Steris Raptor Grasping Device – 360 Operating instructions

Brand
Steris
Model
Raptor Grasping Device – 360
Type
Operating instructions
Raptor™ grasping device – 360
Instruction for Use
Page 2 of 6
!
This product is not made with natural rubber latex.
【Device Name】
Raptor™ grasping device – 360
【Indications for Use】
This device is used to enter the natural cavity of human body like respiratory tract, stomach or intestinal tract through
flexible endoscopy channel to grasp tissue, stone, stents or foreign bodies.
【Key Components】
Stainless steel and ABS.
【Diagram】
【Model and Dimension】
Product Number
Jaw Opening Span
(mm)
Working length (mm)
Device Outer
Diameter (mm)
Rotation
00711179
8.3
2300
2.3
Yes
【
Features
】
1. A flexible tube with smooth appearance is used to avoid damage to the endoscope channel, and under the
guidance of the endoscope, it is easy to enter the human gastrointestinal tract to obtain tissue samples.
2. The Forceps are assembled for more flexible open-close and a safe construction.
3. Arc design is adapted in each transition component of forceps. The damage to the endoscope channel and
human body is small.
4. The product is sterile product and easy to use.
5. Rotation capability with the handle. See Figure 2.
【
Direction for Use
】
1. Observe the target to be removed via endoscope and select suitable grasping forceps.
2. Ensure the grasping jaws are closed by pulling back the slider and insert the grasping forceps into the working
channel of the endoscope.
3. Push slowly the grasping forceps until it is visualized through the endoscope.
4. Push the grasping forceps to the targeted object while maintaining visualization, pushing the slider to open
forceps near the grasping target.
5. Tightly pull the handle to grasp the target and withdraw the endoscope and grasping forceps together from the
natural cavity of human body.
6. The grasper may be rotated clockwise or counterclockwise by turning the entire handle as one unit until correct
position is achieved. See figure 2.
Note: Rotation may be limited by the patient anatomy, endoscope position, or other factors.
Rotary/Fixed Part
Slider
Handle
Spring Tube
Figure 1
Figure 2
Page 3 of 6
!
【
Precaution
】
1. Do not use if the package is damaged.
2. Expired products are prohibited.
3. Read the IFU carefully prior to use.
4. Prior to use, examine the device for any damage or malfunction such as drops, bent components or inability to
open and close the jaws. If the problem exists, please do not use.
5. During use, gently push the forceps through the endoscope channel. If resistance is encountered during
advancing, do not apply force to avoid damage to the endoscope.
6. This device is intended for single-use only. Do not attempt to reuse, reprocess, refurbish, remanufacture, or
resterilize this device. This device is not intended to be reused, reprocessed, refurbished, remanufactured, or
resterilized. Performing such activities on this disposable medical device presents a safety risk to patients (e.g.,
compromised device integrity, cross-contamination, infection).
7. This product must be used by a trained physician.
【
Contraindication
】
The contraindication related to the operation of endoscopy with grasping forceps includes (but not limited to) disorder
of blood coagulation.
【
Potential Complication
】
The potential complications associated with use of endoscopy include (but not limited to) swelling, bleeding and
infection.
【
Operating environment
】
Ambient temperature:10—40℃, Relative humidity:30—85%.
【
Packaging
】
One piece per pouch, with box.
【Manufacturing Date】
It can be found on the package labels.
【
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.
【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.
Warning: An issued or revision date for these instructions is included for the user’s information. In the event two years
has 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.
Page 4 of 6
!
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.
Manufactured for US Endoscopy
5976 Heisley Road
Mentor, OH 44060
1(800)/ 548-4873
www.steris.com
A subsidiary of STERIS Corporation
【Explanation of symbols used on Labels and Instructions for Use】
SDO (if applicable)
Symbol and Reference
Number
Title of Symbol
Meaning of Symbol
ISO 15223-1:2021
Medical Devices
– Symbols to be used with
information to be supplied by the
manufacturer
5.1.3
Date of Manufacture
Indicates the date when the
medical device was
manufactured
5.1.4
Use-by date
Indicates the date after which the
medical device is not to be used.
5.1.5
Batch Code
Indicates the manufacturer’s
batch code so that the batch or
lot can be identified
5.1.6
Catalog Number
Indicates the manufacturer’s
catalogue number medical device
can be identified
5.2.3
Sterilized using ethylene oxide
Indicates a medical device that
has been sterilized using
ethylene oxide
5.2.6
Do Not resterilize
Indicates a medical device that is
not to be resterilized
5.2.8
Do not use if package is
damaged and consult instructions
for use
indicates that a medical device
that should not be used if the
package has been damaged or
opened and that the user should
consult the instructions for use for
additional information
5.3.1
Fragile, handle with care
Indicates a medical device that
can be broken or damaged if not
handled carefully
Page 5 of 6
!
5.3.2
Keep away from
sunlight
Indicates a medical device that
needs protection from light
sources
5.3.4
Keep dry
Indicates a medical device that
needs to be protected from
moisture
5.3.7
Tempera t u re li m i t
Indicates the temperature limits to
which the medical device can be
safely exposed
5.3.8
Humidity limitation
Indicates the range of humidity to
which the medical device can be
safely exposed
5.3.9
Atmospheric pressure
limitation
Indicates the range of
atmospheric pressure to which
the medical device can be safely
exposed
5.4.1
Biological Risks
Indicates that there are potential
biological risks associated with
the medical device
5.4.2
Do not reuse
Indicates a medical device
that is intended for a single use
only
5.4.3
Consult instructions for use or
consult electronic instructions for
use
Indicates the need for the user to
consult instructions for use
5.4.4
Caution
Indicates that caution is
necessary when operating the
device or control close to where
the symbol is placed, or that the
current situation needs operator
awareness or operator action in
order to avoid undesirable
consequences.
5.7.10
Unique Device Identifier
Indicates the unique device
identifier
21 CFR 801.109(b) (1)
N/A
Caution: Federal law (U.S.A.) restricts this device to sale and use by
or on the order of a physician.
N/A
N/A
Contents
Number of devices/kits within
packaging
N/A
N/A
O.D.
Indicates Outer Diameter
N/A
N/A
Length
Indicates length measurement
Page 6 of 6
!
N/A
N/A
360° Rotation
Indicated device can rotate 360°
N/A
N/A
Minimum Channel Diameter
Indicates the minimum channel
diameter to be used with the
device.
ISO 780:2015
Packaging – Distribution
packaging – Graphical symbols
for handling and storage of
packages
No.13
This way up
This is the correct upright position
of the distribution pack-ages for
transport and/or storage
No.16
Stacking limit by 6
Maximum number of identical
transport packages/items which
may be stacked on the bottom
package, where “6” is the limiting
number
File No.: AGQWL01014
Version: V001
Issued date: 2021.11.19
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Steris Raptor Grasping Device – 360 Operating instructions

Brand
Steris
Model
Raptor Grasping Device – 360
Type
Operating instructions
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