00731436 Rev.D
Endo-Boot™ - 内視鏡先端プロテクタ 再注文番号 HZ-711621
Endo-Boot™ - endoscope tip protector Reorder No. HZ-711621
再注文番号 HZ-711622
Reorder No. HZ-711622
取扱説明書
INSTRUCTIONS FOR USE
00731436 Rev.D
This device is not made with natural rubber latex.
INTENDED USE:
The Endo-Boot™ is used as a protective cover for the tip of the endoscope or other surgical instruments (i.e. rigid laparoscope,
laparoscopic instruments) during storage and transport. The Endo-Boot™ will aid in protecting the lens and other delicate components
from damage.
Part Description Part No. Endo-Boot TM
Inner Diameter
Endoscope Outer Diameter
Compatibility Range
Endo-Boot™ - endoscope tip protector – small
00711621 25 x 4.5 mm 3.0 – 8.8 mm
Endo-Boot™ - endoscope tip protector – large 00711622 25 x 9.0 mm 8.8 – 15 mm
WARNINGS AND PRECAUTIONS:
This device is to be used to protect endoscopes and medical/surgical instruments and is not to be used on a patient or as an
endoscope cleaning sponge.
Should the non-sterile Endo-Boot™ endoscope tip protector be placed on a sterilized endoscope or sterilized
medical/surgical instrument, the endoscope or medical/surgical instrument would be considered non-sterile.
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).
DIRECTIONS FOR USE:
When used with a disinfected or sterilized endoscope or a disinfected or sterilized medical/surgical instrument:
(See above warning with use on a sterile endoscope or instrument)
1. Slip the Endo-Boot™ endoscope tip protector onto the distal end of the endoscope or medical/surgical instrument after the
endoscope or medical/surgical instrument has been properly cleaned, disinfected/sterilized, and completely dried.
2. The Endo-Boot™ protector should be placed onto the distal end of the endoscope. The placement should ensure the distal tip
of the endoscope is left uncovered (see picture below).
3. Transport and store the endoscope or medical/surgical instrument.
4. Remove the Endo-Boot™ endoscope tip protector prior to use of the endoscope or medical/surgical instrument on a patient.
When used with a dirty endoscope or medical/surgical instrument:
1. Slip the Endo-Boot™ endoscope tip protector onto the distal end of the dirty endoscope or medical/surgical instrument for
transportation to the cleaning area.
2. Remove the Endo-Boot™ endoscope tip protector prior to cleaning, soaking, disinfecting, and/or sterilizing the endoscope or
medical/surgical instrument to ensure that all surfaces of the endoscope or medical/surgical instrument are exposed during the
selected process.
3. Dispose of device as per institutional guidelines.
4. Never reuse the dirty Endo-Boot™ endoscope tip protector.
00731436 Rev.D
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: October 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.
00731436 Rev.D
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
5.2.7
Non-Sterile
非滅菌
Indicates a medical device that has not been sterilized
滅菌されてい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
5.4.1
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
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
00731436 Rev.D
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
I.D.
内径
Indicates internal diameter
内径を示します
N/A N/A
O.D.
外径
Indicates outer diameter
外径を示します
-
1
-
2
-
3
-
4
-
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