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Related Manuals for Getinge MAQUET X'TEN
Summary of Contents for Getinge MAQUET X'TEN
- Page 1 | 1 | USER MANUAL - EN X‘TEN | User manual | EN | 0130103 | 3A |...
- Page 2 Copyright All rights reserved. May not be duplicated, adapted or translated, in whole or in part, without prior written permission except where allowed by copyright law. © Copyright Maquet SAS Subject to technical changes. The illustrations and technical specifications provided in this manual may, on account of future product developments, differ slightly from the actual product supplied.
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Page 3: Table Of Contents
| 3 | CONTENTS Quality standards compliance � Certification of MAQU�T SAS’s quality system � C� marking � Warnings � Symbols used in this manual � Symbols used on the product � Introduction � Description � �� �.� �xample of double configuration �... -
Page 4: Quality Standards Compliance
| 4 | QUALITY STANDARDS COMPLIANCE CERTIFICATION OF MAQUET SAS’S QUALITY SYSTEM LN�/G-M�D certifies that the quality system developed by MAQU�T SAS for design, implementation, sales, installation and after-sales service of surgical lights complies with the requirements of the following international standards: IS�... -
Page 5: Warnings
| 5 | WARNINGS WARNING Changes or modifications not expressly approved by MAQU�T SAS could void the user’s authority to operate the equipment. WARNING Light is a form of energy that can dry out tissue, particularly if light beams from more than one lighthead are superimposed. - Page 6 | 6 | WARNING To avoid all risk of asepsis, only the medical team may touch the sterilisable handle during procedures. WARNING Do not store objects on the wall power supply units. WARNING Solutions containing glutaraldehyde, phenol, iodine, bleach, alcohol or chloride ions must not be used.
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Page 7: Symbols Used In This Manual
| 7 | SYMBOLS USED IN THIS MANUAL Symbols Meaning Mandatory May affect patient or user safety Recommendation Risk of damage to device or accessories CE label The device complies with the requirements of �uropean directive 9/4�/��C relating to medical devices. Medical Equipment Classified with respect to electric shock, fire and mechanical hazards only in accordance with UL 6�6��-�, I�C 6�6��-�-4�... -
Page 8: Symbols Used On The Product
| 8 | SYMBOLS USED ON THE PRODUCT Symbols Meaning Caution Follow the instructions for use Read the documents supplied with unit carefully Manufacturer Alternating current Direct current R�F. Product technical description and serial numbers. Comply with the applicable handling precautions for products that are sensitive to electrostatic discharges. -
Page 9: Introduction
| 9 | INTRODUCTION INTENDED USE The X’T�N range is designed for use in medical applications to illuminate patients' bodies during operations, diagnosis or treatment. The X’T�N range consists of single-arm, dual-arm or triple-arm ceiling-mounted lights with single or double forks. Some models are equipped with L�D ambient lighting and are prewired for video. - Page 10 | 10 | OPERATION Ambient temperature: ��°C to 4�°C Relative humidity: ��-75% Atmospheric pressure: 7�� to ��6� hPa The X’T�N system must be installed and commissioned in accordance with the �MC information provided in chapter ��. Portable and mobile RF communication devices may affect the correct operation of this equipment.
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Page 11: Description
| 11 | DESCRIPTION EXAMPLE OF DOUBLE CONFIGURATION Figure 1 Main arm Spring arm Double fork Ambient light: ring of L�Ds Side positioning handle Underside Sterilisable handle Shell Cover 10 Lamp holder 11 Keypad 12 Surgical light button 13 Ambient light button X‘TEN | User manual | EN | 0130103 | 3A |... -
Page 12: Versions Available
| 12 | VERSIONS AVAILABLE Standard version Simple surgical light LED Version Surgical light + Ambient light Video version Surgical light + Ambient light + Video prewiring MAIN LIGHTING for performing surgical procedures under the best conditions. AMBIENT LIGHTING for easy viewing of and around operating fields. X'TEN | User manual | EN | 0130103 | 3A |... -
Page 13: Use
| 13 | ENERGIX WPS POWER SUPPLY UNIT The light is turned on and off via the �N�RGIX WPS power supply units. Turns lighthead on and off with a single press. �n/�ff button Lighthead lights up gradually to the last intensity value stored in its memory. -
Page 14: Ptional Lcd
| 14 | OPTIONAL LCD The LCD is used to: Check the service life of consumables (bulbs, bulb holder, batteries), Perform routine tests (backup tests), Troubleshoot malfunctions. OPTIONAL CONTROL VIA A REMOTE PC Light turned on via the Link not operational �N�RGIX unit Settings are adjusted via the �N�RGIX unit... -
Page 15: Ptional Backup Power Supply
| 15 | OPTIONAL BACKUP POWER SUPPLY WARNING In the event of a power cut, only lightheads connected to a backup power supply will remain The power supplies may be optionally equipped for use with your operating room's �4 V backup power supply. -
Page 16: Ptional Video Camera
| 16 | OPTIONAL VIDEO CAMERA The lighthead prewired for video can be used with: a PRV-Z��M camera or a PRV-CFF camera (versions 4 and higher). For information on the camera's features, refer to the Prismavision camera user manual. The camera turns on when the lighthead is switched on. PRV-CFF camera A sterilisable handle with viewing window is required to use the camera. -
Page 17: Positioning
| 17 | POSITIONING MOVING THE LIGHTHEAD The light should be positioned prior to any procedures to avoid having to move it more than necessary later on. Correctly positioning the light for each operation will limit the chances of it coming into contact with other objects (IV pole, pendant, etc.). - Page 18 | 18 | LIGHTHEAD WITHOUT CAMERA Turn the handle to adjust the light volume to the needs of the procedure. The range of the adjustment is limited by stops. LIGHTHEAD WITH CAMERA The image on the screen rotates when the handle is turned.
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Page 19: Pre-Positioning Examples By Speciality
| 19 | PRE-POSITIONING EXAMPLES BY SPECIALITY Pre-positioning Surgical examples specialities General surgery Figure 1 Urology, organ transplants, gynaecology, delivery Figure 2 General surgery, abdominal surgery, digestive surgery, thoracic surgery Figure 3 Proctology Figure 4 X‘TEN | User manual | EN | 0130103 | 3A |... - Page 20 | 20 | Pre-positioning Surgical examples specialities Neurosurgery Figure 5 Plastic and reconstructive surgery, face transplants, oral and maxillofacial surgery Figure 6 �tolaryngology, ophthalmology, dermatology Figure 7 Note: The positions illustrated are given for guidance only. �ach operator will choose the correct position of the light for his/her work habits.
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Page 21: Degrees Of Rotation
| 21 | DEGREES OF ROTATION 360° 360° 45° 330° 310° 360° 50° 330° 290° 205° Double fork version 290° 15° 360° 360° 360° 40° Single fork version 290° 15° 270° 360° 360° 40° Single fork video version X‘TEN | User manual | EN | 0130103 | 3A |... -
Page 22: Fitting The Sterilisable Handle
| 22 | FITTING THE STERILISABLE HANDLE WARNING Check that the sterilisable/disposable handle is compatible with the product. Before reusing the handle after it has been sterilised, always: Check for cracks. Check that the handle clicks into place correctly in the surgical light. click 1 click 2 Figure 2... -
Page 23: Cleaning / Disinfection / Sterilisation
Wipe with a dry cloth. Make sure no liquid residue is left on the device after cleaning. RECOMMENDED PRODUCTS Getinge USA product: T�C-QUAT �56. Anios products: Surfa’Safe; �.5% Hexanios G + R; Aniosyme P.L.A.; Salvanios pH ��; Anios DDSH. Schülke & Mayr products: Antifect Plus. -
Page 24: Cleaning And Sterilising The Handles
Rinsing: Rinse thoroughly in clean water to completely eliminate the detergent solution. Drying: Wipe with a clean lint-free cloth. DISINFECTION Handles may be disinfected by machine (e.g. Getinge) and rinsed at a maximum temperature of 9°C. Typical recommended cycles: Step... - Page 25 | 25 | STERILISATION After cleaning, the handles must be steam sterilised as set out below: Countries Sterilisation Temperature Time Drying cycle [°C] [min] [min] USA & Canada Prevacuum �� - �5 �� �6 � ATNC (Prion) France �4 �8 (Prevacuum) �ther countries Prevacuum...
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Page 26: Maintenance
| 26 | MAINTENANCE FIRST LEVEL MAINTENANCE Daily checks (user) Solutions are listed in Section �� Check the lightheads for chipped paint, impact marks and any other damage. Check the stability/drift of the main arms and the spring arms. Check that the spring arm remains in position. Three checkpoints: bottom, middle, top. -
Page 27: Annual Maintenance
| 27 | ANNUAL MAINTENANCE To preserve your surgical light's original performance and reliability and ensure its safety, annual maintenance and inspections should be performed by: a MAQU�T technician or an authorised MAQU�T distributor, or a hospital technician trained in servicing MAQU�T SAS surgical lights. Note: To find the training solution that best matches your needs, please contact your nearest MAQU�T office. - Page 28 | 28 | Check that the slotted nut is tightly fastened for suspensions with stop. Check the assembly of the spring arm and the positioning of the circlips. Check that the snap ring is present and in the right position (between the spring arm and the fork, and between the fork and the lighthead).
- Page 29 | 29 | Check that the sterilisable handle bracket is not loose. Check the locking mechanism for the sterilisable handle. click 1 click 2 Check that the stop on the fork works properly. Check the cover closing mechanism. Replace the two lamp brackets. Replace the bulbs.
- Page 30 | 30 | Check maximum illumination of the ring of L�Ds: Serial no. < ��,���: �5� lux ± �� % Serial no. > ��,���: ��� lux ± �� % Check the light patch diameter: Serial no. < 20,000: 25 cm ≤ diameter ≤ 30 cm Serial no. > 20,000: 24 cm ≤ diameter ≤ 30 cm Check that the camera operates correctly (CFF or VZ): stable and clean image.
- Page 31 | 31 | Turn the lighthead on and simulate a power supply failure. Check that the switch to batteries (see next page) and to the establishment's emergency system is working. Illumination should remain at > 40,000 lux for at least 1 hour.
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Page 32: Replacing The Bulbs
| 32 | REPLACING THE BULBS WARNING Do not change the bulbs while the system is in use. Do not use the unit with the cover open. When performing maintenance, beware of hot surfaces which are indicated by the following icon: RECOMMENDATION Replace bulbs every 6��... -
Page 33: Accessories
| 33 | ACCESSORIES Accessories Code Part number Set of 5 sterilisable handles 67� � 976 PSX �� Pack of 5 sterilisable handles for lightheads equipped with a CFF camera 67� � 975 PSX ��4 (with viewing window) Pack of 5 sterilisable handles for lightheads equipped with a Z��M 67�... -
Page 34: General Characteristics
| 34 | GENERAL CHARACTERISTICS (IN ACCORDANCE WITH STANDARD IEC 60601-2-41 AND IEC 60601-1) Specifications Unit X’TEN Main light Nominal illumination (�c) ��,��� ± �5% Diameter d�� cm (inches) �6 (��.�”) ± ��% Diameter d5� cm (inches) �5 (5.9”) ± ��% Illumination depth ��% cm (inches) ���... -
Page 35: Mc Declaration
| 35 | EMC DECLARATION (IN ACCORDANCE WITH STANDARD EN 60601-1-2: 2001) Table 201 - Guidance and manufacturer's declaration — electromagnetic emissions The X’T�N system is intended for use in the electromagnetic environment specified below. The customer or the user of the X’T�N system should ensure that it is used in such an environment. - Page 36 | 36 | Table 202 - Guidance and manufacturer's declaration — electromagnetic immunity The X’T�N system is intended for use in the electromagnetic environment specified below. The customer or the user of the X’T�N system should ensure that it is used in such an environment.
- Page 37 | 37 | Table 204 - Guidance and manufacturer's declaration — electromagnetic immunity The X’T�N system is intended for use in the electromagnetic environment specified below. The customer or the user of the X’T�N system should ensure that it is used in such an environment. Immunity IEC 60601 Compliance...
- Page 38 | 38 | Table 206 - Recommended separation distances between portable and mobile RF communications equipment and the X’TEN system The X’T�N system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the X’T�N system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the X’T�N system as recommended below, according to the maximum output power of the communications equipment.
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Page 39: Troubleshooting
| 39 | TROUBLESHOOTING Problem Likely cause Corrective action The lighthead does Faulty or missing bulb Cut off the power supply and not turn on replace the bulb(s) Power cut Check if other devices on the same supply network are operating �ther reason Call MAQU�T technical... - Page 40 MAQU�T SAS Parc de Limère Avenue de la Pomme de Pin CS ����8 ARD�N T h e G � T I N G � G r o u p i s a l e a d i n g g l o b a l p r o v i d e r o f 45�74 �RLÉANS C�D�X �, France equipment and systems that contribute to quality enhancement and Phone number: + (�) �...
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