LED Light Source OP940 Instructions for Use Ver 1.0 Sept 2012

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Effective Document No.: TA013718 - Version: 1.0 - Document ID: SOP-AIC-5001118 Date/Time Printed/Viewed: 09/19/2012 18:07 (CET)

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Effective Document No.: TA013718 - Version: 1.0 - Document ID: SOP-AIC-5001118 Date/Time Printed/Viewed: 09/19/2012 18:07 (CET)

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Aesculap® LED light source OP940 with sterile adapter OP941

Legend 1 Power OFF switch 2 Power ON switch 3 Power ON indicator 4 Brightness control with push function 5 Light source test unit with sterile adapter 6 Lock activator for optical cable socket 7 Optical cable socket 8 Communication interfaces 9 Power cord connector 10 Fuse holder 11 Device feet 12 Potential equalization connection 13 Service interfaces

LED light source OP940 with sterile adapter Aesculap OP941®

Symbols on product and packages Caution, general warning symbol

Follow the instructions for use

Type BF applied part

Optical cable connection

Equipotentialization connector

Unlock

Hazardous electrical voltage Fuse Alternating current On/Off switch Labeling of electrical and electronic devices according to directive 2002/96/EC (WEEE), see Disposal

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Contents

2.

1. 2. 3. 3.1 3.2

Applicable to Safe handling Product description Scope of supply Components required for operating the LED light source OP940 3.3 Intended use 3.4 Operating principle 4. Preparation and setup 4.1 First use 4.2 Presetting the correct voltage 5. Working with the LED light source 5.1 System set-up 5.2 Function checks 5.3 Optical cable test 5.4 Safe operation 5.5 Ending the operation of the device 6. Validated reprocessing procedure 6.1 Disassembling the product before carrying out the reprocessing procedure 6.2 Preparations before cleaning 6.3 Cleaning/disinfection 6.4 Inspection, maintenance and checks 7. Maintenance 8. Troubleshooting list 8.1 Fuse replacement 9. Technical Service 10. Accessories/Spare parts 10.1 Accessories for sterile adapter 10.2 Accessories for power cord 10.3 Spare part for fuse 11. Technical Data 12. Ambient conditions 13. Disposal 14. Distributor in the US/Contact in Canada for product information and complaints

1.

3 3 4 4 4 4 4 5 5 5 5 5 7 7 7 7 8 8 8 8 9 9 9 10 10 10 10 10 10 11 11 11 11

Applicable to

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician!

DANGER

WARNING

Risk of fatal injury from electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply. 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.

► Prior to use, check that the product is in good working order. ► Observe “Notes on Electromagnetic Compatibility (EMC)“, see

TA022130. ► To prevent damage caused by improper setup or operation, and in order

not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► 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. ► 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 35° 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 ► Make certain that only non-conductive optical cables are used. This applies in particular to products from other manufacturers, in order to meet BF requirements.

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

compatibility, see also www.extranet.bbraun.com

the

Aesculap

Extranet

at

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Aesculap® LED light source OP940 with sterile adapter OP941

3. 3.1

Product description

3.4

Scope of supply

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).

Operating principle

Designation

Art. no.

Brightness control

LED light source

OP940

Sterile adapter

OP941

The desired brightness can be continuously adjusted with the brightness control 4.

Instructions for use

TA013718

Standby mode

EMC brochure

TA022130

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.

3.2

Components required for operating the LED light source OP940

Multi optical cable socket

Designation

Art. no.

LED light source

OP940

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.

Sterile adapter

OP941

Light source test unit with sterile adapter

Optical cable with an active diameter of 4.8 mm from Aesculap/Storz, Olympus and Wolf

-

The optical cable test unit is used in the sterile field with a sterile processed sterile adapter OP941.

Power cord

-

3.3

Intended use

The LED light source OP940 is used to illuminate the operative field and areas of the body during medical applications.

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 %)

Indication The LED light source is used to illuminate the operative field during diagnostic and operative endoscopic procedures. 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.

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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.

4.1

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

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.

4.2

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.

5.

Working with the LED light source

5.1

System set-up

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

Presetting the correct voltage

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

WARNING

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. ► 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. ► 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 length) or TA008205 (0.8 m length).

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). Danger of blinding from light rays! ► Never look into the open end of an optical cable or endoscope that is connected.

► 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.

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Aesculap® LED light source OP940 with sterile adapter OP941

Connecting devices for communication

Connecting the optical cable.

The communication interfaces 8 connect the light source to a superordinate device. Through these, the light source receives control signals from the connected device.

► 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). Connecting the accessories Keep the LED light source separated from the optical cable.

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) 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. Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, 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 address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

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

tion. Connecting the sterile adapter ► 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.

Removing the sterile adapter from the LED light source ► After the optical cable test, unscrew sterile adapter OP941from the

optical cable test unit 5. Connecting the power supply

DANGER

Risk of fatal injury from 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.

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5.2

Function checks

5.4

Safe operation

► 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

Optical cable test

If necessary, carry out an optical cable test: ► Screw sterile adapter OP941onto the optical cable test unit 5. ► Screw the distal end of the optical cable to be tested onto the sterile adapter. 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 %)

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to each use of the product. Risk of injury and/or malfunction! ► Use undamaged products/devices only.

WARNING

WARNING

Risk of injury due to application of the product outside the field of view! ► Apply the product only under visual control.

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.

Brightness control ► The brightness can be continuously adjusted by turning the brightness

control 4. Turning it in a clockwise direction increases the light intensity. 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. ► 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 9 on the rear of the device.

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Aesculap® LED light source OP940 with sterile adapter OP941

6.

Validated reprocessing procedure

6.1

Disassembling the product before carrying out the reprocessing procedure

► Disassemble the product immediately after use, as described in the

respective instructions for use.

6.2

Preparations before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

6.3

Cleaning/disinfection

Product-specific safety guidelines on the reprocessing procedure

DANGER

CAUTION

CAUTION

CAUTION

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, 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. 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. Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents which – be approved for plastic material and highgrade steel, – do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowed cleaning temperature.

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Validated cleaning and disinfection procedure Note Reprocessing may only take place in accordance with the following listed procedures in version V6. These are documented in the Validated Reprocessing Procedures brochure (AVA-V6). You can also find this brochure in the Aesculap extranet at www.extranet.bbraun.com Validated procedure

Specific requirements

Reference

Wipe disinfection for electrical devices without sterilization

■ Keep the optical cable interfaces clean. ■ Be sure that the optical cable interfaces are not scratched. Rub the

Chapter Wipe disinfection for electrical devices without sterilization

optical cable interfaces with a wad of cotton.

■ LED light source OP940 Mechanical alkaline cleaning and thermal disinfection

■ Sterile adapter OP941

■ Insert the product in its proper position in the Eccos holder. ■ Connect the internal rinsing equipment at the Eccos holder and at the rinsing connector of the rinsing cart.

■ Place the instrument in a tray that is suitable for cleaning (avoiding

Chapter Mechanical cleaning/disinfecting and subchapter:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

rinsing blind spots).

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-

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.

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

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

LED light source and fan do not work

Device not powered

The plug is 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 doesn’t 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

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Aesculap® LED light source OP940 with sterile adapter OP941

8.1

Fuse replacement Risk of fatal injury from electric shock! ► Unplug the device before changing the fuses!

10. Accessories/Spare parts All accessories and spare parts must only be procured from the manufacturer.

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

9.

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

10.1 Accessories for sterile adapter Art. no.

Designation

OP941

Sterile adapter

10.2 Accessories for power cord Art. no.

Approvals

Color

Length

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

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

agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

10.3 Spare part for fuse Art. no.

Designation

TA022371

Fuse set

Service addresses Aesculap FLEXIMED GmbH Robert-Bosch-Strasse 1 79211 Denzlingen / Germany Phone: +49 7666 9321-0 Fax: +49 7666 9321-580 E-Mail: [email protected] Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 800 214-3392 Fax: +1 314 895-4420 Other service addresses can be obtained from the address indicated above.

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11. Technical Data

13. Disposal

Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

OP940

LED light source

I

OP941

Sterile adapter

I

Voltage range (current consumption)

100 V - 240 V ~ (120 VA)

Frequency

50 Hz to 60 Hz

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

I

Device protection

T 1.6 A (L)

Weight

7 kg

Dimensions L x H x W

305 mm x 125 mm x 305 mm

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

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.

12. Ambient conditions Operation

Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure.

Storage and transport

14. Distributor in the US/Contact in Canada for product information and complaints 3773 Corporate Parkway Center Valley, PA, 18034, USA

Temperature

Relative humidity

90 % 0%

Atmospheric pressure

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- DIR 93/42/EEC

Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap – a B. Braun company

Technical alterations reserved

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06/12

V6

Document No.: TA013718 - Version: 1.0 - Document ID: SOP-AIC-5001118 Date/Time Printed/Viewed: 09/19/2012 18:07 (CET)

Document Control

B|BRAUN

&

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Signature Page

Title: LED LIGHT SOURCE OP90 WITH STERILE ADAPTER OP941 Initiator: Kasey ? Sheeran

This document is signed electronically in compliance with the B. Braun electronic signature policies and procedures by following persons:

UserName: Kasey Sheeran (sheekaus) Title: Document Control Admin Date: Friday, 14 September 2012, 20:26 W. Europe Daylight Time Meaning: Document signed as Author ================================================

UserName: Kathy Racosky (racokaus) Title: Date: Monday, 17 September 2012, 15:50 W. Europe Daylight Time Meaning: Approve Document ================================================

UserName: Angela Olivier (olivanus) Title: Date: Tuesday, 18 September 2012, 22:14 W. Europe Daylight Time Meaning: Approve Document ================================================

UserName: Kasey Sheeran (sheekaus) Title: Document Control Admin Date: Wednesday, 19 September 2012, 17:42 W. Europe Daylight Time Meaning: Final Release of the Document ================================================

Effective Document No.: TA013718 - Version: 1.0 - Document ID: SOP-AIC-5001118 Date/Time Printed/Viewed: 09/19/2012 18:07 (CET)