LED light source OP940

OP940

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OP941

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AESCULAP® LED light source OP940 Legend

Power OFF switch

LED light source OP940 1 Mains Switch OFF 2 Mains Switch ON 3 Mains Display On 4 Brightness control with push function 5 Optical fiber cable test unit (for use with sterile adapter OP941) 6 Lock activator for optical cable socket 7 Optical fiber cable retainer 8 Communication interfaces 9 Mains cable connection 10 Fuse holder 11 Device foot 12 Equipotential connector 13 Service interfaces Sterile adapter OP941(optional) 14 Aesculap/Olympus OES/Storz Adapter 15 Wolf Adapter 16 Sterile adapter (Olympus OES Pro/ACMI connection)

Labeling of electrical and electronic devices according to directive 2002/96/EC (WEEE), see Disposal

Manufacturer

Date of manufacture

Federal Law (US) restricts this device to sale to or on behalf of a physician. Not permitted for use in a magnetic resonance environment Temperature limits during transport and storage

Symbols on product and packages General warning sign

Meaning dependent on the standard that applies in each case: 2nd edition IEC 60601-1: Please take note of the accompanying document! 3rd edition IEC 60601-1: Caution Follow the instructions for use

Type CF applied part

Optical cable connection

Equipotentialization connector

Unlock

Hazardous electrical voltage

Fuse Alternating current Power ON switch

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Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

en Contents 1. 2. 3. 3.1 3.2 3.3 3.3.1 3.3.2 3.4 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 4. 4.1 4.2 5. 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.2 5.3 5.4 5.4.1 5.4.2 5.4.3 5.5 6. 6.1 6.2 6.2.1 6.3 6.4 6.5 7. 8. 8.1 9. 10. 10.1 10.2 10.3 10.4 11. 12. 13.

Applicable to... Safe handling... Product description... Scope of supply... Components required for operating the LED light source OP940 Intended use... Indication... Contraindication... Operating principle... Brightness control... Standby mode... Multi optical cable socket... Light source test unit with sterile adapter... Modes shown on the display... Preparation and setup... First use... Presetting the correct voltage... Working with the LED light source... System set-up... Connecting devices for communication... Connecting the accessories... Connecting the optical cable... Separating the LED light source from the optical cable... Connecting the sterile adapter... Removing the sterile adapter from the LED light source... Connecting the power supply... Function checks... Light lead test unit (optional)... Safe operation... Turning the device on and off... Brightness control... Standby mode... Ending the operation of the device... Validated reprocessing procedure... General safety instructions... Cleaning/disinfection... Product-specific safety guidelines on the reprocessing procedure... Wipe disinfection for electrical devices without sterilization . Inspection, maintenance and checks... Sterilization... Maintenance... Troubleshooting list... Fuse replacement... Technical Service... Accessories/Spare parts... Accessories for sterile adapter... Accessories for power cord... Spare part for fuse... Communications accessories... Technical Data... Ambient conditions... Disposal...

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Applicable to

► For item-specific instructions for use and information on material

compatibility, see also https://extranet.bbraun.com

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the

Aesculap

Extranet

at

Safe handling

DANGER Risk of death by electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply. WARNING Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/ Aesculap agency. WARNING Erroneous method of operation through reduced electromagnetic stability or increased electromagnetic emitted interference! ► Use the product only with the recommended components and accessories. 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 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 light source 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. ► Prior to use, check that the product is in good working order. ► “Follow the instructions on the electromagnetic compatibility (EMC)

for OP940 LED light source” TA022462, see Aesculap Extranet at https://extranet.bbraun.com. ► 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. – Only combine Aesculap products with each other (except for optical fiber cable). ► Only allow products and accessories to be operated and used by individuals who have been trained in the use of endoscopic procedures. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► In the sterile field only use sterile processed sterile adapter OP941. ► Ensure that the electrical facilities in the room in which the device is being used conform to IEC norms.

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en ► Unplug the device by pulling on the plug, and never on the power cord. ► Do not use LED light sources in areas where there is a risk of explosion. ► Make certain that the ambient temperature does not exceed 40 °C. ► Make certain that the device’s ventilation ducts are not covered. ► Make certain that the following minimum distances from other devices

are maintained: – on the sides 50 mm – from the rear 60 mm ► Operate the product with original manufacturer's parts only: video cable, transformer, accessories and power cable. ► The LED light source is intended for daily to weekly use.

3.

Product description

3.1

Scope of supply

Designation

Art. no.

LED light source

OP940

Instructions for use

TA013718

3.2

Components required for operating the LED light source OP940

Designation

Art. no.

LED light source

OP940

Optical cable with a diameter of 4.8 mm of type Aesculap/Storz, Olympus or Wolf

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Power cord

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3.3

Intended use

The LED light source OP940 is used to illuminate the operative field and areas of the body during medical applications. 3.3.1 Indication The LED light source OP940 is used to illuminate the operative field during diagnostic and operative endoscopic procedures. 3.3.2 Contraindication Due to the universal suitability of the device for endoscopy, no specific contraindication can be stated. The use of the device is considered to be contraindicated if the endoscopic procedure is contraindicated or if its use could pose a risk to the patient.

3.4

Operating principle

The LED lamp is very similar to a point light source. The light is propagated through the optical cable and directed to the field of view (operative field). 3.4.1 Brightness control The desired brightness can be continuously adjusted with the brightness control 4.

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3.4.2 Standby mode On pressing the brightness control with push function 4, the active light source is put into Standby mode. On pressing the brightness control with push function 4 again, the light source goes back to the previously set value. 3.4.3 Multi optical cable socket The multi optical cable socket 7 enables different optical tables of type Aesculap/Storz, Olympus and Wolf with an active diameter of 4.8 mm to be plugged in. 3.4.4 Light source test unit with sterile adapter The light lead test unit can be used in the sterile field with a sterile adapter OP941 (optional). The optical cable test unit is used for testing the light transmission of the optical fiber cable connected in each case. 3.4.5

Modes shown on the display

Display

Explanation

Fiber Connection

Optical cable is not plugged in or not plugged in properly

Standby

LED of device is off. Circular green light on the brightness control is off.

Brightness (0 %-100 %)

Percentage of the light output (in increments of 5 %)

4.

Preparation and setup

DANGER Danger of explosion from a device that is improperly set up! ► Do not use the device in explosion-hazard areas. ► Make certain that the power plug is connected to the power supply outside of any areas where there is a risk of explosion. ► Have ready replacement products/light source. 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 HF communication devices (radio devices), including their accessories such as antenna cables and external antennas should not be used at a distance of less than 30 cm from all parts of the visualization system, including the cables specified by the manufacturer. Non-observance may lead to a reduction of the device performance features. WARNING Interference of other devices by the light source OP940! ► When operating the OP940 light source immediately next to other devices or with other devices stacked up, watch OP940 light source and the other devices to make sure they are working properly.

en Non-compliance with the following instructions will preclude all responsibility and liability in this respect 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. Note For the safety of patients and users it is essential that the mains power cord and, especially, the protective earth connection are intact. In many cases defective or missing protective earth connections are not registered immediately. Note The connection of electrical devices to a multiple socket creates a system and can lead to a reduced level of safety. Note If the equipment cart is set up outside of the sterile area, measure the cable length to give enough room for movement so that the sterility is not compromised.

CAUTION Risk of injury if the light source fails! ► Have a ready-to-operate spare light source ready or use a light source that has a spare bulb. ► Set up the device on an even surface in a non-sterile area. ► Make certain that the device support (e.g., table, hanging ceiling light)

is sufficiently stable. ► Make certain that the device is safeguarded against vibration during

operation. ► Make certain that the rear of the device is accessible at all times.

5.1.1 Connecting devices for communication The communication interfaces 8 connect the light source to a superordinate device. Through these, the light source receives control signals from the connected device. The connection of a superordinate device to the communication interfaces leads to the construction of a system.

Note The potential equalization lead can be ordered from the manufacturer as art. no. GK535 (4 m length) or TA008205 (0.8 m length).

WARNING Risk of injury due to unapproved configuration using additional components! ► Make sure that accessory equipment and/or peripheral devices that are connected to the device interfaces verifiably satisfy the IEC 60601-1. ► Make sure that all configurations comply with the system standard IEC 60601-1 chapter 16. ► Do not bend the communications interface cable, to prevent the cable from breaking and the connection from failing.

4.1

5.1.2

► Connect the device via the potential equalization terminal at the rear

panel of the device to the potential equalization system of the room used for medical purposes (see IEC 60601-1/EN 60601-1 or the relevant national standards). ► Ensure that all devices operated in the vicinity meet their relevant EMC requirements.

First use

Connecting the accessories

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. ► Do not use the product in a magnetic resonance environment.

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 CF) of the respective device.

4.2

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. Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC/DIN EN 60601-1 for electromedical devices). All configurations must comply with 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. ► Please contact your B. Braun/Aesculap Partner or Aesculap Technical Service (address: see Technical Service).

Presetting the correct voltage

The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit.

5.

Working with the LED light source

5.1

System set-up

WARNING Risk of burns from excessively high operating temperatures! The optical cable socket and optical cable connections get hot. ► Do not situate optical cables near any flammable objects (e.g. drape). ► Select the lowest lighting level necessary to provide satisfactory illumination of the target area. WARNING Danger of blinding from light rays! ► Never look into the open end of an optical cable or endoscope that is connected.

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en 5.1.3

Connecting the optical cable

WARNING Risk of injury if the optical cable slips out of place! ► Ensure the optical cable is sufficiently fixed in the direct operating field. ► Secure the strain relief cord grip on the optical cable. ► Plug the optical cable into the optical cable socket 7 until it audibly

snaps into place. ► Do not crush or crimp the optical cable or wind it too tightly (minimum

diameter 150 mm). 5.1.4

Separating the LED light source from the optical cable

► To unlock the optical cable, turn the activator 6 in the marked direc-

tion. 5.1.5

Connecting the sterile adapter

optical cable test unit 5. ► If necessary, screw on the adapter for connecting the optical cable.

5.1.6 Removing the sterile adapter from the LED light source ► After the optical cable test, unscrew sterile adapter OP941 from the optical cable test unit 5. Connecting the power supply

DANGER Risk of death by electric shock! ► Connect the product only to a grounded power supply. ► Plug in the power cord into the power cord connector 9 on the rear of

the LED light source. ► Plug in the mains plug at a socket of the building mains. ► Turn on the LED light source with the power ON 2 switch. The power ON 3 indicator lamp shows that the device is activated. ► When operating multiple devices concomitantly, connect the devices to the potential equalization terminal.

5.2

Function checks

► Prior to each use, perform a functionality test for the LED light source.

Make certain that the self-test runs in accordance with legal regulations. If the device functions properly, the light will turn on after the device is switched on. After the device is switched on, the power ON 3 indicator lamp lights up on the front of the device.

5.3

Light lead test unit (optional)

If necessary, carry out an optical cable test: ► Turn on the LED light source with the power ON 2 switch. ► Plug the optical cable into the optical cable socket 7 until it audibly snaps into place. ► Screw the sterile adapter OP941 (optional) onto the light lead test unit 5. Note The optional sterile adapter OP941 consists of three parts. Of these, two bushes serve the connection of the different optical fiber connections.

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bushes of the sterile adapter OP941. Keep the bushes. ► Screw the distal end of the optical cable to be tested onto the sterile adapter. ► Press the optical fiber unit 5 against the light source. Note The optical cable test takes place regardless of the selected light strength (e.g. 80 %).

■ The results are displayed: – Good (100 %-66 %) – Acceptable (65 %-33 %) – Change (32 %-0 %)

5.4

► Before the optical cable test, screw sterile adapter OP941 onto the

5.1.7

► According to the optical fiber connection, unscrew or screw off the

Safe operation

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to each use of the product. WARNING Risk of injury and/or malfunction! ► Use undamaged products/devices only. WARNING Risk of injury due to application of the product outside the field of view! ► Apply the product only under visual control. 5.4.1 Turning the device on and off ► Turn on the LED light source with the power ON 2 switch. The power ON indicator 3 light is on. ► Turn off the LED light source with the power OFF 1 switch. 5.4.2 Brightness control ► The brightness can be continuously adjusted by turning the brightness control 4. Turning it in a clockwise direction increases the light intensity. 5.4.3 Standby mode ► To put the activated LED light source in Standby mode, press the brightness control 4. ► To take it out of Standby mode and put it back to the previously set value, press the brightness control 4 again.

5.5

Ending the operation of the device

► To end the operation of the device, press the power OFF switch 1. ► Disconnect the light lead and any sterile adapter OP941 from the opti-

cal cable test unit 5. ► To completely disconnect the device from the power supply, remove the

plug from the power cord connector 9 on the rear of the device.

en 6.

Validated reprocessing procedure

6.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

6.2

Cleaning/disinfection

6.2.1

Product-specific safety guidelines on the reprocessing procedure

DANGER Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Ensure that no fluids will penetrate the product. CAUTION Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances. ► Never clean the product by ultrasound treatment. CAUTION Risk of damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

6.3

Wipe disinfection for electrical devices without sterilization

CAUTION 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. Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Wipe disinfection

RT

≥1

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Meliseptol Wipes sensitive (17 % Propan-1-ol, 0.23 % Didecyldimethylammoniumchloride)

RT: Room temperature Phase I ► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable

disinfectant wipe. ► Keep the optical cable interfaces clean. ► Be sure that the optical cable interfaces are not scratched. Rub the

optical cable interfaces with a wad of cotton. ► Observe the specified application time (1 min minimum).

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en 6.4

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Check the product for any damage, abnormal running noise, overheat-

ing or excessive vibration. ► Set aside the product if it is damaged.

6.5

Sterilization

CAUTION Risk of damage to the light source OP940 due to sterilization! ► Do not sterilize the light source OP940 under any circumstances. ► Clean the light source OP940 with wipe disinfection only.

7.

Maintenance

To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

LED light source and fan do not work

Device not powered

Plug not inserted in the socket

Insert plug in socket

Indicators not illuminated

Fuses blown

Replace fuses, see Fuse replacement

Indicator light not illuminated even after change of fuse

Malfunction in power supply unit

Have LED light source repaired by manufacturer

Fan does not work

No air comes out of the air outlet

Malfunction in fan

Have LED light source repaired by manufacturer

Brightness significantly lower

The optical cable cannot be removed

Optical cable not completely inserted

Use the correct optical cable connection

Light source cannot be controlled

Light source does not respond to signals from the camera

Interface cable not correctly plugged in or defective

Check connection or replace cable

8.1

Fuse replacement

9.

Technical Service

DANGER Risk of death by electric shock! ► Unplug the device before changing the fuses!

WARNING Risk of injury and/or malfunction! ► Do not modify the product.

Ask your B. Braun/Aesculap agency about the prescribed fuse set.

► For service and repairs, please contact your national B. Braun/Aesculap

► Use a small screwdriver to release the clip on the fuse holder 10. ► Remove fuse holder 10. ► Replace both fuses. ► Reinsert fuse holder 10 so that it audibly snaps into place.

Note If the fuses burn out frequently, the device is faulty and should be repaired, see Technical Service.

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agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 14-939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

en 10. Accessories/Spare parts

12. Ambient conditions

All accessories and spare parts must only be procured from the manufacturer.

Designation

OP941

Sterile adapter

0%

Art. no.

Approvals

Color

Lengt h

TE780

Europe

black

1.5 m

TE730

Europe

black

5.0 m

TE734

Great Britain

black

5.0 m

TE735

USA, Canada, Japan

gray

3.5 m

10.3 Spare part for fuse Designation

A085442

Fuse set

90 %

Relative humidity

10.2 Accessories for power cord

Art. no.

Storage and transport

Temperature

10.1 Accessories for sterile adapter Art. no.

Operation

10.4 Communications accessories Art. no.

Designation

OP942

Communications interface cable

11. Technical Data Voltage range (Current consumption)

100 V~ – 240 V~ (1.0 A – 0.42 A)

Frequency

50/60 Hz

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

I

Device protection

T 1.6 A H 250 V

Weight

7 kg

Dimensions L x H x W

305 mm x 134 mm x 313 mm

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

90 % 10 %

Atmospheric pressure

13. Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. Adhere to national regulations when disposing of or recycling the product, its components and its packaging! 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.

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