EinsteinVision 3.0 Control Unit PV630 Instructions for Use Ver 4.0 April 2021

en

AESCULAP® EinsteinVision 3.0 camera control unit PV630 Legend 1 2 3

Power ON switch Power OFF switch Short press: Image rotation 180° / Long press: Open menu (function in menu: up) 4 Short press: Image documentation / Long press: Video documentation (function in menu: left) 5 Short press: Light source on / Long press: Light source on/off (function in menu: down) 6 Short press: Zoom / Long press: White balance (function in menu: right) 7 White balance 8 Connector for camera head 9 Connector for MIS-Bus connection to LED light source OP950 10 Remote connectors (3.5 mm latches) for external documentation system 11 3G SDI outlets (1080p) for 2D or 3D monitors (Channel R1, R2) 12 HD-SDI output (1080i) for external documentation system 13 Connector for service PC 14 Power cord connector 15 Device foot 16 Fuse holder 17 Equipotential bonding connection 18 Connector Service-Dongle 19 3G SDI outlets (1080p) for 2D or 3D monitors (Channel L1, L2) 20 DVI outputs (1080p) for 2D monitors, left channel 21 3D DVI outlets (1080p) for 3D monitors (operating with 2D camera head: 2D DVI outlet.

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 2.4.3 2.4.4

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About this document... 2 Scope... 2 Safety messages... 3 Clinical use... 3 Product description... 3 Operating principle... 3 Scope of Supply... 6 Components required for use... 7 Areas of use and limitations of use... 7 Intended use... 7 Indications... 7 Contraindications... 7 Safety information... 7 Clinical user... 7 Product... 7 Sterility... 8 Preparation... 9 Set-up environment/set-up location... 9 Electromagnetic tolerance... 10 Combination with medical electrical equipment... 10 Setup... 10

2.5 2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.7 2.7.1 3. 3.1 3.2 3.3 3.3.1 3.4 3.5 3.5.1 3.5.2 3.6 3.6.1 4. 4.1 4.2 4.3 4.4 5. 6. 6.1 6.2 7.

First use... Application... System set-up... Function checks... Configuration... Safe operation... Troubleshooting... Replacing fuses... Reprocessing procedure... General safety instructions... Reusable products... Cleaning/Disinfection... Product-specific safety information on the reprocessing method... Wipe disinfection... Inspection... Visual inspection... Functional test... Storage... Ambient conditions... Repair, maintenance and service... Repair... Maintenance... Technical service... Accessories / spare parts... Disposal... Technical data... Classification acc. to Regulation (EU) 2017/745... Performance data, information about standards... Symbols on product and packaging...

1.

About this document

11 11 11 12 12 13 15 15 16 16 16 16 16 16 17 17 17 17 17 17 17 17 17 18 18 18 18 18 19

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

PV630

EV3.0 camera control unit

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.

en 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 The electromagnetic compatibility (EMC) requirements are described in the brochure TA014630. The rules and information contained therein must be observed during installation and operation of this device. The instructions for use of the camera head used 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 as well as information on 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.

In addition to the general setting options, the camera offers different endoscopic application profiles. These profiles are preconfigured to offer an optimized image display; however, the profiles can also be modified and customized for your specific needs. The current image display can also have effects added, for example to distinguish tissue types better from each other or to get a clearer picture in case of smoke production. For quick access to frequently used functions, each profile can select favorites, which can also be configured individually in the same way as the profiles. Current image settings and status indicators are shown on the screen in the form of symbols and messages. The general setting options include language selection for the configuration menu and monitor displays, and the camera head button settings. The factory setting is English. Main menu on screen The main menu on the screen opens with a long press (≥2 seconds) of the menu button (3) on the camera control unit or connected camera head. The main menu is used to operate and configure the device. The settings options are reached by selecting the relevant symbols. The functions represented by the symbols are explained below. Information on the currently connected camera head. No further setting options Profiles (application profiles and configurable user profiles)

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

Favorites

2.

Clinical use

Brightness

2.1

Product description

2.1.1

Operating principle

WARNING Risk to patient if the image shown is misinterpreted! ► When using image optimization algorithms (e.g. Red Enhancement and Smoke Reduction) be aware that the image shown is not the original image. ► During use of these, never rely solely on the optimized image. CAUTION 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. Note The EV3.0 camera head can only be used for 3D visualization if the LED light source OP950 is used in addition to the EV3.0 camera control unit. For this, the camera control unit and light source must be correctly connected via a MIS-Bus cable. This product is a camera control unit that is intended for use in medical endoscopy. The camera control unit can be used with different camera heads. 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.

Digital zoom

Contrast

Edge enhancement

Image rotation 180° (only available in combination with EV3.0 camera head 30°) Switch to 2D/3D (only available in connection with the EV3.0 camera head) Access to the selectable image effects

System settings, restoring the default settings

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en Navigation in the main menu With a long press of the button (≥2 seconds), the main menu opens and is displayed on the screen. Use the relevant buttons to navigate to the desired item in the menu or submenu.

The symbols displayed when the corresponding function is activated are explained below. AUTO light intensity control deactivated

Zoom function activated

Image roation 180° activated (only available in connection with EV3.0 camera head 30°) Profiles Profiles are preinstalled camera settings, optimized for the application. The following four standard profiles are available when using 3D camera heads (PV631, PV632): ■ LAP General Surgery ■ LAP Uro ■ LAP Gyn ■ Cardio/Thoracic The following 5 standard profiles are available when using 2D camera heads (PV48x): ■ LAP General Surgery ■ LAP Uro ■ LAP Gyn ■ Neuro ■ Cardio/Thoracic Image setting The image display can be changed manually for the set profile. These changes are retained until the next time the type of camera head or profile is changed. The following setting options are available: ■ Brightness (-5 to +5 / increments of: 1) ■ Digital zoom (1 to 1.8 / increments of: 0.2) ■ Contrast (-5 to +5 / increments of: 1) ■ Edge enhancement (-5 to +5 / increments of: 1) ■ Image Rotation 180° (on/off) ■ Toggle 2D/3D (on/off) Effects Effects can be added to the set profile, which can improve the displayed image under certain conditions of use. The following effects are available: ■ Red Enhancement (RE): Red Enhancement intensifies red color tones and enables a better visual distinction of different structures in environments with little differences in color, e.g. to accentuate the colors of vessels. ■ Smoke Reduction (SR): Smoke Reduction produces a clearer picture in smoky environments and therefore a better view (e.g. during coagulation with high frequency surgical devices). ■ Picture out of Picture (PoP): Picture out of Picture is not an image effect in itself but it splits the screen into two equal image areas for the same camera image. The reduced-size original image from the camera is displayed on the left and the reduced-size image with an effect is displayed on the right. With PoP, you can compare the original image with the image with an applied effect and choose between the different effects. ■ Status indicators on screen: The currently activated image settings are displayed on the top right of the screen in the status area. Note The Red Enhancement and Smoke Reduction effects can be combined with each other. 4

2D mode activated (only available in connection with EV3.0 camera head) Picture out of Picture (PoP) activated

Red Enhancement (RE) activated

Smoke Reduction (SR) activated

Favorites Depending on the profile and connected camera head, the device offers a pre-defined selection of functions as favorites for quick access. The favorites in the standard profiles cannot be changed. If user profiles are created, the favorites can then also be individually defined. Control buttons on the front of the device The 4 control buttons on the front of the device in the shape of a cross have different functions depending on the operating mode. The assignment of button functions is always the same on the front of the device and on the camera head. Different functions can be assigned for a short press of the button (<2seconds) and a long press of the button (≥2 seconds). 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 menu cannot be changed. In standard profile, the buttons are assigned as follows. Short press of button

Long press of button

Image roation 180° (only avail- Open menu able in connection with EV3.0 camera head 30°) Zoom

White balance

Light source on

Light source on/off

Single frame image

Video recording start/stop

Note The camera control unit does not have an internal memory. Video and image recordings are only possible if an external documentation device is connected.

en Button assignment when on-screen display is active When on-screen display is active, the buttons can be used to navigate the menu, until the on-screen display function is left.

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.

Short press of button

Long press of button

Short press of button

Long press of button

Up / control +

Leave the menu

Up

-

To the right / level deeper / save controller settings

Leave the menu

Right

Confirm/enter

Down / control –

Leave the menu

Down

-

To the left / level back / save controller settings

Leave the menu

Left

-

Display of faults If the functionality of the device is restricted, faults are displayed in the top left area of the screen. If one of the faults described below occurs, the main menu closes automatically and it cannot be accessed while the fault persists. Therefore existing settings, for example an image rotation or activated effect, cannot be deactivated or undone while the fault persists. Malfunction

Detection

Cause

Remedy

Overheating

On-screen message: "Overheating! Camera may switch off automatically."

The device features an internal temper- Check ventilation slits on the bottom of ature sensor. the device. Set up the device so that sufficient ventilation is guaranteed. Check if light source is placed on top of the camera control unit. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

Interrupted connection to light source

On-screen message: "Malfunction! Connect compatible light source OP950.

After connecting a 3D camera head, the device can only operate if the light source OP950 is properly connected and switched on.

Check MIS bus connection between the camera and light source. If the message appears despite correctly connected OP950: contact B. Braun/Aesculap partner or Aesculap Technical Service.

On-screen message: "AUTO light quantity control deactivated".

While a 2D camera head is connected to the device, the light source OP950 is not properly connected or not active.

Reactivate AUTO light quantity control using the menu.

Failure of the 3D function

On-screen message: "Malfunction! One of the camera channels is out of service."

The 3D function works with two camera modules. If one camera module fails, the device switches to two-dimensional display.

Restart the device. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

Malfunction of the camera control unit

The five control buttons on the front of the device flash quickly.

In case of a malfunction of the device, the connected monitor no longer displays an image.

Restart the device. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

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en Status messages Status messages are superimposed in the right upper area of the screen if there are changes to device status. Status message on screen

Status/Status Change

Remedy

3D Camera Head 0° 3D Camera Head 30° 2D Camera Head

A compatible camera head is attached to the camera control unit and recognized.

–

Connect camera head to control unit.

No compatible camera head is connected to the control unit.

Check the plug connection between the camera head and the camera control unit. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

Connect compatible camera head to control unit.

No compatible camera head is connected to the control unit.

Check compatibility between camera head and camera control unit. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

Light source on Light source off

The light source is switched on or off.

–

Check light guide connection.

The optical fiber is not plugged at all or not cor- Check the plug connection between the optical fiber rectly to the light source OP950. connection and the light source. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

Warning! Symbols of activated image effects will not be displayed.

The display of the status symbols in the user Reactivate status symbols in the menu. menu is deactivated before restarting the camera control unit. The status symbols are only displayed for a short time during activation/deactivation of the relevant function.

White balance successful White balance failed

After activation of the white balance there is a display of whether this has been done successfully.

Tip heating faulty.

The tip heating of the camera head is out of Restart the device. order and the tip of the endoscope is not heated. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

Camera head buttons out of service due to magnetic field.

An external magnetic field disrupts the function of the buttons on the camera head. Operation using the buttons on the camera control unit is still possible.

2.1.2

Scope of Supply

Designation

Art. no.

Cables included

EV3.0 camera control unit

PV630

BNC cable (red)

BNC cable (red, with ferrite bead) length 3.0 m

TA014803

BNC cable (green, with ferrite bead) length 3.0 m

TA014804

MIS Bus cable length 0.75 m

OP942

Instructions for use

TA014615

Open source license brochure

TPO003-121-01

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BNC cable (green)

MIS-Bus cable

–

Restart the device. If the message appears repeatedly: contact B. Braun/Aesculap partner or Aesculap Technical Service.

en 2.1.3 Components required for use The EV3.0 camera control unit PV630 is intended for use with: ■ PV631/PV632 EV3.0 camera head 10 mm 0°/30° In order to guarantee full functionality, the joint use of the following components is recommended: ■ OP950 LED light source ■ PV646 3D monitor For the 2D visualization the following components can also be connected: ■ PV481 Full HD CMOS camera head with pendulum coupler ■ PV482 Full HD CMOS camera head with zoom coupler ■ PV485 Full HD 3CMOS camera head with zoom coupler CAUTION 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 Note Furthermore, if the product is used with third party devices, unrestricted responsibility is passed to the system configurator or medical institution.

2.2

Areas of use and limitations of use

2.2.1 Intended use The EV3.0 camera control unit serves the 3D and 2D visualization of the interior of the body during minimally invasive surgical procedures. The application in combination with a camera head serves 3D and 2D visualization of the intracorporal surgical area during endoscopic diagnostic and surgical procedures. The EV3.0 camera control unit is only used for visualizing and not for diagnosis. Refer additionally to the intended use of the relevant camera heads and components. 2.2.2 Indications There are no medical indications associated with the use of the EV3.0 camera control unit PV630 itself if separated from the endoscopic system. The indications for an endoscopic application depend on the condition of the patient and the individual risk/benefit analysis by the surgeon. 2.2.3 Contraindications 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 contraindications 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.

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 user and patients if the instructions, warnings and precautions are not followed! ► 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 of injury due to electric shock! ► Ensure that the rear of the device and access to the mains plug is freely accessible at all times. ► When installing a medical electrical system, there is a risk of fire, shortcircuit 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 which adhere to the applicable IEC safety standards may only be connected via a medical isolation 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 patient if the device power fails! ► Use the device only with an uninterruptible power supply. To guarantee a continuous power supply a medical emergency supply (UPS) is recommended.

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en Risk to patient due to incorrect application! ► Use the medical device 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. Risk to patient and user due to premature wear! ► Handle and maintain the medical device properly. ► Use the medical device only in accordance with the intended purpose.

Possible restricted function if third party devices are used! ► Use the product with the recommended components and accessories. ► The full functionality of the product can only be guaranteed if the recommended accessory components are used. 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.

Note Ensure that all devices operated in the vicinity meet their relevant EMV requirements. Note 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. Note 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 Only operate the camera control unit when it is closed. Only operate the device in a horizontal position. Note Before putting into operation, check the compatibility of all components and accessories using the accessories list. Note All accessories and spare parts must only be procured from the manufacturer.

Risk of damage to eyes from UV radiation! ► Do not use polarized 3D glasses as sun glasses.

Note Spare parts and fuses must only be replaced by authorized personnel.

Device failure due to incorrect storage and usage conditions! ► Store and operate the product only within the specified environmental

conditions. Risk to patient if the live image fails! Shock from defibrillation can lead to failure of the live-image. It can take up to 3 seconds for recovery of the live-image. Restart of the camera control unit can possibly be necessary by switching off and on. ► Check live-image after defibrillation. Improper operation caused by decreased electromagnetic immunity or increased electromagnetic emissions! ► Use product only with original or by the manufacturer specified transducers, cables and accessories. Note 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). Note The medical electrical device may not be modified in any way. Note To guarantee optimal function of the EinsteinVision components, use in controlled environmental conditions is recommended (air-conditioned operating room). Note Always handle the medical device very carefully as it contains sensitive optic, mechanic and electronic components. Note Do not store the polarized 3D glasses in an environment with high temperatures, e.g., near a radiator.

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Note The connection of electrical devices to a multiple socket creates a system and can lead to a reduced level of safety. Note To disconnect the device completely from power, pull out the power cord on the rear of the device. Note Only operate the device with the original cables (included in scope of delivery) or with specified cables/components. ► See "Information on electromagnetic compatibility (EMC) for EV3.0

camera control unit PV630" TA014630, see B. Braun eIFU at eifu.bbraun.com ► Only combine Aesculap products with each other. ► Always adhere to applicable standards. Ambient conditions The following environmental conditions apply to the use of the product: Temperature

10 °C to 37 °C

Relative humidity

0 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

2.3.3 Sterility The product is supplied non-sterile and must be used under non-sterile conditions. ► Inspect the new product after removing its transport packaging and prior to first use to ensure it is in good working order.

en 2.4

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. WARNING Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Adhere to the instructions for use of any medical device. ► When setting up and operating the product, adhere to:

– national regulations for installation and operation, – national regulations on fire and explosion protection. 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 lead 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 lead can be ordered from the manufacturer as art. no. GK535 (4 m long) or TA008205 (0.8 m long). 2.4.1

Set-up environment/set-up location

DANGER Fire and explosion hazard! ► Use the product outside of explosion hazard zones (e.g. areas with highly pure oxygen or anesthetic gases). The device is authorized for operation in hospitals. Note After being installed and put into operation, the device must not be transported or moved to a different set-up location. ► Make certain that the ventilation slots in the bottom of the housing

and in the rear panel of the device are not covered, e.g. by an OR cloth. ► Make certain that the control elements, mains power switch and power sockets are freely accessible for the user. ► Make sure that the outlet is accessible to the user. ► Make certain the system is set up on a sufficiently stable support (e.g. a table, ceiling support, equipment cart, etc.). ► Follow the instructions for use of the support. WARNING Risk to patient due to improperly conducted earth current due to lack of or defective earth! ► Do not touch the device and patient at the same time. WARNING Risk to patient due to failure of device! ► Keep an operationally ready replacement device on hand. 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 fire or electric shock if moisture penetrates the device! ► Ensure that the device is set up protected from water drips and splashes. ► Do not immerse the housing in any fluid. ► Do not expose the device to rain or any moisture. ► Do not place objects on the product that contain any liquids. WARNING 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. ► Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 100 cm to any part of the EV3.0 visualization system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. CAUTION Risk to patient through poor/lack of view! ► Adjust the monitors and display elements so that they are highly visible to the user. CAUTION Risk of electric shock from incorrect installation of the device! ► First installation without power connection. 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 and user through condensation and short circuit! ► Before putting into operation make sure that all components used have enough time to adjust to the changed environmental conditions. CAUTION Malfunction of the device! ► For sufficient ventilation, set up the EV3.0 camera control unit so that the ventilation slots are always clear. ► Set up and operate the EV3.0 camera control unit horizontally. Note The equipotential plugs for all devices used must be connected with the equipotential tape IEC/EN/DIN 60601-1 or consistent with national standards). Note Unauthorized access to data or loss of data: Only use the EV3.0 camera control unit on secure networks. Note Ensure that the corresponding Interconnection Conditions are kept. Also, the relevant standards and the respective national deviations must be followed.

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en Personnel responsible for setting up or installing medical electrical equipment must possess the necessary qualifications and be familiar with the safety regulations in place at the installation location and the applicable official regulations.

► When using the SDI variant: Place the ferrite beads on the SDI-cable

close to the monitor.

2.4.2 Electromagnetic tolerance Medical electrical equipment is subject to stringent electromagnetic compatibility (EMC) requirements. Despite the device’s high interference immunity and low emitted interference, compliance with EMC-related requirements is necessary with regard to installation, installation location, and ambient conditions. It is therefore important that you observe and follow the related safety messages in this document and the EMC brochure TA014630. 2.4.3 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 different manufacturers and when operating an endoscope and/or endoscopic accessories together with medical electrical equipment, it must be ensured that the applied part is properly isolated: Type CF, defibrillation-proof.

D A

C E

Fig. 1 Legend A DVI cable at 3D DVI output B SDI cable red at 3G SDI output (right channel) C SDI cable green at 3G SDI output (left channel) D Power cord E Equipotential bonding for connection of the camera control unit to the equipotential bonding strip

2.4.4 Setup ► Set up the device. ► When setting up the device, ensure that: – It is positioned on an even, non-slip surface that is able to support its weight – It is installed outside of the patient environment and the sterile area on a sufficiently stable support – It is protected from water drips and splashes – It will not be subject to vibration during operation – The ventilation slots are not obstructed ► Connect the equipotential bonding connection on the rear of the device to the POAG connection at the installation site. Stacking of units ► Do not exceed the maximum stack height of 450 mm. ► Place the units in a stable position. ► Aesculap devices must be stacked on top of each other facing identi-

cally. ► Never stack in an offset arrangement.

Connecting 3D monitors Follow the instructions for use of the monitors used. ► Connect a 3D-DVI-connector to a 3D monitor or connect two 3G SDI connectors (R1/L1, R2/L2) to a 3D monitor. Note Either the DVI or the SDI cables are to be used for operation. The SDI cable comes standard. Both variants are represented in the following figures.

B

C

A

B

G

F

Fig. 2 Legend A DVI cable at DVI input (3D DVI) B SDI cable red at 3G SDI input (right channel) C SDI cable green at 3G SDI input (left channel) F Equipotential bonding for connection of the monitor to the equipotential bonding strip G Ferrite beads Connecting 2D monitors Follow the instructions for use of the monitors used. ► Connect a 2D- or 3D-DVI connection with a 2D monitor or a 3G SDI connection (R1/R2/L1/L2) with a 2D monitor. Connecting a documentation system In combination with an external documentation system (e.g., EDDY3D/EDDY), images and videos can be taken with the EV3.0 camera control unit. Follow the instructions for use of the documentation system. ► Connect a remote connection (Remote 1 or Remote 2) of the camera control unit with the corresponding connection on the documentation system.

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en Connecting the light source OP950 The connected light source can be controlled using the buttons on the camera head. ► Connect MIS bus connection of the camera control unit and the light source. ► Ensure that the connectors engage in place when inserting them.

2.5

First use

WARNING Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Adhere to the instructions for use of any medical device. Requirement: Installation must have been completed. ► Connect the camera head. ► Switch on the device and all devices being used. ► If there is a focusing ring, focus the image. ► Set the white balance. ► Check that a good image is displayed on the monitor at working dis-

tance without vertical lines, color variations, or flickering. When using a 3D camera head, perform a function test with 3D polarization glasses. ► Ensure that the buttons on the camera head and camera control unit can be operated properly. ► If applicable, ensure that the light source can be switched on and off via the buttons on the camera head and camera control unit. Voltage The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit.

2.6

Application

2.6.1

System set-up

WARNING Risk of infection due to unsterile parts! ► Unsterile components must not enter the sterile area. ► Process products and accessories that are delivered unsterile before use and only use them with sterile accessories. CAUTION Risk to patient through addition of earth currents! ► If the product is used with medical electrical equipment and/or power-driven endoscope accessories, the leakage currents can multiply. WARNING Risk to patient and user through 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. Note Before application of endoscopic high frequency 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).

WARNING Risk of injury due to improper use! ► Observe the intended use of the camera control unit. 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). Note In combination with the EV3.0 camera control unit, the endoscope is classed as a type CF defibrillation-proof applied part. 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. Typ CF defibrillationproof) 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. All devices connected to the interfaces must also be proven to fulfill the relevant IEC standards. IEC 60950 for data processing devices and IEC/EN/DIN 60601-1 for medical electrical devices). All configurations must fulfill the fundamental standard IEC/EN/DIN 60601-1. The person connecting the devices with each other is responsible for the configuration and must ensure that the fundamental standard IEC/EN/DIN 60601-1 or relevant national standards. ► Please contact your B. Braun/Aesculap partner or the Aesculap Technical Service, see Technical service. Connecting the power supply DANGER Risk of death by electric shock! ► Connect the product only to a grounded power supply. ► Ensure that the mains voltage at the site of operation corresponds to

that specified on the device nameplate. ► Connect the power cord to the mains connection socket on the rear of the device. ► Connect the power cord to the power supply. ► Lay the cable so that no-one can trip over it or get caught in it. Visual inspection Carry out a visual inspection prior to every procedure. ► Ensure that the device has been properly set up. Ensure that the equipotential bonding has been properly connected. ► Ensure that the housing is free from external damage. ► Ensure that the power cord and all other cables are not damaged. ► Ensure that the contacts in the connection sockets for the camera head are free from moisture and contamination.

11

en 2.6.2

Function checks

WARNING Risk of electric shock from defective cables or devices! ► Inspect the electrical equipment regularly. ► Replace loose, worn or defective cables/connections. 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 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). WARNING Risk to patient through improperly represented image! ► Prior to application and after every change of settings (e.g. image rotation or activation of algorithms) check the correct display of the live image. If necessary, perform white balance. 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 Do not continue to use damaged products. Carry out a function check prior to every procedure. For 3D visualization, a direct alignment of the 3D monitor with the surgeon is required for a good display of the three-dimensional image. ► Connect the camera head to the camera control unit. ► Switch on the device and all devices being used. ► If there is a focusing ring, focus the image. ► Point the camera head to an object within the normal working distance. ► Set the white balance. ► Align the monitor to the surgeon. ► Put on the polarized 3D glasses and ensure that they fit well. If necessary, use a suitable glasses strap or have them fitted by an optician. ► Ensure that a good 3D live image is displayed on the monitor without vertical lines, color variations, or flickering. ► Ensure that the buttons on the camera head and camera control unit can be operated properly. ► If applicable, ensure that the light source can be switched on and off via the buttons on the camera head and camera control unit. 12

2.6.3

Configuration

System settings The following settings can be applied under the menu item System Settings: ■ Language: To select the language for the camera menu (default setting: English) ■ 50 Hz/60 Hz: To select the image refresh rate ■ Network setup: To create a network connection for the technical service ■ Display status bar: To select whether symbols with information on the currently active image settings should be displayed in the status area of the screen. ■ Acoustic signal Remote output (deactivated as standard): To select whether an acoustic signal should sound when an image is taken or when starting and ending a video recording. ■ Restore default settings: To restore all device settings to the default settings The following system information can also be displayed under this menu item: ■ Software version of the camera control unit, connected camera head and connected light source ■ Serial number of the camera control unit, connected camera head and connected light source The submenu Network Setup can also be used to display an overview of the current network settings. ► Open menu and navigate to menu item System Setup ► Navigate to the required item and apply the settings. User profiles In the Profile submenu up to three individual user profiles may be created for each type of camera head. To create a user profile, an initial profile first needs to be selected, of which the image settings can then be changed and saved in the user profile. In addition to the image settings, the following can also be set in the user profile: ■ Activation/Deactivation of the AUTO light intensity control ■ Button function assignment on the camera control unit and camera head ■ Individual favorites menu The user profile creation process ends with the assignment of a profile name for the created user profile using the on-screen keyboard. The profile name must not be more than 16 characters and it must be different from the standard profile names. A created user profile can be changed or deleted when the relevant camera head type is connected. ► Open menu and navigate to menu item Profile. ► Navigate to Create user profile and select an initial profile. ► Apply the individual settings. ► Navigate to Save and exit and use the on-screen keyboard to enter a name for the user profile. ► With a long press of the white button (≥2 seconds), the user profile is saved under the entered name. ► To change, go to Change user profile and navigate to the entry that needs changing. ► To delete, go to Delete user profile and navigate to the user profile that needs deleting.

en Favorites For the standard profiles, the favorites are pre-defined and cannot be changed. For the individually configurable user profiles, the favorites can be selected individually and changed if necessary. Up to 10 favorites can be defined if necessary. ► Open menu and navigate to menu item Profile. ► Navigate to Create user profile and then to Configure favorites menu. ► To change the settings, go to Change user profile and then Configure favorites menu. Button function assignment for control buttons For the standard profiles, the button functions are pre-defined and cannot be changed. For the individually configurable user profiles, the button functions can be selected individually and changed if necessary. If the button functions are changed, the control buttons on the front of the device and on the camera head automatically have the same functions. ► Open menu and navigate to menu item Profile. ► Navigate to Create user profile and then to Button function assignment. ► Select a function for a long press and short press for each button. ► To change the settings, go to Change user profile and then Button function assignment. 2.6.4

Safe operation

Excessive temperatures in combination with light sources WARNING Risk of injury due to excessive temperature! ► Do not touch the light guide connector, distal end of the endoscope or the tip of the sterile cover during use or immediately after use. Light sources, especially high-power light sources, emit large amounts of light energy and thermal energy. The light guide connector, distal end of the endoscope and the tip of the sterile cover can become extremely hot. 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. ► Always 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 AUTO 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 guide connector to come into contact with patient tissue or with combustible or heat-sensitive materials. ► Do not touch the distal end of the endoscope. ► Remove contamination from the distal end surface or light emission surface. WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

WARNING Risk to patient through fogging of the optics and limited view! ► To prevent 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 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 Electric shock due to misdirected leakage currents! ► Before thoracic or cardiothoracic surgery, deactivate implanted defibrillators (ICD). ► Before any kind of defibrillation, remove the used camera head from the patient. WARNING Malfunction in connection with magnetic resonance! ► Do not use the product in a magnetic resonance environment. WARNING Risk to patient through gas embolism! ► Avoid overinsufflation before high frequency surgery (e.g., with air or inert gas). CAUTION Risk of injury due to development of heat at the tip of the endoscope and sterile cover! ► Make sure that the tip temperatures on the type of the endoscope and the sterile cover prescribed by IEC/EN/DIN 60601-2-18 are not exceeded. ► 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 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. ► 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 guide connector, distal end of the endoscope or the tip of the sterile cover during use or immediately after use. Note If the 3D display fails, the operation can be continued with 2D display. Note The current assignment of the camera head buttons is displayed on the screen as camera head information after opening the camera menu. 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. Electrosurgical procedures may only be conducted by trained specialist staff.

13

en Active profile after switching on. If no camera head is connected when the camera control unit is switched on, the standard profile "LAP General Surgery" is activated on startup. If a 2D or 3D camera head is connected before the unit is switched on, the last profile used for the relevant camera head is activated on startup. Active profile after changing the camera head. If the camera head is removed from the active camera control unit, the existing profile remains active if a camera head of the same type (2D or 3D) is connected, even if there is a switch between a 3D-0° and a 3D-30° camera head. If another camera head type is attached, the standard profile "LAP General Surgery" is activated. User profiles dependent on camera head Three user profiles may be individually configured for both types of camera head (2D and 3D). The relevant user profiles can only be displayed, activated or changed if the corresponding camera head type is connected. Switching On and Off Switching on ► Press the ON switch. Switching off ► Press the OFF switch.

Disconnecting the device completely from the mains power ► Pull out the power cord on the rear of the device. Connecting the camera head Note The camera cable is fragile when bent, kinked, twisted, pulled, or pressed. These may damage the optical components (e.g. light guide fibers) and thus lead to inoperability. For further details on the camera head, see the respective instructions for use. ► Insert the connection plug fully into the connection sockets on the camera control unit, until it engages. Profile Selection ► Open menu and navigate to menu item Profile. ► Select the required profile.

Performing white balance ► Perform a white balance prior to every procedure.

Note Note that ambient light that deviates significantly from the color temperature of the light source can affect the results of the white balance. Note When using a sterile cover, perform the white balance after mounting the sterile cover, otherwise the result of the white balance will be falsified. ► Connect the camera head being used for the procedure. ► Connect the light guide to the light source. ► When using a 3D camera head: use a sterile cover on the camera head. ► Switch on all system components. ► Point the endoscope to a white object at a distance of approx. 5 cm. ► Press the White Balance button on the front of the camera control

unit or the relevant button on the camera head. If the white balance is successful, the message "white balance successful" appears on the 3D monitor. If the white balance is unsuccessful, the message "white balance unsuccessful" appears.

14

If the white balance is unsuccessful: ► Prevent overexposure. – Enlarge the distance to the white object. – Adjust the brightness of the light source. ► Repeat the white balance. Image display The image display can be changed manually for individually created profiles. These changes are retained until the next time the type of camera head or profile is changed. The following changes are possible: ■ Brightness ■ Digital zoom ■ Contrast ■ Edge enhancement ■ Image roation 180° (only available in connection with EV3.0 camera head 30°) ■ Switch to 2D/3D (only available in connection with the EV3.0 camera head) ► Open menu and navigate to the required menu item. ► Using the arrow buttons, apply the setting to the controller or switch a function on or off. Effects Effects can be added to the set profile. ► Open menu and navigate to menu item Effects. ► Select and activate the effect. ► Deactivate the effect in the same way.

en 2.7

Troubleshooting

Problem

Cause

Remedy

No image on the monitor

No power supply

Set up the equipment properly, see Preparation.

Defective fuse on the camera control unit

Change the fuse according to the instructions in "Changing a fuse".

Controller incorrectly connected to monitor

Connect the camera control unit properly, see Preparation.

Connection cable not connected or defective

Connect the camera head to the camera control unit. Check the plug for moisture. If the cable is defective, send it for repair.

Monitor not tuned in to the correct input signal

Tune in the monitor to the correct input signal.

Poor color rendering

Monitor not configured correctly

Check monitor settings.

Colored stripes through the image

Video cable defective

Replace the video cable or send the product for repair.

Unnatural color rendering

White balance not set correctly

Set the white balance, see Preparation.

Image is distorted

Settings not completed correctly

Set the device properly, see Preparation.

Monitor not set correctly

Readjust monitor settings according to Instructions For Use of monitor.

No operation

No power supply

Check the mains connection and connect the power if necessary. Check the fuse and replace if necessary.

Not enough light

Light guide cable not connected correctly

Check that the light guide cable is connected properly; correct if necessary.

Light guide defective

Replace the light guide.

2.7.1

Replacing fuses

DANGER Danger to life through electric shock! ► Unplug the device before changing the fuses. Specified fuses: T2,00AH/250 V~ ► Use a small screwdriver to release the clip on the fuse holder. ► Pull out the fuse holder. ► Replace both fuse sets. ► Reinstall the fuse holder so that it audibly clicks into place.

Note If the fuses burn out frequently, the device is faulty and should be repaired, see Technical service. Note Follow the country-specific regulations of the fuse. Repairs For repairs (except changing the fuse), 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: ■ Article number (REF) ■ Serial number (SN) ■ Detailed description of defects Note If a component in 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 any replacement of a device.

15

en 3.

Reprocessing procedure

3.1

General safety instructions

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.

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

Risk of defects, consequential damage or a shortened product service life! ► Follow and observe the manufacturer's requirements for reprocessing

Note Successful reprocessing of this medical device can only be ensured through a validated reprocessing procedure. The operator/reprocessing technician is responsible for this.

Risk of electric shock and damage to the device from moisture! ► Carry out the wipe disinfection with damp cloths only. Never use dripping wet cloths. ► Remove excess cleaning solution from the device immediately. ► Only reconnect the camera control unit to power when all cleaned parts are completely dry.

Note For up-to-date information about reprocessing and material compatibility, see also B. Braun eIFU at eifu.bbraun.com

3.2

Note The housing of the EV3.0 camera control unit and the polarized 3D glasses are only suitable for wiping with a moist cloth (wipe disinfection). Do not immerse into liquid.

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. 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.

3.3

Note Do not sterilize the camera control unit or reprocess it in a cleaning/disinfecting machine.

Cleaning/Disinfection

3.3.1

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. ► Ensure that no fluids will penetrate the product. Damage to the product due to improper reprocessing! ► Use only wipe disinfection for cleaning and disinfecting the camera control unit. ► 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. ► Do not sterilize the product under any circumstances.

3.4

Wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT

1

-

-

Alcohol(s), quaternary compound(s) *

II

Wipe disinfection

RT

≥1

-

-

Alcohol(s), quaternary 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, disposable

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

16

en 3.5

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.5.1

Repair, maintenance and service

4.1

Repair

Send damaged products to the manufacturer or authorized repair center. Authorized repair centers can be inquired about from the manufacturer.

Visual inspection

► Make certain that all soiling has been removed. In particular, pay

attention to mating surfaces, hinges, shafts, recessed areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical service. 3.5.2 Functional test ► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check the product for any atypical running noise, overheating or excessive vibration. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.6

4.

Storage

CAUTION Damage to product due to improper storage! ► Store the product protected from dust in a dry, well ventilated, and temperature-controlled room. ► Store the product protected from direct sunlight, high temperatures, high air humidity or radiation. ► Do not expose the device to direct UV light, radioactivity or strong electromagnetic radiation. ► Store the product separately or use containers in which it can be fixed in place. ► Always transport the product with care, even if it is in an equipment trolley. 3.6.1 Ambient conditions The following environmental conditions apply to the transport and storage of the product: Temperature

-20 °C to 70 °C

Relative humidity

0 % to 90 %

Atmospheric pressure

500 hPa to 1 060 hPa

WARNING Risk of infection due to soiled or contaminated products! ► Clean, disinfect and sterilize the product and any accessories thoroughly before sending. Otherwise prepare the product in as far as is possible, and label it correspondingly. ► Prior to sending, remove the sterile cover from the camera head. ► Select suitable and safe packaging (ideally the original packaging). ► Package the product in such a way that the packaging does not become contaminated. Note The specialized repair company may refuse to repair soiled or contaminated products for safety reasons. The manufacturer reserves the right to return contaminated products to the sender.

4.2

Maintenance

This medical product contains no components or parts that must be replaced in the form of service at regular intervals specified by the manufacturer. A repeat inspection of the medical product must be performed every 12 months. This must also be carried out after any repair and after it was dropped, damaged or misused. The repeat inspection may only be carried out by persons authorized to do so by the manufacturer, using the service manual. ► Comply with applicable national and international standards. For services to that end, please contact your national B. Braun/Aesculap agency, see Technical service.

4.3

Technical service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not modify the product. ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. CAUTION Malfunction of the product due to damage in transport! ► Select suitable and safe packaging (ideally the original packaging). ► Keep the original packaging for possible returns in case of service. ► Package the product in such a way that the packaging does not become contaminated.

17

en Warranty The manufacturer gives a 12 month warranty for the function of the product. This warranty is restricted to claims which are immediately made in writing within the specified warranty period starting from the date of invoice, if applicable with reference to repairs, and indicating the invoice number. Statutory warranty claims are not restricted by this warranty. This warranty is only applicable to defects that cannot be attributed to normal wear and tear, misuse, incorrect handling, third party interference, lack of or incorrect reprocessing or Force Majeure. Warranty claims shall not be accepted if the user himself or a non-authorized repair center carries out repairs or makes changes to the product. In the event a product has to undergo maintenance, the same applies for maintenance work which is not explicitly authorized. Liability claims arising from improper use or combinations with other devices or accessories cannot be made. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

4.4

Accessories / spare parts

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Cleaning/Disinfection. The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical service.

6.

Technical data Classification acc. to Regulation (EU) 2017/745

Art. no.

Designation

6.1

PV647

Stand for 3D monitor

Art. no.

Designation

Class

PV646

3D monitor

PV630

EV3.0 camera control unit

I

PV648

32" Full HD 3D Monitor

PV644

31" 4K UHD 3D Monitor

PV845

Transmitter for wireless video transmission

Mains voltage ranges (Current intake)

100 - 240 V~ (1,0 A - 0,5 A)

PV846

Receiver for wireless video transmission

Power consumption

120 W

PV621

Polarized 3D glasses (15 units)

I

PV622

3D anti-mist polarization glasses

Protection class (pursuant to IEC/EN/DIN 60601-1)

PV623

Polarized 3D glasses clip

Protection rating

IP21

PV624

3D eye protection polarization glasses

Device protection

T2,00AH/250 V~

A075305

Fuse T2,00AH/250 V~

Applied part

Type CF, defibrillation-proof

OP942

MIS-Bus cable, 0.75 m

Frequency

50/60 Hz

PV437

DVI cable, 3.0 m

Video signal

TA014803

BNC cable, red, 3.0 m

TA014804

BNC cable, green, 3.0 m

2 x 3D via 3G SDI (1080p) 2 x 3D via DVI-D (1080p) 2 x 2D via DVI-D (1080p) 1 x 2D via HD-SDI (1080i)

GK535

Equipotentialization cable, 4.0 m

Weight

10,2 kg

TA008205

Equipotentialization cable, 0.8 m

Dimensions (W x H x D)

330 mm x 146 mm x 353 mm

TE780

Power cord for Europe, black 1.5 m

Operating mode

Suitable for continuous operation

TE730

Power cord for Europe, black 5.0 m

Conforming to standard

IEC/EN/DIN 60601-1

TE734

Power cord for United Kingdom, Ireland, black 5.0 m

EMC

IEC/EN/DIN 60601-1-2

TE735

Power cord for USA, Canada, Japan, gray 3.5 m

CISPR 11

Class A

FS095

Power cord for Switzerland, orange

TE676

IEC extension cord for low-heat devices 1.0 m

TE736

IEC extension cord for low-heat devices 2.5 m

18

6.2

Performance data, information about standards

en 7. Symbol

Symbols on product and packaging Explanation Signal word: WARNING Indicates a hazard. If not avoided, the hazard can result in death or serious injury. Signal word: CAUTION Indicates a potential hazard. If not avoided, this hazard may result in injury and/or damage to the product. Caution (IEC/EN/DIN 60601-1 3rd Edition)/Attention, note the accompanying documents (IEC/EN/DIN 60601-1 2nd Edition) Follow the instructions for use

Defibrillation protected application part type CF pursuant to IEC/EN/DIN 60601-1 Equipotential bonding

Permissible storage temperature

Permissible relative air humidity during storage

Permissible atmospheric pressure during storage

Article number Serial number Manufacturer

Date of manufacture

Fuse Separate collection for WEEE (waste of electrical and electronic equipment) Hot temperature

Not permitted for use in a magnetic resonance environment

Alternating current US federal law requires that the product may only be supplied to a physician or a person acting on the physician's behalf Medical device Non sterile

19