Alltion AC-1000 Series User manual

Alltion (Guangxi) Instrument Co., Ltd.
Medical Device compliant with Regulation (EU) 2017/745
AC-1000 Series Colposcope
User's Manual
(Please read the instruction carefully before using it)
A
ll serious accidents concerning the medical device
supplied by us must be reported to the manufacturer
and competent authority of the member state where
your registered office is located.
AC1000-UM03-EN
Version: A0
2021-10-26
AC-1110 (29612) – AC1310 (29613)

Symbols, labels and information:
Manufacturer
Authorized representative in
the European Community
Serial number
Medical Device compliant
with R
egulation (EU)
2017/745
Date of manufacture PSE label
Lot number Follow instructions for use
WEEE disposal Handle With Care
Keep in a cool, dry
place
Upward
For indoor use
Equipotentiality
Medical device
Product code
Alltion (Guangxi) Instrument Co., Ltd.
Alltion Building, NO.10, 3rd Road, Wuzhou Industrial Park,
Wuzhou, Guangxi, China.
Made in China
Obelis s.a
Bd. Général Wahis 53 1030 Brussels, BELGIUM
Imported by:
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail] - www.gimaitaly.com

Security Warning
For using the instrument safely in a correct way and ensuring the instrument in a
good state, please read this instruction carefully before operating.
It shall change some components to improve the quality and performance of
instrument. Therefore, it may have some different with the instruction. Please know
that the stander equipment be provided by factory shall prevail.
Please attach importance to and perform the
contraindications and announcements

Contents
1Introduction .........................................................................................................................................................1
1.1 Product Feature..............................................................................................................................................1
1.2 Adaptation of Product....................................................................................................................................2
1.3 Product Formation .........................................................................................................................................2
2Security................................................................................................................................................................2
2.1 Intended Use ..................................................................................................................................................2
2.2 The Environment for Use..............................................................................................................................3
2.3 Feature of Security.........................................................................................................................................3
3Instruction for Colposcope................................................................................................................................4
3.1 Single-step Colposcope AC-1110 ........................................................................................................4
3.2 Three-step Colposcope AC-1310 ........................................................................................................6
3.3 45° Three-step Colposcope AC-1320 .................................................................................................8
3.4 Indications for Use ...............................................................................................................................10
3.5Features ................................................................................................................................................10
3.5.1 AC-1110 Features ............................................................................................................................10
3.5.2 AC-1310 Features............................................................................................................................10
3.5.3AC-1320 Features............................................................................................................................11
4Installation of Colposcope...............................................................................................................................12
4.1 Contents of Box....................................................................................................................................12
4.2 Removing the Colposcope from the Box..........................................................................................12
4.3 Setting up the Colposcope .................................................................................................................12
5Precautions .......................................................................................................................................................13
6Adjustment of the Eyepieces..........................................................................................................................13
7Adjustment of the Diopter Knobs...................................................................................................................14
8Colposcope Instructions for Use....................................................................................................................16
9Selecting Your Preferred Level of Magnification .........................................................................................18
10 Moving the Colposcope...............................................................................................................................19
11 Technical Data Continued...........................................................................................................................20
12 Troubleshooting............................................................................................................................................24
13 Information about disinfection for Alltion LED Colposcope....................................................................25
14 Dispose of Wastes.......................................................................................................................................25
15 Gima Warranty Terms .....................................................................................................................................25

1
1 Introduction
1.1 Product Feature
● Vaginal surgery microscope（Colposcope）apply to gynecological microsurgery and
gynecological examination.
● The Colposcope of AC-1000 series have 2 model with one-step magnification and
three-step magnification, huge depth of field, improve contrast by green filter, can acquire
high definition images, excellent 3D percept, can identify microscopic variation by high
quality illuminant and high magnified image; operate easily, can use for diagnostics and
treatment. It provide more advanced ways to clinical diagnosis and teaching research.
● Classified by prevent electric shock type: II type
● Colposcope model labeled graph as follows：
AC -X X X X
the code for built-in CCD camera （expression by a number）
the code for the eyepieces of binoculars （expression by a number）
the code for magnification （expression by a number）
the code for series （expression by a number）
the code for name （the code of Colposcope ）
the code for series：1--- AC-1000 Series
the code for magnification：3--- Three-step Magnification
the code for the binocular head：1--- The straight binocular head, 2--- The inclined binocular head
the code for built-in CCD camera：0--- Without built-in CCD 1--- With built-in CCD
Note: AC-1000 Series Without built-in CCD.
● Adoption Standard
IEC60601-1, IEC60601-1-2
● Intended Service Life: 5 years