Gima AC-2311DA LED VIDEO COLPOSCOPE User guide

Alltion (Guangxi) Instrument Co., Ltd.

AC-2000 Series Colposcope

User's Manual

(Please read the instruction carefully before using it)

All 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.

AC2000-UM03-EN

Version: A0

26/10/2021

M29624-GB-Rev.0-02.22

AC-2311 (GIMA 29624) – AC-2311DA (GIMA 29625)

Medical Device compliant with Regulation (EU) 2017/745

Symbols、labels and information:

Manufacturer

Authorized representative in the European Community

Serial number

Medical Device compliant with Regulation (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 gima@gimaitaly.com - export@gimaitaly.com - 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

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 Introduction .............................................................................................. Errore. Il segnalibro non è definito.

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

3.2

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

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 Adjust 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 Moving the Colposcope ............................................................................................................................ 13

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

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

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

15 Dispose of Wastes ...................................................................................................................................... 19

16 Gima Warranty Terms ................................................................................................................................ 19

1 Introduction

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

1.2 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；

● 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 Instruction For Colposcope

3.1 Three-Step Colposcope（L Stand）

Featuring LED Light Source * Lasts longer * Cool to the touch

[1] LED Bulb cover [4] Head Inclination Knob [5] Fine Height Adjustment Handle [6] Fine Focus Handle [7] Gross Height Adjustment and Locking Knob [8] The Rolling Base, with 5 locking wheels [9] On/Off Switch and Power Indicator Light [10] L Stand

1 4 5

Rolling Base

AC-2311DA (Rolling Base) Label

[1] LED Bulb cover [2] Diopter knobs [3] Three-step Magnification Knob [5] Fine Height Adjustment Handle [6] Fine Focus Handle [11] Green Filter Knob [12] Rheostat Knob [13] These circles give you the

millimeter size at the tissue site according to the magnification you’re using.

[14] Eye shields help block external

light

2 3 5

3.2

Three-Step Colposcope（Upright Stand）

Featuring LED Light Source * Lasts longer * Cool to the touch

[1] LED Bulb cover [2] Diopter knobs [3] Three-step Magnification Knob [4] Head Inclination Knob [5] Fine Height Adjustment Handle [7] Gross Height Adjustment and Locking Knob [8] The Rolling Base, with 5 locking wheels [9] On/Off Switch and Power Indicator Light [10] Upright Stand [12] Rheostat Knob

1 2 3

4 5 7

AC-2311 (Rolling Base) Label

size at the tissue site according to the magnification you’re using.

[14] Eye shields help block external light

3.3 Indications for Use

The ALLTION C

olposcope is a device designed for viewing of the tissues of the vagina and cervix by a telescopic system located outside of the vagina. A colposcope is used to diagnose and examined abnormalities of the vagina and cervix.

3.4 Features

* Total magnification 3.75X, 7.5X, 15X for 3-step models and 7.5X for single

magnification models * 300mm focal length * Field of View: 79mm, 39mm, 19mm dia. For 3-step magnification models and

39mm for single

magnification models

* Depth of Field: 4.5mm, 1.13mm, 0.76mm for 3-step magnification models and

1.13mm for single

magnification models * Light intensity: >25,000 LUX * Individually adjustable eyepiece 16.7X

* The two built-in circles of right eyepieces can measure the size of the problem. * Built-in rheostat for brightness adjustment * User-selectable built-in green filter for enhanced contrast * LED bulb is easily changeable.

* Working Height: 950mm to 1250mm

(AC-2000DA: 950mm to 1150mm)

* Fine focus adjustment Handles * Two(Gross/Fine)height adjustment Handles * Upright Stand Colposcope has been installed before leaving the factory, it can be

used as long as turn on the power/ Please install the head of L Stand Colposcope before turning on the power and using it .

* Main Power Supply:

DC12/3A (Adapter:Input:AC100-240V 50/60Hz, Output:DC12V 3A) * CMOS Sensor: 1/2.8 in CMOS imaging sensor * HDMI Output Image: clear image,

resolution ratio is1920x1080, the fastest speed of preview can reach 60 FPS

4 Installation of Colposcope

4.1 Contents of Box

After removing the main packing materials, you will find the colposcope components located as shown below: *

1 Colposcope (Upright Stand) * 1 Colposcope stand and 1 Colposcope head(L Stand) *

Power adaptor

1 P

lug (US, UK, EU, AUS)

* 1 Plastic Dust Cover * 1 Instructions for use * 1 Cloth * 1 Pair Eye shields * 1 HDMI transmission line (only the colposcope with CCD camera have it)

4.2

Removing the Colposcope from the Box

Upright Stand

L Stand

The Colposcope comes with a two years warranty with free repairs (Shipping not included). Please keep the box and the protective foam for at least two years in case the production need to be returned to ALLTION company for any warranty repairs. Otherwise we will charge a fee for sending a new box.

* The box must be placed in the up position according to the arrows that are printed on the outer box during being carried and unpacked.

* Remove top protective material. * Grasp the Colposcope at the center post (A cutout in the foam for your hands is provided.)

and lift the Colposcope straight out of the protective material. Note: When removing the instrument out of the protective foam, remove with care to prevent the instrument from being damaged.

4.3 Setting Up the Colposcope

A. Remove the power

adapter

from the shipping box.

B. Insert the

adapter

into the plug located at the back end of

the base(1).

C. Insert the other end of the

adapter

into the wall socket.

Connect the power line of stand(3) to the Camera socket(4).

E. When the instrument need to be turned on .Press the on

button(2) then the light of power indicator come up .

F. Important: Rotate the Rheostat Knob(5) to turn on the

Viewing Light. (5B.)

G. When the instrument need to be turned off. Press the off

button then the light of power indicator light of the light of power indicator go out.

5 Adjustment of the Eyepieces

You must adjust the eyepieces to your interpupillary distance (IPD). IPD means the distance between your eyes.

5.1 To Adjust the IPD (5C)

A. Turn on power by pressing the switch on the base.

B. Turn the black Rheostat Knob on the left to adjust the light intensity.

Light will project from upper part of the Colposcope.

C. Gently place your eyes against the black rubber eyepieces.

Grasp the metal housing with both hands. Gently rotate the barrels together or apart.

D. A singular circular image should be seen through both eyepieces.

This adjustment is similar to adjusting the eyepieces of binoculars.

IPD

Tilting Base

6 Adjustment of the Diopter Knobs

Set the Diopter Knobs

zero.

B. Turn the colposcope on, place your eyes against the eyepieces, and focus the colposcope on a

fixed object until that object appears clear and sharp.

C. It is recommended to focus on letters such as a book or a magazine. Do not focus on an object

like a piece of fruit.

D. Close your right eye. With your left hand, rotate the Diopter Knob until the object is clear and

sharp for your left eye. Note: The Diopter allows you to adjust for plus and minus vision corrections.

E. Then close your left eye. Rotate the right diopter knob with right hand

until the object is clear and sharp for your right eye. Note: The Diopter allows you to adjust for plus and minus vision corrections.

F. It is important to keep a record of the adjustments on the

Diopters for both your left and right eyes. Since most offices have multiple people using the Colposcope, the eyepieces will be different when someone else wants to use it. By remembering your diopter settings, clarity can be achieved by simply moving the diopters to your setting when you are ready to use the Colposcope. This avoids you going through steps A–E each time.

Lenses Before Adjustment

Lenses During Adjustment

Lenses Adjusted

6D and 6E

G. You will see two measuring circles through the lens. Since your Colposcope has three different

magnifications, the measurement at the tissue site will vary according to the magnification you’re using. The reference chart gives you the correct size per magnification change.

Note: There is

a chart on the right metal housing.

7 Colposcope Instructions for Use

The following briefly describes using the Colposcope with a patient. It is recommended that you practice using the Colposcope to familiarize your- self with all of the features it has to offer.

A. Let patient in a supine position. Your

Colposcope should be placed so that the head of the scope is 300mm from the area you wish to view, with the post to as near vertical as possible. Rotate the Gross Height Adjustment and Locking Knob to loosen it and move the inner post up or down. Tighten the knob to lock the inner post in place.

B. In a sitting position, place your eyes against the eyepiece. Adjust for pupillary distance and make sure that you set your correct diopter reading. Place your right

hand on the Fine Height Adjustment Handle and your left hand on the Fine Focus Handle. Note: Do not try to focus with Fine Focus.

C. With your hand on the Fine Height Adjustment Handle, slowly push or pull the Colposcope, until the field comes into view.

D. Adjust the Fine Focus Controls to provide clear, magnified views of the area to be examined. Rotate your left hand on the Fine Focus Handle which will finely move the optics towards or away from the object that you wish to view. Also, rotate your right hand which is on the Fine Height Adjustment Handle up or down to raise or lower the optics. Adjust light intensity rheostat as needed by turning the black Rheostat Knob. Turn the silver Green Filter Knob for optimum assessment of affected area.

Note: Both the black Rheostat Knob and the silver Green Filter Knob are conveniently located on the

Colposcope head, thus allowing the user complete control without looking up from the eyepieces.

E. The Colposcope head may be tightened or loosened according to your preference by turning the Head Inclination Adjusting Knob.

Note on all photos All 1 step colposcopes use the same adjustment techniques as

shown on these pages, although models shown may differ.

8 Selecting Your Preferred Level of Magnification

The ALLTION offers you the advantage of increasing or decreasing magnification during a colposcopic examination.

A. When viewing the cervix, reach up and rotate the Three-Step

Magnification Knob.

B. Rotate it to your desired magnification(3.75, 7.5, or 15).When

moving from one magnification to another, slight adjustments

in the fine focusing mechanism might be necessary. C. Turn the Fine Focus Handle. If patient is not centered, you can move the Colposcope head in multiple directions to change your field of vision. See photos D–F.

8E. Pull the Fine Height Adjustment Handle backward and to the right, or Push the Fine Height Adjustment Handle forward and to the left.

8F. Push the Fine Focus Handle down and forward, or pull it up and backward.

8D. Twist the Fine Height Adjustment Handle to move the head up or down slightly. Use the Gross Height Adjustment Knob to make larger height adjustments.

9 Integrated Video Camera

An integrated video camera (1 CCD) is available in specific models.

It is very convenient for the doctors to communicate with the patient by this device.

1.CCD camera power: connect the black wire(3) from the bracket to the camera socket in the head.

2.Video Output：Connect the attached HDMI line to the HDMI port (1) in the head, and then connect the other end of attached HDMI line to the HDMI port of TV or Monitor AV adapter.

3. Internal CCD Camera: The images from integrated video camera can be inputted into a monitor or a TV set directly. Or it can be inputted into a computer by image collection with USB 3.0 HDMI adapter or stored into a hard disk recorder

10 Storage and Precautions

A. For storage, the instrument should be placed in a clean, dry environment with stable temperatures to extend the life of the components and ensure longevity of the instrument.

B. Please cover the Colposcope with the plastic dust cover that is included with this instrument. This will keep the optics and components relatively dust free.

C. When storing or carrying the instrument, adjust the instrument to the lowest position. This will help ensure that if it is inadvertently hit, it will resist tipping over.

11 Moving the Colposcope

Rotate the Gross Height Adjustment and Locking Knob to move the post to a comfortable position.

Tighten the Gross Height Adjustment and Locking Knob.

Place your foot between the wheels at the front end of the base.

With your hand on the Fine Height Adjustment Handle, pull forward and roll across the floor.

10B

12 Technical Data Continued

12.1 Guidance and Manufacturer´s Declaration – electromagnetic Emission – for

all Equipment and Systems

Guidance and manufacturer´s declaration – electromagnetic emission

The AC-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AC-2000 should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR11

Group 1

The AC-2000 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR11

Class A

The AC-2000 is suitable for use in all establishments, including domestic establishments and tho se directly connected to the public low-voltage power supply networ k that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

12.2 Guidance and Manufacturer's Declaration – electromagnetic Immunity – for

all Equipment and Systems

Guidance and manufacturer´s declaration – electromagnetic immunity

The AC-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AC-2000 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV contact ± 15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrostatic transient / burst IEC 61000-4-4

± 2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

0 % UT ; 0.5 cycle At 0°,45°,90°,135°, 180°,225°,270°and 315°

0 % U

1 cycle

and

0 % UT ; 0.5 cycle At 0°,45°,90°,135°, 180°,225°,270°and 315°

0 % U

1 cycle and

Mains power quality should be that of a typical commercial or hospital environment. If the user of the AC-2000 requires continued operation during power mains interruptions, it is recommended that the AC-2000 be powered from an uninterruptible power

70 % U

25/30 cycles Single phase: at 0°

0 % UT; 250/300 cycle

70 % U

25/30 cycles Single phase: at 0°

0 % UT; 250/300 cycle

supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE U

is the a. c. mains voltage prior to application of the test level.

12.3 Guidance and Manufacturer´s Declaration – electromagnetic Immunity – for

Equipment and Systems that are not Life-supporting

Guidance and manufacturer´s declaration – electromagnetic immunity

The AC-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AC-2000 should assure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Compliance

level

Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V rms 150 kHz to 80 MHz

6 V in ISM bands between 0,15 MHz and 80 MHz

3 V/m 80 MHz to 2.7 GHz

3 V rms 150 kHz to 80

MHz 6 V in ISM bands between 0,15 MHz and 80 MHz

3 V/m 80 MHz to 2.7

GHz

Portable and mobile RF communications equipment should be used no closer to any part of the AC-2000, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d ]

5.3

[

d ]

5.3

[

80 MHz to 800 MHz

d ]

[

800 MHz to 2.7 GHz

where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance

level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and

reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AC-2000 is used exceeds the applicable RF compliance level above, The AC-2000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AC-2000.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

12.4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Equipment or System-for Equipment and Systems that are not Life-Supporting

Recommended separation distances between

portable and mobile RF communications equipment and the AC-2000

The AC-2000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AC-2000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AC-2000 as recommended below, according to the maximum output power of the communications equipment

Rated maximum

output of

transmitter

Separation distance according to frequency of transmitterm

150 kHz to 80 MHz

d ]

5.3

[

80 MHz to 800 MHz

d ]

5.3

[

800 MHz to 2.7 GHz

d ]

[

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

13 Troubleshooting

Trouble

Check

Possible reason

Remedy

Illumination failure

Power switch indicator Not light Main power broken-down

Contact a local electrician

Never switch on the power switch.

Switch on the power switch.

The adaptor has been melted

Replacing the adaptor

Power switch indicator light Illuminate brightness adjusting button is in low position

Adjust the button to the high position

The LED has burnt.