AGFA EASYLIFT User manual
EASYLIFT
6009/100
User Manual
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
2225E EN 20191025 1001
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
General ....................................................................11
Safety ...................................................................... 11
Environmental Compliance ......................................11
Equipment Classification ..................................................... 12
Training ...............................................................................13
Product Complaints ............................................................. 14
System Documentation ........................................................15
Installation .......................................................................... 16
Compatibility .......................................................................17
Labels .................................................................................. 18
Cleaning and Disinfecting .................................................... 19
Cleaning .................................................................. 20
Disinfecting ............................................................. 21
Approved disinfectants ............................................ 22
Safety Directions ..................................................................23
Basic workflow .................................................................... 26
Technical data ..................................................................... 28
ii | EASYLIFT | Contents
2225E EN 20191025 1001
Legal Notice
Agfa NV, Septestraat 27, B-2640 Mortsel - Belgium
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.
Agfa NV makes no warranties or representation, expressed or implied, with
respect to the accuracy, completeness or usefulness of the information
contained in this document and specifically disclaims warranties of suitability
for any particular purpose. Products and services may not be available for
your local area. Please contact your local sales representative for availability
information. Agfa NV diligently strives to provide as accurate information as
possible, but shall not be responsible for any typographical error. Agfa NV
shall under no circumstances be liable for any damage arising from the use or
inability to use any information, apparatus, method or process disclosed in
this document. Agfa NV reserves the right to make changes to this document
without prior notice. The original version of this document is in English.
Copyright 2019 Agfa NV
All rights reserved.
Published by Agfa NV
B-2640 Mortsel - Belgium.
No part of this document may be reproduced, copied, adapted or transmitted
in any form or by any means without the written permission of Agfa NV
Disclaimer
Agfa assumes no liability for use of this document if any unauthorized
changes to the content or format have been made.
Every care has been taken to ensure the accuracy of the information in this
document. However, Agfa assumes no responsibility or liability for errors,
inaccuracies or omissions that may appear in this document. To improve
reliability, function or design Agfa reserves the right to change the product
without further notice. This manual is provided without warranty of any kind,
EASYLIFT | Legal Notice | 3
2225E EN 20191025 1001
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.
4 | EASYLIFT | Legal Notice
2225E EN 20191025 1001
Scope of this Manual
This manual contains information for the safe and effective operation of the
EASYLIFT.
EASYLIFT | Scope of this Manual | 5
2225E EN 20191025 1001
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.
WARNING:
A warning safety notice indicates a hazardous situation which
can lead to a potential serious injury to a user, engineer, patient
or any other person.
CAUTION:
A caution safety notice indicates a hazardous situation which
can lead to a potential minor injury to a user, engineer, patient
or any other person.
An instruction is a direction which, if it is not followed, can
cause damage to the equipment described in this manual or any
other equipment or goods and can cause environmental
pollution.
A prohibition is a direction which, if it is not followed, can cause
damage to the equipment described in this manual or any other
equipment or goods and can cause environmental pollution.
Note: Notes provide advice and highlight unusual points. A note is
not intended as an instruction.
6 | EASYLIFT | About the safety notices in this document
2225E EN 20191025 1001
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).
EASYLIFT | Intended Use | 7
2225E EN 20191025 1001
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
attempting to work with this equipment, the user must read, understand, note
and strictly observe all warnings, cautions and safety markings on the
equipment.
8 | EASYLIFT | Intended User
2225E EN 20191025 1001
Configuration
7 8
1
2
3
4
56
1. EASYLIFT
2. Lever of the locking mechanism
3. Handle to adjust height
4. Release clamp
5. DR detector holder
6. CR cassette holder
7. Configuration for DR Full Leg Full Spine Retrofit System
8. 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.
EASYLIFT | Configuration | 9
2225E EN 20191025 1001
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
• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
EASYLIFT | Compliance | 11
2225E EN 20191025 1001
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.
Continuous Operation The unit is suitable to run continuously.
Expected service life Minimum 7 years.
12 | EASYLIFT | Equipment Classification
2225E EN 20191025 1001
Training
The user must have received adequate training on the safe and effective use of
the system before attempting to work with it. Training requirements may vary
from country to country. 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:
• Intended Use.
• Intended User.
• Safety Directions.
EASYLIFT | Training | 13
2225E EN 20191025 1001
Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify
Agfa.
If, during the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its authorised
representative and to your national authority.
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
14 | EASYLIFT | Product Complaints
2225E EN 20191025 1001
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.
Refer to the System User Documentation before using the Full Leg Full Spine
application:
• User Manual of the DR system and related user documentation
• NX User Manual
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
EASYLIFT | System Documentation | 15
2225E EN 20191025 1001
Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
16 | EASYLIFT | Installation
2225E EN 20191025 1001
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. Such changes must comply with best engineering
practice and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
EASYLIFT | Compatibility | 17
2225E EN 20191025 1001
Labels
This mark shows compliance of the equip-
ment with Regulation 2017/745 (for Euro-
pean Union).
Figure 1: Example of type label
Type label
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
Instruction card
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
CR FULL BODY CASSETTE HOLDER CR FULL BODY CASSETTE HOLDER
Lock-unlock instruction card
Pinch Points
18 | EASYLIFT | Labels
2225E EN 20191025 1001
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. The user is
responsible for selecting a disinfection procedure.
Topics:
•Cleaning
•Disinfecting
•Approved disinfectants
EASYLIFT | Cleaning and Disinfecting | 19
2225E EN 20191025 1001
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. Make sure no liquid gets in the
device.
CAUTION:
Clean the equipment with only a little moisture. Do not
spray disinfectants or detergents directly on the equipment.
Do not pour liquid directly on the equipment.
Using unsuitable cleaning agents or methods can damage the property
when surface becomes dull and brittle (e.g. alcohol-containing agents).
20 | EASYLIFT | Cleaning and Disinfecting
2225E EN 20191025 1001
Table of contents
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