00731875 Rev. C
Exacto® コールド スネア 再注文番号HZ-711115
Exacto® cold snare Reorder No. HZ-711115
取扱説明書
INSTRUCTIONS FOR USE
00731875 Rev. C
This product is not made with natural rubber latex.
Intended Use:
The Exacto® cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
gastrointestinal tract.
Warnings and Precautions:
Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques.
Consult the medical literature relative to techniques, contraindications, complications and hazards prior to any endoscopic
procedure.
A thorough understanding of the technical principles, clinical applications, and risks associated with cold snaring (non-electrical)
polypectomy and tissue resection is necessary before using this product.
These devices are compatible with an endoscope channel of 2.8 mm or larger.
Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. STERIS Endoscopy did not design this
device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this
disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).
Disengage the snare from the polyp if there is a risk of complication.
Care should be exercised when grasping tissue to avoid inadvertently grasping tissue or organs not intended for retrieval.
If resistance to insertion is encountered, reduce the angulation (or lower the forceps elevator if applicable) until the instrument
passes smoothly.
Short strokes, 1”-1.5” (2.5cm – 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.
The following conditions may not allow the device to function properly or cause patient injury:
1) Attempting to advance the handle to the open position with too much speed or force,
2) Attempting to pass or open the device in an extremely articulated endoscope,
3) Attempting to actuate the device in an extremely coiled position and/or,
4) Attempting to actuate the device when the handle is at an acute angle in relation to the sheath.
Contraindications:
Contraindications include, but are not limited to, those specific to any endoscopic procedure.
Prior to Use:
1. Prior to clinical use, inspect and familiarize yourself with the device. If there is evidence of damage, do not use this product and
contact your local Product Specialist.
2. Ensure that the device is compatible with an endoscope channel of 2.8mm or larger before insertion.
3. Remove the device from the package and uncoil the entire device and drape in a “U” shaped configuration, holding the proximal
end in one hand and the distal sheath in the opposite hand.
4. Move the finger rings back and forth to confirm that the snare loop opens and closes smoothly prior to inserting into the endoscope.
5. Ensure the snare loop is fully retracted into the catheter prior to insertion into the endoscope.
Note: The Exacto® cold snare is not intended to be used with diathermic energy and, therefore, has no diathermic handle
connection.
Directions for use:
1. Insert the device into the biopsy port of the endoscope using short strokes, approximately 1”-1.5” (2.5cm – 3.8cm) in length
throughout device passage to avoid sheath kinking.
2. When the polyp has been endoscopically visualized, extend the distal tip of the catheter into the endoscopic field of view.
3. Gently deploy the snare loop to a fully open position.
4. Place the snare around the polyp tissue being resected using proper endoscopic technique.
5. After the polyp(s) has been satisfactorily resected, the snare should be retracted back into the catheter.
6. The polyp tissue should be collected and the specimen(s) prepared according to standard technique for histologic evaluation.
Description Product Number Sheath
Diameter
Sheath
Length
Wire
Diameter
Approximate Snare
Size (mm) Width
and Length
Exacto® cold snare HZ-711115 2.4 mm 230 cm 0.30mm
.012 inches 9 X 19
00731875 Rev. C
Product Disposal:
After use, this product may be a potential biohazard which presents a risk of cross-contamination. Handle and dispose of in
accordance with accepted medical practice and applicable local, state and federal laws and regulations.
Issued Date: September 2019
Warning:
An issued or revision date for these instructions is included for the user’s information. In the event that two years have elapsed between
this date and product use, the user should contact STERIS to determine if additional information is available.
Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark Office, or are trademarks
owned by STERIS Corporation.
Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and competent authority
in the country where the incident occurred.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
Made in the U.S.A.
00731875 Rev. C
ラベルおよび取扱説明書にあるマークの説明
Explanation of symbols used on Labels and Instructions for Use
SDO (if
applicable)
Symbol and
Reference Number
Title of Symbol Meaning of Symbol
ISO 15223-1
Medical Devices
– Symbols to be
used with
medical device
labels, labelling,
and information
to be supplied
5.1.1
Manufacturer
メーカー
Indicates the medical device manufacturer
医療機器の製造業者を示します
5.1.3
Date of Manufacture
製造日
Indicates the date when the medical device was
manufactured
医療機器が製造された日付を示します
5.1.4
Use By
使用期限
Indicates the date after which the medical device is
not to be used.
医療機器が使用されなくなる日付を示します
5.1.5
Batch Code
バッチ コード
Indicates the manufacturer’s batch code
メーカーのバッチ コードを示します
5.1.6
Catalog Number
カタログ番号
Indicates the manufacturer’s catalogue number
メーカーのカタログ番号を示します
5.2.3 Sterilized by Ethylene Oxide
酸化エチレンで滅菌済み
Indicates a medical device that has been sterilized
using ethylene oxide
酸化エチレンを使用して滅菌された医療機器であ
ることを示します
5.2.6
Do Not Re-Sterilize
再滅菌禁止
Indicates a medical device that is not to be
resterilized
再殺菌されない医療機器であることを示します
5.2.8
Do not use if package is
damaged
包装が破損している場合は使
用禁止
Do not use if the product sterile barrier system or its
packaging is compromised.
製品の無菌バリア システムまたはその包装が破
損している場合は使用しないでください。
5.3.4
Keep dry
湿気厳禁
Indicates a medical device that needs to be
protected from moisture
湿気から保護する必要がある医療機器であること
を示します
5.3.1
Biological Risks
生物学的リスク
Indicates that there are potential biological risks
潜在的な生物学的リスクがあることを示します
00731875 Rev. C
5.4.2
Do not reuse
再利用の禁止
Indicates a medical device that is intended for a
single procedure
単一の手順を対象とした医療機器でることを示し
ます
5.4.3
Consult instructions for use
使用説明書の参照
Indicates the need for the user to consult
instructions for use
使用説明書を参照する必要があることを示します
5.4.4
Caution
注意
Consult instructions for use for cautionary
information
注意事項については、使用説明書を参照してくだ
さい
21 CFR 801.109
(b) (1)
N/A
Rx Only (U.S.A)
Caution: Federal law (U.S.A.) restricts this device to sale or on the order of a physician.
注意：連邦法（米国）により、本機器の販売先は医師の指示を受ける者のみに制
限されています。
N/A N/A
Unique Device Identifier
固有の機器 ID
Indicates the unique device identifier
固有の機器 ID を示します
N/A N/A
Medical Device
医療機器
Indicates the product is a medical device
本製品は医療機器であることを示します
N/A N/A
Contents
内容物
Number of devices/kits within packaging
包装内の機器/キットの数
N/A N/A
Length
長さ
Indicates length measurement
長さ測定値を示します
N/A N/A
O.D.
外径
Indicates outer diameter
外径を示します
/
