Cooper Surgical Endosee ES8000 User manual

Endosee®Hysteroscope
with Disposable Diagnostic
(Dx) and (Cx) Cannula for
Cystoscopy Only
Hystéroscope Endosee® à canule
de diagnostic (Dx) et (Cx) Pour
cystoscopie uniquement
Histeroscopio Endosee®con cánula
de diagnóstico desechable (Dx) y
(Cx) solo para cistoscopía
User Manual |Manuel de l’utilisateur |
Manual de usuario

About This Manual
This manual provides instructions on how to use the
Endosee®Hysteroscope with the Disposable Diagnostic
(Dx) 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 Hysteroscope Part Number:
ES8000 (USA, Canada, Mexico):
Contains IEC plug type A
ES8000-INT (Rest of World):
Contains IEC plug types A, C, G, and I
Endosee Dx Cannula Part Numbers:
ESDX5 - Cannula with endometrial suction curette
ESDY5 - Cannula only
Endosee Cx Cannula Part Number:
ESCX5 - Cystoscopy Cannula
95 Corporate Drive •Trumbull, CT, 06611 •USA
Phone: [phone] • Fax: [phone]
www.coopersurgical.com
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EN

Endosee®Hysteroscope - User Manual
Table of Contents
Warranty.................................................................................... 4
1 General Description and Intended Use ................... 5
1.1 General Description....................................................... 5
1.2 Indications for Use......................................................... 6
1.3 Contraindications........................................................... 6
2 Warnings and Precautions ........................................ 7
2.1 General.......................................................................... 7
2.2 Inspection, Use and Disposal ....................................... 8
2.3 Battery and Power Supply ..........................................10
2.4 Environmental..............................................................11
3 Symbol Legend..........................................................12
4 Preparation for Use...................................................13
4.1 Unpacking and Inspection of Cannula........................ 13
4.2 Power Requirements................................................... 13
4.3 Environmental Requirements...................................... 13
5 Description of Components..................................... 14
5.1 Product Description..................................................... 14
5.2 Reusable Handheld Monitor ....................................... 14
5.3 Charging/Docking Station ........................................... 15
5.4 Sterile, Single-use Disposable Diagnostic
(Dx) Cannula ...............................................................16
5.5 Device Classification, Technical and
Safety Specification.....................................................17
5.5.1 Technical Specifications.............................................. 17
6 Basics of Operation and Procedure ....................... 18
6.1 Cautions for Handling and Use................................... 18
6.2 Fluid Delivery System..................................................18
6.3 Cannula Attachment and Detachment........................ 19
6.4 Power Button Function................................................20
6.5 Brightness Button........................................................ 20
6.6 Video/Single Frame Button......................................... 20
6.7 Touch Screen Functions ............................................. 21
6.8 Patient Examination Procedure .................................. 24
6.9 Removal of the System...............................................25
6.10 Disposal of Biohazardous Material ............................. 25
6.11 Battery Charging ......................................................... 26
7 External Interface Information................................. 26
7.1 Charging/Docking Station ........................................... 26
8 Maintenance...............................................................28
8.1 Cleaning/Disinfecting Instructions............................... 28
8.2 Intermediate Level Combined
Cleaning/Disinfecting Instructions............................... 28
8.3 Low Level Combined
Cleaning/Disinfecting Instructions............................... 30
8.4 Disposable Cannula Handling/Care ........................... 31
8.5 Maintenance................................................................ 31
9 Storage & Shipping...................................................32
10 Technical Assistance................................................32
11 Troubleshooting Guide ...........................................32
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Endosee®Hysteroscope - User Manual
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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Endosee®Hysteroscope - User Manual
1 General Description and Intended Use
1.1 General Description
The Endosee Hysteroscope with the Disposable
Diagnostic (Dx) 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 Hysteroscope is a lightweight, handheld,
battery operated portable system. It is used with a
single-use Disposable Diagnostic (Dx) Cannula with a
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. An LCD touch screen display monitor on
the hysteroscope is used for viewing.
Note: The Endosee Hysteroscope cannot be used
with an external monitor.
System Components
Figure 1: Ready-to-use assembly
12
Cannula Handheld
Monitor
5
1. Sterile, Single-use Disposable
Diagnostic (Dx) Cannula
2. Reusable Handheld Monitor

Endosee®Hysteroscope - User Manual
1.2 Indications for Use
The Endosee Hysteroscope and the Disposable
Diagnostic (Dx) Cannula are 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 Hysteroscope and disposable diagnostic
(DX) cannula can also be used to permit viewing of the
adult urinary bladder through a minimally invasive
approach by utilizing natural orifices to access the
diagnostic site.
1.3 Contraindications
• Acute Pelvic Inflammatory 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 Infections (UTIS) and those with
severe Coagulopathy.
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Endosee®Hysteroscope - User Manual
2 Warnings and Precautions
This section contains important safety information related to
use of the Endosee Hysteroscope and the cannula. Other
important safety information is repeated throughout this
manual in sections that relate specifically to the precautionary
information. Read all text surrounding all warning and
precautionary information prior to performing any procedures
with this equipment.
2.1 General
• Federal Law (USA) restricts the device to sale by
or on the order of a physician.
• The Endosee Hysteroscope with the cannula is
intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs
and symptoms.
• The Endosee Hysteroscope with the cannula is for
use only by physicians with adequate training
in hysteroscopy and/or cystoscopy.
•When a liquid distension medium is used, strict
fluid intake and output surveillance should be
maintained. Intrauterine instillation exceeding
1 liter should be followed with great care to
reduce the possibility of fluid overload.
•Potential complications of continuous
flow 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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Endosee®Hysteroscope - User Manual
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 fluids, it is important that the
correct fluid be chosen and that the volumes of
inflow and outflow be strictly observed.
Appropriate measures should be undertaken
to prevent the possibility of fluid 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 Hysteroscope. Do not use the system
if indications of external damage are observed.
• The Endosee Hysteroscope 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 Hysteroscope
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 level of contamination of the device.
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Endosee®Hysteroscope - User Manual
•The Endosee Hysteroscope can only be
used with the LCD touch screen display on
the Handheld Monitor. A separate video
monitor cannot be used.
• Do not allow any fluids or substances to be
spilled into or around the removable cannula
connector on the Handheld Monitor, as
damage to the electronics may occur.
•Do not misalign the connectors between
the removable cannula and the Handheld
Monitor during assembly, as damage
may occur.
• When detaching the cannula from the
Handheld Monitor, be sure that fluid does
not contact the connector in the Handheld
Monitor. 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 Hysteroscope
should be opened for cleaning or disinfecting.
• Do not pour water or any cleaning solution
directly onto Handheld Monitor during
cleaning or disinfection. Doing so may
damage electronic components and reduce
product life.
• Do not immerse any component of the
Handheld Monitor into solutions during the
cleaning or disinfecting processes, as damage
to the electronic components may occur.
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Endosee®Hysteroscope - User Manual
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.
• 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 Handheld Monitor should be fully charged
before use. A fully charged battery will provide at
least 2 hours of continuous operating time under
normal operating conditions.
•Fully charge the Handheld Monitor after
each procedure.
• Refer to battery power indicator on the touch
screen monitor 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,
fire, 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.
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Endosee®Hysteroscope - User Manual
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 Hysteroscope.
• Due to the proliferation of radio-frequency
transmitting equipment and other sources of
electrical noise in healthcare environments (for
example cellular phones, 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.
• The Endosee Hysteroscope is not designed for
use in environments in which strong interference
may impact the performance of 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 Hysteroscope
-Incrementally turn off equipment in the vicinity to
identify the interfering device
• Do not attempt to transport or ship the Endosee
Hysteroscope without using proper packaging
to protect the product.
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Endosee®Hysteroscope - User Manual
Consult instructions
for use.
Do not re-use.
Nonsterile
Not made with natural
rubber latex.
Do not use if package
is damaged.
BF Applied Part
Power On/Off Switch
Battery
Manufacturer
!
LATEX
-+
WARNING:
STERILIZE
2
R
x
Only
!
CAUTION:
Reorder number
Batch code
Serial number
Sterilized using
ethylene oxide.
U.S. Federal law
restricts this device
to sale by or on the
order of a licensed
practitioner.
Do not resterilize.
This symbol is used
to indicate information
that may relate to serious
adverse reactions and
potential safety hazards,
limitations in use
imposed by them, and
steps that should be
taken if they occur.
This symbol is used to
indicate information
regarding any special
care to be exercised
by practitioner and/or
patient for the safe
and effective use of
the equipment.
MEDICAL EQUIPMENT
WITH RESPECT TO
ELECTRICAL SHOCK,
FIRE AND MECHANI-
CAL HAZARD ONLY IN
ACCORDANCE WITH
AAMI/ANSI ES 60601-1
(2005), IEC 60601-2-18
AND CAN/CSA C22.2
NO. 60601.1:08
3Symbol Legend
The following symbols are used in this manual, and/or
on the product labeling.
6D33
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Endosee®Hysteroscope - User Manual
4 Preparation for Use
4.1 Unpacking and Inspection of Cannula
Follow below to unpack, inspect, and install the
cannula and the Endosee Hysteroscope. Each single-
use, disposable cannula comes sealed in a pouch and
is Ethylene Oxide (ETO) sterilized (Figure 2). Check
that the expiration date has not passed before use.
Figure 2: Cannula in a pouch
•Packing Materials: Save the packing materials
for potential future transportation and storage
of the Endosee Hysteroscope.
• Inspection: Inspect all components for damage
during shipment, or discrepancies upon arrival.
4.2 Power Requirements
The Endosee Hysteroscope operates on DC voltage, from
an internal battery source. The Handheld Monitor must be
fully charged before the initial use.
• Place the Handheld Monitor on Charging/Docking
Station, and connect the two.
• Attach power supply to the
Charging/Docking Station.
• Plug the power supply to a wall outlet.
• Continue to charge until the battery power
indicator on the touch screen monitor shows
100%, indicating that the battery is fully charged.
The Handheld Monitor 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 Hysteroscope is intended
to be operated for patient use. If ANY of the seen
environmental parameters are present, the Endosee
Hysteroscope should not be operated until modifications
to the environmental conditions are met.
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Endosee®Hysteroscope - User Manual
5 Description of Components
5.1 Product Description
The Endosee Hysteroscope is comprised of the
following components:
5.2 Reusable Handheld Monitor
The Handheld Monitor contains electronics
including a power on/off button, a video processor,
a display unit (LCD display), a rechargeable
battery, battery management electronics,
microcontrollers, storage for images and video,
and firmware. The device uses a rechargeable
battery. The battery is charged when the
Handheld Monitor is connected to the
Charging/Docking Station and the Charging/
Docking Station is plugged into a wall outlet.
A power supply is provided with the device.
Figure 3 shows the reusable Handheld Monitor.
The detailed battery requirements are listed in
section 4.2.
Figure 3: Reusable Handheld Monitor
1. LCD Touch Screen Monitor
2. Power On/Off Button
3. Brightness Button
4. Video/Single Frame Button
1
2
4
43
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Endosee®Hysteroscope - User Manual
5.3 Charging/Docking Station
The Charging/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 downloaded from
the internal memory of the Handheld Monitor to an
external computer.
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 4: The Handheld Monitor on the
Charging/Docking Station
!
!
!
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Endosee®Hysteroscope - User Manual
5.4 Sterile, Single-use Disposable Diagnostic
(Dx) Cannula
The cannula contains a miniature CMOS camera and
light-emitting diode (LED) illumination module at the
tip. The cannula connects to the Handheld Monitor
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 fluid. Fluid infusion is
achieved by attaching either a pre-filled syringe or a
pressurized bag of distending medium to the inflow
port through an extension tube or a tubing set. The
outflow port is at the distal tip of the cannula and
empties around the cannula and out the vaginal vault.
The cannula has a pre-curved tip section at an angle
of 25°± 5°. The cannula tip section should not be
altered. The cannula maximum temperature will not
exceed 41°C. Figure 5 shows the cannula.
Figure 5: Disposable Diagnostic (Dx) Cannula
1
2
3
4
1. Handheld Monitor Connector
2. Inflow Port
3. Tip Section
4. CMOS Camera & LED
Illumination Module
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Endosee®Hysteroscope - User Manual
5.5 Device Classification, Technical and
Safety Specification
5.5.1. Technical Specifications
HANDHELD MONITOR
Length (Handheld Monitor): 117.5 mm (4.6 in)
Diameter (Handheld Monitor): 29.8 mm (1.2 in)
Weight (cannula, battery, display): 90 g (0.2 lb)
STERILE, SINGLE-USE CANNULA
Length: 276 mm (10.9 in)
Outside Dimensions: 4.3 mm (0.2 in)
Pre-fixed tip angle: 25° ± 5°
LCD DISPLAY PANEL
Diagonal Size of Display Area: 88.9 mm (3.5 in)
Thickness: 13.2 mm (0.5 in)
Horizontal: 93.0 mm (3.7 in)
Height: 72.0 mm (2.8 in)
POWER ADAPTER REQUIREMENTS
Input Power Range: 100-240V AC/0.5A
Frequency: 50/60Hz
Output: 5.0V DC/2.0A
Charging Connector: AC Adapter incorporated into
Charging/Docking Station
BATTERY SPECIFICATIONS
Battery Type: AA Lithium-ion rechargeable
battery
Capacity: 3.7V rating, 2500mAh
Maximum Voltage when Battery is 4.2V
fully charged:
Voltage when system power is
≤ 3.7V
turned off:
Full Charge Time: Approx. 4 hours
Operating Time: >2 hours
SITE REQUIREMENTS — OPERATING CONDITIONS
Operating Temperature: Room Temperature
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Endosee®Hysteroscope - User Manual
6 Basics of Operation and Procedure
6.1 Cautions for Handling and Use
The following cautions should be strictly observed
in the handling and use of the Endosee Hysteroscope.
WARNING: The Endosee Hysteroscope is for
use only by physicians with adequate training
in hysteroscopy/cystoscopy.
6.2 Fluid Delivery System
Fluid infusion is achieved by attaching either a
pre-filled syringe or a pressurized bag of distending
medium to the inflow port of the cannula through an
extension tube or a tubing set.
WARNING: When a liquid medium is used,
strict fluid intake and output surveillance
should be maintained. Intrauterine instillation
exceeding 1 liter should be followed with great
care to reduce the possibility of fluid overload.
WARNING: Potential complications of
Continuous Flow Hysteroscopy include:
• 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 me-
dium, and limiting the infused volume to less
than 1000 mL is recommended to
decrease the risk of the above complications.
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.
!
!
!
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Endosee®Hysteroscope - User Manual
CAUTION: Do not allow any fluids or
substances to be spilled in or around the
cannula connector on the Handheld Monitor,
as damage to the electronics may occur.
6.3 Cannula Attachment and Detachment
In preparation for use, attach the cannula to the
electrical connector on the Handheld Monitor per
the following:
1. Peel apart the proximal end of the package and
remove the cannula.
2. Rotate the cannula to a position where the
“red dot” marking on the cannula aligns with
the matching dot on the Handheld Monitor.
Press it fully into place until a subtle
“click” of the connector detent locking
mechanism is felt.
CAUTION: Do not misalign the connectors
between the cannula and the Handheld Monitor
during assembly, as damage may occur.
Figure 6: Cannula Attachment
!
!
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Endosee®Hysteroscope - User Manual
6.4 Power Button Function
The function of the Handheld Monitor Power Button
on the Hysteroscope is described below.
WARNING: Inspect the integrity of the unit
and condition before powering-on the fully
assembled unit. Do not use the system if vi-
sual signs of external damage are observed.
Figure 7: Power Button
Touch Function Action
Power On Press-and-Release
Power Off Press-Hold (1s) and Release
6.5 Brightness Button
The LED Brightness control is a cycle-through push
button. There are four (4) steps of LED brightness
adjustments.
Figure 8: Brightness Button
6.6 Video/Single Frame Button
The Video/Single Frame Button allows user to save
still images and video images. The image capture
operations are described below.
Figure 9: Video/Single Frame Button
Video/Single frame Touch Function Action
Capture Still Image Press-and-Release
Capture Video Clip Press-and-Hold: See Page 22
While system is capturing
Stop Video Capture video, press button one
more time
!
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