EinsteinVision 3.0 Camera PV631 and PV632 Instructions for Use Ver 4.0 Jan 2022

1

3

2

4 5

6

A

9

10 11

8 7

B

9

12

8

C

13

14

15

16

15

16

15

16

D

17

E

F

15

16

*click* 70°

G

H

15

16

16

15

I

J

15

K

16

en

AESCULAP® EinsteinVision® 3.0 Camera heads PV631/PV632 PV641SU/PV642SU

and

Legend A 1 2 3 4 5 6

Endoscope shaft Coupling for sterile cover Camera head buttons Connection cable to camera control unit/light source Connector for camera control unit Connector for light source

B 7 Coupling adapter to camera head 8 Sterile hose 9 Tip segment 10 Shaft – 315 mm / 316 mm working lengths(PV651/PV652 in connection with sterile cover PV641SU/PV642SU), 10 mm outside diameter 11 Receptacle for attachment in the endoscope holder 12 Sterile cover insertion area C to K: Mounting the sterile cover 13 Cardboard position 14 Coupling part 15 Non-sterile person 16 Sterile person 17 Arrows

Contents 1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 2.4 2.4.1 2.4.2 2.5 2.6 2.6.1 2.7 2

About this document Scope Safety messages Clinical use Product description Operating principle Scope of Supply Components required for use Areas of use and limitations of use Intended use Indications Contraindications Safety information Clinical user Product Sterility Preparation Combination with medical electrical equipment Tests General notes on use System set-up Connecting the accessories Functional test

3 3 3 3 3 3 4 4 5 5 5 5 6 6 6 7 8 8 9 9 9 10 10

sterile 2.8 2.8.1 2.8.2 2.8.3 2.8.4 2.8.5 2.9 2.9.1 3. 3.1 3.2 3.3 3.4 3.5 3.5.1 3.5.2 3.6 3.7 3.7.1 3.8 3.8.1 3.8.2 3.9 3.9.1 3.10 3.10.1 3.10.2 3.11 3.11.1 3.11.2 3.12 3.13 3.13.1 3.13.2 4. 4.1 4.2 4.3 4.4 5. 6. 6.1 6.1.1 6.1.2 7.

covers

for

camera

heads

Application Excessive temperatures in combination with light sources Connection to camera control unit Connection to the light source Mounting the sterile cover Removing the sterile cover Troubleshooting Repairs Validated reprocessing procedure General safety information General notes Disassembling the product before carrying out the reprocessing procedure Preparing for cleaning Cleaning/Disinfection Product-specific safety information on the reprocessing method Validated cleaning and disinfection procedure Wipe disinfection Manual cleaning/disinfection Manual cleaning with immersion disinfection Mechanical cleaning/disinfection Lay the camera head in the basket Mechanical alkaline cleaning and thermal disinfection STERRAD sterilization Performing sterilization Material-compatible cleaning and disinfecting agents Wipe disinfection Manual immersion disinfection Inspection Visual inspection Functional test Packaging Storage Camera head holder Ambient conditions Maintenance, care and service Repair Maintenance Technical service Accessories / spare parts Disposal Technical data Classification as per Directive 93/42/EWG (EEC) and Regulation (EU) 2017/745 Camera head Sterile cover Symbols on product and packaging

11 12 12 12 12 13 14 14 15 15 15 15 15 16 16 17 17 18 18 19 19 20 20 20 20 20 20 21 21 21 21 21 21 21 21 21 22 22 22 22 22 22 22 22 23

en 1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for the following products: Art. no.

Designation

PV631

EV3.0 camera head 10 mm 0°

PV632

EV3.0 camera head 10 mm 30°

PV641SU

Sterile cover for camera head 0°

PV642SU

Sterile cover for camera head 30°

JF444R

Tray for 3D camera head

Note The applicable CE mark for the product can be seen on the label or packaging of the product. These instructions for use are an integral component of the device and contain all the information required by users and operators for safe and proper use. Target group These instructions for use are intended for physicians, medical assistants, medical technicians and employees of sterile services who are entrusted with the installation, operation, maintenance and reprocessing of the device. Using and storing this document These instructions for use 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 be handed over to the new owner. Supplementary documents For the use and assignment of the camera head buttons and the related options and possible functions, observe the instructions for use of the camera control unit concerned. The instructions for use of the sterile cover and instructions for use of all other devices used must be observed to ensure the safe use of the device. ► For article specific instructions for use and material compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Product description

2.1.1 Operating principle Note The EV3.0 camera head can only be used for 3D visualization if, in addition to the camera control unit PV630 or PV650, the LED light source OP950 or WL/FI light source OP951 is used. For this, the camera control unit and light source must be correctly connected via an MIS-Bus cable. The camera heads within the scope of these instructions for use can be used with the EV3.0 camera control unit or EV3.0 FI camera control unit and may only be connected to this unit. Together, the camera control unit and camera head comprise the camera. In combination with a suitable monitor, the camera can provide either two-dimensional or three-dimensional images. For three-dimensional visualization, the user requires polarized 3D glasses. The EV3.0 camera heads 0°/30° must be used with the matching sterile cover PV641SU/PV642SU (0°/30°). The sterile covers are used during surgical procedures to create a sterile barrier between the camera head used and the patient. The sterile cover is tightly screwed onto the camera head. After correctly mounting the sterile cover, it completely surrounds the camera head and cable. The integrated light cable transmits light between the light source and EV3.0 camera head. The camera head features four configurable camera head buttons that can be used to control image display, record images and video, or to navigate and change the settings in the configuration menu of the camera control unit. Camera head buttons The camera head buttons have different functions depending on the operating mode. The assignment of the buttons is always synchronous with the assignment of the buttons on the front of the camera control unit. Different functions can be assigned for a short press of the button (<2 sec.) and a long press of the button (≥2 sec.). The procedure for changing the assigned functions is described in the instructions for use of the PV630 EV3.0 camera control unit or PV650 EV3.0 FI camera control unit.

3

en Button assignment in live mode The button assignment in live mode depends on whether a standard profile or user profile is set. If a user profile is set, the buttons can be assigned individually, however the assignment for entering the camera control unit menu cannot be changed. In standard profile, the buttons are assigned as follows. Short press of button

Long press of button

Image rotation 180°

Open menu

Zoom

Light source on/off

Single frame image

Video recording start/stop

Button assignment when on-screen display is active When on-screen display is active, the buttons can be used to navigate in the menu until the menu is exited. Short press of button

Long press of button

Up / control +

Exit the menu

Down / control –

To the left / level back / save controller settings

Short press of button

Long press of button

Up

–

Right

Confirm/enter

Down

–

Left

–

White balance

Light source on

To the right / level deeper / save controller settings

Button assignment when on-screen keyboard is active When the on-screen keyboard is active, the buttons can be used to navigate on the keyboard, until the on-screen keyboard function is exited.

Usable trocars The endoscope with corresponding sterile cover is intended for use with a trocar system designed for 10 mm endoscopes. Due to possible deviations of the inner diameter of the trocars, not all 10 mm trocars may be compatible. This must be checked before the surgical procedure. The sterile cover must be able to be inserted into the trocar without using force. 2.1.2

Scope of Supply

Art. no.

Designation

PV631/PV632

EV3.0 camera head 10mm 0°/30°

TA014618

Instructions for Use

2.1.3

Components required for use

Camera heads The EV3.0 camera head, 10 mm 0°/30° (PV631/PV632) assists with 3D visualization with endoscopic surgical interventions. The integrated light cable transmits light between the light source and EV3.0 camera head. The EV3.0 camera head 10 mm 0°/30° must be used in combination with the sterile cover for camera head 0°/30°. The EV3.0 camera heads are intended for use with the following components: ■ PV630 EV3.0 camera control unit or PV650 EV3.0 FI camera control unit ■ PV641SU/PV642SU sterile cover for camera head 0°/30° (for PV631/PV632) ■ OP950 LED light source or OP951 WL/FI light source These components are optimally aligned with one another and offer the best possible quality and unrestricted functionality. Sterile cover The disposable sterile cover for the 0°/30° camera head is part of the sterile design for the EV3.0 camera head, 10 mm 0°/30°. The sterile cover is placed on the endoscope and is the sterile barrier between the non-sterile endoscope and the patient. The sterile cover ensures safe use of the endoscope under sterile conditions. The sterile cover is available with a 0° (PV641SU) or 30° (PV642SU) tip.

4

en 2.2

Areas of use and limitations of use

2.2.1

Intended use

EV3.0 camera head, 10 mm 0°/30° (PV631/PV632) The EV3.0 camera head 10 mm 0°/30° and the other EinsteinVision components are used for 3D visualization during: ■ laparoscopic standard endoscopy* ■ minimally invasive thoracic and cardiothoracic surgical procedures *Currently existing clinical data with regard to the effectiveness and safety of an application of EinsteinVision components to children are limited. Any application to this patient population should therefore be carried out at the discretion of the surgeon and after thorough consideration of the individual risk-benefit situation. The decision should in particular be based on the anatomical facts/proportions as well as the size and place of the surgical access needed. In order to assure a safe application, standards/guidelines released by official organizations such as scientific societies of endoscopic surgery have to be considered. Refer additionally to the intended use of the relevant components. Sterile cover for camera head 0°/30° (PV641SU/PV642SU) The sterile cover for camera head 0°/30° in combination with an EV3.0 camera head 0°/30° or EV3.0 FI camera head 0°/30° and the other EinsteinVision components are used for 3D visualization during: ■ laparoscopic standard endoscopy* ■ minimally invasive thoracic and cardiothoracic surgical procedures *Currently existing clinical data with regard to the effectiveness and safety of an application of EinsteinVision components to children are limited. Any application to this patient population should therefore be carried out at the discretion of the surgeon and after thorough consideration of the individual risk-benefit situation. The decision should in particular be based on the anatomical facts/ proportions as well as the size and place of the surgical access needed. In order to assure a safe application, standards/guidelines released by official organizations such as scientific societies of endoscopic surgery have to be considered. Observe the additional intended uses of the relevant components. Tray for 3D camera head Aesculap sterilizer baskets incl. accessories made of silicone/plastic or with silicone/plastic components are used by OP and AEMP personnel and are dimensionally stable containers intended for repeated use. They used for holding goods to be sterilized, for transport and storage in a sterile barrier system (e.g. sterilization containers, etc.).

2.2.2 Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. EV3.0 camera head, 10 mm 0°/30° (PV631/PV632) The EV3.0 camera head 10 mm 0°/30° and the other EinsteinVision components are indicated for visualization during: ■ urological, gynaecological and general laparoscopy ■ video-assisted minimally invasive mitral valve surgery ■ video-assisted minimally invasive tricuspid valve surgery ■ video-assisted minimally invasive ablation (radiofrequency and cryoablation) of atrial fibrillation ■ video-assisted minimally invasive ASD (Atrial Septal Defect) and VSD (Ventricular Septal Defect) closure ■ video-assisted thoracic surgery lobectomy Sterile cover for camera head 0°/30° (PV641SU/PV642SU) The sterile cover for camera head 0°/30° in combination with an EV3.0 camera head 0°/30° or EV3.0 FI camera head 0°/30° and the other EinsteinVision components are indicated for visualization during: ■ urological, gynaecological and general laparoscopy ■ video-assisted minimally invasive mitral valve surgery ■ video-assisted minimally invasive tricuspid valve surgery ■ video-assisted minimally invasive ablation (radiofrequency ablation and cryoablation) of atrial fibrillation ■ video-assisted minimally invasive ASD (Atrial Septal Defect) and VSD (VentricularSeptal Defect) closure ■ video-assisted thoracic surgery lobectomy Tray for 3D camera head For indications, see Intended use. 2.2.3

Contraindications

EV3.0 camera head, 10 mm 0°/30° (PV631/PV632) and sterile cover for camera head 0°/30° (PV641SU/PV642SU) The use of the EinsteinVision components and their accessories is contraindicated if endoscopic procedures are contraindicated for any reason. As is appropriate with any surgical procedure, consideration must be given to patient size and workspace volume when using the EinsteinVision components. Depending on the patient’s disease, there may exist contraindication that rely on the general condition of the patient or the specific disease pattern. The decision to perform an endoscopic procedure rests with the responsible surgeon and should be made on the basis of an individual risk-benefit analysis. Tray for 3D camera head No known contraindications.

5

en 2.3

Safety information

2.3.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product. 2.3.2

Product

Product-specific safety information Risk to patient from a defective sterile barrier! ► Use the sterile cover for camera head (PV641SU and PV642SU) only with a compatible EV3.0 camera head. ► If the sterile cover for the camera head is inserted in the patient without a trocar, this must be done completely without friction. No lateral pressure must be applied to the shaft in such a case. ► The sterile cover is delivered sterile. Cleaning, disinfection and/or sterilization of the sterile cover are prohibited. Risk to user and patient from non-observance of instructions, warnings and precautions. ► Use the product only according to these instructions for use. ► Check the product is in good working order before use. ► Carry out function checks before using the equipment. ► Do not use the product if irregularities are observed during inspections and checks. Risk to patient due to incorrect application! ► Use the product only after instruction by the manufacturer or by an authorized person. ► The instructions for use enclosed with the individual EinsteinVision components and all products used (e.g. high frequency surgery) must be observed. ► Endoscopic procedures may only be carried out by specialists who have the necessary medical training, knowledge and experience.

6

Risk to patient and user due to premature wear! ► Handle and maintain the product properly. ► Use the product only in accordance with the intended purpose. Risk of injury due to electric shock! ► When installing a medical electrical system, there is a risk of fire, short-circuit or electric shock. Installation must be performed by qualified personnel only. ► For the combination of electrical devices, follow annex 1 of IEC/EN/DIN 60601-1. Non-medical devices that comply with the applicable IEC safety standards can be connected only via a medical isolating transformer. Do not connect any additional non-medical devices to a medical electrical system. ► Signal lines from devices with a functional connection, which are connected to different branches of the mains power supply, must be galvanically isolated at both ends. ► Connect the devices only to a power supply with a protective earth conductor. ► After installation of a medical electrical system, perform a test pursuant to IEC/EN/DIN 62353. Risk to the patient if the product is not used gently/a damaged product is used! ► Handle the product with appropriate care. ► Do not use the product if it has been subjected to strong mechanical stress or if it has been dropped, and send the product to the manufacturer or an authorized repair center for inspection. Risk of damage to eyes from UV radiation! ► Never use polarized 3D glasses as sunglasses. Risk to patient if the device power fails! ► Use the product only with an uninterruptible power supply. A medical emergency power supply (UPS) is recommended here. Possible restricted function if third party devices are used! The full functionality of the product can only be guaranteed if the recommended components and accessories are used. ► Only operate the device with the original cables (included in scope of delivery) or with specified cables/components. ► Use the product with the recommended components and accessories. ► Before putting into operation, check the compatibility of all components and accessories using the accessories list. ► Procure all accessories and spare parts only from the manufacturer. Device failure due to incorrect storage and usage conditions! ► Store and operate the product only within the specified environmental conditions. Risk to patient due to failure of a device! ► Keep an operationally ready replacement device on hand. If necessary change to conventional surgical methods. Risk of intolerances such as vertigo, headache and nausea due to 3D visualization! ► Before first use, check tolerance. If intolerances occur during use, switch over to 2D imaging.

en If the recommended components are not used, the following errors/complications may occur, among others: ■ Incorrect color display ■ No/incorrect display of the camera menu ■ No/incorrect 3D display ■ Restricted operating function from the camera head ■ Increased fogging on the outlet of the optical lens ■ No switching between 2D and 3D display ■ Damage to the sterile cover ► Use the product only with the recommended components. The EinsteinVision components are used to visualize the inside of the body during minimally invasive procedures. ► Do not use the components for diagnostic purposes. This applies in particular with the use of image optimization algorithms. Images and videos recorded are for documentation purposes only. ► Do not use for diagnosis or findings, as the image quality is reduced in the event of data compression. Note The endoscope with corresponding sterile cover is intended only for use with a trocar system designed for 10 mm endoscopes. Note A thorough understanding of the principles and methods used for example in electro-surgical procedures is necessary to avoid risks of shock or burns to patients and users as well as damage to other equipment and instruments. Electro-surgical procedures must only be performed by trained personnel. ► Observe “Information on electromagnetic compatibility (EMC) for

EV3.0 camera control unit PV630 and EV3.0 FI camera control unit PV650” TA014630, see B. Braun eIFU at eifu.bbraun.com ► Only combine Aesculap products with each other. ► Always adhere to applicable standards. ► Do not modify the product in any way. ► Always handle the product very carefully as it contains sensitive optic, mechanic and electronic components. Do not strike or drop the EV3.0 camera head. Ambient conditions The following environmental conditions apply to the use of the product: Camera head/sterile cover Temperature

10 °C to 34 °C

Relative humidity

0 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

2.3.3

Sterility

Non-sterile packaged products Art. no.

Designation

PV631/PV632

EV3.0 camera head 10 mm 0°/30°

The product is supplied non-sterile and must be used in combination with a sterile cover (PV641SU or PV642SU). ► Clean the new product (manually or mechanically) after removal of the transport packaging. Art. no.

Designation

JF444R

Tray for 3D camera head

The product is supplied non-sterile. ► Clean the new product after removal of the transport packaging and prior to its initial sterilization. Sterile products Art. no.

Designation

PV641SU/PV642SU

Sterile cover for camera head 0°/30°

The product has been gamma-sterilized and packaged sterilely. The safe sterile provision of the product is only guaranteed if the sterile packaging is undamaged and unopened and the use-by date has not passed. ► Store products in their original packaging in a dust-protected, dry and temperature-controlled room. ► Protect products from direct sunlight. ► Remove products from their original protective packaging only just prior to application. ► Visually inspect the product packaging to ensure that the sterile barrier system is intact. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. Single-use products Art. no.

Designation

PV641SU/PV642SU

Sterile cover for camera head 0°/30°

The product is intended for single-use. ► Do not reuse the product. The processing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not process the product.

7

en 2.4

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. ► When setting up and operating the product, adhere to: – national regulations for installation and operation, – national regulations on fire and explosion protection. The device is authorized for operation in hospitals. Note For the safety of patients and users it is essential that the mains power cord and, especially, the protective ground connection are intact. In many cases defective or missing protective ground connections are not recognized immediately. ► Using the potential equalization cable mounted to the rear panel of

the device, connect the device to the potential equalization system of the room used for medical purposes. Note The potential equalization cable can be ordered from the manufacturer as art. no. GK535 (4 m long), GK534 (1.5 m long) or TA008205 (0.8 m long). WARNING Risk to patient from misdirected leakage current due to incorrect or defective earthing! ► Do not touch the product and patient at the same time WARNING Risk to patient due to failure of a device! ► Keep an operationally ready replacement device on hand and if necessary change to conventional surgical methods. WARNING Danger of explosion from a device that is improperly set up! ► Make certain that the power plug is connected to the power supply outside of any areas where there is a risk of explosion. ► Do not use the product in potentially explosive areas or close to highly flammable or explosive gases (e.g. oxygen, anesthetic gases). WARNING Risk of injury to the eyes! ► When checking the light cable, do not plug the light cable connector into the light source. WARNING Risk to patient and user due to condensation and short-circuit! ► Before putting into operation make sure that all components used have enough time to adjust to the changed environmental conditions. WARNING Risk to patient due to use of damaged products! ► Do not use products if they have sharp edges or other hazardous surface damage.

8

CAUTION Risk to patient and user due to condensation and short-circuit. ► Do not use products with damaged fiber optics, damaged glass surfaces or stubborn deposits which cannot be removed by cleaning. CAUTION Risk to persons and risk of damage to equipment due to improper cable routing! ► Lay all cables and leads so that they do not present a tripping hazard. ► Do not place objects on the cables. CAUTION Risk to patient due to poor/lack of vision! ► Adjust the monitors and display elements so that they are highly visible to the user. CAUTION Interference of high frequency energy with the device! ► Do not use any mobile or portable equipment that emit high-frequency energy (e.g. mobile phones, cell phones, GSM phones) in the vicinity of the product. CAUTION Reduced illumination of the operating field due to damaged light cable! ► Wind combination cable with integrated light cable only with a bend radius of more than 7 cm. ► Do not manipulate combination cable with sharp objects. ► Do not apply mechanical force to the combination cable. ► Do not modify the light cable. ► Do not damage the fiber surfaces of the light cable ends. Note The product including the combination cable is fragile when bent, kinked, twisted, pulled, or pressed. These may damage the optical components (e.g. light cable fibers) and thus lead to inoperability. Note Handle the camera head, combination cable and sterile cover carefully. No not exert any mechanical forces and avoid mechanical impacts. Please contact Service if the light output decreases. Note Ensure that the corresponding interconnection conditions, standards and respective national deviations are observed. 2.4.1 Combination with medical electrical equipment The product can be used with components from other manufacturers if they fulfill the requirements of IEC/EN/DIN 60601-1 for the safety of medical devices. It is the operator’s responsibility to check and make sure that the system is and remains fully operational. When using devices from various manufacturers and when using an endoscope and/or endoscopic accessory with electrical medical devices, the electrical shielding of the part must be indicated: Type CF defibrillation protected.

en 2.4.2 Tests Carry out the following inspection steps before reprocessing and immediately before use of the device: Inspection of the glass surfaces ► Before each use, inspect the endoscope and sterile cover for damage such as rough surfaces, sharp edges or protrusions to avoid injuries to the patient. ► Perform a visual inspection of the glass surfaces. The surfaces must be clean and smooth. ► If there are impairments/damage, see Troubleshooting. Inspection of the light cable ► Before each use, inspect the light cable for damage and ascertain

whether there is effective light transmission. ► Expose the distal end of the endoscope to the ambient light or move it in front of a bright ceiling lamp or similar (no cold light source) and hold the light cable connector close to the eye. The transmission properties of the light cable fibers change with time. Black spots on the end surface indicate broken glass fibers or wear of the light cable fibers. If only isolated light cable fibers are affected, this is safe. If the light output has noticeably reduced due to too high a breakage rate (see Figure 2 "Damaged light cable fibers"), it is recommended to send the endoscope for repair. Never continue to use endoscopes with damaged light cables or combination cables.

First use WARNING Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Follow the instructions for use of all products required.

2.5

General notes on use

The camera cable is fragile when bent, kinked, pulled, pressed, compressed and twisted. Observe the maximum bend radius of 7 cm and handle the cable with care. No not make any changes to the cable and do not load with sharp-edged objects. To avoid or reduce fogging of the optical surfaces, it can be helpful to supply the insufflation gas via an other trocar than the camera trocar. If the optical lens or tip of the sterile cover fogs over or gets soiled during the procedure, clean the lens if necessary with anti-fogging solution or sterile 0.9 % sodium chloride solution. Depending on the condition and output of the light source and the light cable, combinations can occur which lead to the excessive development of heat at the proximal end of the light cable and damage the light cable, thus significantly reducing the transmission. In this case contact the manufacturer. During cardiothoracic ablation, make sure that the ablation probe does not come into direct contact with the sterile cover.

2.6

System set-up

WARNING Risk of infection due to unsterile parts! ► Ensure that unsterile components do not enter the sterile area. ► Process products and accessories that are delivered unsterile before use and only use them with sterile accessories. WARNING Risk of infection due to unsterile, soiled or contaminated products! ► Disinfect the camera head and camera cable after each use. ► Only use the camera head in the sterile area if it is in sterile condition. To do so, use the camera head with the correctly applied sterile cover. Fig. 1

Intact light cable fibers WARNING Risk of injury due to broken glass! ► Only mount the appropriate sterile cover on the camera head (0° on 0°, 30° on 30°). WARNING Risk to patient due to lack of vision of operating site! ► When mounting the sterile cover ensure that this noticeably engages on the camera head coupling.

Fig. 2

Damaged light cable fibers

WARNING Risk to patient due to addition of leakage currents! ► If the product is used with medical electrical equipment and/or power-driven endoscope accessories, the leakage currents can multiply.

9

en WARNING Risk to patient and user from burns, sparks or explosion! ► When using a high frequency surgical device during an endoscopic procedure, observe the safety instructions of the corresponding instructions for use. WARNING Risk of injury due to improper use! ► Observe the intended use of the 3D endoscope and the sterile cover. ► Do not use the 3D endoscope and sterile cover as a lever. WARNING Risk of infection due to unsterile cover! ► Check the integrity of the packaging of the sterile cover before opening. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after the expiry date. CAUTION Internal fogging due to humidity between endoscope/camera head and sterile cover! ► Mount the sterile cover on a dry endoscope/camera head only. ► If necessary, dry the endoscope with a sterile, lint-free cloth. CAUTION Interference of electromagnetic emissions with the image quality (e.g. minor banding, minor color changes on the monitor image)! ► Check the image quality if used in combination with additional peripheral devices (e.g. monitor, documentation system). The EV3.0 camera head can only be operated with the EV3.0 camera control unit and EV3.0 FI camera control unit. In combination with the EV3.0 camera control unit and EV3.0 FI camera control unit, the endoscope is classified as a type CF defibrillation-proof applied part. Additional equipment and/or peripheral devices which are connected to the interfaces of the product must show their relevant specifications (such as IEC/EN/DIN 60601-1). To guarantee optimal function of the EinsteinVision components, use in controlled environmental conditions is recommended (air-conditioned operating room). ► Before application of endoscopic high frequency surgery (HF surgery) prepare the patient accordingly. ► Take measures to remove or avoid formation of combustible gases (e.g. gastro-intestinal tract/colonoscopy, urinary bladder/transuretheral resection). ► Ensure that all devices operated in the vicinity meet their relevant EMC requirements.

10

2.6.1

Connecting the accessories

DANGER Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device. Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC/DIN EN 60601-1 for medical electrical equipment). All configurations must fulfill the basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards. ► In case of questions, contact your B. Braun/Aesculap partner or Aesculap Technical Service, address see Technical service.

2.7

Functional test

WARNING Risk to patient due to incorrectly displayed image! ► Before mounting the sterile cover, ensure that the endoscope tip and flat glass of the sterile cover are clean. ► Remove any contamination on the optical lens before the surgery. Clean the endoscope with a cloth soaked in alcohol (70 % ethanol) or with a neutral cleaning agent. ► Remove any contamination immediately during the surgery. Clean the optical surfaces, e.g. with a damp sterile cloth and/or antifogging solution. ► Prior to application and after changing the settings (e.g. image rotation or activation of algorithms) check the correct display of the live image. If necessary, perform white balance. WARNING Risk of infection and injury due to defective sterile cover! ► Before mounting the sterile cover, ensure that the endoscope tip and flat glass of the sterile cover are intact. ► After mounting the sterile cover, check it visually to ensure it is intact. ► At the end of the surgery, check the tip of the sterile cover to ensure it is intact. WARNING Risk of damage to eyes if light is beamed directly into eyes! ► Do not look directly into the light exit at the distal end of the endoscope. ► When checking the light cable, do not plug the light cable connector into the light source.

en WARNING Risk to patient due to impaired or lack of 3D image impression! ► Check the fit of the polarized 3D glasses before use and if necessary use a suitable glasses strap or have them fitted by an optician (e.g. if loupe glasses are also to be used in combination with the polarized 3D glasses). ► Do not store the polarized 3D glasses in an environment with high temperatures, e.g. near a radiator. ► Do not use worn, scratched, broken or damaged polarized 3D glasses. WARNING Risk to patient and user from functional failure or electric shock! ► Use only dry components (e.g. plug connector for camera control unit, optical lens). Note Only perform the surgical procedure if all of the components being used are in a flawless condition. Note Before each use, after a power failure or any interruption, the functionality of all connected devices must be checked and all connections must be checked to see they are correct. Note The endoscope image must be focused, bright and clean at an appropriate working distance. Note In case of any noticeable mechanical damage (e.g. damage to the silicone tube), the camera head must not be used further with the combination cable. Note Do not continue to use damaged products. Note Differences in temperature and air humidity can cause the optical lens to fog up on insertion into the patient.

2.8

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. WARNING Risk to patient due to fogging of the optical lens and restricted view! ► To avoid or reduce fogging of the optical surfaces, it can be helpful to supply the insufflation gas via an other trocar than the camera trocar. WARNING Risk of infection due to damaged sterile barrier! ► Before mounting the sterile cover, ensure that the light source is deactivated. ► Do not exert increased forces (e.g. rotation forces) to any part of the sterile cover (shaft and coupling). ► Before use, ensure that the sterile cover and the trocar system (10 mm) available in the OR are compatible. ► Only insert the endoscope and sterile cover in the trocar if it is possible to do so without friction and without exerting force. ► Do not insert an endoscope and sterile cover into any damaged trocar. ► Do not expose the sterile cover to excessive temperatures. ► Avoid direct contact between high frequency electrodes and the sterile cover. ► The camera head and sterile cover must be gripped in the holding arm only at the point intended for this. ► Do not allow the ablation probe and other applied parts to come into contact with the endoscope shaft and sterile cover during use. ► Do not use the sterile cover together with external tip heating. ► Only mount the appropriate sterile cover on the camera head (0° on 0°, 30° on 30°). ► Before mounting the sterile cover, ensure that the endoscope tip and flat glass of the sterile cover are intact.

Application

WARNING Risk of burns due to heat development at the tip of the endoscope and sterile cover (likely > 41 °C)! ► Do not put down the endoscope on the patient during use. ► In the patient's abdominal cavity, always leave a sufficient distance between the optical lens and the tissue surfaces and mucous membranes of the patient. ► Use automatic light intensity control or set the light source so that a bright, well-lit image is visible with the lowest possible light intensity. ► Switch off the light source if the illumination is no longer needed or if the endoscope is out of the patient for a longer period of time. ► Do not touch the light cable connector, distal end of the endoscope or the tip of the sterile cover during use or immediately after use.

WARNING Risk of injury from burns and unwanted deep penetration and risk of damage to product! ► Only switch on high frequency current when the corresponding applied part (electrode) can be seen through the endoscope and there is no contact between the two. WARNING Risk of infection due to contamination of the sterile area! ► Fasten the combination cable covered by the sterile cover in the operating field so that it does not come into contact with unsterile surfaces. ► Fasten the combination cable so that the rear end of the combination cable, which is not covered by the sterile cover, does not enter the sterile area.

11

en WARNING Risk of injury due to misdirected leakage currents! ► Before thoracic or cardiothoracic surgery, deactivate implanted defibrillators (ICD). ► Before any kind of defibrillation, remove the camera head from the patient. WARNING Risk of fire and injury and risk to patient due to overheating at the endoscope light exit! ► Never leave the EV3.0 camera head unattended when light is being transmitted from the light source. ► During operation, do not place the EV3.0 camera head on the patient, in the operating field, or on temperature-sensitive or flammable objects. WARNING Risk to patient from gas embolism! ► Avoid overinsufflation e.g. with air or inert gas before high frequency surgery. WARNING Risk to patient from damage to the optical lens or sterile cover! ► Withdraw the endoscope and sterile sheath slowly from the used trocar. ► If a trocar with a manual opening valve is being used, only the withdraw the endoscope and sterile sheath from the trocar when the valve is open.

2.8.1 Excessive temperatures in combination with light sources Light sources, especially high-power light sources, emit large amounts of light energy and thermal energy The light cable connector, distal end of the endoscope and the tip of the sterile cover can become extremely hot as a result of this. Risks from use of light sources: ■ Irreversible tissue damage or unwanted coagulation to the patient or user ■ Burns or thermal damage to surgical equipment (e.g. surgical drapes, plastic materials, etc.) ■ If the light source fails during use, this may endanger the patient. Therefore keep an operationally ready replacement light source on hand. Safety precautions ► Do not illuminate the inside of the patient for longer than necessary with the light source. ► Use the automatic light intensity control or set the light source so that a bright, well-lit image is visible with the lowest possible light intensity. ► Do not allow the distal end of the endoscope or the light cable connector to come into contact with patient tissue or with combustible or heat-sensitive materials. ► Do not touch the distal end of the endoscope. ► Avoid contamination of the distal end surface or light emission surface. 2.8.2 Connection to camera control unit ► Insert the connection plug fully into the connection socket of the camera control unit until it engages in place.

WARNING Risk of infection due to unsterile cover! ► Replace the sterile cover if it falls on the ground or if it is touched by unsterile objects/persons.

2.8.3 Connection to the light source ► Insert the connection plug fully into the light cable socket on the light source until it engages in place.

CAUTION Impairment of vision due to reflections! ► Before mounting the sterile cover, ensure that the light source is deactivated.

WARNING Risk of blinding from light rays! ► Put light source into standby mode before mounting the sterile cover.

CAUTION Malfunction in connection with magnetic resonance! ► Do not use the product in a magnetic resonance environment.

Mounting is carried out by a non-sterile person 15 and a sterile person 16. ► The non-sterile person 15 opens the sterile cover packaging. ► The sterile person 16 removes the sterile cover from the packaging and performs a visual inspection to check whether the flat glass is in a flawless condition. ► The sterile person 16 holds the sterile cover while it is mounted on the shaft. ► The non-sterile person 15 may only touch the sterile cover by the blue coupling part 14 and at the cardboard portion 13, see Fig. C. ► To mount the sterile cover the non-sterile person 15 holds the camera head and the sterile person 16 holds the sterile cover, see Fig. D. ► The sterile person 16 holds the sterile cover with the arrow markings 17 facing up, see Fig. E.

Note If the 3D display fails, the operation can be continued with 2D display. Note The current layout of the camera head buttons is displayed on the screen as “camera head information” after opening the camera menu.

12

2.8.4

Mounting the sterile cover

en ► For better coordination the non-sterile person 15 can hold the blue

coupling part 14 while inserting the endoscope tip in the sterile cover, see Fig. F. ► The non-sterile person 15 inserts the endoscope into the sterile cover shaft and the sterile cover is passed over the complete endoscope shaft, see Fig. G. ► The non-sterile person 15 locks the locking mechanism by turning the coupling mechanism (70° counterclockwise), see Fig. H. A perceptible click confirms correct fastening. ► The non-sterile person 15 pulls the plastic sleeve of the sterile cover completely over the camera head and camera cable, see Fig. I to Fig. K. Make sure that the plastic sleeve is only held at the very rear by the cardboard portion 13. ► Turn on the light source and test the live image of the camera. Do not look directly into the light coming out of the light cable or endoscope. ► Only perform the surgical procedure if all of the EinsteinVision components being used are in a flawless condition. Do not hit or exert mechanical forces on the endoscope, camera head or sterile cover. 2.8.5

Removing the sterile cover

WARNING Risk of infection/injury to patients and users! ► Use the sterile cover for camera head only once. ► Do not reprocess the sterile cover. ► Remove the sterile cover by unlocking the locking mechanism at the

coupling. To do this, open the locking mechanism by turning the coupling (70° clockwise).

Fig. 3 ► Then remove the sterile cover from the combination cable and camera

head and dispose of according to the regulations.

Fig. 4

13

en 2.9

Troubleshooting

Problem

Possible cause

Remedy

Image cloudy

Glass surfaces soiled

Clean the glass surfaces according to the Cleaning and Disinfection section.

Stubborn residue on the glass surfaces

Remove residues according to the Cleaning and Disinfection section; check water quality.

Leaky, defective lens system

Send in endoscope system/camera head for repair.

Glass surfaces soiled

Clean the glass surfaces according to the Cleaning and Disinfection section.

Light cable not attached to light source correctly

Check that the light cable is connected properly.

Defective fiber optics

Check the glass surfaces.

Light cable defective

Replace camera head.

Soiled fiber optics

Clean the glass surfaces, see Cleaning/Disinfection.

Light cable dirty, defective

Check light cable (e. g. illuminate onto a white surface).

Inadequate cleaning (e.g. remaining protein residue)

Clean again, rub thoroughly if necessary.

Excessive chloride concentration

Check water quality.

Heavy metal ions and/or silicates, increased content of iron, copper, manganese in water

Check water quality; if applicable, only use deionized (fully desalinated) water.

Image too dark, too little illumination

Illumination has yellow tint

Corrosion, staining, discoloration

Too high concentration of mineral substances (e.g. calcium) or organic substances Contaminated cleaning/disinfecting solutions, too frequent use

The cleaning and disinfecting solutions should be replaced regularly.

Extraneous rust, (e.g. resulting from previously damaged or non-corrosion-resistant instruments being reprocessed at the same time)

Check supply systems; in case of joint reprocessing, check material compatibility, for existing damage and avoid mutual contact

Contact corrosion

Avoid contact with other components.

2.9.1 Repairs For repairs, contact the manufacturer or authorized repair center. Authorized repair centers can be inquired about from the manufacturer. For a fast processing of your service requests, send in the product indicating: ■ Item number (REF) ■ Serial number (SN) / Batch number (LOT) ■ Detailed description of defects Note If a component of the visualization system is replaced (e. g. service, upgrade), the system start-up process must be performed again. It is also recommended to perform servicing after any maintenance or replacement of a device.

14

en 3. 3.1

Validated reprocessing procedure General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeld-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note The EV3.0 camera heads, PV631/PV632 cannot be autoclaved. Therefore, the EV3.0 camera heads PV631/PV632 and the sterile covers PV641SU/PV642SU may not be used in patients in which there is a suspicion of Creutzfeld-Jacob disease or Creutzfeld-Jacob disease has already been diagnosed. Note For EV3.0 camera heads PV631/PV632, the sterile barrier is ensured with the sterile cover. The sterile cover must be used for each application and must only be used once. It is recommended to perform wipe disinfection of the camera head and endoscope after use with the sterile cover (after removing the used sterile cover). If severe contamination occurs due to the removal of the sterile cover or due to further handling in the OR, manual cleaning with immersion disinfection or mechanical alkaline cleaning and thermal disinfection and STERRAD sterilization of the EV3.0 camera heads PV631/PV632 can be performed. Note Successful reprocessing of this medical device can only be ensured through use of a prior validated reprocessing procedure. The operator/reprocessor is responsible for this. Note For up-to-date information about reprocessing and material compatibility, see also B. Braun eIFU at eifu.bbraun.com Note The validated sterilization procedure was performed using the Aesculap sterile container system.

3.2

General notes

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 6 hours should pass between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non stainless steel. Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and result in damage to the products in case of non stainless steel. These must be removed by rinsing thoroughly with desalinated water and then drying. Perform additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for reprocessing the product. All of the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Visual changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging, or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion. ► For more detailed information on hygienically safe reprocessing which is protective of materials and retains their value, please see www.a-k-i.org Heading “AKI-Brochures”, “Red brochure”.

3.3

Disassembling the product before carrying out the reprocessing procedure

► Completely remove the sterile cover from the camera head: you can

remove the sterile cover by unlocking the locking mechanism at the coupling. Then remove it and dispose of it according to regulations. The sterile cover is only intended for single use. ► Unplug the camera plug from the camera control unit. ► Unplug the light cable connector from the light source.

3.4

Preparing for cleaning

► Remove any visible surgical residues as much as possible with a damp

(wet with tapwater or HP water) lint-free cloth. Use a soft cloth for this to avoid scratching the optical lens. ► Carry out wipe disinfection. ► If the product is contaminated or if there is a suspicion of product contamination, transport the dry product in a closed disposal container and transport for cleaning and disinfection within six hours.

15

en 3.5

Cleaning/Disinfection

3.5.1

Product-specific safety information on the reprocessing method Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. Risk of cross-contamination during preparation. It is not possible to prepare the contaminated product if there is suspicion that the product came into contact with Creutzfeld-Jakob disease pathogens. ► Do not reprocess the product if there is a concern about contamination. ► Dispose of the product if there is a suspicion of contamination. Risk of infection for patient and/or user! ► Ensure that there is no residue from cleaning and disinfecting agents on the product. ► Avoid insufficient or incorrect cleaning and disinfection of the product and accessory. Damage to the product due to improper reprocessing! ► Do not, under any circumstances, clean or disinfect the product in an ultrasonic cleaning bath. ► Use cleaning and disinfecting agents which are suitable and approved for the present product. ► Observe the manufacturer’s cleaning and disinfecting instructions regarding concentration, temperature and exposure time. ► Only reconnect the system to power when all cleaned parts are completely dry. ► Do not autoclave the product. Risk to patients and users due to high temperature after preparation. ► Make sure that the product has cooled down sufficiently before use. Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions. The cleaning and disinfecting agent must be approved for plastics and high-grade steel, and it must not attack softeners (e.g. silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 60 °C. Risk of defects, consequential damage or a shortened product service life! ► Follow and observe the manufacturer's requirements for reprocessing ► Heated devices are very sensitive to shock. Carefully handle the camera head, and do not bump it. ► Sudden temperature changes can lead to product damage. Do not quench the product after preparation. Allow them to cool to room temperature without any supplemental cooling. Note There may be significant discoloration of the EV3.0 camera head when using Cidex OPA. However, this discoloration has no influence on the functionality or safety of the product. Note The surfaces of the silicone elements of the preparation basket JF444R can become brittle over their lifetimes. If there are signs of brittleness, replace the silicone elements using the exchange set JF444500.

16

en 3.5.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Wipe disinfection

no

see Wipe disinfection

■ Drying phase: use a lint-free cloth or medical compressed air.

see Manual cleaning/disinfection and subsection: see Manual cleaning with immersion disinfection

■ EV3.0 camera heads PV631/PV632 Manual cleaning with immersion disinfection

■ EV3.0 camera heads PV631/PV632 Mechanical alkaline cleaning and thermal disinfection

■ Place the PV631/PV632 product on a JF444R tray (avoid rinse spots). see Mechanical cleaning/disinfection and subsection: see Mechanical alkaline cleaning and thermal disinfection

■ EV3.0 camera heads PV631/PV632

■ Tray for 3D camera heads JF444R

3.6

Wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT

1

-

-

Alcohol(s), quaternary ammonium compound(s)*

II

Wipe disinfection

RT

≥1

-

-

Alcohol(s), quaternary ammonium compound(s)*

RT: *

Room temperature Recommended: Meliseptol wipes sensitive (B. Braun)

Phase I ► Remove any visible residues with a disposable disinfectant wipe. Phase II ► Wipe all surfaces of the optically clean product with a fresh, dispos-

able disinfectant wipe. ► Observe the application time (1 min minimum).

17

en 3.7

Manual cleaning/disinfection

Full functionality for up to 300 reprocessing cycles can be guaranteed on the basis of material tests. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection. Note Scratch-sensitive surfaces Risk of corrosion. Do not use metal brushes, metal objects or abrasive cleaners. ► After manual cleaning/disinfection, check visible surfaces visually for

residues. ► Repeat the cleaning/disinfection process if necessary.

3.7.1

Manual cleaning with immersion disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Cleaning

35-45/ 95-113

2-5

0.8

D–W

Enzymatic detergent Cidezyme/Enzol (Johnson & Johnson)

II

Intermediate rinse

RT (cold)

3x1

-

D–W

-

III

Disinfection

20-25/ 68-77

12

0.55

–

Ortho-phthalaldehyde solution Cidex OPA (Johnson & Johnson)

IV

Final rinse

RT (cold)

3x2

-

FD–W

-

V

Drying

RT

-

-

-

-

DW: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature Phase I ► Fully immerse the product in the cleaning/disinfecting solution for at

least 2 5 minutes. Ensure that all accessible surfaces are wet. ► Clean all external surfaces of the components in the cleaning solution

with a soft, lint-free, non-sterile cloth or with a soft brush until no more soiling is visible. Brush for at least one minute or until no more remnants can be removed. Phase II ► Lay all parts in a tapwater bath and carefully rinse all accessible sur-

faces three times each for at least one minute. ► Use fresh water for every rinse. ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the disinfecting solution. Phase III ► Fully immerse all parts in a disinfectant solution for at least 12 min-

utes. The accessible surfaces must remain fully immersed in the disinfectant solution during the entire disinfection process. ► Remove any air bubbles adhering to the surfaces of the parts.

18

Phase IV ► Rinse/flush the product three times thoroughly (all accessible surfaces) for 2 minutes. ► Use fresh water for every rinse. ► Drain any remaining water fully. Phase V ► Carefully dry all parts with a clean, lint-free cloth or a lint-free surgical cloth. ► Dry accessible areas with medical compressed air (Pmax = 0.5 bar).