Cytology brushes (Gastroenterology)

CYTOLOGY BRUSH IFU ENGLISH SCD-742000-025 Rev 2023-11-29

INSTRUCTION FOR USE DISPOSABLE CYTOLOGY BRUSH

DEVICE DESCRIPTION

• Cytology Brushes are endoscopic accessories that allow the

location and retrieval of tissue with the endoscopes.

INTENDED USE

• Horizons Cytology Brush is intended to be used in the flexible

endoscope to collect cell sampling, or to perform surveillance

cultures.

INTENDED USERS

The device is intended to be used by licensed physicians only (excluding

non-physician specialists) with adequate training and experience to collect

cell sampling, or to perform surveillance cultures, using the flexible

endoscope under endoscopic visualization.

INDICATIONS

The Cytology Brush is indicated for endoscopic procedures (Endoscopy)

when the doctor needs to be able to recover tissue or cell samples, from

within a patient’s body or body cavity.

When selecting the Cytology Brush for use, the physician shall the

suitability of the device for the patient age and anatomy. In general, a 2.5mm

diameter device is designed for adults (aged 21 or over). A 1.7mm diameter

device is indicated for pediatrics (excluding neonates and infants).

ENVIRONMENT OF USE

The intended environment of use is at a physician’s office or hospital

operating room

CAUTION

Endoscopy should only be performed by a physician who has adequate

experience and training.

Please read these instructions carefully, failure to follow these instructions

may lead to serious medical consequences.

This device is for single use only. Do not reuse, reprocess or re-sterilize.

Reuse, re-processing or re-sterilization may compromise the structural

integrity of the device and/or lead to device failure which in turn may result

in patient injury, illness or death. Reuse, reprocessing or re-sterilization may

also create a risk of contamination of the device and/or cause patient

infection or cross-infection including, but not limited to, transmission of

infectious disease(s) from one patient to another. Contamination of the

device may lead to injury illness or death of patient.

Used product and packing should be disposed of in accordance with hospital,

administrative and/or local government policy.

WARNINGS

• Endoscopy should only be performed by a physician who has

adequate experience and training.

• Please read these instructions carefully, failure to follow these

instructions may lead to serious medical consequences.

• This device is for single use only. Do not reuse, reprocess or re-

sterilize. Reuse, re-processing or re-sterilization may compromise

the structural integrity of the device and/or lead to device failure

which in turn may result in patient injury, illness or death. Reuse,

reprocessing or re-sterilization may also create a risk of

contamination of the device and/or cause patient infection or

cross-infection including, but not limited to, transmission of

infectious disease(s) from one patient to another. Contamination

of the device may lead to injury illness or death of patient.

• Used product and packing should be disposed of in accordance

with hospital, administrative and/or local government policy.

PRECAUTIONS

• The device is ETO sterile. Do not use this device if there is any

evidence of damage to the sterile package.

• Do not use this device for any purpose other than the stated

intended use.

• Verify the expiration date on the package label of sterile devices

prior to using the product. If the expiration date has lapsed, do

not use or re-sterilize the device.

CONTRAINDICATIONS

1. General medical condition that would not allow tolerance to

endoscopy and/or other manipulation required.

2. Patients demonstrating resistance.

3. The device may not be used for applications other than for which

it is intended.

4. The device must not be passed through an incompatible

endoscope.

5. 6. The device must not be re-sterilized and reused.

The device is not intended to be implanted.

INSTRUCTIONS FOR USE

1. Choose an appropriate cytology brush according to working

channel. The sheath OD should be smaller than channel ID, and

the working length should be longer than endoscope itself. The

sheath should be of no crease and bush head should be of no

damage. Try to operate the brush that it can get in and out of the

sheath smoothly. Please prepare spare cytology brush in case of

accident.

2. Under the inspection of endoscope, slowly move the brush for 2

to 3 cm each time. Move the brush to the sampling position.

3. Brush back and forth for 4 to 5 times on sampling position.

After sampling, withdraw the brush into sheath and then retreat

the cytology brush from working channel.

REPORTING

Customer in the EU shall report any serious incident associated with the

device to their National Competent Authority, distributor, and Horizon

International Corp..

Any serious incident that has occurred in relation to the device must be

notified to the manufacturer and to the competent authority of the Member

State in which the user and/or patient is established..

Accessing Electronic Versions of IFU – Step-by-Step Guide

1. Start by opening a web browser on your device and enter the official

website URL for Horizons Corp: https://www.horizonscorp.com.

2. Once the website loads, you will be directed to the main page, which

features various tabs and options. Look for the tab labeled “Products.”

3. Click on the “Products” tab to access a dropdown menu that categorizes

different product options. Within this tab, you can choose the specific

product category that aligns with your requirements. Alternatively, you can

enter the following URL https://www.horizonscorp.com/products which will

take you directly in the product pages

4. Within your chosen product category, you will find a list of individual

devices or models. Select the specific device that corresponds to your needs.

5. After selecting the device, the main page will load with comprehensive

information about the chosen product. At this point, you will have multiple

options to explore, including “Specifications,” “IFU,” “Brochure,” or

“Video.”

6. To access the Instructions for Use (IFU), click on the “IFU” option. This

will lead you to a section where the latest revision of the readable IFU is

presented in an electronic format

7. In the IFU section, you will have the opportunity to view and read the

most recent version of the IFU directly on the webpage. Additionally, if you

prefer, you can choose to download a PDF copy of the IFU for offline

reference.

8. If you are interested in accessing previous revisions of the IFU, you can

find these versions within the same IFU section. Look for the category

labeled “Previous Versions.“

By following these steps, you will be able to access and utilize electronic

versions of the Instructions for Use (IFU) for Horizons Corp products.

Remember to make use of the IFU to ensure the proper and safe use of the

products as intended.

CE 2862

SCD-742000-025

Revision Date 2023-11-29