Steris Centra Disposable Biopsy Forceps Operating instructions

Brand
Steris
Model
Centra Disposable Biopsy Forceps
Type
Operating instructions
Instructions for Use
REF # #
BX00711255
BX00711256
BX00711257
BX00711258
BX00711259
Disposable Swinging Biopsy Forceps
Model
AG-5021-2323
AG-5022-2323
AG-5022-2316
AG-5023-2323
AG-5024-2323
Rx ONLY
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1
【Device Name】
【Indications for Use】
This device is used to enter human gastrointestinal tract via flexible endoscope to obtain tissue sa
order to understand disease pathology.
【Key Components】Stainless steel and ABS
【Diagram】
Plain Plainoval oval with needle
Serrated type serrated with needle
【Model and Dimension】
Product
Number
Jaw
OD
Jaw
Opening
(mm)
Jaw
Length
(mm)
Working
Length
(mm)
Min.
Working
Channel
(mm)
Needle Style Swinging
00711255 2.3 8
8
8
8
8
4
4
4
4
4
2300
2300
2300
2300
1600
2.8 N Plain Cup Y
00711256 2.3 2.8 Y Plain Cup
Plain Cup
Y
00711257 2.3 2.8 N
2.8 Y
Serrated Y
00711258
00711259
2.3
2.3
2.8 Y Serrated Y
Y
4
Manufactured for:
File No.: AG9.502US.0000.SM1
Version: Z
Issued date: 2020. 6.30
US Endoscopy
5976 Heisley Road
Mentor, OH 44060
800 -548-4873
www.steris.com
A subsidiary of STERIS Corporation
Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80, 20537 HamburgGermany
Phone: 0049-40-2513175 Fax: 0049-40-255726
Hangzhou AGS MedTech Co., Ltd.
Address:Building 5, Building 6, No.597. Kangxin Road,
Yuhang District, 311106 Hangzhou, Zhejiang, China
Phone: 86-571-87671223 Fax: 86-571-87671230
Disposable Swinging Biopsy Forceps
【Feature】
1. Using flexible tube with smooth appearance to avoid any possible damage to the endoscope channel; under the
guidance of endoscope it can easily enter human gastrointestinal tract to obtain tissue sample.
2. The forceps adopt assembly structure; the opening and closing of forceps is more flexible, and structure is safer.
3. The transition part of each component of forceps adopts circular arc transition. The damage to endoscopy channel
and wound to human body is smaller.
4. The device is sterile and easy to operate.
【Directions for Use】
1. Observe the biopsy site through endoscopy and choose suitable biopsy forceps for the endoscope and tissue.
2. Pull spool to close the cups and insert forceps into the endoscope channel.
3. Slowly advance the biopsy forceps until the forceps can be seen through endoscopy.
4. Advance forceps to biopsy site, open cups and advance into tissue sample.
5. Pull spool to close forceps to grasp tissue.
6. Caution: If forceps fail to close, remove endoscope and biopsy forceps together from natural cavity of the
human body, then manually close cups and withdraw biopsy forceps from endoscope.
7. Pull back the spool to keep cups closed and gently withdraw forceps from endoscope.
8. Prepare specimen for testing following institutional guidelines of country and area.
【Attention】
1. Do not use if the package is damaged.
2. Expired product should not be used.
3. Before using the device, read IFU carefully to know the using method clearly.
4. The whole device should be checked whether there is any damage (i.e.bend of connection part and inflexible
opening and closing of forceps) before using this product. If the problem exists, please do not use.
5. When using this product, gently advance forceps to biopsy site via endoscope channel. If resistance is
encountered during advancing, it cannot be pushed forcibly so as to avoid damaging the endoscope.
6. This device is sterile and single-use, please dispose of after completion of procedure according to the country or
local institutional guidelines of bio-hazardous medical waste. Reuse is forbidden.
7. The device should be only used by trained users.
【Warning】
1. Do not force the distal end of the insertion portion against body cavity tissue. Doing so could cause patient injury,
such as perforation, bleeding, or mucous membrane damage.
2. Do not insert the instrument into the endoscope while the cups are open. Otherwise, patient injury, such as
perforation, bleeding, or mucous membrane damage could occur. It could also damage the endoscope
and/or instrument.
3. Biopsy may cause bleeding. If you take a large sample or press the instrument's distal end against tissue
excessively, the risk of bleeding will increase. Perform biopsy on minimum necessary spots only.
4. Make sure that the cups close evenly and are properly aligned when the slider is pulled.
【Contraindication】
The contraindication related to the operation of endoscopy with biopsy forceps includes (but not limited) disorder
of blood coagulation.
【Potential Complications】
Those associated with gastrointestinal endoscopy include, but are not limited to: mucosal tearing, swelling,
23
bleeding, perforation and infection.
【
【
Packaging】
】
One piece per pouch, with box.
【Manufacturing Date】It can be found on the package labels.
【Labeling Instructions】
Do not reuse Consult instruction for use
Sterilized using Ethylene
Oxide
Keep away from sunlight
Do not use if package is
damaged
Keep dry
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layers
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Atmospheric pressure
limitation
Humidity limitation
Temperature limitation
To sale by or on the order of a
physician.
【Sterilization Method】EO sterilization.
【Expiration for Sterilization】Three years after sterilization.
【Storage】
After packaging, the device shall be stored in an environment of relative humidity below 80%, temperature of -10℃-
40℃, and noncorrosive gases and well-ventilated room.
Operating environmentAmbient temperature:10—40, Relative humidity:30—85%
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Steris Centra Disposable Biopsy Forceps Operating instructions

Brand
Steris
Model
Centra Disposable Biopsy Forceps
Type
Operating instructions
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