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Summary of Contents for Getinge Maquet Orchide
- Page 1 Instructions for use Maquet Orchide IFU 04661 EN 02 2021-08-09...
- Page 2 © Copyright 2021 Maquet SAS Subject to technical changes. The illustrations and technical specifications provided in this manual may, on account of future product devel- opments, differ slightly from the actual product supplied. V02 09.08.2021 Maquet Orchide IFU 04661 EN 02...
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Page 3: Table Of Contents
1.14 Instructions for reducing the environmental impact ................Safety-related information..................15 Environmental conditions ........................Safety instructions ..........................2.2.1 Safe use of the product......................16 Control interfaces ....................17 Use..........................19 Daily inspections before use......................... Maquet Orchide 3 / 44 IFU 04661 EN 02... - Page 4 Technical specifications..................39 Electrical specifications of cameras and receivers ................EMC declaration ........................... 10 Waste management ....................43 10.1 Disposal of packaging .......................... 10.2 Product ..............................10.3 Electrical and electronic components ....................Maquet Orchide 4 / 44 IFU 04661 EN 02...
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Page 5: Introduction
Your hospital has chosen Getinge's innovative medical technology. We thank you for the confid- ence you have shown in us. Getinge is one of the world’s leading suppliers of medical equipment for operating rooms, hybrid rooms, induction rooms, intensive care units and patient transport. Getinge always puts the needs of healthcare staff and patients first during the development of its products. -
Page 6: Menus And Buttons
Additional assistance or useful information not relat- ing to risks of injuries or risks of material damage. ENVIRONMENT Information relating to recycling or to appropriate disposal of waste. Tab. 2: Types of indication in the document Maquet Orchide 6 / 44 IFU 04661 EN 02... -
Page 7: Groups Of People
The product must not be modified in any way without the prior written consent of Getinge. Compliant use of the device Getinge may not be held liable for any direct or indirect damage that results from actions not set out in this user’s manual. -
Page 8: Expected Service Lifetime
This 10-year service lifetime applies subject to the annual periodic checks being performed by personnel trained and approved by Getinge. After this time, if the device is still in use, an inspec- tion must be carried out by personnel trained and approved by Getinge to ensure the continued safety of the device. -
Page 9: Location And Explanation Of The Device Identification Label
Product code Product overview Fig. 2: Maquet Orchide cameras The camera is designed to capture a perioperative view, which may be shared, saved or broadcast. It is not intended to be used for assistance during an operation or to establish a diagnosis. -
Page 10: Components
The label must bear the indication "VP". If the camera is installed on a lighthead that is not pre-wired for video, the camera will be detected, but no viewing of the video will be possible. Maquet Orchide 10 / 44 IFU 04661 EN 02... -
Page 11: Camera With Wireless Video System (Only On Volista)
1.9.2 Accessories Illustration Description Part num- STG PSX VZ sterilisable handle STG PSX This handle is compatible with all cameras. VZ 01 Tab. 3: Maquet Orchide accessories table Maquet Orchide 11 / 44 IFU 04661 EN 02... -
Page 12: Standards Applied
ISO 13485 2016 ments for regulatory purposes EN ISO 14971 2012 Medical devices – Application of risk management to med- ISO 14971 2007 ical devices Tab. 5: Compliance with quality management standards Maquet Orchide 12 / 44 IFU 04661 EN 02... -
Page 13: Information Relating To Intended Use
This product does not have any contraindications. 1.12 Primary purpose The primary purpose of the Maquet Orchide range of cameras is to capture a view of the surgical site, while being compatible with the illumination intensity of the surgical lights. 1.13 Clinical benefit Maquet Orchide cameras are medical devices. -
Page 14: Instructions For Reducing The Environmental Impact
Follow the specified maintenance schedule in order to keep the level of environmental impact as low as possible. • For questions relating to waste treatment and device recycling, refer to the Waste manage- ment [8 Page 43] chapter. Maquet Orchide 14 / 44 IFU 04661 EN 02... -
Page 15: Safety-Related Information
500 hPa to 1060 hPa Tab. 7: Environmental conditions for transport/storage Environmental conditions for use Ambient temperature +10°C to +40°C Relative humidity 20% to 75% Atmospheric pressure 700 hPa to 1060 hPa Tab. 8: Environmental conditions for use Maquet Orchide 15 / 44 IFU 04661 EN 02... -
Page 16: Safety Instructions
Anyone not trained in installation, maintenance or decommissioning opera- tions is exposed to the risk of injury or electric shock. Installation, maintenance and decommissioning of the device or components of the device must be performed by a Getinge technician or a Getinge-trained service technician. AR NI NG... -
Page 17: Control Interfaces
Control interfaces Control interfaces Fig. 5: Maquet PowerLED II control interfaces Lighthead control keypad Wall-mounted control keypad (optional) Touchscreen control panel (optional) Maquet Orchide 17 / 44 IFU 04661 EN 02... - Page 18 Control interfaces Fig. 6: Volista control interfaces Lighthead control keypad Wall-mounted control keypad (optional) Touchscreen control panel (optional) Maquet Orchide 18 / 44 IFU 04661 EN 02...
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Page 19: Use
Integrity of sterilisable handles 1. After sterilisation, check that there are no cracks or soiling on the handle. 2. Also after sterilisation, check that the lock- ing mechanism operates correctly. Fig. 8: Sterilisable handles Maquet Orchide 19 / 44 IFU 04661 EN 02... -
Page 20: Installing/Removing A Ql Camera On A Volista Lighthead
Pre-positioning prior to installation On the camera Fig. 9: Pre-positioning the camera 1. Rotate the baseplate to align with the tip and form a green arrow Ø The camera is ready to be positioned. Maquet Orchide 20 / 44 IFU 04661 EN 02... -
Page 21: Fitting The Device To The Lighthead
Fig. 11: Positioning the lighthead Fig. 12: Instructions for installing the Quick Lock system 1. Present the camera with the pin opposite the slot 2. Place the two arrows opposite each other. Maquet Orchide 21 / 44 IFU 04661 EN 02... -
Page 22: Removing The Device
2. Keep the button pressed and, using two hands, rotate the base of the device anticlockwise. 3. Remove the Quick Lock camera by pulling upwards Ø The device is removed. Fig. 15: Removing the lighthead Maquet Orchide 22 / 44 IFU 04661 EN 02... -
Page 23: Installing/Removing A Ql+ Camera On A Maquet Powerled Ii Lighthead
2. Once the lighthead is turned over, rotate the locking interface anti-clockwise and then remove the camera whilst holding the locking interface Ø The camera has been removed. Fig. 17: Removing a Quick Lock device Maquet Orchide 23 / 44 IFU 04661 EN 02... -
Page 24: Installing And Removing The Sterilisable Handle
3. Rotate the handle until its rotation is locked. Ø The handle is now locked in place and ready for use. Installing a sterilisable handle for use with a camera Fig. 18: Maquet Orchide 24 / 44 IFU 04661 EN 02... -
Page 25: Wired Video System
Video input #1 3G-SD1 video output #1 Video input #2 3G-SD1 video output #2 If two wired cameras are installed, two power adapters must be used. Contact the Getinge technical department if necessary. Maquet Orchide 25 / 44 IFU 04661 EN 02... -
Page 26: Wireless Video System (On Volista Lighthead Only)
The use of wireless accessories other than those supplied or specified by the manufacturer can affect the operation and performance of the device. Use only the wireless accessories specified by Getinge. For optimal use of the system, do not use more than two cameras within a radius of 10 m, and do not position a camera more than 10 m away from its receiver. -
Page 27: Controlling The Camera
Adjusting the camera zoom 1. Press Camera Zoom 2. Press Plus or Minus to modify the zoom level. Ø The level indicator varies according to the zoom level setting on the camera. Maquet Orchide 27 / 44 IFU 04661 EN 02... -
Page 28: From The Touchscreen Control Panel
Ø The camera page is displayed and the camera is turned on. Fig. 25: Camera page Turning off the camera 1. From the camera page, press Camera ON/OFF to turn off the camera. Ø The button and the camera are turned off. Maquet Orchide 28 / 44 IFU 04661 EN 02... - Page 29 Adjusting the contrast 1. Press Contrast to access the contrast adjustment menu. 2. Press Increase contrast or Decrease contrast to select one of the three contrast levels Fig. 27: White balance control Maquet Orchide 29 / 44 IFU 04661 EN 02...
- Page 30 Zooming in and out 1. Press Zoom to access the zoom adjustment menu. 2. Press Zoom in or Zoom out to adjust the size of the image on screen in real time. Maquet Orchide 30 / 44 IFU 04661 EN 02...
- Page 31 Ø The button is lit blue and the camera focus is automatic. 3. Position the camera at the desired distance. 4. Press Manual Focus Ø The button is lit blue and the camera focus is fixed. Maquet Orchide 31 / 44 IFU 04661 EN 02...
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Page 32: Error Messages And Alarm Indicators
Error messages and alarm indicators Error messages and alarm indicators Not applicable for this product. Maquet Orchide 32 / 44 IFU 04661 EN 02... -
Page 33: Troubleshooting
2. Disconnect and reconnect the receiver power cable 3. Re-register the camera 4. Contact the Getinge tech- nical department Image lost for more than Interference with another sys- 1. The system should reset it- 20 seconds with the OHDII... -
Page 34: Cleaning / Disinfection / Sterilisation
3. Remove the cleaner using a cloth moistened with water and then wipe with a dry cloth. 7.1.2 Disinfecting the device Wipe evenly with a cloth soaked in disinfectant. Follow the manufacturer’s recommendations. Maquet Orchide 34 / 44 IFU 04661 EN 02... -
Page 35: Disinfectants To Be Used
▪ Ethylene diamine tetraacetic acid (2.5%) Tab. 10: Lists of active substances suitable for use Examples of commercially available products tested • ANIOS product®** : Surfa’Safe®** • Other products: 20% or 45% isopropyl alcohol Maquet Orchide 35 / 44 IFU 04661 EN 02... -
Page 36: Cleaning And Sterilising Maquet Sterigrip Sterilisable Handles
Typical cleaning cycles in a washer-disinfector The use of non-enzymatic detergents is recommended. Enzymatic detergents may damage the handles. Never soak the handles in these detergents for prolonged periods. Rinse thor- oughly. Maquet Orchide 36 / 44 IFU 04661 EN 02... -
Page 37: Sterilisation Of The Maquet Sterigrip Handles
4. Run the sterilisation cycle according to the steriliser manufacturer’s instructions. Sterilisation cycle Temperature Time (°C) (min) (min) ATNC (Prion) ̶ Prevacuum Tab. 12: Example of a steam sterilisation cycle Maquet Orchide 37 / 44 IFU 04661 EN 02... -
Page 38: Maintenance
During the guarantee period, maintenance and inspec- tions must be performed by a Getinge technician or a Getinge-approved dealer. After this period, maintenance and inspections may be performed by a Getinge technician, a Getinge-approved dealer or a hospital technician trained by Getinge. -
Page 39: Technical Specifications
820 g 790 g Dimensions (without sterile handle) 93 x 150 mm 129 x 167 mm 132 x 198 mm (Diam. x H) Tab. 14: Electrical specifications of cameras via touch screen only Maquet Orchide 39 / 44 IFU 04661 EN 02... - Page 40 Wireless HDMI video transmission system EXT-WHD-1080P-SR GEFEN** VE819 ATEN** OTICE The technical specifications of the AIR03 and AIR04 wireless systems are de- scribed in the documentation available on the GEFEN and ATEN websites. Maquet Orchide 40 / 44 IFU 04661 EN 02...
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Page 41: Emc Declaration
B defined in CISPR 11 is normally required), this device may not provide sufficient pro- tection for radio frequency communication services. The user may need to take corrective measures, such as relocating or re-orienting the device. Maquet Orchide 41 / 44 IFU 04661 EN 02... - Page 42 Immunity to voltage dips and EN 61000-4-11 0% Ut, 10 ms short interruptions (0°; 45°; 90°; 135°; 180°; 225°; 270°; 315°) 0% Ut, 20 ms 70% Ut, 500 ms 0% Ut, 5 s Tab. 18: EMC declaration Maquet Orchide 42 / 44 IFU 04661 EN 02...
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Page 43: Waste Management
Do not dispose of this device as unsorted municipal waste. Take it to a collection facility for value enhancement, recycling or re-use. For full information relating to processing of the device once it is no longer in use, contact your local Getinge representative. 10.3 Electrical and electronic components All electrical and electronic components used during the life of the product must be processed in an environmentally friendly manner, in line with applicable local standards. - Page 44 *MAQUET POWERLED II, VOLISTA, MAQUET ORCHIDE, MAQUET, GETINGE and GETINGE GROUP are trademarks or registered trademarks of Getinge AB, its divisions or its subsidiaries. **SURFA'SAFE is a trademark or registered trademark of ANIOS Laboratories, its divisions or its subsidiaries. **ANIOS is a trademark or registered trademark of ANIOS Laboratories, its divisions or its subsidiaries.
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