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

2
1.2 Adaptation of Product
The colposcope apply to clinical observation for the lesion of vagina, cervix, vulva, etc.
Contraindication：
（1）Should not checking during menstrual period or vaginal bleeding
（2）Should not perform gynecological examination and cervical
scraping smear before 24 hours of vaginal examination to
avoid the damage of epithelial cell.
（3）Should not have sex 3 hours before the vaginal examination.
（4）Should not take bath in tub ,vaginal douche and use suppository
1 day before the vaginal examination
1.3 Product Formation
The colposcope of AC-1000 series are composed with optical system (include objective,
variable-power lens, eyepiece, illuminating system, stand and electrical system. You can
choice various corresponding mountings for different requirements.
2 Security
2.1 Intended Use
The colposcopy Examination can help doctor to discover and ensure the information
(location, detail, condition, range and extent) of cervical erosion, cervical polyp, cervical
intraepithelial neoplasia (CIN), cervical cancer, colpitis, cervical intraepithelial neoplasia,
subclinical vulvar papilloma lesion.
The colposcope is not only worth diagnosing cervical precancerous lesions and
distinguishing tumor or inflammation, but also have special applied worth in treatment,
especially the lesion of cervical intraepithelial neoplasia (CIN).Because the colposcope can
see the location and range of epithelia changement, you can use the colposcope take more
information about the examination of urethra and vulva in the same way. Its main function：
● Ensure cervical precancerous lesions, it is in favor of wipe out earlier, prevent it grow
into cancer；
● Choice abnormal lesion, Locating biopsy, Increase the positive rate of biopsy；

3
● Ensure the extent of disease, especially cervical canal；
● Ensure the Squamous Colum Junction(SCJ) is normal or abnormal and the range of
transition zone；
● Distinguish infiltrating carcinoma.
2.2 The Environment for Use
a) Transport and Storing
● Ambient Temperature Range：-40℃～55℃；
● Relative Humidity Range：10%～80%；
● Barometric Pressure Range：500 hPa～1060 hPa。
b) Operation
● Ambient Temperature Range：5℃～40℃；
● Relative Humidity Range：30%～80%；
● Barometric Pressure Range：700 hPa～1060 hPa；
● Power Supply: DC12/3A (Adapter:Input:AC100-240V 50/60Hz, Output:DC12V
3A)。
2.3 Feature of Security
a) Classified by prevent electric shock type：II type；
b) Classified by prevent electric shock degree：No Applied Part；
c) Classified by input fluid protection degree：IPX0
d) The Colposcope doesn’t belong to AP&APG equipment；
e) Classified by operation mode：continuous operation；
f) Power Supply: DC12/3A (Adapter:Input:AC100-240V 50/60Hz, Output:DC12V 3A)。
g) Max input power：22VA；
h) The Colposcope can’t defend the defibrillator discharge ；
i) The colposcope does not have signal output or signal input parts.

4
3 Instruction for Colposcope
3.1 Single-step Colposcope AC-1110
Featuring LED Light Source:
Lasts longer
Cool to the touch
Gives you move of a sure color balance
Now easier to move with our new roller base.
Plus, once in position, the platform remains
stable.
360°Motion On/off Switc
h and
Power Indicator Light
Roller Base
Rheostat Knob
LED Bulb Cover
Diopter Knobs
Fine Focus Handle
Gross Height Adjustment
and Locking Knob
Clutter Reducing
Internal Power Cables

5
DC Power Plug
5.5*2.1mm
LED Bulb Cover
Green Filter Knob
Rheostat Knob
Head Inclination
Adjusting Knob
Diopter Knobs
Fine Height
Adjustment Handle
Fine Focus Handle
Gross Height
Adjustment and
Locking Knob

6
3.2 Three-step Colposcope AC-1310
Featuring LED Light Source:
Lasts longer
Cool to the touch
Gives you move of a sure color balance
Now easier to move with our new Roller
base. Plus, once in position, the platform
remains stable.
LED Bulb Cover
Diopter Knobs
Three-step
Magnification
Knobs
Head Inclination
Adjusting Knob
Rheostat Knob
Fine Focus Handle
Gross Height
Adjustment and
Locking Knob
Clutter Reducing Internal
Power Cables
Roller Base
On/off Switch and
Power Indicator Light
360
°
Motion