Polypectomy Snare
Instructions for Use
-Micro-Tech (Nanjing) Co., Ltd-
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IMPORTANT INFORMATION
Caution: Federal law restricts this device to sale by or on the order of a
physician. Read all instructions carefully before use. They contain essential
information on using this device safely and effectively. Keep these
instructions in a safe, accessible location, as you may need to refer to
them again. If you have any questions or comments about any
information in these instructions, please contact Micro-Tech.
INTENDED USE
1. The Polypectomy Snares are used endoscopically in the removal of
diminutive polyps, sessile polyps, and pedunculated polyps within the
GI tract.
2. Single or multiple gastrointestinal polyps with diameter less than 2cm;
3. Non-infiltration type polyp(s) confirmed by histopathology and multiple
polyps with quantity less than 30 pieces;
4. Early stage cancer only confined in mucous layer.
CONTRAINDICATIONS
Contraindications include, but may not be limited to:
1. Poor physical fitness, with serious heart or/and lung disease, and can’t
tolerate endoscopy and endoscopic treatment;
2. Bleeding tendency, an extended bleeding and prolonged
coagulation time, or thrombocytopenia or lack of prothrombin which
couldn’t be treated
3. A polyp / polyps with a large base more than 2cm for gastric poly and
1.5cm for normal polyp.
4. A polypoid cancer which has infiltrated into tissue or organ and has
deteriorated;
5. Patients with implanted pacemaker or implanted with a metal valve /
values(It is classified as relative contraindication);
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6. Diabetes, regardless of whether blood sugar is normal(poor healing
capacity) (It is classified as relative contraindication);
7. Uncooperative patients or family members.
POTENTIAL COMPLICATIONS
• Bleeding, perforation, trans-mural burn, thermal injury, respiratory
depression or apnea, arrhythmia or cardiac arrest;
• Infection, septicaemia, etc.;
• Complications which may exist and are not known or observed.
WARNINGS
1. The product is intended for single use only! DO NOT re-use, re-sterilize,
and/or reprocess. Re-use, re-sterilization or reprocessing may
compromise the structural integrity of the device and/or lead to
device failure which, in turn, may result in patient injury, illness or death.
Re-use, re-sterilization or reprocessing may also create a
contamination of the device and/or cause patient infectious
disease(s). Contamination of the device may lead to injury, illness or
death of the patient. Micro-Tech assumes no liability with respect to
instruments reused, re-sterilized or reprocessed .
2. Do not use this instrument for any purpose other than its intended use.
3. The product is only intended for adult populations.
4. This device is not made with natural rubber latex.
5. Patients should be informed of the potential risks and complications,
which may lead to injury, illness or death of the patient.
6. The instrument is intended for use under the direct supervision of a
suitably trained physician only. A thorough understanding of the
technical principles, clinical applications, and associated risks is
expected before usage.。
7. Confirm that the endoscopy view is clear before use. Do not insert the
instrument into the endoscope unless you have a clear endoscopic
risk of
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field of view. Insertion without clear endoscopic field of view could
cause patient injury, such as perforation, hemorrhage or mucous
membrane damage. Damage to the endoscope and/or the
instrument may also occur.
8. When applied to a patient with a pacemaker implanted, the instrument
may cause malfunction or failure of the pacemaker, seriously affecting
the patient. Consulting cardiologist or the manufacturer of the
pacemaker is recommended before instrument application.
9. When using the instrument in the vicinity of the heart, be sure to use it
with the minimum necessary output. Spark discharge during operation
may affect the heart.
10. When using an electrocardiograph or other physiological monitoring
equipment simultaneously with the instrument, any monitoring
electrodes should be placed as far away as possible from the
electrodes used with the electrosurgical unit. Needle monitoring
electrodes should not be used. Physiological monitoring equipment
incorporating high-frequency current limiting device is
recommended.
11. When the endoscope is used with the device, the leakage currents
may be relatively increased. Ensure a proper path from patient return
electrode to electrosurgical unit is connected and maintained
throughout the procedure.
12. Before use, please check the insertion patients body parts, ensure that
no sharp edge.
13. Do not touch energized handle components (e.g. the high-frequency
applied mandrel)and do not contact with conductive object as
shown in Fig.1 and Fig.2 below.
Fig.1 Fig.2
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14．Operation without strictly following instructions from electrosurgical
unit manufacturer could cause the Snare invalid, patient or user injury.
15. The applicable electrosurgical unit should not be used adjacent to or
stacked with other equipment and that if adjacent or stacked use is
necessary, the electrosurgical devices should be observed to verify
normal operation in the configuration in which it will be used.
16. The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by the
electrosurgical unit manufacturers replacement parts for internal
components, may result in increased emissions or decreased
immunity of the electrosurgical unit.
17. Since supporting the use of Olympus endoscopic system, Olympus
endoscopic system’s light source may affect Polypectomy Snare’s
temperature to exceed 41℃,to minimize the risk of injury, please
ensure the correct use of it according to Olympus endoscopic system
and the manufacturer’s instructions.
【 Product Name 】Polypectomy Snare
【 Packaging 】Packed in Pouch
【 Production Date 】 See packaging
【 Sterilization 】 Sterilized by EO (ethylene oxide) gas
【 Shelf Life】 3 years
【 Compatible Working Channel 】≧φ 2.8 mm
【Applicable Electrosurgical Unit】
High-frequency Electrosurgical unit that which is legal listing in USA is
recommended such as CONMED Electrosurgery 60-8200-230 and its
matched 474-L active cord.
【Rated High-Frequency Voltage】
DO NOT use higher repeated peak voltage than the Cut -1200Vp（
2400Vp-p）
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STRUCTURE
The Polypectomy Snare consists of a loop assembly which can be
extended and retracted from the snare’s outer tube by manipulating the
handle assembly.( Refer to Fig.3 ).
Fig.3 Structural Sketch of Sterile Snare with type II handle
1. Oval Snare Loop 2. Outer Tube 3. Conductive Plug 4. Handle assembly
Note: This is the sketch map of one kind of loop, the other loop shapes are
not shown here.
PREPARATION
1. Reference the product label and choose the appropriate device.
2. Contents supplied STERILE.
3. Inspect the package before use for any damage. Do not use if
package is damaged. Open the package carefully after verifying the
shelf life.
4. Carefully remove the device from its packaging and uncoil it. Do NOT
use excessive force as this may damage the device and affect
performance.
5. Before use, please check the insertion patients body parts, ensure that
no sharp edge.
6. If this device shows any signs of damage, do not use. Do not attempt
to repair a nonfunctional or damaged device.
7. Before use, operate the slider back and forth to observe whether the
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Snare loop extends and retracts smoothly. The Snare loop shall be free
of distortion, deformation, frayed wires, disconnections and sharp
protrusions. Do not use if any abnormality is found.
8. Before use, remove inflammable gas which is accumulated in human
body in case of the risk of explosion.
9. Attach the negative plate of the high-frequency electrosurgical unit on
the patient’s vascular/muscle-rich part .
10. Inspect active cord.It must be free of kinks,bends,breaks and exposed
wires to allow for accurate transfer of current.If an abnormality is
noted,do not use that active cord.
NOTE:The active cord should be accordance with the applicable
electrosurgical device accompanying documents.
INSTRUCTIONS FOR USE
Hot Snare Use:
1. Retract the handle of the Snare and confirm that the Snare loop is fully
retracted into the catheter prior to inserting the catheter into the
endoscope.
2. Advance the catheter through the endoscope channel until the lesion
is clearly identified and targeted. Snare loop could be rotated if
rotatable function is available.
3. With electrosurgical unit off,securely connect the active cord to the
Snare handle and electrosurgical.
4. Turn the electrosurgical unit ON.
NOTE:the device should be installed and put into service according
to the EMC information provided in the electrosurgical unit
accompanying documents.
NOTE:In strict accordance with the applicable electrosurgical device
operational mode and Input feature during operation.
Take the CONMED Electrosurgery 60-8200-230 as an example:
Operational mode: intermittence 15s open/30s close;
The rated Input :100~240V,4A max.50/60Hz.
5. Operate the handle to extend the Snare loop and snare the target
tissue gently. Press the foot switch to active output. Pull the slider and
resect the target tissue. Do not apply excessive force when snaring the
tissue. This could cause patient injury, such as punctures, hemorrhages
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or mucous membrane damage or thermal injury.
6. Retract the snare prior to removing the instrument from the endoscope
7. Upon completion of the procedure, disconnect the active cord from
the Snare handle and dispose of the device according to the
institutional guidelines for biohazard medical waste and local
regulatory requirements.
Cold Snare Use:
1. Retract the handle of the snare and confirm that the Snare loop is fully
retracted into the catheter prior to inserting the catheter into the
endoscope.
2. Advance the catheter through the endoscope channel until the lesion
is clearly identified and targeted. Snare loop could be rotated if
rotatable function is available.
3. Operate the handle to extend the Snare loop and snare the target
tissue gently. Pull the slider and resect the target tissue.
4. Repeat steps 3 & 4 as required.
5. Retract the snare prior to removing the instrument from the endoscope
EMC CONDITIONAL
Guidance and manufacturer’s declaration - electromagnetic emissions -
for all ME EQUIPMENT and ME SYSTEM.
Table 1:Guidance and manufacturer’s declaration – electr omagnetic emissions
The Polypectomy Snare is intended for use in the electromagnetic environment
specified below. The customer or the user of the Polypectomy Snare should
assure that it is used in such an environment.
Emissions test Compliance
RF emissions
CISPR 11
RF emissi ons
CISPR 11
Harmoni c emissions
IEC 61000 -3-2
Voltage fluctuations/
Flicker emissions
IEC 61000 -3-3
Complies
Group 1
Class A
A
Electromag netic environment -
guidance
The Polypectomy Snare uses RF energy
only for its internal function. Therefore, its
RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment
The Polypectomy Snare is suitable for use
in all establishments other than domestic
establishments and those directly
connected to the public low -voltage
power supply network that supplies
buildings used for domestic purposes
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Guidance and manufacturer’s declaration - electromagnetic
Floors should be wood, concrete
at least 30%.
immunity - for all ME EQUIPMENT and ME SYSTEM.
Table 2:Guidance and manufacturer’s declaration – electromagnetic immunity
The Polypectomy Snare is intended for use in the electromagnetic environment
specified below. The customer or the user of the Polypectomy Snare should assure that it
is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic environment guidance
Electrostatic
Discharge(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
±6 kV contact
±8 kV air
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±1 kV lines to
lines
±2 kV lines to
earth
<5% UT
(>95% dip in
UT)
For 0,5 cycle
40% UT
(60% dip in UT)
For 5 cycle
70% UT
(30% dip in UT)
For 25 cycle
<5% UT
(>95% dip in
UT)
For 5 cycle
3A/m 3A/m
±6 kV contact
±8 kV air
±2 kV for
power supply
lines ±1 kV for
input/output
lines
±1 kV lines to
lines
±2 kV lines to
earth
<5% UT
(>95% dip in
UT)
For 0,5 cycle
40% UT
(60% dip in UT)
For 5 cycle
70% UT
(30% dip in UT)
For 25 cycle
<5% UT
(>95% dip in
UT)
For 5 cycle
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
Mains power quality should be
that of a typical commercial or
hospital environment
Mains power quality should be
that of a typical commercial or
hospital environment.
r q
Mains powe
that of a typical commercial or
hospital environment. If the user
of Polypectomy Snare requires
continued operation during
power mains interruptions, it is
recommended that the
Polypectomy Snare be powered
from an uninterruptible power
supply or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment
uality should be
Note: UT is the a.c. mains voltage prior to application of the test level.
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MICRO-TECH USA SHALL HAVE NO OBLIGATION OR LIABILITY, WHETHER
ARISING IN CONTRACT (INCLUDING WARRANTY), TORT (INCLUDING
ACTIVE, PASSIVE, OR IMPUTED NEGLIGENCE, STRICT LIABILITY, OR
PRODUCT LIABILITY) OR OTHERWISE, FOR ANY SPECIAL, CONSEQUENTIAL,
PUNITIVE, INCIDENTAL, OR INDIRECT DAMAGES, OR FOR LOSS OF USE,
LOSS OF REVENUE, LOSS OF BUSINESS, LOST PROFIT, OR OTHER FINANCIAL
LOSS ARISING OUT OF OR IN CONNECTION WITH ANY PRODUCT OR
OTHER GOODS OR SERVICES FURNISHED BY MICRO-TECH USA, EVEN IF
MICRO-TECH USA WAS AWARE OF THE POSSIBILITY OF SUCH DAMAGES
OR LOSS.
A revision date and number for these instruction is included directly below
the contact information. In the event that more than two years have
passed between this date and the use of the device, the user should
contact Micro-Tech to see if additional product use information is
available.
Portable and mobile RF
5.3
5.3
the following symbol:
Guidance and manufacturer’s declaration – electromagnetic
Table 3: Guidance and manufacturer’s declaration – electromagnetic immunity
The Polypectomy Snare is intended for use in the electromagnetic environment
specified below. The customer or the user of the Polypectomy Snare should assure that
it is used in such an environment.
Immunity test IEC 60601 test level
immunity for ME EQUIPMENT and ME SYSTEM that are not
LIFE-SUPPORTING.
Complianc
e level
Electromagnetic
environment-guidance
ducted RF
Con
IEC 61000-4-6
3 Vrms
Radiated RF
IEC 61000-4-3
150 kHz to 80MHz
3 V/m
80MHz to 2.5GHz
3V
3V/m
communications equipment
should be used no closer to any
part of the SYSTEM, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
d ]
d ]
d ]7[1=
Where P is the maximum output
power rating of the transmitter in
watts(W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
P
[1=
V
P
[1=
E
80MHz to 800MHz
P
E
800MHz to 2.5GHz
Interference may occur in the
vicinity of equip
ment marked with
9
Recommended separation distances between portable and mobile
Separation distance according to frequency of transmitter
m
150kHz to 80 MHz
5.3
80MHz to 800MHz
5.3
800MHz to 2.5GHz
RF communications equipment and the ME EQUIPMENT and ME
SYSTEM – for ME EQUIPMENT and ME SYSTEM that are not
LIFE-SUPPORTING.
Recommended separation distances between portable and mobile RF communications
The Polypectomy Snare is intended for use in an electromagnetic environment in which
radiated RF disturbances are control led. The customer or the user of the Polypectomy Snare can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters ) and the Polypectomy Snare
as recommended below, a ccording to the maximum outp
equipment.
Rated maximum
output power of
transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
equipment and the Polypectomy Snare
ut power of the communications
d ]
P
[1=
V
d ]
P
[1=
E
d ]7[1=
P
E
STORAGE
The product should be stored in a cool, dry, clean, well-ventilated,
non-corrosive gas environment.
Do not expose the package to organic solvent, ionizing radiation or
ultraviolet radiation.
The product shelf life is 3 years.
PRODUCT DISPOSAL
After use, this product may be a potential biohazard. Handle and dispose
of in accordance with hospital, local and administrative laws and
regulations.
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Limited Warranty and Disclaimers：
1. Limited Warranty to Buyer. Micro-Tech USA warrants to Buyer that, for
the earlier of one (1) year from the date of purchase, or until the
product is used by Buyer, the products will be free from defects in
materials and workmanship when stored and used in accordance
with the instructions for storage and use provided by Micro-Tech USA
and in accordance with applicable regulatory requirements.
Descriptions or specifications appearing in Micro-Tech USA’s literature
are meant to generally describe the products and do not constitute
any express warranties. In the event that Micro-Tech USA gives
technical advice with respect to the product, it is agreed that such
advice is given without any liability on Micro-Tech USA’s part. Any
guarantee of specific properties of or in the products shall only be
effective if and to the extent specifically confirmed by Micro-Tech USA
in writing. These warranties shall not apply for product failure or
deficiency due to improper storage, alteration, or the consequences
of uses for which the products were not designed or that adversely
affect the products’ integrity, reliability, or performance.
2. Disclaimer and Release. THE WARRANTIES, OBLIGATIONS, AND LIABILITIES
OF Micro-Tech USA AS SET FORTH HEREIN ARE EXCLUSIVE. BUYER
HEREBY WAIVES ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, ARISING
BY LAW OR OTHERWISE, WITH RESPECT TO THE PRODUCTS AND ANY
OTHER GOODS OR SERVICES DELIVERED BY BUYER, INCLUDING, BUT
NOT LIMITED TO: (1) ALL OTHER EXPRESS AND IMPLIED WARRANTIES,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, AND (2) ANY IMPLIED WARRANTY
ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING, OR
USAGE OF TRADE.
3. Implied Warranties. The purchase of products may be subject to laws
in the territories applicable to the sale of the products by Micro-Tech
USA to Buyer that impose implied warranties, conditions, or obligations
that cannot be excluded, restricted, or modified, or can only be
excluded, restricted, or modified to a limited extent. The provisions of
Paragraphs 2 and 4 shall apply to the greatest extent allowed by such
laws.
4. Limitation of Liability. EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE
LAW, Micro-Tech USA’S LIABILITY UNDER THIS WARRANTY IS LIMITED TO:
(a) THE REPLACEMENT OF THE PRODUCTS OR THE RE-SUPPLY OF
EQUIVALENT PRODUCTS; (b) THE REPAIR OF THE PRODUCTS OR
PAYMENT OF THE COST OF REPAIRING THE PRODUCTS; or (c) PAYMENT
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OF THE COST OF REPLACING THE PRODUCTS OR ACQUIRING
EQUIVALENT PRODUCTS. MICRO-TECH USA SHALL HAVE NO
OBLIGATION OR LIABILITY, WHETHER ARISING IN CONTRACT
(INCLUDING WARRANTY), TORT (INCLUDING ACTIVE, PASSIVE, OR
IMPUTED NEGLIGENCE, STRICT LIABILITY, OR PRODUCT LIABILITY) OR
OTHERWISE, FOR ANY SPECIAL, CONSEQUENTIAL, PUNITIVE,
INCIDENTAL, OR INDIRECT DAMAGES, OR FOR LOSS OF USE, LOSS OF
REVENUE, LOSS OF BUSINESS, LOST PROFIT, OR OTHER FINANCIAL LOSS
ARISING OUT OF OR IN CONNECTION WITH ANY PRODUCT OR OTHER
GOODS OR SERVICES FURNISHED BY MICRO-TECH USA, EVEN IF
MICRO-TECH USA WAS AWARE OF THE POSSIBILITY OF SUCH DAMAGES
OR LOSS.
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Manufacturer
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech
Industrial Development Zone, Nanjing 210032 ,Jiangsu
Province, PRC
TEL:+ 86 25 58609879, 58646393
FAX:+ 86 25 58744269
Email: info@micro-tech.com.cn
www.micro-tech.com.cn;
Distributed By
Micro-Tech USA Inc.
2855 Boardwalk Drive, Ann Arbor, MI 48104 USA
Tel: 734-259-3768
Toll free: 877-552-4027
info@micro-tech-usa.com
Shanghai International Holding Corp. GmbH(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
MTN-NPFS-SM-USA-01 REV: 5
2018-02-24
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