losing sight of the working ar- 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 33: Moving The Product
To remove the handle from the light head, simply press the handpiece re- lease and remove it. 6.1.7 Installing the handle (See "Figure 7") To reinstall the handle, align it with the black support and slide it into place until it locks. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 34: Optional Camera
① Power button (on / off key) ② Image rotation ③ Zoom adjustment (digital and optical) ④ Focus adjustment (automatic and manual) ⑤ Exposure adjustment (automatic and manual) ⑥ Freeze image ⑦ White balance 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 35: Removing The Handle Of The Camera Ready Light Head
See camera connection “Figure 12:” and “Figure 13:” on Page 36. Press the lock lever, fit the camera up tight and release the lever. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 36: Camera Connection Light Head Side
④ Tx communication ⑤ DC IN 6.1.13 Camera connection camera side Figure 13: Camera (See "Figure 13") Camera ① GND (0Vdc) ② HD-SDI signal ③ Rx communication ④ Tx communication ⑤ DC IN 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 37: Removing The Camera
6.1.14 Removing the camera Figure 14: Removing the camera (See "Figure 14") To remove the camera body from the light head, press the lock lever with your finger and move the camera downwards. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 38: Camera Handpiece Installation
Position. 6.1.16 Removing the handpiece Figure 16: Removing the handpiece (See "Figure 16") To remove the sterilizable handpiece from the light head, simply press the handpiece release and remove it. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 39: Recommended Work Distance
1000mm (40"). The Product nevertheless also ensures a good light intensity at a dis- tance between 700mm (28") and 1400mm (56"). 1000mm (40") 700mm (28") 1000mm (40") Max lx 1400mm (56") 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 40: Emc Declaration
Measures may have to Voltage fluctuations Conforming be taken to reduce such disturbance, such as Product reposi- /flicker emissions tioning or shielding of premises. IEC 61000-3-3 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... - Page 41 The magnetic fields at mains frequency should mains frequency have the characteristic levels of a typical locality in (50/60Hz) a commercial or hospital environment. IEC 61000-4-8 NOTE U mains voltage in AC before application of test level. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 42 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects an people. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 43 The carrier shall be modulated using a 50% duty cycle square wave signal. As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modula- tion, it would be worst case. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 44 Note 1: at 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects an people. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
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Page 45: Part 3: Dovera Pendant System
Titelseite Text Part 3: DoVera Pendant System 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 46: Operation
(e.g. flat screen, OR light, etc.) do not remain stable in the set posi- tion, the spring tension or brake force must be adjusted as described in the service manual. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 47: Part 4: Dovera Monitor Carrier
Titelseite Text Part 4: DoVera Monitor Carrier 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 48: Operation
If the spring arm or the screen do not remain stable in their set posi- tion, the spring tension or the brake force must be adjusted as described in the service instructions. 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 49: Part 5: Technical Data
Titelseite Text Part 5: Technical Data 1567030, Edition 2020-04, Version 1 Light System DoVera DM520... -
Page 50: Technical Data Of The Light System Dovera Dm520
Titel Bildseite ohne Strich Technical Data of the Light System DoVera DM520 General data Color RAL 9010 Applicable European Directive 93/42/EEC and 2007/47/EC Particular Standard EN/IEC 60601-1 / 60601-2-41 Classification of Medical Device according to European Directive Class I Classification according to FDA for OR light... - Page 51 Light intensity control [%] 25-100 Technical details of pendant system Product labels The Light System DoVera DM520 product label is located on the right side of the lowest extension arm (see Chapter 2.4, “Information on the product label”, on Page 20). Noise level...
- Page 52 Bildseite ohne Strich Technical Data of the Light System DoVera DM520 Adaptions Approved adaptions • The components have been adapted to each other and are safe to operate. Any other type of installation, and in particular the use of components from third-party manu- facturers, is strictly prohibited because these compo- nents can be potential sources of danger.
- Page 53 Titel Bildseite ohne Strich Notes 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 54 Titel Bildseite ohne Strich Notes 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
- Page 55 Titel Bildseite ohne Strich Notes 1567030, Edition 2020-04, Version 1 Light System DoVera DM520...
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