Olympus EndoTherapy HX-110LR User manual

AUTOCLAVABLE
INSTRUCTIONS
Rotatable Clip Fixing Device
HX-110LR HX-110QR HX-110UR
Clip
HX-610-090 HX-610-135
Long Clip
HX-610-090L
Short Clip
HX-610-090S HX-610-135S
Colored Short Clip
HX-610-090SC

Contents
Rotatable Clip Fixing Device i
Contents
Symbols.................................................................. 1
Important Information – Please Read Before Use 2
Intended Use ..................................................................... 2
Instruction Manual ............................................................. 3
User Qualifications............................................................. 3
Instrument Compatibility .................................................... 3
Reprocessing and Storage ................................................ 4
Repair and Modification ..................................................... 4
Signal Words ..................................................................... 5
Warnings, Cautions and Notes .......................................... 5
Chapter 1 Checking the Package Contents..... 7
1.1 Checking the Package Contents .............................. 7
Chapter 2 Instrument Nomenclature and
Specifications ................................... 9
2.1 Nomenclature and Functions.................................... 9
2.2 Specifications............................................................ 10
Chapter 3 Preparation,
Inspection and Operation ................ 16
3.1 Preparation ............................................................... 18
3.2 Inspection ................................................................. 19
3.3 Operation.................................................................. 24
Chapter 4 Emergency Treatment...................... 41
4.1 Emergency Treatment .............................................. 41
Chapter 5 Reprocessing.................................... 45
5.1 General Policy .......................................................... 45
5.2 Required Reprocessing Equipment .......................... 49
5.3 Cleaning.................................................................... 51
5.4 Lubrication ................................................................ 53
5.5 Sterilization ............................................................... 54

Contents
Rotatable Clip Fixing Device
ii
Chapter 6 Storage .............................................. 57
6.1 Inspection Before Storage ........................................ 57
6.2 Storage ..................................................................... 58

Symbols
Rotatable Clip Fixing Device 1
Symbols
The meaning(s) of the symbol(s) shown on the package,
the back cover of this instruction manual and/or this
instrument are as follows:
Refer to instructions.
Single use only
Use by (expiration date)
Sterilized using irradiation
Sterilization lot number
Lot number
Manufacturer
Authorised representative in
the European Community

Important Information – Please Read Before Use
Rotatable Clip Fixing Device
2
Important Information – Please
Read Before Use
Intended Use
This instrument has been designed to be used with an
Olympus endoscope for endoscopic clip placement
within the gastrointestinal (GI) tract for the purpose of
Do not use this instrument for any purpose other than its
intended uses.
Due to the range of procedures, the
indications for use of this instrument
should be evaluated by the physician,
taking into account factors such as the
anatomical site, histology, lesion type
and the patient’s condition. In addition,
the cautions and notes contained in
“Warnings, Cautions and Notes” on
page 5 should be thoroughly reviewed
before starting the procedure.
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal/sub-mucosal defects < 3 cm,
(b) bleeding ulcers,
(c) arteries < 2 mm,
(d) polyps < 1.5 cm in diameter,
(e) diverticula in the colon,
(3) as a supplementary method, closure of GI tract
luminal perforations < 20 mm that can be treated
conservatively.

Important Information – Please Read Before Use
Rotatable Clip Fixing Device 3
Instruction Manual
This instruction manual contains essential information on
using this instrument safely and effectively. Before use,
thoroughly review this manual and the manuals of all
equipment which will be used during the procedure and
use the instruments as instructed.
Keep this and all related instruction manuals in a safe,
accessible location.
If you have any questions or comments about any
information in this manual, please contact Olympus.
User Qualifications
The operator of this instrument must be a physician or
medical personnel under the supervision of a physician
and must have received sufficient training in clinical
endoscopic technique. This manual, therefore, does not
explain or discuss clinical endoscopic procedures.
Instrument Compatibility
Refer to the tables in Section 2.2, “Specifications” to
confirm that this instrument is compatible with the
ancillary equipment being used. Using incompatible
equipment can result in patient injury or equipment
damage.

Important Information – Please Read Before Use
Rotatable Clip Fixing Device
4
Reprocessing and Storage
This instrument was not sterilized before shipment.
Before using this instrument for the first time, reprocess it
according to the instructions given in Chapter 5,
“Reprocessing”.
After using this instrument, reprocess and store it
according to the instructions given in Chapter 5,
“Reprocessing” and Chapter 6, “Storage”. Improper and/
or incomplete reprocessing or storage can present an
infection control risk, cause equipment damage or
reduce performance.
Clips are shipped in a sterile condition. Store them
following the instructions given in Chapter 6, “Storage”.
Improper storage can present an infection control risk,
cause equipment damage or reduce performance.
All clips are single-use, disposable items that are not to
be reprocessed after use. Do not reuse or attempt to
sterilize them after use.
Repair and Modification
This instrument and clip do not contain any
user-serviceable parts. Do not disassemble, modify or
attempt to repair them; patient or user injury and/or
equipment damage can result.

Important Information – Please Read Before Use
Rotatable Clip Fixing Device 5
Signal Words
The following signal words are used throughout this
manual:
Indicates a potentially hazardous
situation which, if not avoided, could
result in death or serious injury.
Indicates a potentially hazardous
situation which, if not avoided, may result
in minor or moderate injury. It may also
be used to alert against unsafe practices
or potential equipment damage.
Indicates additional helpful information.
Warnings, Cautions and Notes
Follow the warning, cautions and notes described below
when handling this instrument and clip. This information
is to be supplemented by the warnings, cautions and
notes described in each chapter.
• Operation of this instrument is based on
the assumption that open surgery is
possible as an emergency measure if the
clip cannot be detached from the
instrument or if any other unexpected
circumstance takes place. In this case,
refer to Chapter 4, “Emergency
Treatment”.

Important Information – Please Read Before Use
Rotatable Clip Fixing Device
6
• It might be impossible to stop bleeding
depending on the hemorrhage situation
because the clip performance for
hemostasis is limited. Prepare more than
one hemostatic device and select
appropriate hemostatic device or use it
together to respond to different
hemorrhage situations appropriately.
Choose a surgical hemostasis if
necessary.
• Re-bleeding may occur on the clipping
site, depending on the local condition.
Check the patient for any re-bleeding
after the operation as appropriate.
• Do not use this instrument when
hemostasis cannot be verified visually
within the endoscopic field of view after
application.
• Do not perform MRI procedures on
patients who have clips placed within
their gastrointestinal tracts. This could be
harmful to the patient.
• Limited studies indicate that lesions
located in the esophagus and the lesser
curvature of the stomach may be difficult
to treat with a forward-viewing
endoscope.
• Limited studies indicate that the
treatment of esophageal varices may
require clipping in combination with a
sclerosing agent.
• Limited studies indicate that clipping hard
or severely fibrotic lesions to achieve
hemostasis may be more difficult.