LED Light Source OP950 Instructions for Use Ver 4.0 Nov 2020

OP950

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OP941

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Aesculap® LED light source OP950 Legend

2.8 2.8.1 2.8.2 2.8.3 2.9 2.10 2.10.1 2.10.2 2.10.3 3. 3.1 3.2 3.3 3.4 3.4.1

LED light source OP950 1 Mains Switch OFF 2 Mains Display On 3 Mains Switch ON 4 Brightness control with push function 5 Optical fiber cable test unit (for use with sterile adapter) 6 Lock activator for optical cable socket 7 Optical fiber cable retainer 8 Communication interfaces 9 Fuse holder 10 Mains cable connection 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)

Contents 1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 2.4 2.4.1 2.4.2 2.5 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6 2.5.7 2.5.8 2.6 2.7 2

About this document... Scope... Safety messages... Clinical use... Product description... Scope of supply... Components required for operation... Operating principle... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Preparation... Set-up environment/set-up location... Stacking of units... System set-up... Connecting devices for communication... Connecting the optical cable... Separating the LED light source from the optical cable... Connecting the sterile adapter (optional)... Removing the sterile adapter from the LED light source... Connecting the power supply... Connecting the accessories... Putting out of operation... Functional test... Optical cable test...

3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6

3.5 3.6 3.6.1 3.6.2 3.7 3.7.1 4. 4.1 4.2 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 5. 6. 6.1 6.2 7.

Application... Turning the device on and off... Brightness control... Activation/standby mod... Ending the operation of the device... Troubleshooting list... Error with error code... Malfunctions... Replacing fuses... Validated reprocessing procedure... General safety instructions... General information... Reusable products... Cleaning/Disinfection... Product-specific safety information on the reprocessing method... Wipe disinfection... Inspection... Visual inspection... Functional test... Storage... Ambient conditions... Maintenance and service... Maintenance... Technical service... Accessories / spare parts... Accessories for sterile adapter... Accessories for power cord... Spare part for fuse... Communications accessories... Light lead accessories... Equipotential bonding cable accessories... Disposal... Technical data... Classification acc. to Regulation (EU) 2017/745... Performance data, information about standards... Symbols on product and packaging...

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en 1.

About this document

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

1.1

Scope

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

Designation

OP950

LED light source

► For article-specific instructions for use as well as information on mate-

rial compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

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

2.

Clinical use

2.1

Product description

2.1.1

Scope of supply

Brightness control The brightness is adjusted gradually (5 % increments) via the brightness control 4. If a camera system with auto light quantity control is connected via the communication interface cable OP942, the light intensity can be controlled via the camera. When the brightness control 4 is adjusted during active auto light quantity control, the system is immediately switched to manual mode and the light intensity is displayed in %. Activation/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. If a camera system with auto light quantity control is connected via the communication interface cable OP942, the LED light source can also be activated or deactivated via the camera. Multi optical cable socket Various optical fiber cables from Aesculap/Storz, Olympus and Wolf with an active diameter of 3.5 mm or 4.8 mm can be plugged into the multioptical cable socket 7. Light source test unit with sterile adapter The optical cable test unit can be used in the sterile field with a sterile adapter OP941. The optical cable test unit is used for testing the light transmission of the 4.8 mm optical fiber cable connected in each case. The testing of 3.5 mm optical fiber cables causes false measurement results. Modes shown on the display

Designation

Art. no.

LED light source

OP950

Instructions for use

TA014627

2.1.2

2.1.3 Operating principle The LED light source OP950 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).

Display

Explanation

STANDBY

Standby Device is switched on, LED is off. Circular green light on the brightness control is deactivated.

100 %

Light intensity % (0 % to 100 %)

Components required for operation

Automatic light quantity control is active Is only displayed if a corresponding camera system is automatically controlling the light quantity.

Designation

Art. no.

LED light source

OP950

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

-

Optical cable is not plugged in or not plugged in properly

Power cord

-

Optical cable is being tested

AUTO

Result of optical cable test: Optical cable OK. Result of optical cable test: Optical cable should be replaced.

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en 2.2

Areas of use and limitations of use

2.2.1 Intended use The LED light source OP950 is intended for use in endoscopy systems for human medicine. In combination with a light cable, endoscope, camera and monitor, its purpose is to illuminate the inside of the human body. 2.2.2 Indications There are no medical indications associated with the use of the LED light source OP950 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 There are no medical contraindications associated with use of the LED light source OP950 itself if separated from the endoscopic system. Depending on the intended use of the applied part, contraindications may exist in respect of the patient’s general condition or the specific presenting disease.

Device failure due to incorrect storage and usage conditions! ► Store and operate the product only within the specified environmental conditions. ► Observe "Notes on electromagnetic compatibility (EMC) for LED light

source OP950" TA022463, see B. Braun eIFU at eifu.bbraun.com ► Only combine Aesculap products with each other (except for optical

fiber cable). ► Always adhere to applicable standards. ► In the sterile field only use sterile processed sterile adapter OP941

(optional). ► Only allow products and accessories to be operated and used by indi-

viduals who have been trained in the use of endoscopic procedures. ► Ensure that the electrical facilities in the room in which the device is

being used conform to IEC norms. ► 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.

2.3

Safety information

► Make certain that the device’s ventilation ducts are not covered.

2.3.1

Clinical user

Ambient conditions The following environmental conditions apply to the use of the product:

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 of death by electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply. Risk of injury from current leakage when touching the patient! ► Never touch the patient and the device housing or accessible contacts

of electric devices at the same time. ► Never touch the patient and non-medical electric devices at the same

time. Possibly hazardous optical radiation emitted from this product! ► Do not stare at operating lamp. May be harmful for the eye.

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Temperature

10 °C to 40 °C

Relative humidity

30 % 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.

2.4

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. ► When setting up and operating the product, adhere to: – national regulations for installation and operation, – national regulations on fire and explosion protection. 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. ► 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. Note The potential equalization lead can be ordered from the manufacturer as art. no. GK535 (4 m long) or TA008205 (0.8 m long).

en 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). ► 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 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. The device is authorized for operation in the operating room. Note After being installed and put into operation, the device must not be transported or moved to a different set-up location. 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. ► 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 following minimum distances from other devices are maintained: – on the sides 50 mm – from the rear 60 mm ► Make certain that the control elements, mains power switch and power socket are freely accessible for 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. 2.4.2

Stacking of units

► Do not exceed the maximum stack height of 450 mm. ► Position units so that they are stable. ► Stack Aesculap devices evenly on top of each other.

2.5.1 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. 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. 2.5.2

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). 2.5.3 Separating the LED light source from the optical cable ► To unlock the optical cable, turn the activator 6 in the marked direction. 2.5.4 Connecting the sterile adapter (optional) ► Before the optical cable test, screw sterile adapter OP941 onto the optical cable test unit 5. ► If necessary, screw on the adapter for connecting the optical cable. 2.5.5 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.

► Never stack in an offset arrangement.

2.5.6

2.5

DANGER Risk of death by electric shock! ► Connect the product only to a grounded power supply.

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.

Connecting the power supply

Note The connection of electrical devices to a multiple socket creates a system and can lead to a reduced level of safety. ► 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.

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. 5

en 2.5.7

Connecting the accessories

Display

Explanation

DANGER Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device. Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC/DIN EN 60601-1 for medical electrical equipment). All configurations must fulfill the basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards. ► In case of questions, contact your B. Braun/Aesculap partner or Aesculap Technical Service, address see Technical service. 2.5.8 Putting out of operation Note The safe and all-pole disconnection of the product from the main power supply is only guaranteed when the power cord is unplugged. ► Switching off the device: Activate the power OFF switch 1. ► Unplug the power cord from the power socket.

The operation of the device is safely terminated.

2.6

Functional test

► Prior to each use, perform a functionality test for the LED light source. ► Make certain that the self-test runs in accordance with legal regula-

tions. If the self-test is successful, the word "STANDBY" appears after the start logo. After activating the brightness control, the request appears to plug in the optical fiber cable. In case of an error, an error code appears in the display, see Error with error code. If the device is functioning properly, the LED light source is activated when the optical fiber cable is plugged in and the brightness control is activated. After the device is switched on, the power ON 2 indicator lamp lights up on the front of the device.

2.7

Optical cable test

If necessary, carry out an optical cable test: ► Turn on the LED light source with the power ON 3 switch. ► Plug the optical cable into the optical cable socket 7 until it audibly snaps into place. ► Screw sterile adapter OP941 onto the optical cable test unit 5. Note The sterile adapter OP941 consists of three parts. Of these, two bushes serve the connection of the different optical fiber connections. ► According to the optical fiber connection, unscrew or screw off the

bushes of the sterile adapter OP941. Keep the bushes. ► Screw the distal end of the optical cable to be tested onto the sterile

adapter. ► Activate the brightness control 4 to switch on the light. ► Press the optical fiber unit 5 against the light source.

The results are displayed in the display. 6

Optical cable can still be used. (100 % - 41 %) Optical cable should be replaced. (40 % - 0 %) Note The optical cable test takes place regardless of the selected light strength (e.g. 80 %).

2.8

Application

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to each use of the product. WARNING Risk of injury due to application of the product outside the field of view! ► Apply the product only under visual control. 2.8.1 Turning the device on and off ► Turn on the LED light source with the power ON 3 switch. The power ON indicator 2 light is on. ► Turn off the LED light source with the power OFF 1 switch. 2.8.2 Brightness control ► To adjust the brightness in increments (5 % increments), turn the brightness control 4. Turning it in a clockwise direction increases the light intensity. Note The brightness can also be automatically controlled using a corresponding camera system. 2.8.3 Activation/standby mod ► To activate the LED light source, press the brightness control 4. ► To put the active LED light source (optical fiber cable is plugged in, light is emitted) 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. Note The LED light source can also be activated/deactivated using a corresponding camera system.

2.9

Ending the operation of the device

► To end the operation of the device, press the power OFF switch 1. ► Remove the optical cable from the sterile adapter 5. ► To completely disconnect the device from the power supply, remove the

plug from the power cord connector 10 on the rear of the device.

en 2.10 Troubleshooting list 2.10.1 Error with error code Error code in display

Cause

Remedy

Error Code 1

LED light intensity cannot be adjusted or LED is defective.

Replace the LED light source as soon as possible with a replacement.

Error Code 2

Failure of housing fan

Replace the LED light source as soon as possible with a replacement.

Error Code 3

Housing temperature is more than 60 °C. The light output is limited to 70 % light output. The device will not switch off, but is not guaranteed to remain fully functional.

Replace the LED light source as soon as possible with a replacement.

Error Code 4

The device is fitted with two internal fans for cooling the LEDs. The first fan is defective.

Replace the LED light source as soon as possible with a replacement.

Error Code 5

The device is fitted with two internal fans for cooling the LEDs. The second fan is defective.

Replace the LED light source as soon as possible with a replacement.

Detection

Cause

Remedy

Plug not inserted in the socket

Insert plug in socket

Indicators not illuminated

Fuses blown

Replace fuses, see Replacing fuses

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

Check connection or replace cable

2.10.2 Malfunctions Malfunction

LED light source and fan do not work Device not powered

Interface cable not correctly plugged in or defective

2.10.3 Replacing fuses DANGER Risk of death by electric shock! ► Unplug the device before changing the fuses. Ask your B. Braun/Aesculap agency about the prescribed fuse set. ► Use a small screwdriver to release the clip on the fuse holder 9. ► Remove fuse holder 9. ► Replace both fuses. ► Reinsert fuse holder 9 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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en 3.

Validated reprocessing procedure

3.1

General safety instructions

3.4

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

3.4.1

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.

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.

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 LED light source to power when all cleaned parts are completely dry.

Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com

3.2

General information

Damage to the product due to improper reprocessing! ► Use only wipe disinfection for cleaning and disinfecting the LED light source. ► 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.

Note The housing of the LED light source is only suitable for wiping with a moist cloth (wipe disinfection). Do not immerse into liquid.

3.3

Cleaning/Disinfection

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.

3.5

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).

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en 3.6

Inspection

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

3.6.1

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. 3.6.2

Functional test

4.

Maintenance and service

4.1

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

4.2

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 perform any servicing or maintenance work under any circumstances while the product is being used on a patient.

► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges,

locks/latches, sliding parts etc.). ► Check the product for any atypical running noise, overheating or exces-

sive vibration. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap

Technical Service, see Technical service.

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.

Temperature

-10 °C to 50 °C

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.

Relative humidity

10 % to 90 %

4.3

500 hPa to 1 060 hPa

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

3.7

Storage

► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area. 3.7.1 Ambient conditions The following environmental conditions apply to the transport and storage of the product:

Atmospheric pressure

4.3.1

Accessories / spare parts

Accessories for sterile adapter

Art. no.

Designation

OP941

Sterile adapter

4.3.2

Accessories for power cord

Art. no.

Approvals

Color

Length

TE676

IEC power cable

gray

1.0 m

TE730

Europe

black

5.0 m

TE734

Great Britain

black

5.0 m

TE735

USA, Canada, Japan

gray

3.5 m

TE736

IEC power cable

gray

2.5 m

TE780

Europe

black

1.5 m

9

en 4.3.3

Spare part for fuse

6.

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

Art. no.

Designation

6.1

TA022249

Fuse set

Art. no.

Designation

Class

OP950

LED light source

I

OP941

Sterile adapter

I

4.3.4

Communications accessories

Art. no.

Designation

OP942

Communications interface cable, 0.75 m

4.3.5

Light lead accessories

6.2

Performance data, information about standards

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

I IP21

Art. no.

Designation

Housing protection rating according to IEC/EN/DIN 60529

EV2-000022

Light lead CF, ∅ 4.8 mm, 5.0 m

Applied part

Type CF, defibrillator-safe

OP906

Light lead, ∅ 4.8 mm, 1.8 m

Mains voltage ranges

100–240 V~

OP913

Light lead, ∅ 4.8 mm, 2.5 m

OP914

Light cable, ∅ 4.8 mm, 3.5 m

Current consumption (ready for operation)

0.07 A (at 100 V~) 0.09 A (at 240 V~)

OP923

FullHD light lead, ∅ 4.8 mm, 2.5 m

Current consumption (maximum load)

2.0–1.0 A

Frequency

50/60 Hz

Operating mode

Continuous operation

Device fuse (acc. to IEC 60127-1)

T 2.0 AH, 250 V Structural design: 5 x 20 mm

Weight

8.5 kg

Dimensions (W x H x D)

330 mm x 146 mm x 362 mm

Conforming to standard

IEC/EN/DIN 60601-1

EMC

IEC/EN/DIN 60601-1-2

CISPR11

Class B

4.3.6

Equipotential bonding cable accessories

Art. no.

Designation

TA008205

Equipotential bonding cable, 0.8 m

GK535

Equipotential bonding cable, 4.0 m

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 Validated reprocessing procedure. 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.

10

en 7.

Symbols on product and packaging 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

CE marking according to regulation (EU) 2017/745

Possibly hazardous optical radiation emitted from this product! Do not stare at operating lamp. May be harmful for the eye. Medical Device

“OFF” (power supply)

“ON” (power supply)

Defibrillation-protected applied part of type CF Optical cable connection

Equipotentialization connector

Unlock

Hazardous electrical voltage

Fuse Alternating current Manufacturer

Labeling of electrical and electronic devices according to directive 2012/19/EU (WEEE), see Disposal

Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

11