Alltion AC-2000 User Manual

AC-2000 Series Colposcope

User's Manual

Version: B3

14/09/2020

(Please read the instruction carefully before using it)

Alltion (Guangxi) Instrument Co., Ltd.

AC2000-UM02-EN

Product Information:

Product Name: Colposcope

Product Model: AC-2000 series

Date of Manufacture: Please see the instrument label

Manufacturer:

Alltion (Guangxi) Instrument Co.,Ltd.

Manufacturing Address: No. 10, 3 Road, Industrial Park, Wuzhou, Guangxi

E-Mail: [e-mail] or [e-mail]

Phone: [phone]

Fax: [phone]

Postal Code: 543000

Website: http://www.alltion.com

 Symbols、labels and information：

Keep in a cool, dry

Alltion (Guangxi) Instrument Co., Ltd

Obelis s.a

Bd. Général Wahis 53 1030 Brussels, BELGIUM

Manufacturer

Serial number

Date of manufacture

Lot number

WEEE disposal

place

For indoor use

Authorized representative
in the European community

Medical Device complies
with Directive 93/42/EEC

PSE label

Consult instructions for use

Fragile, handle with care

Upward

Equipotentiality

Imported by:

Product code

Moisture limitation

Alltion Building, NO.10, 3rd Road, Wuzhou Industrial Park,
Wuzhou, Guangxi, China 543000
Made in China

Temperature limitation

Atmospheric pressure
limitation

GIMA S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) - Italy

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 has 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

In order to prevent the instrument from tipping during handling,

please keep the instrument at the lowest position.

Tilting Base: Do not place the instrument on a surface that is

more than 5 degrees. There is a risk of imbalance.

Contents

1 Intrduction ........................................................................................................................................................... 1

1.1 Product Feature ..................................................................................................................................... 1

1.2 Adaptation of Product .......................................................................................................................... 2

1.3 Product Formation ................................................................................................................................ 2

2 Security ................................................................................................................................................................ 2

2.1 Intended Use .......................................................................................................................................... 2

2.2 The Environment For Use ................................................................................................................... 3

2.3 Feature of Security ............................................................................................................................... 3

3 Instruction For Colposcope ........................................................................................................................... 4

3.1 Three-Step Colposcope（L Stand） ................................................................................................ 4

Three-Step Colposcope（Upright Stand） .................................................................................... 6

3.2

3.3 Indications for Use ................................................................................................................................ 8

3.4 Features ................................................................................................................................................... 8

4 Installation of Colposcope ........................................................................................................................... 8

4.1 Contents of Box ..................................................................................................................................... 8

4.2

Removing the Colposcope From the Box .................................................................................... 8

4.3 Setting Up the Colposcope ................................................................................................................. 9

5 Adjustment of the Eyepieces ......................................................................................................................... 9

5.1 To A d just the IPD (5C) .......................................................................................................................... 9

6 Adjustment of the Diopter Knobs ............................................................................................................... 10

7 Colposcope Instructions for Use ................................................................................................................. 11

8 Selecting Your Preferred Level of Magnification .................................................................................... 12

9 Integrated Video Camera .............................................................................................................................. 13

10 Storage and Precautions .......................................................................................................................... 13

11 1Moving the Colposcope .......................................................................................................................... 13

12 TECHNICAL DATA CONTINUED ........................................................................................................... 14

13 Troubleshooting .......................................................................................................................................... 18

14 Information about disinfection for Alltion LED Colposcope ........................................................... 19

15 Disposal ................................................................................................. Errore. Il segnalibro non è definito.

16 GIMA WARRANTY TERMS ........................................................................................................................ 19

1 Intrduction

1.1 Product Feature

● Vaginal surgery microscope（Colposcope） apply to gynecological microsurgery and

gynecological examination.

● The Colposcope of AC-2000 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; and can show the nidus on the monitor

clearly(AC-2311).Doctor can observe the nidus on the monitor, 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：

Model

AC - 2 X X X X

Stand form: Null- Upright Stand , DA-L Stand

Built-in CCD camera: 0-Without CCD, 1-With CCD

the eyepieces of binoculars: 1-The straight binocular head

Magnification: 3-Three-step Magnification

Product series: 2-AC-2000 Series

Product name: AC-the code of Colposcope

● Adoption Standard

IEC60601-1, IEC60601-1-2

● Intended Service Life: 10 years

1

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-2000 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, such as CCD and so on.

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, cervicallntraepithelial

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；

2

● 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：32VA ；

h) The Colposcope can not defend the defibrillator discharge ；

i) The colposcope have a accessory what build-in optical splitter camera with a signal

output unit which is HDMI 1080P

3