IR Telescope Instructions for Use

Contents 1 General information... 5 1.1 User instructions... 5 1.2 Signal words... 5 1.3 Conventions throughout this document... 5 1.4 Trademarks... 6 1.5 Manufacturer... 6 1.6 Serious incident reporting... 7 2 Safety information... 8 2.1 Intended use... 8 2.2 Contraindications... 8 2.3 User qualification... 9 2.4 Environment of use... 10 2.5 General warnings and cautions... 10 3 Product description... 14 3.1 Scope of delivery... 14 3.2 Product functions... 14 3.3 Operating elements... 15 3.4 Symbols... 17 3.5 Warranty... 18 4 Before use... 19 4.1 Safety information for preparation... 19 4.2 Inspecting the telescope... 20 4.3 Connecting the telescope... 21 5 Use... 23 5.1 Safety information for use... 23 5.2 Using visible light imaging... 25 5.3 Using fluorescence imaging... 25 6 After use... 26 6.1 Disconnecting the telescope... 26 6.2 Preparation for reprocessing at the point of use... 27

7 General information for reprocessing... 28 7.1 Overview of the reprocessing cycle... 29 7.2 Validated reprocessing methods... 31 8 Cleaning and disinfection... 33 8.1 Safety notes for cleaning and disinfection... 33 8.2 Manual cleaning... 34 8.3 Automated cleaning and thermal disinfection... 36 8.4 Inspection and maintenance... 39 9 Sterilization... 40 9.1 Safety notes for sterilization... 40 9.2 Steam sterilization... 41 10 Repair, shipment and disposal... 43 10.1 Repair... 43 10.2 Shipment... 44 10.3 Disposal... 44 11 Compatible equipment... 45 11.1 Visible light imaging... 46 11.2 Fluorescence imaging... 47 12 Technical data... 48 12.1 General dimensions... 48 12.2 Specifications... 48 12.3 Ambient conditions... 48

General information

1 General information This section provides general information on how to use these instructions for use.

1.1 User instructions Before use, thoroughly read the instructions for use. If the instructions for use are missing, immediately contact an Olympus representative. Keep the instructions for use in a safe, accessible location.

1.2 Signal words The following signal words are used throughout this document. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. NOTICE Indicates a property damage message.

1.3 Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information.

5

General information 1. A numeration indicates a sequence of actions. 2. 3. ● Bullet points indicate individual actions or different options for action. – Dashes indicate the listing of data, options or objects. – – 1) Numbers with right parenthesis name elements in illustrations 2) 3)

1.4 Trademarks – STERRAD® – NXTM – V-PRO® – Cidex OPA® – One-Step® are trademarks of their respective owner.

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany Refer to the contact information for customers included in the scope of delivery for country-specific information.

6

General information

1.6 Serious incident reporting If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

7

Safety information

2 Safety information This section provides general safety information for using the telescope. The safety information includes: – Intended use – Contraindications – Necessary user qualifications – Environment of use – General safety notes

2.1 Intended use These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.

2.2 Contraindications There are no absolute contraindications against laparoscopy, thoracoscopy, transanal and transvaginal procedures which do not equally apply to open surgery in general. The operating physician must judge according to professional standards whether a specific procedure is appropriate or not. Known relative contraindications against laparoscopy include: – previous surgery/severe adhesions – pulmonary diseases – heart diseases – pregnancy Do not use the device for procedures in which it would regularly come in physical contact with the beating heart.

8

Safety information Laparoscopy in gynecological procedures may also be contraindicated by the following conditions, depending on their severity or extent: – Class IV cardiac decompensation – Bowel obstruction – Ileus – Cardiac disease – Intraperitoneal hemorrhage – Diaphragmatic hernia – Infection with acute peritonitis – Previous abdominal surgery – Obesity – Thin nulliparous patient – Chronic obstructive lung disease – Liver failure with established collateral vessels PRECAUTION – Ultrasonography before laparoscopy may identify clinical conditions that will alter patient management. – Abdominal puncture sites 7 mm or greater (for the introduction of auxiliary instrumentation) may be a source of herniation. – The abdomen can be adequately distended by pressure in the range of 15–20 mmHg. It is seldom necessary to use an abdominal pressure greater than 20 mmHg. – During unipolar electrosurgery, inadvertent burns can occur when the appropriate patient return path is obstructed or as a result of capacitive coupling. An important maxim: Avoid combinations of devices made of both conducting and insulating materials, especially metal trocars with nonconductive trocar anchors, screws, etc. That is: “Use like with like.”

2.3 User qualification Medical use This product is only intended to be used by a trained physician. 9

Safety information These instructions for use do not explain or discuss clinical procedures. Reprocessing Reprocessing of the product may only be performed by qualified hygiene personnel.

2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. Reprocessing This product must be reprocessed according to the applicable national and local standards and regulations.

2.5 General warnings and cautions The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the dangers, warnings and cautions given in each chapter in this document or in the instructions for use of any product being used with this product. WARNING Risk of injury to the patient and the user An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury or damage to the product. ● Make sure to have the complete set of instructions for use. ● Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure.

10

Safety information WARNING Risk of injury to the patient and the user The use of a damaged product or of a product with improper functioning can cause an electric shock, mechanical injury, infection and thermal injury. ● Before each use, observe the instructions in the section “4.2 Inspecting the telescope” on page 20. ● Do not use a damaged product or a product with improper functioning. ● Replace a damaged product or a product with improper functioning. WARNING Risk of injury to the patient There is a risk of an electric shock when using endoscopic equipment or when using endoscopic equipment in combination with energized endotherapy devices. The patient leakage currents can be additive. ● Only use F-Type applied part endoscopic equipment. ● Before each use, check the applied part classification of the endoscopic equipment and especially the energized endotherapy devices used during the procedure. ● Only use endoscopic equipment or endoscopic equipment in combination with energized endotherapy devices that meet at least the same requirements of applied part classification. This is particularly important if a type CF applied part endoscope is used. In this case a type CF applied part energized endotherapy device should be used to minimize total leakage current. ● For the applied part classification, refer to the respective instructions for use. WARNING Risk of injury to the patient There is a risk of electric shock when using light sources with non-insulated light-guide connectors. ● Only use light sources or light-guide cables that meet at least the same requirements of applied part classification.

11

Safety information ● For the applied part classification, refer to the respective instructions for use. WARNING Risk of injury to the patient There is a risk of injury to the patient due to malfunction of the equipment. ● Always have spare equipment available. WARNING Risk of injury to the patient and the user There is a risk of injury to the patient and the user caused by unauthorized repairs and product modification. Possible injuries include mechanical injuries, electric shock, burns, and toxication. ● Do not attempt to repair or modify the product. ● Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. ● Contact an Olympus representative or an authorized service center for repair information. CAUTION Risk of injury to the patient and the user Using incompatible equipment can lead to injury of the patient and the user as well as damage to the product. ● For information on compatible equipment, refer to the chapter “11 Compatible equipment” on page 45. CAUTION Risk of injury to the user There is a risk of injury to the user when using endoscopic equipment in combination with laser equipment. ● Use suitable protection measures (e.g., filters, protective goggles). NOTICE Risk of damage to the product The endoscope is a precise optical device. Careless handling can damage the endoscope. ● Always handle the endoscope with care. 12

Safety information ● Do not hold the endoscope by the distal end only. ● Do not bend the insertion tube. NOTICE Risk of damage to the product If the product is stored or transported with other devices without use of an instrument tray, product damage may occur. ● Use instrument trays to store or transport the product. ● Load instruments separately into instrument trays. ● Only remove instruments from the instrument tray directly before use. ● Avoid that the endoscopes touch each other or other devices during reprocessing, transport or storage.

13

Product description

3 Product description This section provides a general overview of the product and its functions. This includes the following information: – Scope of delivery – Product functions – Operating elements – Explanation of symbols – Warranty information

3.1 Scope of delivery Before use, check that all items listed below are available. Contact an Olympus representative or an authorized service center if any items are missing or damaged. WAIR100A, WAIR130A: – Telescope – Instructions for use – Contact information for customers The product is delivered in unsterile condition. Reprocess the product before first and each subsequent use.

3.2 Product functions A telescope is a rigid endoscope. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The endoscopic image can be viewed using the eyepiece cup or by connecting a compatible camera head. Telescopes are precise optical devices which are very sensitive to mechanical impacts.

14

Product description An IR telescope is designed for fluorescence imaging in the near infrared range using indocyanine green (ICG) as dye. A filter exclusively designed for ICG is built into the telescope. Light of suitable wavelength passes through the filter and enhances visualization on compatible imaging systems. For information on compatibility, refer to the chapter “11 Compatible equipment” on page 45.

3.3 Operating elements This section shows all operating elements of the product and gives a brief description of the purpose of these elements. 3.3.1 Entire telescope

1) Insertion tube For insertion into the patient. 2) Main body For holding and using the telescope.

15

Product description 3.3.2 Insertion tube Distal end

1) Objective cover glass For viewing the endoscopic image. 2) Light emission surface For illumination of the endoscopic image. 3.3.3 Main body

1) Insertion tube For insertion into the patient. 2) Light-guide connector For connecting the light-guide cable. 3) Eyepiece cup For connecting the camera head or viewing the endoscopic image.

16

Product description Eyepiece cup

1) Eyepiece cover glass For viewing the endoscopic image. Direction of view

The direction of view is indicated in degree on the main body of the telescope.

3.4 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product.

17

Product description Symbol

Explanation

Symbol

Explanation

Catalog number

Non-sterile

Serial number

Storage conditions

Quantity of content

Transport conditions

Manufacturer

Indicates the range of humidity to which the medical device can be safely exposed

Date of manufacture

Indicates the temperature limits to which the medical device can be safely exposed

Consult instructions for use

Indicates a recovery/recyclable package or package material

Federal (USA) law restricts this device to sale by or on the order of a physician

Green Dot-symbol for dual recycling system

CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation

Autoclavable

3.5 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

18

Before use

4 Before use This section describes all necessary steps to prepare the telescope for use. Full preparation includes the following: – Inspection – Connection of a light-guide cable – Connection of a camera head

4.1 Safety information for preparation WARNING Risk of injury to the patient and the medical personnel Improper and incomplete reprocessing can cause infection of the patient and medical personnel as well as damage to the product. ● Reprocess the product before first and each subsequent use. ● For reprocessing the product, observe the instructions in this document. ● Do not use a product that has not been reprocessed. ● Before each use, inspect the product as described in the section “4.2 Inspecting the telescope” on page 20. ● Do not use a damaged product. WARNING Risk of injury to the patient If the light-guide cable is not properly connected to the telescope or the light source, the endoscopic image can suddenly disappear during the procedure. This can lead to mechanical injury of the patient. ● Properly connect the adapters to the light-guide cable and the telescope. ● Properly connect the light-guide cable to the telescope and the light source.

19

Before use

4.2 Inspecting the telescope Some reprocessing methods can lead to increased wear of the products. Inspect the products thoroughly before use for traces of wear as described in this section. 4.2.1 Checking for mechanical defects

1. Check that the product has: – no dents, cracks, bending, or deformations – no deep scratches – no corrosion – no lens damages or cover glass damages – no missing or loose parts 2. Check all markings on the product for clear visibility. 3. If the product is damaged or does not function properly, do not use the product. Contact an authorized service center for repair. 4.2.2 Checking for performed reprocessing 1. Check that the product has been properly reprocessed. 2. Visually inspect the product thoroughly. The product must be visually clean. Only use the telescope if it is visually clean. Reprocess the telescope again if necessary. 20

Before use 4.2.3 Checking the light transmission 1. Hold the distal end of the telescope against a lamp. 2. Look into the light-guide connector of the telescope. Black dots indicate damaged light-guide fibers. 3. Only use the telescope if less than 25 to 30% of light-guide fibers are damaged. Replace the telescope if necessary. 4.2.4 Checking the image quality 1. Hold a piece of writing at approximately 50 mm from the objective cover glass. 2. Check that the image is not cloudy, out of focus or dark. 3. Only use the telescope if the writing is clearly visible through the telescope. Replace the telescope if necessary.

4.3 Connecting the telescope This section describes all necessary steps to fully connect the telescope to the ancilliary equipment. 4.3.1 Connecting the light-guide cable 1. If applicable, remove inappropriate light-guide adapters from the telescope.

21