Cystoscopes and accessories Instructions for Use

TPA361-233-1411-20_D Version: D 2015 - Dec - 17

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 2 of 74

0

1

2

3

4

5

6

Content Important Information About this Document...7 0.1

General Information... 7

0.2

List of Products...7

0.3

Target User Group Qualifications...7

0.4

Using and Storing this Document...7

0.5

Safety Messages in this Document...8

0.6

Symbols Used in this Document... 8

General Information About the Device...9 1.1

Indications for Use...9

1.2

Contraindications... 9

1.3

Device Descriptions... 10

1.4

Symbols Used on the Devices and Packaging...13

General Safety Information... 14 2.1

Basic Safety Information... 14

2.2

Electrical Equipment Safety Requirements (IEC 60601)... 14

Device Operation Including Inspection and Assembly...15 3.1

Safety Instructions... 15

3.2

Staff Qualifications...16

3.3

Initial Receipt of Device...16

3.4

Device Inspection and Test... 17

3.5

Device Assembly... 18

3.6

Device Pre-Cleaning...19

Reprocessing... 20 4.1

General Information... 20

4.2

Safety Instructions... 20

4.3

Staff Qualifications...21

4.4

General Guidelines for Reprocessing... 22

4.5

Typical Reprocessing Sequences (Process Flows)... 23

4.6

Detailed Reprocessing Instructions... 23 4.6.1

Manual Cleaning... 23

4.6.2

Manual Cleaning with Disinfection... 26

4.6.3

Automatic Cleaning (with Thermal Disinfection)... 28

4.6.4

High Level Disinfection (HLD)...30

4.6.5

Sterilization...31

Maintenance and Repairs... 33 5.1

Common Issues and Solutions... 33

5.2

Repair... 33

Product Data... 34 6.1

Technical Data...34 6.1.1

Cystoscope 2.9 mm... 34

6.1.2

Cystoscope 4.0 mm... 34

6.1.3

Light guide... 34

6.1.4

Sheath... 34

6.1.5

Visual obturator... 34

6.1.6

Telescope bridge... 34

6.1.7

Working bridge with lockable working channel...34

6.1.8

Cleaning and storage basket... 34

6.1.9

Grasping forceps, double action, flexible... 34

6.2

Ambient Conditions... 35

6.3

Spare Parts and Accessories... 36

7

Disposal... 37

8

DISCLAIMER OF WARRANTY... 38

9

Appendix A: Customer Service Contact Information...39

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 3 of 74

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 6 of 74

0 Important Information About this Document 0.1 General Information

0

Important Information About this Document

0.1

General Information These instructions for use are an integral component of the device and contain the information required by users and operators for safe and proper use. These instructions for use do not describe endoscopic procedures or techniques during surgery.

0.2

List of Products These instructions for use apply to the following devices and their included accessories: UL-SCOPE / UL-SCOPE-FE cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view UL-SCOPE4 / UL-SCOPE4-FE cystoscope, 4 mm diameter x 302 mm length, 30° angle of view, wide angle UL-SHEATH sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock) UL-VO visual obturator, 20 Fr. UL-BRIDGE telescope bridge UL-WBRIDGE working bridge with lockable working channel UL-GRASP grasping forceps, double action, flexible, 7 Fr., 400 mm UL-GUIDE high-power light guide, 3.5 x 2300 mm UL-TRAY cleaning and storage basket All devices are sold separately in a quantity of one. FE Factory Exchange: Devices with a part number ending in „FE“ have been repaired or refurbished to meet original product specifications.

0.3

Target User Group Qualifications These instructions for use are to be used by physicians, medical support personnel, and reprocessing personnel knowledgeable about the use, handling, and reprocessing of the device.

0.4

Using and Storing this Document This operating manual must be stored in a defined location so that it may be accessed at all times by the target group. In the event of the sale of this device or its relocation, this document must accompany the device.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 7 of 74

0 Important Information About this Document 0.5 Safety Messages in this Document

0.5

Safety Messages in this Document Safety instructions are listed at the start of each chapter that contains instructions that carry a specific risk. Safety instructions are listed within each chapter when applicable, directly prior to steps that carry a specific risk. Take time to read these safety messages carefully and bear them in mind when performing the activities concerned. The severity of the potential risk is expressed by the signal word in the beginning of the message. WARNING! refers to a risk that could lead to death or serious injury. CAUTION! refers to a risk that could lead to minor or moderate injury. NOTICE! refers to activity that carries a risk of material damage. For every risk, the signal word will be followed by the nature and origin of the risk, potential consequences of non-observance, and preventive action.

0.6

Symbols Used in this Document General warning sign

Biohazard warning sign, risk of infection

Hot surfaces warning sign

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 8 of 74

1 General Information About the Device 1.1 Indications for Use

1

General Information About the Device

1.1

Indications for Use The cystoscopes, sheath, visual obturator, bridges and grasper are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The devices are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

1.2

Contraindications Contraindications may exist with respect of the patient’s general condition or the specific presenting disease. The decision to perform a procedure is the responsibility of the treating physician and should be made on the basis of an individual benefit/risk analysis.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 9 of 74

1 General Information About the Device 1.3 Device Descriptions

1.3

Device Descriptions These instructions for use apply to each of the following devices. UL-SCOPE / UL-SCOPE-FE and UL-SCOPE4 / UL-SCOPE4-FE

Figure 1-1: Telescope (UL-SCOPE or UL-SCOPE4)

1

Eyepiece

2

Light Guide Connector (ACMI)

3

Light Guide Adapter (Storz)

4

Light Guide Adapter (Wolf)

5

Telescope Shaft

6

Telescope Tip UL-SHEATH

Figure 1-2: 20F Sheath (UL-SHEATH). The numbers at the proximal end of the sheath indicate the outer diameter of the sheath and the maximum outer diameter of an instrument that is compatible with the sheath (number surrounded by a circle).

1

Connector

2

Irrigation Connectors

3

Tube Connector for Luer Lock

4

Tube Connector for Luer Lock with Stopcock

5

Atraumatic tip UL-VO

Figure 1-3: Visual Obturator (UL-VO)

1

2.9 mm Telescope Connector

2

20F Sheath Connector

3

Atraumatic tip

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 10 of 74

1 General Information About the Device 1.3 Device Descriptions

UL-BRIDGE

Figure 1-4: Bridge (UL-BRIDGE)

1

2.9 mm Telescope Connector

2

20F Sheath Connector UL-WBRIDGE

Figure 1-5: Bridge with One Working Channel (UL-WBRIDGE)

1

4 mm Telescope Connector

2

Instrument Channel

3

20F Sheath Connector

4

Working Channel Stopcock UL-GRASP

Figure 1-6: Endoscopic Grasper (UL-GRASP)

1

Handle

2

Flexible Shaft

3

Grasping Jaw

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 11 of 74

1 General Information About the Device 1.3 Device Descriptions

UL-TRAY

Figure 1-7: Cleaning and Storage Basket (UL-TRAY)

1

Small Component Tray

2

Loading Instruction Plate

3

Light Cable Holder

Figure 1-8: Cleaning and Storage Basket lid

4

Lid lock

5

Forceps Holder

Figure 1-9: Basket Fluid Inlet, connection to the automated washer

6

Basket Fluid Inlet

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 12 of 74

1 General Information About the Device 1.4 Symbols Used on the Devices and Packaging

1.4

Symbols Used on the Devices and Packaging The device is suitable for autoclave sterilization. CE mark: The device satisfies the requirements of Council Directive 93/42/EEC. The number beneath the CE mark, if present, indicates the number of the relevant notified body. Part Number

Serial Number

Lot Number

Quantity in Package

Direction of View

Manufacturer

Date of Manufacture

Caution

Non-sterile, sterilize prior to each use

The Cystoscopes and Accessories are MR unsafe

Permissible temperature during storage

Permissible relative humidity during storage

Permissible atmospheric pressure during storage CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 13 of 74

2 General Safety Information 2.1 Basic Safety Information

2

General Safety Information

2.1

Basic Safety Information Our products are developed and manufactured to the highest quality standards. Risks can nonetheless arise during initial use, reprocessing, or maintenance. Therefore, it is important that you read through these instructions for use carefully and observe the warnings indicated. Each device must be inspected prior to each use and used only if they are free from damage and in full working order. Follow the instructions for use for all devices that are to be used in conjunction with this device. WARNING! This device is supplied in a non-sterile condition, which carries arisk of infection. Carry out sterile processing of the device and its accessories prior to first use. WARNING! Unauthorized modifications to the device carry a risk of serious injury. Do not make any unauthorized modifications. WARNING! Component failure during a surgical procedure carries a risk to the patient. Keep spares on hand for emergency replacement. WARNING! High-intensity light source. Risk of injury to eyes. Do not look directly into the light exit at the distal end of the telescope. WARNING! Magnetic resonance imaging (MRI). Magnetic force, electromagnetic interactions, heating of metal components. Do not operate the device in the vicinity of MRI scanners. WARNING! Using the device during operation of a defibrillator carries a risk to persons. Before discharging a defibrillator, remove device from the operating field. CAUTION! Rough handling may lead to damage of the device and therefore carries a risk to the patient. Handle the device with appropriate care. If the device is dropped or subjected to high mechanical stress, stop using it and send to the manufacturer for inspection. WARNING! Improper handling, maintenance, and use carries a risk to the patient and user, or can lead to premature wearing of the device.

2.2

Electrical Equipment Safety Requirements (IEC 60601) The device is intended to be used in combination with light sources and camera systems that are compliant with the requirements for applied parts classified as type BF (that is parts offering increased protection against electric shock), or as type CF according to IEC 60601-1. This insulation barrier can be realized by the medical electrical devices themselves or by the connecting cables to the telescope and must be assured for every connection between the telescope and connected devices.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 14 of 74

3 Device Operation Including Inspection and Assembly 3.1 Safety Instructions

3

Device Operation Including Inspection and Assembly

3.1

Safety Instructions

WARNING Interactions between devices in simultaneous use Risk to the patient and user, image distortion, damage to the device Ensure that all the devices in use are compliant with the requirements for applied parts classified as type BF according to IEC 60601-1 Observe the labeling and instructions for use of the devices used

WARNING Displaying a recorded image instead of the live image or an altered image orientation Risk to the patient Ensure that the monitor is displaying the live image from the endoscopic camera Ensure that the live image is displayed in the correct orientation (not mirrored)

WARNING Use of non-sterile parts Infection risk for the patient Use only properly reprocessed telescopes and endoscopic accessories Accessories supplied in a non-sterile condition must be subject to sterile processing before use Always carry out a visual inspection prior to use Anchor the light guide in the operating field and secure against slipping, allowing some slack for maneuvering

WARNING Recontamination resulting from improper handling Infection risk for the patient Adhere to the infection control practices that are in place

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 15 of 74

3 Device Operation Including Inspection and Assembly 3.1 Safety Instructions

CAUTION High temperatures resulting from light source usage Irreversible tissue damage to patient or undesirable coagulation, user injury, material damage Use only light guides that are suitable for use with the telescope Avoid the prolonged use of intense light You should always use the lowest light output setting that will allow you to complete the task at hand Do not touch the immediate vicinity of the light source Do not touch light guide connectors Do not allow the distal end of the telescope to come into contact with patient tissue, combustible, or heat-sensitive materials Use telescopes only in conjunction with a sheath

NOTICE Improper handling Risk of damage to the device Set down carefully without bending or knocking Avoid scratching the surface Take care when removing instruments from the operating field

3.2

Staff Qualifications The device may be used only by physicians, surgeons, and surgical assistants who have received instruction in how to use the device and who have the requisite training, knowledge, and practical experience in the procedure to be performed as defined by the provisions in place at the site of service.

3.3

Initial Receipt of Device Complete a visual inspection (section 3.4) upon receipt of the device. Contact Customer Service (Appendix A) if the device does not meet the inspection criteria. Note: The original packaging should be retained and reused when returning a device for servicing.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 16 of 74

3 Device Operation Including Inspection and Assembly 3.4 Device Inspection and Test

3.4

Device Inspection and Test Complete a visual inspection prior to each use of the Telescope Check the telescope and all the components to be used for external damage. Do not use the device if it has any sharp edges or corners, defects, or rough surfaces that might cause injury to the patient. Check that the fiber optics in the telescope are in full working order. Do this by holding the distal end toward a bright light (not a cold light source) and the light guide connector toward your eyes. Gently move the telescope from side to side, taking note of the brightness of the fibers. If more than 20 % of the fibers remain dark, the telescope must not be used and a repair must be arranged. Check that the glass surfaces and fiber optic end faces of the telescope are clean and smooth. Do not use the telescope if the surfaces are soiled or scratched. Set aside the telescope and follow the steps described in Section 4.6. Make sure you can see a clear, bright, complete image. Look through the eyepiece and assess the image quality. Do not use the telescope if the image is yellowed, dark, speckled, or cropped. Set aside the telescope and follow the steps described in Section 4.6. Check that all the equipment to be used for the procedure is mutually compatible. Operate all equipment according to manufacturer's instructions. Only use electrical equipment with an isolation barrier for protecting against electric shock; equipment must comply with the requirements for applied parts classified as type BF according to IEC 60601-1 (see Section 2.2 "Electrical Equipment Safety Requirements"). Complete a Functional Test Prior to Each Use of the Device Connect the camera and the light source to the telescope. Verify that the connections are secure. Switch on all the system components that you intend to use for the procedure. Direct the camera head at a nearby object in the room and focus the image. Verify that you are able to achieve a sharp, bright, good quality image. Do not use the system if the image contains vertical lines or color variations, flickers, or you are unable to achieve a sharp, bright, good quality image. Connect the fittings of all of the mating equipment items. Verify that the connections are secure.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 17 of 74

3 Device Operation Including Inspection and Assembly 3.5 Device Assembly

3.5

Device Assembly The Bridge and Visual Obturator are to be used with the 2.9 mm Telescope (UL-SCOPE). The Working Bridge is to be used with the 4 mm Telescope (UL-SCOPE4). Align the swivel joints on the Telescope Connection and Sheath Connection on the Bridge or Visual Obturator such that the rotatable pieces snap into place. Align the Bridge, Working Bridge or Visual Obturator and the Sheath so that the two zeros are across from each other (Figure 3-1).

Figure 3-1: Visual Obturator and Sheath in alignment.

Push the Bridge, Working Bridge or Visual Obturator completely into the Sheath (Figure 3-2)

Figure 3-2: Visual Obturator and Sheath engaged, ready for the lever to be locked.

Lock the Bridge, Working Bridge or Visual Obturator into the Sheath by rotating the lever on the Sheath connector one-quarter turn.

Figure 3-3: Visual Obturator and outer sheath are tightly joined.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 18 of 74

3 Device Operation Including Inspection and Assembly 3.6 Device Pre-Cleaning

Insert the Telescope into the Telescope Connector on the Bridge, Working Bridge or Visual Obturator. Align the Telescope light guide connector with the engraved line on the Bridge, Working Bridge or Visual Obturator.

Figure 3-4: Telescope light guide connector aligned with the engraved line on the Telescope Connector of the Visual Obturator.

Push the Telescope completely into the Bridge, Working Bridge or Visual Obturator (Figure 3-5)

Figure 3-5: Telescope and Visual Obturator are engaged, the lever is locked.

Lock the Telescope into the Bridge, Working Bridge or Visual Obturator by rotating the lever on the Telescope Connector one-quarter turn. Basic assembly is complete. Pull gently to verify that all components are securely connected (Figure 3-6).

Figure 3-6: Complete Assembly of Telescope, Visual Obturator (or Bridge) and Sheath.

To connect the Light Guide, screw the appropriate adapter to the Light Guide connector on the Telescope (Figure 1-1). Screw or press the Light Guide onto the Light Guide connector. Attach the free end of the Light Guide to the light source. To use the Grasping Forceps, assemble the Working Bridge and 4 mm Telescope to the Sheath as described above. To assemble the Grasping Forceps, close the jaws using the handle and insert the jaws through the working channel of the Working Bridge. Advance the Grasping Forceps until the tip can be seen using the Telescope. The device is now assembled and ready for the intended use.

3.6

Device Pre-Cleaning Pre-clean the device immediately after use as follows: Unlock and fully separate all devices and detach all removable parts. NOTICE! The eyepiece cup is not removable. Prepare enzymatic cleaning solution per the manufacturer’s instructions. For details on cleaning agents see section 4.6. Pre-clean all used parts of the fully disassembled device at the conclusion of the procedure by wiping with a lintfree wipe wetted with an enzymatic cleaning solution until visibly clean. Arrange for reprocessing. All devices should be reprocessed within six hours.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 19 of 74

4 Reprocessing 4.1 General Information

4

Reprocessing

4.1

General Information The instructions provided in this document include multiple methods of device reprocessing. Reprocessing procedures may be subject to institutional, local, and national regulations and standards. It is the responsibility of the end user to select and adhere to the appropriate methods in accordance with all relevant requirements. If particular instructions are specific to reprocessing within the United States or outside of the United States, a note will be used to indicate the relevant geography.

4.2

Safety Instructions

WARNING Suspicion of product contact with pathogens causing Creutzfeldt-Jakob Disease - reprocessing of contaminated product is not possible Risk of cross-contamination during reprocessing Do not reprocess products suspected of being cross-contaminated Dispose of products suspected of being crosscontaminated

WARNING Disinfection Risk to patient Cidex OPA is contraindicated for patients with a history of bladder cancer

CAUTION Improper cleaning and disinfection Risk to patient due to inadequate cleaning and disinfection, damage to the device If automated cleaning and disinfection equipment is used, it must meet the performance requirements of ISO 15883-1 Load the device in such a way as to ensure that all contents are rinsed and cleaned fully (no rinsing ‘blind spots’) If automated cleaning and disinfection equipment is used, connect all instruments with lumens directly to the dedicated fluid connectors on the Cleaning and Storage Tray Disassemble all valves on instruments Ensure proper maintenance of cleaning and disinfection equipment Only use cleaning and disinfecting media that are approved for the device The devices must be pre-cleaned immediately after use and reprocessed within 6 hours When pre-cleaning, do not use fixing temperatures in excess of 45 °C When pre-cleaning, do not use fixing detergents or disinfectants (active ingredients: aldehyde, alcohol)

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 20 of 74

4 Reprocessing 4.3 Staff Qualifications

NOTICE Damage from contact with chloride-based solutions Corrosion and destruction of the device Avoid contact with chloride-based solutions as contained for example in: surgical residue, tinctures, pharmaceutical products, saline solutions and cleaning and disinfection solutions After contact with chloride-based solutions, rinse devices thoroughly with deionised water and dry completely

NOTICE Damage from ultrasonic cleaning Damage to telescope Do not expose telescope to ultrasonic cleaning bath

NOTICE Unsuitable detergents and process chemicals Corrosion damage, premature aging and visible material deterioration Only use cleaning and disinfecting media that are approved for the device Only use process chemicals that are compatible with the device’s materials according to the chemical manufacturer’s recommendations Follow all the chemical manufacturer’s application specifications regarding temperature, concentration and contact time Do not use process chemicals that may cause stress cracking or brittleness of plastic materials

4.3

Staff Qualifications The qualifications required by personnel responsible for the reprocessing and sterilization of medical devices are regulated by law in most countries. The reprocessing of the devices must be performed by qualified personnel who have the necessary knowledge and expertise.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 21 of 74

4 Reprocessing 4.4 General Guidelines for Reprocessing

4.4

General Guidelines for Reprocessing The device has been validated to multiple processing methods (Table 4-1). It is the operator’s responsibility to introduce, document, implement, and maintain a validated reprocessing procedure and to make sure the equipment used for reprocessing is properly installed and maintained. Users should wear personal protective equipment during reprocessing. The device must be thoroughly cleaned at the start of reprocessing. It is essential that the sterilization and/or disinfection medium reach all parts of the device. New and recently repaired devices must undergo the entire reprocessing procedure prior to their initial use. Table 4-1: Validated Reprocessing Methods

Product

Manual Cleaning

Manual Cleaning with Disinfection

Automated Cleaning (with Thermal Disinfection)**

High Level Disinfection (HLD)

Sterilization

Enzymat- EnzymatAlkaline ic cleaner ic cleaner detergent 2-5 minutes, 2-5 minutes, @ 60 ºC; 3x rinse* rinse, water (section Cidex rinse @ 4.6.1) OPA 12 90 ºC* minutes, (section 3x rinse* 4.6.3) (section 4.6.2)

Cidex OPA 12 minutes, 3x rinse* (section 4.6.4)

134 ºC, 3 minutes minimum* / 132 °C 4 minutes minimum*, (section 4.6.5)

ULSCOPE

X

X

X

X

X

ULSCOPE4

X

X

X

X

X

ULSHEATH

X

X

X

X

X

UL-VO

X

X

X

X

X

ULBRIDGE

X

X

X

X

X

ULWBRIDGE

X

X

X

X

X

ULGRASP

X***

X***

X

X****

X

ULGUIDE

X

X

X

X

X

* Refer to section number listed in box for detailed instructions. ** Automatic cleaning validation was performed using UL-TRAY. *** UL-GRASP requires 15 minutes of ultrasonic cleaning for Manual Cleaning and Manual Cleaning with Disinfection (see tables 5-2, 5-3). **** UL-GRASP requires additional brushing for HLD.

Instructions For Use | 17 - Dec - 2015 | Version: D

Page 22 of 74