Cooper Surgical Endosee ES9000 User manual

Endosee® System
With Cannula
Sistema Endosee®
con cánula
Système Endosee®
Avec canule
User Manual | Manual de usuario |
Manuel de l’utilisateur

2
About This Manual
This manual provides instructions on how to use the
Endosee® System with the Disposable Cannula safely and
effectively for its intended use. It is important
to read and observe the information provided in this
manual prior to use for proper performance, correct
operation, and to ensure patient and operator safety.
The user is responsible for operating this device as
indicated in this guide.
Endosee System Part Number:
ES9000 (USA, Canada, Mexico):
Contains Display Module, Docking Station,
Power Supply (IEC Plug Type A), USB Cable
and IFU
Spare Unit Part Numbers*:
ESDISP-SP: Display Module, Spare Unit
ESDOCK-SP: Docking Station, Spare Unit
ESCABL-SP: USB/Power Supply, Spare Units
* Must have previously purchased ES9000 System
to order spare units
Endosee Cannula Part Numbers:
ESPX5 - Cannula with endometrial suction
pipet curette
ESPY5 - Cannula only
95 Corporate Drive •Trumbull, CT, 06611 •USA
Phone: [phone] • Fax: [phone]
www.coopersurgical.com
EN

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Table of Contents
Warranty ..............................................................................5
1 General Description and Intended Use ....................6
1.1 Indications for Use ...............................................7
1.2 Contraindications .................................................7
2 Warnings and Precautions ........................................8
2.1 General.................................................................8
2.2 Inspection, Use and Disposal ...............................9
2.3 Battery and Power Supply ..................................10
2.4 Environmental .................................................... 11
3 Glossary of Symbols ................................................13
4 Preparation for Use ..................................................15
4.1 Unpacking and Inspection of Cannula ...............15
4.2 Power Requirements .........................................15
4.3 Environmental Requirements ............................16
5 Description of Components ....................................17
5.1 Product Description ............................................17
5.2 Reusable Handheld Display Module ..................17
5.3 Docking Station ..................................................18
5.4 Sterile, Single-use Disposable Diagnostic
Cannula ..............................................................19
 5.5 DeviceClassication,Technicaland
  SafetySpecication ............................................20
 5.5.1TechnicalSpecications ...................................20
6 Basics of Operation and Procedure .......................21
6.1 Cautions for Handling and Use ..........................21
6.2 Fluid Delivery System .........................................21
6.3 Cannula Attachment and removal to the
Display Module ...................................................22
6.4 Power Button Function .......................................23
6.5 Video and Picture (Single Frame Button) ...........23
6.6 Touch Screen Functions .....................................24
6.7 Patient Examination Procedure ..........................30
6.8 Removal of the System ......................................31
6.9 Disposal of Biohazardous Material .....................31
6.10 Battery Charging ................................................31

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7 External Interface Information ................................32
8 EMC Compliance Information .................................36
8.1 Guidance and Manufacturer’s Declaration
– Electromagnetics emissions ............................36
8.2 Guidance and Manufacturer’s Declaration –
Electromagnetics immunity ................................37
9 Maintenance .............................................................39
9.1 Cleaning/Disinfecting Instructions ......................39
9.2 Intermediate Level Combined
Cleaning/Disinfecting Instructions ......................39
9.3 Disposable Cannula Handling/Care ...................41
9.4 Maintenance .......................................................41
10 Storage & Shipping ..................................................41
11 Technical Assistance ...............................................42
12 Troubleshooting Guide ............................................42

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Warranty
CooperSurgical, Inc. warrants that the device(s) supplied
is free from defects in materials or workmanship.
This warranty is valid only if the product is supplied to the
end user by a CooperSurgical, Inc. approved agent or
distributor and has been maintained in accordance with
procedures documented in the User Manual. If failure
occurs from manufacturing defects within 12 months of
purchase, CooperSurgical, Inc. will repair or replace the
defective item.

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1 General Description and Intended Use
Endosee® System with Cannula is intended for use
in viewing the cervical canal, uterine cavity, or female
urinary tract, including the bladder, for the purpose of
performing diagnostic procedures in an outpatient or in
an office setting. Hysteroscopy can be used for the
evaluation of the uterine cavity for pathology such as
submucous myomas, endometrial polyps, malignancy
and other conditions.
The Endosee System is a lightweight handheld battery
operated portable system. It is used with a single-use
Disposable Cannula with a working channel, camera
and light source at the distal end to illuminate the area
for visualization and image and video capture. The video
signal is electronically transferred to the main body of
the hysteroscope via an electrical connector. A LCD
touch screen Display Module is mounted on the
Cannula for viewing.
Note: The Endosee System cannot be used with an
external monitor.
1. Sterile, Single-use Disposable Cannula
2. Reusable Display Module
Figure 1: Ready-to-use assembly
2. Display Module
1. Cannula

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1.1 Indications for Use
The Endosee® System is used to permit viewing
of the adult cervical canal and uterine cavity for the
purpose of performing diagnostic procedures.
Generally recognized indications for diagnostic
hysteroscopy include:
• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain
The Endosee® System can also be used to permit
viewing of the adult urinary bladder through a minimally
invasiveapproachbyutilizingnaturaloricestoaccess
the diagnostic site.
1.2 Contraindications
Hysteroscopy is contraindicated in patients with known
orsuspectedacutepelvicinammatorydisease.
Hysteroscopy may be contraindicated by the following
conditions depending on their severity or extent:
• Inability to distend the uterus
• Cervical stenosis
• Cervical/Vaginal infection
• Uterine bleeding or menses
• Known pregnancy
• Invasive carcinoma of the cervix
• Recent uterine perforation
• Medical contraindication or intolerance to anesthesia
Cystoscopy is contraindicated in febrile patients with
urinary tract infection (UTIs) and those with severe
coagulopathy.

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2 Warnings and Precautions
This section contains important safety information
related to use of the The Endosee® System and the
Cannula . Other important safety information is
provided throughout this manual in sections that relate
specicallytotheprecautionaryinformation.Readalltext
surrounding all warning and precautionary information
prior to performing any procedures with this equipment.
2.1 General
• CAUTION: Federal Law (USA) restricts the device to
sale by or on the order of a physician.
• The Endosee® System is intended only as an
adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
• The Endosee® System is for use only by physicians
with adequate training in hysteroscopy and/or
cystoscopy.
• Whenaliquiddistensionmediumisused,strictuid
intake and output surveillance should be maintained.
Intrauterine instillation exceeding 1 liter should be
followed with great care to reduce the possibility of
 uidoverload.
• Potentialcomplicationsofcontinuousow
hysteroscopy:
- Hyponatremia
- Hypothermia
- Uterine perforation resulting in possible injury to
bowel, bladder, major blood vessels and ureter
- Pulmonary edema
- Cerebral edema
- Infection
- Bleeding
- Pain
The use of normal saline as a distending medium,
and limiting the infused volume to less than 1000 mL
is recommended to decrease the risk of the above
complications.

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• Intrauterine distension can usually be accomplished
with pressures in the range of 35 - 75 mmHg.
Unless the systemic blood pressure is excessive, it
is seldom necessary to use pressures greater than
75-80 mmHg.
• Vaginal ultrasonography before hysteroscopy may
identify clinical conditions that will alter patient
management.
• Since most urological endoscopy procedures utilize
 irrigationuids,itisimportantthatthecorrectuid
 bechosenandthatthevolumesofinowand
 outowbestrictlyobserved.Appropriatemeasures
should be undertaken to prevent the possibility of
 uidoverloadofthepatient
2.2 Inspection, Use and Disposal
• Inspect the integrity of the unit and condition before
powering-on the fully assembled Endosee® System.
Do not use the system if indications of external
damage are observed.
• The Endosee® System contains no operator
serviceable components within the enclosure.
To avoid electrical shock or damage, the unit must
not be disassembled. Doing so will void the
warranty.
• Do not operate the Endosee® System if any
shipping damage or other defects to the equipment
are noted during inspection. Immediately notify
CooperSurgical, Inc. Customer Service if any defect
is found.
• Do not use the Cannula if the package has
been damaged or the expiration date on the label
has passed. The cannula is single use only. Do not
reuse or resterilize the cannula.
• The Cannula must be disposed of as
biohazardous waste according to the safety
guidelines of user facility/institution.
• Follow all cleaning procedures provided for the
device (applies to reusable Display Module).
• The Endosee® System can only be used with
the LCD touch screen display on the Display
Module. A separate video monitor cannot be used.

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• Donotallowanyuidsorsubstancestobespilled
into or around the removable cannula connector on
the Display Module, as damage to the electronics
may occur.
• Do not misalign the connectors between the
removable cannula and the Display Module during
assembly, as damage may occur.
• When detaching the cannula from the Display
 Module,besurethatuiddoesnotcontactthe
connector in the Display Module. Do not rotate
or twist the cannula while removing.
• Do not alter the shape of the distal end of
the cannula.
• No portion of the Endosee® System should be
opened for cleaning or disinfecting.
• Do not pour water or any cleaning solution
directly onto Display Module during cleaning or
disinfection. Doing so may damage electronic
components and reduce product life.
• Do not immerse any component of the Display
Module into solutions during the cleaning or
disinfecting processes, as damage to the
electronic components may occur.
2.3 Battery and Power Supply
Comply with the following to prevent damage to
the battery:
• Use only the power supply provided with the device.
Use of other chargers may damage the device and
will void the warranty.
!
!
WARNING: Use of this equipment adjacent to or
stacked with other equipment should be avoided
because it could result in improper operation. If
such use is necessary, this equipment and the
other equipment should be observed to verify
that they are operating normally.
WARNING: Use of accessories other than
those provided by CooperSurgical, Inc. could
result in increased electromagnetic emissions or
decreased electromagnetic immunity of this
equipment and result in improper operation.

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• Charge the battery at room temperature.
• Do not charge the battery near a heat source.
• Do not disassemble or alter the battery in any way.
• Battery is not user-replaceable.
• The Display Module should be fully charged
before use. A fully charged battery will provide at
least 1 hour of continuous operating time under
normal operating conditions.
• Fully charge the Display Module after each
procedure. A Low Emission Diode (LED) indicator
located on the Docking Station will display a
steady green light when the unit is fully charged.
• Refer to battery power indicator on the touch
screen Display Module to determine remaining
battery power.
• Do not attempt to use any power source or battery
not directly provided by CooperSurgical, Inc.
Comply with the following to reduce the risk of
burns,re,electricshock,orinjurytopersons:
• Do not operate the power supply if it has a damaged
cord or plug, if it is not working properly, if it has been
dropped or damaged, or if it has fallen into water.
• Do not charge the battery where oxygen is
being administered.
• Do not unplug power supply by pulling on the cord.
To unplug, pull on the plug, not the cord.
2.4 Environmental
• Failure to ensure that all of these environmental
requirements are met may result in improper
performance or damage to the electronic
components within the Endosee® System.
• Due to the proliferation of radio-frequency
transmitting equipment and other sources of
electrical noise in healthcare environments
(for example cellular phones, MRI, or active HF
surgical equipment, etc.) it is possible that high
levels of such interference due to close proximity
or strength of a source may result in a disruption of
the performance of this device.

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• The Endosee® System is not designed for use in
environments in which strong interference may
impact the performance of the equipment.
• 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o󰀨eradequateprotectiontoradio-frequency
communication services. The user might need to
take mitigation measures, such as relocating or
re-orienting the equipment
• If this occurs, the site of use should be surveyed
to determine the source of this disruption, and the
following actions may be taken to eliminate
the source:
- Remove, reorient or relocate the
interfering equipment
- Increase the separation between the interfering
equipment and the Endosee® System
 - Incrementallyturno󰀨equipmentinthevicinity
to identify the interfering device
• Do not attempt to transport or ship the
Endosee® System without using proper
packaging to protect the product.
• This product is intended for indoor use only.

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3 Glossary of Symbols
The following symbols are used in this manual, and/or
on the product labeling.
REF. # Symbol Title Description
5.1.1 Manufacturer
Indicates the medical
device manufacturer,
asdenedin
EU Directiver 90/385/
EECV, 93/42/EEC
and 98/79/EC.
5.1.4 Use-by
Date
Indicates the date after
which the medical
device is not to be
used.
5.1.5
LOT
Batch
code
Indicates the
manufacturer’s batch
code so that the batch
orlotcanbeidentied.
5.1.6
REF
Catalogue
number
Indicates the
manufacturer’s
catalogue number so
that the medical device
canbeidentied.
5.1.7
SN
Serial number
Indicates the
manufacturer’s serial
number so that a
specicmedicaldevice
canbeidentied.
5.2.3
STERILE EO
Sterilized
using
ethylene
oxide
Indicates a medical
device that has been
sterilized using
ethylene oxide.
5.2.4
2
Do not re-use
Indicates a medical
device that is intended
for one use, or use on
a single patient during
a single procedure.
5.2.6
STERILIZE
2
Do not
resterilize
Indicates a medical
device that is not to
resterilize
5.2.7 NON
STERILE
Non-sterile
Indicates a medical
devicethat has not
been subjected to a
sterilization process.
The symbols below are referenced in ISO-15223-1:2016

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REF. # Symbol Title Description
5.2.8
Do not
use if
package is
damaged
Indicates a medical
device that should not
be used if the package
has been broken or
damaged.
5.4.4
!
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.
Symbols not listed in the ISO-15223-1:
6D33
MEDICAL EQUIPMENT WITH RESPECT TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARD ONLY IN ACCORDANCE WITH
UL60601-1 AND CAN/CSA C22.2 No.601.1

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4 Preparation for Use
4.1 Unpacking and Inspection of the Cannula
Follow below to unpack, inspect, and install the
Cannula and the Display Module. Each single- use,
disposable cannula comes sealed in a pouch and is
Ethylene Oxide (ETO) sterilized (Figure 2). ESPX5
contains an individually wrapped cannula and an
individually pouched endometrial suction pipet curette;
ESPY5 contains only the individually wrapped cannula.
Check that the expiration date has not passed
before use.
Figure 2: Disposable Cannula in pouch
• Packing Materials: Save the packing materials for
potential future transportation and storage of the
Endosee System®.
• Inspection: Inspect all components for damage
during shipment, or discrepancies upon arrival.
Ensure there are no unintended rough surfaces,
sharp edges or protusions which may cause harm.
4.2 Power Requirements
The Endosee® System operates on DC voltage, from an
internal battery source. The Display Module must be fully
charged before the initial use.
• Connect the Display Module to the Docking Station,
as shown below:
Figure 3: Display Module connected to Docking Station.

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• Attach power supply cord to the Docking Station.
• Plug the power supply to a wall outlet.
• Continue to charge until the LED indicator on the
Docking Station displays a steady green light,
indicating the Display Module is fully charged.
Once it is charged, the Display Module is ready
for use.
4.3 Environmental Requirements
All of the environmental requirements listed in the
Warnings and Precautions section must be met in
the location where the Endosee® System is intended
to be operated for patient use. If ANY of the seen
environmental parameters are present, the Endosee®
Systemshouldnotbeoperateduntilmodicationsto
the environmental conditions are met.

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5 Description of Components
5.1 Product Description
The Endosee® System is comprised of the
following components:
5.2 Reusable Handheld Display Module
The Display Module contains electronics including
apoweron/o󰀨button,avideoprocessor,adisplay
unit (LCD display), a rechargeable battery, battery
management electronics, microcontrollers, storage for
imagesandvideo,andrmware.Thedeviceusesa
rechargeable battery. The battery is charged when the
Display Module is connected to the Docking Station
and the Docking Station is plugged into a wall outlet.
A power supply is provided with the device. Figure 4
shows the reusable Display Module. The detailed
battery requirements are listed in section 5.5.
1. LCD Touch Screen Monitor
2. PowerOn/O󰀨Button
Figure 4: Reusable Display Module on Docking Station
12

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5.3 Docking Station
The Docking Station has dual functions. It allows the
battery to be charged using the power supply and allows
video recordings and single frame photographs to be
transferred via USB Cable from the internal memory
of the Display Module to an external computer.
Recordings and single frame photographs can also be
downloaded directly from the Display Module via Wi-Fi.
WARNING: Use only the power supply
provided with the device. Use of other
chargers may damage the device and will void
the warranty.
WARNING: Charge the battery at
room temperature.
WARNING: Do not charge the battery near
a heat source.
Figure 5: The Display Module on the Docking Station
!
!
!

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5.4 Sterile, Single-use Disposable Cannula
The disposable Cannula contains a miniature CMOS
camera and light-emitting diode (LED) illumination mod-
ule at the tip. The cannula connects
to the Handheld Display Module through an electrical
connector for: DC power, image data transfer and
removal and control of the CMOS camera and
illumination module. The cannula has an inner channel
fortheinfusionofuid.Fluidinfusionisachievedby
attachingeitherapre-lledsyringeorapressurizedbag
ofdistendingmediumtotheinowportthrough
anextensiontubeoratubingset.Theoutowportisat
the distal tip of the cannula and empties out around the
tiptoinfuseuidintotheuterinecavityorfemalebladder.
The cannula has a pre-curved tip section at an angle of
20°± 5°. The cannula tip section should not be altered.
The cannula maximum temperature will not exceed 41°C.
Figure 6 shows the cannula.
1. Handheld Display Module Connector
2. InowPort
3. Tip Section
4. CMOS Camera & LED Illumination Module
Figure 6: Disposable Cannula
2
1
3
4

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5.5 Device Classification, Technical and
Safety Specification
5.5.1. Technical Specifications
DISPLAY MODULE
Diagonal Size of Display Area: 125 mm (4.9 in)
Thickness: 22 mm (0.9 in)
Horizontal: 136 mm (5.4 in)
Height: 91 mm (3.6 in)
Weight (cannula, display): 281 g (0.6 lbs)
STERILE, SINGLE-USE CANNULA
Cannula Working Length: 278 mm (11 in)
Tip Largest Outside Dimension: 4.3 mm (0.17 in)
Pre-fixed tip angle: 20° ± 5°
POWER ADAPTER REQUIREMENTS
Input Power Range: 100-240V AC/0.2-0.4A
Frequency: 50/60Hz
Output: 5.99V DC/2.0A
Cable Length: 4 ft.
Charging Connector: AC Adapter incorporated into
Docking Station
BATTERY SPECIFICATIONS
Battery Type: Lithium-ion rechargeable battery
Capacity: 3.7V rating, 1320mAh
Maximum Voltage when 4.2 V
Battery is fully charged:
Minimum working voltage is: ≤3.0V
Full Charge Time: Approx. 2 hours
Operating Time: 1 hour
SITE REQUIREMENTS — OPERATING CONDITIONS
Operating Temperature: Environmentally Controlled
Room Temperature