Endosee Advance ES9000 User Manual Rev A Feb 2019

Endosee® System - User Manual

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 Classification, Technical and Safety Specification ...20 5.5.1 Technical Specifications ...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 3

Endosee® System - User Manual 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

4

Endosee® System - 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.

5

Endosee® System - User Manual

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.

2. Display Module 1. Cannula

1. Sterile, Single-use Disposable Cannula 2. Reusable Display Module Figure 1: Ready-to-use assembly

6

Endosee® System - User Manual

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 orifices to access the diagnostic site. 1.2 Contraindications Hysteroscopy is contraindicated in patients with known or suspected 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 infection (UTIs) and those with severe coagulopathy.

7

Endosee® System - User Manual

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 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 •

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 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.

8

Endosee® System - 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® 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.

9

Endosee® System - User Manual

•

Do not allow any fluids 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 fluid 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.

!

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.

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.

10

Endosee® System - User Manual

•

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, 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.

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. 11

Endosee® System - User Manual

•

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 offer 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 off 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.

12

Endosee® System - User Manual

3 Glossary of Symbols The following symbols are used in this manual, and/or on the product labeling. The symbols below are referenced in ISO-15223-1:2016 REF. #

Title

Description

5.1.1

Manufacturer

Indicates the medical device manufacturer, as defined 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

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

Serial number

Indicates the manufacturer’s serial number so that a specific medical device can be identified.

Sterilized using ethylene oxide

Indicates a medical device that has been sterilized using ethylene oxide.

Do not re-use

Indicates a medical device that is intended for one use, or use on a single patient during a single procedure.

Do not resterilize

Indicates a medical device that is not to resterilize

Non-sterile

Indicates a medical devicethat has not been subjected to a sterilization process.

5.1.6

5.1.7

5.2.3

5.2.4

5.2.6

5.2.7

Symbol

LOT

REF

SN

STERILE EO

2 2

STERILIZE

NON STERILE

13

Endosee® System - User Manual

REF. #

Symbol

5.2.8

5.4.4

!

Title

Description

Do not use if package is damaged

Indicates a medical device that should not be used if the package has been broken or damaged.

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

14

Endosee® System - User Manual

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.

15

Endosee® System - User Manual

•

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 modifications to the environmental conditions are met.

16

Endosee® System - User Manual

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/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 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

2

1. LCD Touch Screen Monitor 2. Power On/Off Button Figure 4: Reusable Display Module on Docking Station

17

Endosee® System - User Manual

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

18

Endosee® System - User Manual

5.4 Sterile, Single-use Disposable Cannula The disposable Cannula contains a miniature CMOS camera and light-emitting diode (LED) illumination module 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 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 out around the tip to infuse fluid 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 3

2 4

1.

Handheld Display Module Connector

2.

Inflow Port

3.

Tip Section

4.

CMOS Camera & LED Illumination Module

Figure 6: Disposable Cannula

19

Endosee® System - User Manual

5.5 Device Classification, Technical and Safety Specification 5.5.1. Technical Specifications DISPLAY MODULE Diagonal Size of Display Area: Thickness: Horizontal: Height: Weight (cannula, display):

125 mm (4.9 in) 22 mm (0.9 in) 136 mm (5.4 in) 91 mm (3.6 in) 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: Frequency: Output: Cable Length: Charging Connector: Docking Station

100-240V AC/0.2-0.4A 50/60Hz 5.99V DC/2.0A 4 ft. AC Adapter incorporated into

BATTERY SPECIFICATIONS Battery Type: Capacity: Maximum Voltage when Battery is fully charged: Minimum working voltage is: Full Charge Time: Operating Time:

Lithium-ion rechargeable battery 3.7V rating, 1320mAh 4.2 V ≤ 3.0V Approx. 2 hours 1 hour

SITE REQUIREMENTS - OPERATING CONDITIONS Operating Temperature:

Environmentally Controlled Room Temperature

20

Endosee® System - 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 System.

!

WARNING: The Endosee® System 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 medium, 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

21