INSTRUCTIONS FOR USE

PENTAX Electro-Surgical Knife

DP-D2622

1. Standard Set List Applications

This package includes the following items: 1. Intended medical use:

• PENTAX Electro-Surgical Knife Dissection/peeling of living tissue can be performed using a high
• Instructions for Use (IFU) frequency current.
2. Patient populations:
Patients ranging from pediatric to adult (patients who are consid-
Note ered suitable for application of the equipment by the physician)
Read this Instructions for Use (hereinafter referred to as IFU) be- 3. Intended anatomical area (tissues/organs):
fore operating. Failure to read and thoroughly understand the in- Esophagus, stomach, duodenum, large bowel, rectum
formation presented in this IFU, as well as those developed for 4. User:
other endoscopic equipment may result in serious injury to the An operator with experience or an operator working under the su-
patient and/or user. Furthermore, failure to follow the instruc- pervision of someone with experience (an expert who thoroughly
tions in this IFU may result in damage to, and/or malfunction of, understands the functions and characteristics of the device and is
this equipment. It is the responsibility of each medical facility familiar with endoscopic treatment procedures)
to ensure that only well educated and appropriately trained per- 5. Usage environment:
sonnel, who are competent and knowledgeable about the endo- A medical facility
scopic equipment, antimicrobial agents/processes and hospital
infection control protocol be involved in the use of these medi-
Warning
cal devices. Known risks and/or potential injuries associated
• This device has been ETO sterilized for single patient use.
with flexible endoscopic procedures include, but are not limited
NEVER reuse, reprocess, or resterilize. Reuse, reprocessing,
to, the following: perforation, infection, hemorrhage, burns and
or resterilization may lead to device failure, patient injury, and/
electric shock.
or illness. Reuse, reprocessing, or resterilization may also cre-
ate a risk of cross-contamination of the device and/or cause
2. Intended Use patient infection. It may lead to injury and/or illness of the
PENTAX electro-surgical knife is intended to aid physicians in the patient.
endoscopic dissection/peeling of mucous membrane from the gas- • Do NOT use this device if the sterile package shows any ab-
trointestinal tract for histologic examination. These accessories are normality.
introduced via the endoscope when indications consistent with the • Do NOT use this device if it has received impact due to drop-
need for the procedure are observed. ping. The sterilization bag may be damaged or the device may
malfunction.
• Verify the expiration date on the package label. Do NOT use
Caution or resterilize this device beyond the expiration date of the de-
NEVER use this device for any purpose other than that for vice.
which they have been designed. Since endoscopic devices are • NEVER attempt to repair or modify this device. Use of improp-
designed to be used in conjunction with other medical devices erly repaired or modified device may result in patient injury.
(endoscopes and electrosurgical generators), the effectiveness
of a device is dependent upon a number of factors including the
condition of the endoscope and electrosurgical generator.
Symbols on the Label
Symboles Distinctifs
Product Outline Authorised Representative in
This device can be used for dissection/peeling of living tissue by in- Manufacturer the European Union
EC REP
serting via the endoscope channel to the target site and then using an Fabricant Représentant autorisé dans
I’Union européenne
electrosurgical generator to apply a high frequency current through
Sterilized using etylene
the knife electrode at the distal end of the insertion portion to gener- Do not resterilize. oxide
ate heat. Ne pas restériliser Stérilisé avec de l’oxyde
This device is comprised of a flexible insertion portion, with an electri- d’éthylène
cally conductive knife electrode and a surrounding insulated sheath, Serial number Do not reuse
and a handle with a plug for an electrosurgical generator. SN
Numéro de serié Ne pas réutiliser
The distal end including the knife electrode can be rotated by rotating
Do not use if damaged
the handle. Use by
Ne pas utiliser si l’emballage
This device is a single use product and provided as Ethylene Oxide Date limite d’utilisation
est endommagé
Gas Sterilized.
Warning Caution
Avertissement Attention
Functions Used Frequently Type BF applied part (Safety
Refer to Instruction degree specified by IEC
The following are the frequently used functions of this device. manual 60601-1)
• Knife electrode rotation via rotation of the handle Respecter les instruc- Partie appliquée de type BF
tions d’utilisation (niveau de sécurité définie
par la norme CEI 60601-1)

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3. Nomenclature 5. Preparation and Inspection before Use

Connect to an electrosurgical generator

ACTIVE CORD Caution

(optionally available)
ACTIVE PORTION Use sterilized rubber gloves when performing the pre-use in-
Active cord Active cord spection.
Knife Marker jack plug

Connect to plug 1. Prior to use, the endoscope to be used with the device must be
Finger grip
carefully and thoroughly inspected for cleanliness and proper func-
Plug tion to determine that it is appropriate for patient use. Refer to the
IFU supplied with the endoscope.
Insulated tube
2. Select an appropriate device to satisfy the technical characteristics
Line as well as the intended application of the endoscopic device.

Compatible Endoscopes
Maximum Active
Working *Minimum
Insertion Portion Working
Handle Length Instrument
Portion Width Length Length
Channel Width
ø2.8 mm or 1900 mm or
Insertion portion DC-D2622 ø2.6 mm 2200 mm 2.5 mm
more less

* There is no guarantee that the devices selected solely using this

Note minimum instrument channel width will be compatible in combina-
This device can be used only with the active cord shown below. tion.
• AC-VCA (HOYA Corporation) • This device complies with IEC60601-1, IEC60601-2-2, and IEC60601-
• AC-ECA (HOYA Corporation) 2-18.
• Degree of protection against electric shock: type BF
• Ingress Protection Rating/Waterproof Rating: IPX0

4. System Configuration Caution

This device should only be used with an endoscope with
Active cord forward-viewing optics. NEVER use with an endoscope with
oblique- or side-viewing optics.
Accessory
Electro-
surgical
generator
Active pole 3. Check the sterilization expiration date printed on the device pack-
age/ labeling and confirm that the device has not expired. Ensure
Endoscope that there are no signs of abnormalities such as stains, wetness,
Active portion tears, or any other indications that the packaging has previously
Patient pole Light
Patient cord source, been opened or compromised.
Processor
Patient plate
Feedback terminal Warning
• Do NOT use a device if it is expired or if the sterilization pack-
Electrosurgical generators which are used together with this device age shows any abnormalities. In such cases, the sterility can-
are as follows: not be guaranteed and clinical use of the device could result
ERBE ELECTROSURGICAL Generator ERBE VIO series in patient infection or an allergic reaction.
ERBE ERBOTOM ICC series high frequency surgical units • Do NOT resterilize a device as it may cause the device to mal-
function.

Note
4. Ensure that there are no abnormalities, such as dents, wrinkles,
This device can be used only with the high frequency power
and kinks, within or on the device.
supply unit indicated above. Do not use other high frequency
5. The entire device must be clean. Ensure that there are no foreign
power supply units with this device.
material, debris, or dirt attached to it before use.
6. Open the handle (push the finger grip) slightly.
Warning
(1) Push
There are two types of Floating Ground Electrosurgical Genera- (1)
tors. The operator should confirm if the Floating Ground Elec-
trosurgical Generator requires an endoscope feedback cord
(S-cord)
• In case of Floating Ground Electrosurgical Generator without
an endoscope feedback cord (S-cord), DO NOT use optional
functional ground cord. To do so may be dangerous if the met-
al portion of the endoscope distal end comes in contact with
patient tissue or mucous during procedures.
• In case of Floating Ground Electrosurgical Generator with an
endoscope feedback cord (S-cord), connect the endoscope
feedback cord to the feedback terminal of the endoscope.
If the processor does not have an equipotential terminal, do
NOT connect any functional ground cord.

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7. With the proximal area of the insertion part held, rotate the handle
to make sure that the active portion rotates ( 0-360 degrees) in Caution
proportion to handle movement. NEVER pull the finger grip excessively. It may hinder rotation of
the active portion in the later step.

Warning
Use of a device that shows any signs of damage or operational
difficulty must be avoided. Any malfunction of a device during
a patient procedure could result in serious injury to the patient.
Use of damaged devices may also result in serious and costly
damage to the endoscope.
8. After positioning the direction of the active portion, squeeze the
handle (pull the finger grip) slightly to ensure the active portion is
fixed (the distal tip rotates no longer). Caution
As a precaution, always have an extra (spare) device available as
(1) Pull a standby device should any unforeseen event or circumstance
(1) render the original device inoperable and/or unsafe for patient
use.

6. Directions for Use

Warning
• The user must carefully read and follow all instructions in the
Caution IFU supplied with all the related equipment. The equipment
should be carefully and thoroughly inspected to determine
Avoid tight coiling or bending of the insertion portion where the
that it is appropriate for patient use.
diameter is smaller than 15cm. Doing so could damage the in-
• NEVER use these devices in the presence of a high concen-
sertion portion of the device.
tration of oxygen or flammable explosive gases or chemicals.
• Do NOT use the device together with any substance with any
9. With the active portion fixed, introduce the insertion portion into specific effect, such as argon gas.
the instrument channel from the instrument channel inlet of the • To avoid patient and user burn, use only the floating-type elec-
endoscope. A slight resistance may be felt at the beginning of in- trosurgical generator. Do NOT use non-floating (B type) elec-
sertion. Pinch the insertion portion at 5 cm above the inlet seal and trosurgical systems.
slowly insert. If you feel any resistance during insertion, do not at- • Physicians and assistants must take appropriate protection
tempt to insert further. Doing so may break the endoscope channel measures, such as wearing rubber gloves, face masks, and
or other parts, rendering the device unusable. goggles, for protection against infection and burns.
• If a fiberscope is used, attach a rubber eye shield to the eye-
(1) 5 cm
piece to prevent burns.
• If the device is to be used for a patient with a pacemaker, con-
sult a physician specialized in circulatory organs or pacemaker
(1)
manufacturers for safety preparation before deciding whether
or not to use the device. In addition, ensure that the high fre-
quency energy released does not affect the pacemaker.
• When high frequency energy is applied in the vicinity of the
heart, the output of the high frequency power supply unit
must be set as low as needed.
Caution • When the electrosurgical generator and physiological moni-
toring equipment are used simultaneously on the same pa-
Squeeze the handle (pull the finger grip) slightly and insert the
tient, any monitoring electrodes should be placed as far as
device into the instrument channel.
possible from the surgical electrodes. Needle monitoring
electrodes are not recommended. In all cases, monitoring
systems incorporating high frequency current limiting devices
Note are recommended.
Do not apply excessive force when inserting or withdrawing • To avoid damaging the sheath and/or the control wire within
this device through the instrument channel inlet of the endo- the sheath, when inserting or withdrawing any device through
scope so as to avoid damaging (bending or breaking) the sheath the instrument channel inlet of an endoscope, keep the en-
or the control wire inside the sheath.A damaged (bent or bro- doscope in a straight position and slowly insert, advance, or
ken) sheath or control wire inside the sheath will lower the rota- withdraw the device; NEVER apply excessive force. Do NOT
tion function of the knife electrode and/or insertability to the twist, rotate, or bend any of the strain relief boots of an endo-
endoscope. scope as these areas are particularly susceptible to damage.
• If the equipment exhibits unusual performance characteris-
10. After the device exits the distal end of the endoscope, open the tics or the patient experiences difficulty during a procedure,
handle (push the finger grip) slightly. With holding the sheath stop the procedure immediately and withdraw the endoscope
stem with one hand, rotate the handle to ensure the distal tip carefully from the patient.
(the active portion) rotates responsively. • Rotation of the active portion of this device will stop by
11. Squeeze the handle (pull the finger grip) slightly and withdraw the slightly pulling the handle backward. Do NOT ever pull back
device from the endoscope. the handle any further and perform endoscopic electrosurgi-
cal procedures. This could cause the distal end of the cutting
knife to be retracted into the insulated tube and become the
cause of malfunction.

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1. Slowly insert the endoscope under direct vision. 8. After positioning the active portion in an appropriate direction,
2. With the high frequency power supply unit turned OFF, connect the squeeze the handle (pull the finger grip) slightly to fix the active
active cord of the high frequency power supply unit to the plug of portion.
the handle mechanism. 9. Check that the knife electrode is not too close to the surrounding
3. A patient plate should already be appropriately positioned under tissue of the target site or to metal (e.g., the metallic distal end of
the patient. the endoscope or hemostasis clips), then turn on the power of an
4. Squeeze the handle (pull the finger grip) slightly and insert the electrosurgical generator to perform dissection or ablation of living
device through the slit in the inlet seal with the endoscope in a tissue using high frequency current.
straight position.
Warning
Caution Do NOT use the electrosurgical generator at settings exceeding
NEVER pull the finger grip excessively. It may hinder rotation of the following high frequency voltage rating. Failure to observe
the active portion in the later step. this may result in burns to the user and the patient or damage
to the device.

Note
Maximum Rated Voltage
Do not apply excessive force when inserting or withdrawing Model Name
this device through the instrument channel inlet of the endo- Cutting Mode Coagulation Mode
scope so as to avoid damaging (bending or breaking) the sheath DP-D2622 704Vp 1000Vp
or the control wire inside the sheath. A damaged (bent or bro-
ken) sheath or control wire inside the sheath will lower the rota-
tion function of the knife electrode and/or insertability to the
endoscope.

Note
When the distal end of the device is first passed through the
inlet seal, a temporary resistance will be encountered. Hold the
shaft tightly at approximately 5 cm from the distal end of the
device and push it through the inlet seal.

(1) 5 cm

(1)

Note
Slowly handle and insert/remove this device into/from an en-
doscope as well as its operation with securing the endoscopic
field of view or without applying unnecessary force. If any resis-
tance is felt during insertion/removal of this device into/from the
endoscope, NEVER attempt to force it in or pull it out. It may be
impossible to insert or remove this device due to the state of
bending of the endoscope bending section. In this case, slightly
straighten the bending of the bending section to insert or re-
move the device.

5. When the distal portion of the device becomes visible in the view-
ing field, carefully advance the device towards the target area.

Caution
Always maintain a view of the endoscopic device during ad-
vancement of the device beyond the distal end of the endo-
scope, use, and withdrawal of the device.

Caution
The handle mechanism to rotate the active portion should oper-
ate freely. NEVER apply excessive force. Reduce the angulation
of the endoscope and slowly advance the device.

6. Ensure the distal end of the endoscope does not touch the target
area.
7. Open the handle (push the finger grip) slightly. With holding the
sheath stem with one hand, rotate the handle to rotate the active
portion.

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 Warning Note
To avoid burns to the patient and the user, follow the instruc- • If this device is used repeatedly, remove coagulated tissues
tions given below before electrosurgical energy is delivered. and blood adhering to the knife before reuse. Using the de-
1) The position of the target area, the insulated distal portion vice without cleaning may cause push/pull failure or energiza-
of the diathermic device, and the active portion of the dia- tion failure.
thermic device should be visible. • If the device is temporarily taken out from the endoscope
2) The active portion of the diathermic device should not while in use and is left to stand before being reused, check
touch/come close to the metallic distal portion of the endo- the operation and appearance of the knife before the device
scope or the clip used for hemostasis directly or via fluids. is reinserted into the endoscope. Any blood or body fluid ad-
3) The metallic portion of the endoscope should not touch the hering to the knife may coagulate and may cause a push/pull
surrounding tissue directly or via fluids. failure or energization failure. If any abnormality is suspected,
4) The active portion of the diathermic device should not make stop using the device and switch to the standby device (new
any contact, directly or indirectly through body fluids, with device).
any body tissue other than the area intended to be treated.
5) The head of any lesion such as a polyp should not touch the
surrounding tissue directly or via fluids. 10. After the procedure is completed, hold the active portion away
6) Physicians and assisting personnel should avoid contact from the target area and turn off the electrosurgical generator
with the patient while high frequency energy is being deliv- before unplugging the active cord from the device.
ered.
7) Electrosurgical energy should be delivered for as short a
Warning
time period (shortest time and lowest energy possible) as
necessary to accomplish the desired clinical effect. Continu- NEVER turn off the electrosurgical generator while the active
ous long term energization may increase temperature in the portion is touching the target area. The active portion may stick
area where the patient plate is attached, resulting in burn to the target area, and separation from the target area may
injury to the patient. damage the tissue.
8) While delivering the electrosurgical energy, NEVER squeeze
the handle ( pull the finger grip ) excessively. It could change 11. Withdraw the device slowly with the handle squeezed slightly.
the once fixed proper direction of the active portion.
9) When repeating delivery of electrosurgical energy, ensure
that coagulated tissue and/or blood is not attached to the Warning
active portion to avoid fracture, melting and/or conductivity • Do NOT withdraw the device rapidly. This could cause a reflux
failure of the active portion. of body fluid from the patient.
10) Select a high frequency output power setting suitable for • To avoid damaging the rotating function, squeeze the handle
the intended procedure in order to avoid thermal invasion slightly when inserting/withdrawing any device through the
of the tissue or insufficient coagulation, each of which can instrument channel inlet of an endoscope.
result in excessive bleeding.
11) To avoid the risk of thermal injury, use only insulated de-
vices. NEVER use non-insulated devices while performing
endoscopic electrosurgical procedures.
12) NEVER simultaneously use a diathermic device in one chan- 7. Care after Use
nel and another device (e.g., forceps, retrieval device) in the
other channel unless both devices are insulated (two-chan-
nel endoscopes). Warning
13) While this device is in use, do NOT bundle up the cords with This device is for single patient use. NEVER reuse or resteril-
those of other medical devices (e.g., ECG monitor, endo- ize any portion of a device. For disposal, follow the applicable
scopic video processor, electrosurgical generator, etc.) protocol at your medical facility as well as the local or national
14) Use with adequate ventilation because surgical smoke regulations.
might be generated during electrosurgical procedures us-
ing PENTAX Medical equipment.
15) Do NOT use a patient return electrode in a surgery that uti-
lizes a bipolar electrode endoscopic device.
16) Apply the whole contact surface of the patient plate to the 8. Conditions of Storage and Use
patient’s skin firmly. If the contact area is small, the patient Devices: DP-D2622
may suffer from a burn injury.
17) Do NOT allow the patient’s body to come in direct contact Storage and Ambient temperature −20°C to 60°C
with the metal portion of the operation table or similar transport Relative humidity 10%–85% RH
structures. Direct contact may cause burn injury or electric conditions Air pressure 700–1060 hPa
shock to the patient.
Ambient temperature 10°C–40°C
18) Care must be taken to avoid skin-to-skin contact (e.g., con- Operating
tact between the arm and the body of the patient). In case Relative humidity 30%–85% RH
conditions
such contact cannot be avoided, dry gauze or an equivalent Air pressure 700–1060 hPa
between the two body parts to prevent direct contact.
19) The active cord must be placed such that it does not come • This device should not get wet and should be placed in a clean
in contact with the patient or other cords. place, away from direct sunlight, heat, and moisture.
20) If desirable effect of therapy is unable to be obtained re- • When this device is not being used, keep them in the packaging
gardless of normal power setting, this may be due to car- box.
bide adhesion on the knife, loose connection of the active
cord, and insufficient attachment of the patient plate. By
performing the following actions, make sure that there is
no abnormality, and increase output little by little within the
range of the MAXIMUM Rated Voltage.
(1) Inspect visually whether there is any carbide adhesion
on the knife.
(2) Reconnect the active cord, or replace the active cord.
(3) Confirm that the whole surface of the patient plate is
applied properly and firmly to the patient’s skin.

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 * Specifications are subject to change without notice and without any
obligation on the part of the manufacturer.

USA
Caution: Federal law restricts this device to sale by or on the order
of a physician or other appropriately licensed medical professionals.

Contacts

Manufacturer
HOYA Corporation
6-10-1 Nishi-shinjuku,
Shinjuku-ku, Tokyo
160-0023 Japan

Distributors
PENTAX Europe GmbH PENTAX Medical Shanghai Co., Ltd.
Julius-Vosseler-Straße 104 Room 701, 291 Fumin Road, Shanghai
22527 Hamburg, Germany 200031 P. R. China
Tel: +49 40 561 92-0 Tel: +86 21 6170 1555
Fax: +49 40 560 42 13 Fax: +86 21 6170 1655

PENTAX Medical PENTAX Medical Singapore Pte. Ltd.

A Division of PENTAX of America, Inc. 438A Alexandra Road, #08-06
3 Paragon Drive Alexandra Technopark, 119967 Singapore
Montvale, NJ 07645-1782 Tel: +65 6507 9266
USA Fax: +65 6271 1691
Tel: +1 201 571 2300 Customer Service Toll Free:
Toll Free: +1 800 431 5880 400 619 6570 (within China)
Fax: +1 201 391 4189 1800 2005 968 (within India)
1300 PENTAX (within Australia)

Manufacturing Site
HOYA Corporation, PENTAX Yamagata Factory
4-1 Hinode-cho, Nagai-shi, Yamagata, 993-0012 Japan

47220
2016.10 7090000 Y020 R07 printed in JAPAN