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Summary of Contents for AGFA EASYLIFT
- Page 1 CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER EASYLIFT 6009/100 User Manual CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER...
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Page 2: Table Of Contents
| EASYLIFT | Contents Contents Legal Notice ................3 Disclaimer ..............3 Scope of this Manual ............. 5 About the safety notices in this document ......6 Intended Use ................. 7 Intended User ................ 8 Configuration ................ 9 Compliance ................10... -
Page 3: Legal Notice
For more information on Agfa products, please visit www.agfa.com. Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. EASYLIFT is a trademark of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement. - Page 4 4 | EASYLIFT | Legal Notice implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Note: In the United States, Federal law restricts this device to sale by or on the order of a physician.
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Page 5: Scope Of This Manual
EASYLIFT | Scope of this Manual | 5 Scope of this Manual This manual contains information for the safe and effective operation of the EASYLIFT. 2225E EN 20191025 1001... -
Page 6: About The Safety Notices In This Document
6 | EASYLIFT | About the safety notices in this document About the safety notices in this document The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. DANGER: A danger safety notice indicates a hazardous situation of direct, immediate danger for a potential serious injury to a user, engineer, patient or any other person. -
Page 7: Intended Use
EASYLIFT | Intended Use | 7 Intended Use The intended use of the EASYLIFT is lifting up and lowering down the attached cassette holder (CR Full Leg Full Spine application) or the attatched detector holder (Full Leg Full Spine DR Retrofit System). -
Page 8: Intended User
8 | EASYLIFT | Intended User Intended User This manual is written for trained users of Agfa products and trained clinical personnel. Users are considered as the persons who actually handle the equipment as well as the persons having authority over the equipment. Before... -
Page 9: Configuration
Configuration for CR Full Leg Full Spine application The position of the release clamp is configurable and can be mounted to the left or right side of the EASYLIFT at installation by the trained service engineer. 2225E EN 20191025 1001... -
Page 10: Compliance
10 | EASYLIFT | Compliance Compliance Topics: • General • Safety • Environmental Compliance 2225E EN 20191025 1001... -
Page 11: General
EASYLIFT | Compliance | 11 General • The product has been designed in accordance with Regulation (EU) 2017/745 on medical devices (MDR) • ISO 14971 Safety • IEC 60601-1 • AAMI ES 60601-1 • CSA C 22.2 No.60601-1 Environmental Compliance •... -
Page 12: Equipment Classification
12 | EASYLIFT | Equipment Classification Equipment Classification Per EN/IEC60601-1, this device is classified as following: Table 1: Equipment classification Water Ingress This device does not have protection against ingress of water. Cleaning See section on maintenance and cleaning. Disinfection See section on maintenance and cleaning. -
Page 13: Training
The user must make sure that training is received in accordance with local laws or regulations that have the force of law. Your local Agfa or dealer representative can provide further information on training. The user must note the following information in the system documentation: •... -
Page 14: Product Complaints
Manufacturer address: Agfa Service Support - local support addresses and phone numbers are listed on www.agfa.com Agfa - Septestraat 27, 2640 Mortsel, Belgium Agfa - Fax +32 3 444 7094... -
Page 15: System Documentation
EASYLIFT | System Documentation | 15 System Documentation The documentation shall be kept with the system for easy reference. The most extensive configuration is described within this manual, including the maximum number of options and accessories. Not every function, option or accessory described may have been purchased or licensed on a particular piece of equipment. -
Page 16: Installation
16 | EASYLIFT | Installation Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. 2225E EN 20191025 1001... -
Page 17: Compatibility
Compatibility The system must only be used in combination with other equipment or components if these are expressly recognized by Agfa as compatible. A list of such equipment and components is available from Agfa service on request. Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa. -
Page 18: Labels
18 | EASYLIFT | Labels Labels This mark shows compliance of the equip- ment with Regulation 2017/745 (for Euro- pean Union). Type label Figure 1: Example of type label Instruction card CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER... -
Page 19: Cleaning And Disinfecting
EASYLIFT | Cleaning and Disinfecting | 19 Cleaning and Disinfecting All appropriate policies and procedures should be followed to avoid contamination of the staff, patients and equipment. All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into (close) contact with the device. -
Page 20: Cleaning
20 | EASYLIFT | Cleaning and Disinfecting Cleaning To clean the exterior of the equipment: Wipe the exterior of the device with a clean, soft, damp cloth. Use a mild soap or detergent if required. Do not use any corrosive, dissolving or abrasive cleaning or polishing agents. -
Page 21: Disinfecting
If you plan to use other disinfectants, approval of Agfa is needed before use, as most disinfectants can damage the device. UV disinfection is also not allowed. Perform the procedure following the instructions for use, the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital. -
Page 22: Approved Disinfectants
22 | EASYLIFT | Cleaning and Disinfecting Approved disinfectants Refer to the Agfa website for specifications on the disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device. -
Page 23: Safety Directions
Safety is only guaranteed when changes, additions, maintenance or repairs are carried out by an Agfa certified field service engineer. A non certified engineer performing a modification or service intervention on a medical device, acts on his own responsibility and makes the warranty void. - Page 24 Never move the CR cassette holder or DR detector holder without having at least one hand on its handle. WARNING: Never lean or allow leaning on the EASYLIFT with attached CR cassette holder or DR detector holder. WARNING: Never use or allow to use the EASYLIFT with attached CR cassette holder or DR detector holder as a support.
- Page 25 WARNING: The CR cassette holder or DR detector holder can be brought to floor level by the EASYLIFT device. Take caution that no object or body part has been placed underneath or above the CR cassette holder or DR detector holder! In that case some serious risk of harm can be caused.
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Page 26: Basic Workflow
26 | EASYLIFT | Basic workflow Basic workflow 1. Verify that the locking mechanism is in the unlocked position. The lever of the locking mechanism is pushed inward. CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER 2. - Page 27 EASYLIFT | Basic workflow | 27 4. Push back release clamp. CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER CR FULL BODY CAS S ETTE HOLDER 5. Let go of the handle of the CR cassette holder or DR detector holder.
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Page 28: Technical Data
28 | EASYLIFT | Technical data Technical data Table 2: EASYLIFT technical data 6009/100 Type Dimensions Width: 390 mm Height: 2300 mm Depth: 135 mm Weight approx. 73 kg 7 years Expected product lifetime Table 3: EASYLIFT environmental requirements Environmental requirements (operation) Room temperature 10°C to 35°C...
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