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
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Cannula Handheld
Monitor
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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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