Caldera Benesta CAL-TR1511 User manual

1
BenestaTM Tissue Removal Device
Instructions for Use
CAL-TR1511 (1 pack)
CAL-TR1513 (3 pack)
Manufactured by:
Caldera Medical, Inc.
5171 Clareton Drive
Agoura Hills, CA 91301
U.S. Toll Free: 866-4-CALDERA
Telephone: [phone]
Fax: [phone]
www.calderamedical.com 10-418 Rev A
CONTROLLED COPY

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Symbol Glossary
The following is an explanation of symbols that may be used on Caldera Medical’s productsand packaging:
Symbol Title/ Meaning/ Referent Function/ Description
ISO 7000
Reg. no.
ISO 15223-
1 or Other
Manufacture
Manufacturer Indicates the medical device manufacturer. 3082
5.1.1
EU Authorized Representative
Indicates the authorized representative in the European community.
N/A
5.1.2
Date of Manufacture Indicates the date when the medical device was manufactured. 2497 5.1.3
Use by Date Indicates the date after which the medical device is not to be used. 2607 5.1.4
Batch Code
Indicates the manufacturer's batch code so that the batch or lot can be
identified.
2492 5.1.5
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can
be identified.
2493
5.1.6
Sterility
Sterilized Using Ethylene Oxide
Indicates a medical device that has been sterilized using ethylene oxide.
2501
5.2.3
Do Not Re-sterilize Indicates a medical device that is not to be re-sterilized. 2608 5.2.6
Do Not Use If Package Is Damaged Indicates a medical device that should not be used if the package has been
damaged or opened. 2606 5.2.8
Non-sterile Indicates a medical device that has not been subjected to a sterilization process. 2609 5.2.7
Storage
Keep Dry Indicates a medical device that needs to be protected from moisture. 0626 5.3.4
Temperature Limit
Indicates the temperature limits to which the medical device can be safely
exposed 0632 5.3.7
Humidity Limitation Indicates the range of humidity to which the medical device can be safely
exposed 2620 5.3.8
Safe Use
Do Not Re-use
Indicates a medical device that is intended for one use, or for use on a single
patient during a single procedure.
1051 5.4.2
Consult Instructions for Use Indicates the need for the user to consult the instructions for use. 1641 5.4.3
[IFU URL]
Consult Instructions for Use, or
For Instructions for Use Refer to
Indicates the need for the user to consult the instructions for use and where the
electronic instructions for use (eIFU) and symbols glossary can be found.
1641 5.4.3
Follow Instructions for Use Refer to Instruction manual/booklet; on medical electrical equipment, Follow
Instructions for Use
ISO 7010-
M002 N/A
Caution
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a
variety of reasons, be presented on the medical device itself.
0434A 5.4.4
General Warning General Warning Sign N/A
ISO 7010-
W012
Type BF Applied Part Signifies Applied Part Type N/A
IEC 60517-
5840
IPX2 Ingress Rating
Signifies that the device is rated to level 2 for water ingress protection, and that
water splashing against the enclosure from any direction shall have no harmful
effect.
N/A N/A
Non-Ionizing Electromagnetic
Radiation
Indicates generally elevated, potentially hazardous levels of non-ionizing
radiation, or to indicates equipment or systems e.g. in the medical electrical area
that include RF transmitters or that intentionally apply RF electromagnetic
energy for diagnosis or treatment.
N/A IEC 60417-
5140
NRTL Certification Signifies that the device meets regulatory and performance requirements
verified by NRTL N/A N/A
Other
Packaging Unit Indicates the number of pieces in the package. 2794 N/A
Prescription Only Requires prescription in the United States of America. N/A
21 CFR
801.109

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The brief operating instructions in this guide will make the system easier to
use. As with any surgical instrument, there are important health and safety
considerations.
Device Description
The BenestaTM Tissue Removal Device is a sterile, single-use hand-held
device that is used to hysteroscopically remove intrauterine tissue. It is
battery-powered and primarily hand-operated through the use of a button
that controls the motor inside the handle and the resulting cutting action of
the blade of the device. Additionally, a safety switch is located on the
proximal end of the device handle that can be used to turn on or off the
device.
Indications for Use
The BenestaTM Tissue Removal Device is intended for intrauterine use by
trained gynecologists to hysteroscopically resect and remove tissue such
as: submucous myomas, endometrial polyps, and retained products of
conception.
Contraindications
The BenestaTM Tissue Removal Device is contraindicated in pregnant
patients or patients exhibiting pelvic infection, cervical malignancies, or
previously diagnosed endometrial cancer.
Warnings
•Before using the BenestaTM Tissue Removal Device for the first time,
please review all available product information.
•Before using the BenestaTM Tissue Removal Device, you should be
experienced in hysteroscopic surgery with powered instruments. Healthy
uterine tissue can be injured by improper use of the tissue removal
device. Use every available means to avoid such injury.
•Careful pre-operative assessment, including preoperative imaging,
should be performed on each patient prior to a hysteroscopic procedure
to evaluate for conditions which may, depending on their severity or
extent, affect the appropriateness of hysteroscopy. These include but are
not necessarily limited to: evidence and level of placental invasion of the
myometrium, acute pelvic inflammatory disease, cervical or vaginal
infection, known or possible viable pregnancy, carcinoma of the cervix,
placental invasion of the myometrium, or previously diagnosed
endometrial cancer.
•Removal of retained products of conception in the setting of known or
suspected placenta accreta, placenta increta, or placenta percreta poses
a risk of significant and potentially life-threatening bleeding with the
highest risk occurring in the immediate postpartum phase.
•Ensure that a compatible vacuum system that can develop a pressure of
at least 200 mm Hg is appropriately connected before commencing
surgery.
•Uterine tissue containing suspected fibroids may harbor an occult
malignancy. The safety of using mechanical tissue removal device has
not been evaluated in the potential presence of cancer cells. Exercise
extreme caution when resecting tissue in patients who have implants
that extend into the uterine cavity.
– Do not use the BenestaTM Tissue Removal Device to resect tissue
that is adjacent to an implant. When resecting tissue in patients that
have implants, assure that:
– The BenestaTM Tissue Removal Device cutting window is facing
away from (i.e., 180° opposite) the implant;
– The visual field is clear; and
– The BenestaTM Tissue Removal Device cutting window is engaged in
tissue and is moved away from the implant as tissue resection
proceeds.
•If visualization is lost at anypoint during a procedure, stop cutting
immediately.
•Periodically irrigate the device to prevent accumulation of excised tissue
in the surgical site.
•Operating the device inside the uterine cavity with no tissue contact may
result in the loss of uterine distension.
•Do not use in the presence of flammable or explosive materials.
•Not for use in an oxygen-rich environment.
•No modification of this equipment is allowed.
Precautions
•Do not use after expiration date.
•The BenestaTM Tissue Removal Device is sterilized by ethylene oxide.
Verify that the BenestaTM Tissue Removal Device is sterile prior to use.
Do not use the device if the sterile package is open or appears
compromised. Do not use the device if damage is observed.
•The BenestaTM Tissue Removal Device is intended for single use only.
Do not re-sterilize. Do not reuse. Use of a reprocessed, single-use tissue
removal device may permanently damage, impede performance, or
cause failure of the BenestaTM Tissue Removal Device. Use of such
products may render any warranties null and void.
•Discard all opened, unused devices.
CAUTION: Premature unpacking of the device may result in
additional and unacceptable risk
•Exercise care when inserting or removing the device. Insertion and
removal of the device should be performed under direct visualization at
all times.
•To avoid perforation, keep the device tip under direct visualization and
exercise care at all times when maneuvering it or cutting tissue close to
uterine wall. Avoid using the tip of the tissue removaldevice as a probe
or dissecting tool.
•Excessive leverage on the BenestaTM Tissue Removal Device does not
improve cutting performance and, in extreme cases, may result in wear,
degradation, and seizing of the inner assembly.
•Do not allow the cutting window of the tissue removal device to touch
any metallic object such as a hysteroscope. Damage to both instruments
is likely. Damage to the BenestaTM Tissue Removal Device can range
from a slight distortion or dulling of the cutting edge to actual fracture of
the tip in vivo. If such contact does occur, inspect the tip. If you find
cracks, fractures, or dulling, or if you have any other reason to suspect a
tissue removal device is damaged, replace it immediately.

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•Exercise care when inserting or removing the device. Excessive bending
of the device distal tip can cause the BenestaTM Tissue Removal Device
cutter to come out of the cutting window. If such damage occurs, replace
the device immediately.
BenestaTM Tissue Removal Device
CAL-TR1511 (1 pack)
CAL-TR1513 (3 pack)
The hand-operated BenestaTM Tissue Removal Device is shown below in
Figure 1. The parts of the device are listed below:
Figure 1. BenestaTM Tissue Removal Device
Safety Switch: This switch turns power to the entire device on or off
depending on the position of the switch. During shipment, the position is
in the “off” (O) position to prevent any accidental activation. The safety
switch must be turned to the “on” (I) during the preparation phase of an
operative procedure for the device to function and resect tissue.
Trigger: Depressing the trigger actuates cutting action. The device will
continuously cut and allow the passage of fluid and tissue while the
trigger is depressed and will stop as soon as the trigger is released. The
cutting window will remain closed while cutting isnot activated, but will
still allow for some fluid outflow in this position.
Outflow Tubing: the outflow tube removes waste fluid and resected
tissue through a compatible suction canister and tissue trap.
Cutting Window: side-facing cutting window at the distaltip
Cutting Window Indicator: indicates orientation of cutting window when
cutting window is not under direct visualization
Distal Tip Locating Mark: Indicates depth relative to hysteroscope and
can be used during initial insertion of the tissue removal device into the
hysteroscope.
Pathology Measurement Lines: contains markings spaced 1mm apart to
help estimate pathology size under direct visualization
Components not included with the BenestaTM Tissue Removal Device:
– Under-buttocks drape
– IV Pole, pressure cuff or fluid management system (FMS)
– Distending media
– Vacuum source, suction canister and tissue trap
– BenestaTM Hysteroscope and outflow channel
– Inflow tubing
– Y-tubing
– Hysteroscope and outflow channel end cap seals
SET-UP
Please review the system configuration diagram in Figure 2 for a diagram
of the system setup.
Figure 2. System configuration diagram
Distending Media Set-Up
•It is strongly recommended that isotonic media such as 0.9% Normal
Saline or Ringer’s Lactate be the media used for distending the
endometrial cavity.
•Either a purpose-built hysteroscopic fluid management system or a
protocol for manual estimation of systemic absorption should be in place.
•For purpose-built fluid management systems, carefully follow the
manufacturer’s instructions.
•If using a manual fluid management system:
– Procure an intravenous (IV) pole from which to hang either a 1L or
3L bag of distending media at least 40 inches above the patient’s
uterus
– A pressure sleeve may be placed around the fluid bag to increase
inflow and uterine pressure and improve visualization during the
procedure.
– When using the BenestaTM Hysteroscope, open the packaging for the
Y-tubing and connect it to the hysteroscope inflow ports. Connect the
Y-tubing to the fluid bag containing distention media using
compatible inflow tubing.
– When using with the BenestaTM Hysteroscope (and/or outflow
channel), make sure the single-use seal is installed in the
hysteroscope (and/or outflow channel).
•Position an under-buttocks drape with an integrated fluid reservoir or
similar fluid collection system that allows estimation of fluid volume.
•Connect the outflow tubing to atissue trap in line with tubing that
attaches to an appropriate suction canister.
•Attach the suction canister to the regulated vacuum source which is set
to approximately 250 mmHg.
– Make sure the lid is securely attached to the cannister prior tousing.
Safety
Switch
Outflow
Tubing
Trigger
Distal Tip
LocatingMark
Cutting Window
Cutting Window Indicator
Pathology Measurement. Lines

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– Connect the outflow vacuum tubing to the tissue trap connection on
the cannister lid.
OPERATION
1. Prior to opening the device, inspect the package for any signs of
damage. If damage is found, do not use the device and contact
Technical Support.
2. Open the device by peeling back the corner of the Tyvek® lid
completely to expose the device.
3. Holding the tray securely, grasp the handle of the device firmly and pull
up to release the device from the tray.
4. Remove connected outflow tubing and, leaving the end of the tubing
free, straighten out the tubing so that it is completely unwound.
5. Turn the safety switch from the “off” (O) position to the “on” ( I ) position.
6. Temporarily actuate the BenestaTM Tissue Removal Device trigger prior
to introducing into the working channel of the hysteroscope to ensure
that the power is on.
– Do not operate the BenestaTM Tissue Removal Device in a non-
irrigated, open-air environment for an extended period of time as this
may cause damage to the device.
7. Introduce the inactivated BenestaTM Tissue Removal Device through
the working channel of the hysteroscope until the distal tip of the tissue
removal device is visible under clear visualization.
– When used with the BenestaTM Hysteroscope, the tip of the
BenestaTM Tissue Removal Device will extend approximately 3.2 cm
from the end of the hysteroscope.
8. Actuate the BenestaTM Tissue Removal Device trigger for 2-3 seconds
while under clear visualization and away from any patient tissues to
prime the device with the distending media. You can also retract the
tissue removal device into the hysteroscope until the cutting window is
within the hysteroscope working channel to prime the device.
– If the system is turned off for any reason or the treatment is
interrupted for any reason, remove the device from any tissue, wait
15 seconds and repeat steps 5 through 8 before continuing
9. Rotate to align the cutting window with the target pathology. Rotating
the hysteroscope may be necessary to achieve desired visualization of
the cutting window and target tissue pathology.
10. Bring the cutting window in proximity with the target tissue pathology.
11. Press the trigger to actuate cutting action in a fashion that allows for
excision of the excised tissue.
– The suction pressure and/or media infusion pressure can be
adjusted to optimize visualization and cutting performance.
– Optimal function may be achieved by resecting the tissue in bursts of
a few seconds each. This may aid in maintenance of distension of
the endometrial cavity and facilitate monitoring of the cutting
progress as well as device orientation or position.
12. Do not apply excessive leverage on the device by pushing hard into
target pathology. Excessive leverage on the device does not improve
cutting performance and may result in decreased performance and/or
unintended excision of tissue pathology.
13. Excised tissue is collected in the tissue trap.
Ending the Procedure
1. Retract the BenestaTM Tissue Removal Device into the hysteroscope
until the cutting window is within the hysteroscope working channel.
2. Actuate the trigger for a few seconds to ensure that all tissue is
transferred into the tissue trap.
3. Remove the BenestaTM Tissue Removal Device from the hysteroscope.
Device Disposal
Dispose of the BenestaTM Tissue Removal Device according to your
facility’s policies and local, state or Federal procedures for biohazardous
materials, sharp waste, and battery disposal.
Storage
•The BenestaTM Tissue Removal Device should be stored at room
temperature, away from moisture and direct heat.
•The device should not be stored at temperatures below 40°F or above
120°F, or in conditions where the humidity is below 40% or above 60%.
Troubleshooting
•If the device does not actuate, remove the device from the hysteroscope.
Turn the safety switch from the “off” (O) position to the “on” ( I ) position.
Temporarily actuate the trigger to ensure that the power is on before
reintroducing into the hysteroscope.
•If the distal tip of the tissue removal device is not visible after insertion,
remove the device completely from the hysteroscope. Reintroduce the
inactivated device through the working channel of the hysteroscope until
the distal tip of the device is visible under clear visualization. If the issue
does not resolve, please check the hysteroscope for obstructions and/or
field of view. Ensure vacuum tubing is connected and functioning and
vacuum is set to 250mmHg minimum.
– Note: If troubleshooting steps do not resolve the issue, please
contact Technical Support.
Electrical and Electromagnetic Safety
•All equipment performance is considered to be safety-related
performance, including any degradation of performance caused by
reciprocal interference. If the product is not put into service in
accordance with the electromagnetic safety requirements in this manual
and fails to perform as specified, the procedure should be aborted
immediately, and biomedical engineering staff should be alerted to the
observed issues
•The BenestaTM Tissue Removal Device is an applied part Type BF
device, meaning that it complies with specific requirement for protection
against electric shock. This device is not suitable for direct cardiac
application.
•The type F applied part status of energized hysteroscopes intended for
use with a multiplicity of supply units and/or light guide cables is ensured
by, for instance, using only supply units having isolated light guide output
sockets
•The standard operating voltage of the BenestaTM Tissue Removal Device
is 7.7V – 9.0V, and the operating current is ~0.2A.

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•Interconnections conditions require the applied parts of other medical
electrical equipment used within the configuration for hysteroscopic
application to be type BF applied parts or type CF applied parts
•This equipment is designed and tested to minimize interference with
other electrical equipment. However, if interference occurs with other
equipment it may be corrected by one or more of the following
measures:
1. Reorient or relocate this equipment, the other equipment, or both.
2. Increase the separation between the pieces of equipment.
3. Connect the pieces of equipment into different outlets or circuits.
4. Consult a biomedical engineer. Electrical safetytesting should be
performed by a trained biomedical engineer or other qualified
person.
•It is the responsibility of the person(s) installing, utilizing and
decommissioning the BenestaTM Tissue Removal Device to ensure that
the electromagnetic environment does not exceed or deviate from the
specifications listed in Tables 1-4.
The following tables provide information on the electromagnetic
environment that the BenestaTM Tissue Removal Device is capable of
operating in safely.
Table 1. Declaration of Electromagnetic Emissions
The BenestaTM Tissue Removal Device is intended for use in the electromagnetic environment
specified below. The customer or the user of the BenestaTM Tissue Removal Device
should assure that
it is used in such an environment.
Emissions test Test Level/ Limits Electromagnetic Environment / Recommendations
RF emissions CISPR 11 Class A The EMISSIONS characteristics of this equipment make
it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate
protection to radio-frequency communication services.
The user might need to take mitigation measures, such
as relocating or re-orienting the equipment
Harmonic distortion
IEC 61000-3-2
IEC 61000-3-2
Class A Not Applicable - device is battery operated
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Pst ≤1.0
Plt ≤ 0.65
dc ≤ 3.3%
dmax ≤4.0%
Not Applicable - device is battery operated
Table 2. Declaration of Electromagnetic Immunity
Immunity Test
Test Level / Limits
Electromagnetic Environment
/ Recommendations
Electrostatic
Discharge (ESD)
IEC 61000-4-2
8 kV (±) Contact
15 kV (±) Air
Floors should be wood,
concrete, or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%
Electrical Fast
Transients
IEC 61000-4-4
±2 kV AC/DC power supply
±1 kV input/output lines Not Applicable – device is battery-operated
Surge
IEC 61000-4-5
±1 kV to line(s)
±2 kV to line(s) to earth
Not Applicable – device is
battery-operated
Radio Frequency
(RF) Common Mode
IEC 61000-4-6
3 Vms
150kHz to 80MHz Not Applicable – device is battery-operated
Power Frequency
Magnetic Field
IEC 61000-4-8 30 A/m
Power frequency magnetic fields
should be at levels typical
commercial or hospital
environments.
Voltage Dips and
Interruptions
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
40% UT(60% dip in UT) for 5 cycles
70% UT(30% dip in UT) for 25 cycles
<5% UT(>95% dip in UT) for 5 sec
Not Applicable – device is
battery-operated
UTis the A.C. mains voltage prior to application test level
Table 3. Guidance and Manufacturer’s Declaration of Electromagnetic
Immunity
The BenestaTM Tissue Removal Device is intended for use in the electromagnetic environment
specified below. The customer or the user of the BenestaTM Tissue Removal Device should assure that
it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Conducted
Radiated
RF
IEC
61000-4-3
3 Vrms
3 V/m
80 MHz to
2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the BenestaTM
Tissue Removal Device, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance (in meters)
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis 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.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the BenestaTM Tissue Removal Device is used exceeds the applicable RF compliance
level above, the BenestaTM Tissue Removal Device should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the BenestaTM Tissue Removal Device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4. Recommended separation distance between potable and mobile RF
communications equipment and the BenestaTM Tissue Removal Device
The BenestaTM Tissue Removal Device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the BenestaTM Tissue Removal
Device can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the BenestaTM Tissue Removal
Device as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter
Separation distance according to frequency of transmitter (in meters)
150 kHz to 80 MHz
d = 1.2√P
80MHzto800 MHz
d=1.2√P
800MHzto2.5 GHz
d=2.3√P
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
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Warranty
•Caldera Medical products are warrantied to be free from defects in
material and workmanship for the warranty period beginning from the
date of invoice.
•This limited warranty is restricted to replacement by Caldera Medical, at
its option, of any product found to be defective during the warranty
period.
•Damage inflicted to a product by the user will result in additional charges
and may void the warranty.
– There are no serviceable components of the BenestaTM Tissue
Removal Device.
– No modification of this equipment is allowed. Modifications may
cause serious injuries to both patient and/or user. Any modifications
will void any warranty and the risk of use is transferred to the user.
– This includes but is not limited to normal use related damage, any
attempted repairs by unauthorized service providers, use of a
sterilization method not approved by Caldera Medical,and use of the
product in a way that is not intended by Caldera Medical.
•All warranties apply to the original buyer only and are not transferable.
•In no event shall Caldera Medical be liable for any anticipated profits,
consequential damages or loss of time incurred by the buyer with the
purchase or use of any product.
•Refer to the current Caldera Medical Terms and Conditions for full
warranty details or contact Customer Service for specific warranty
information.
•NO OTHER WARRANTY, EXPRESSED OR IMPLIED, IS GIVEN.
Technical Support
For technical support and product return information, please contact
Caldera Medical via email ([email protected]) or telephone, at 866-
422-5337.
All Caldera Medical Instruction for Use (IFU) documents are available in print form
at no additional cost upon request. If you would like to request a copy please
contact us at 818.879.6555, fax [phone],
or email [e-mail].
To learn more about Caldera Medical, other products for incontinence,
product evaluations, and training opportunities, contact Caldera Medical at
866.422.5337 or visit our website at www.calderamedical.com.
Benesta is a trademark of Caldera Medical, Inc. and/or its subsidiaries in
the United States.