AXeL 300 Instructions for Use Ver 6 July 2013

Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 3. 3.1 3.2 4. 4.1 4.2 4.3 5. 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 6. 6.1 7. 7.1 8. 9. 9.1 9.2 9.3 9.4 9.5 10. 10.1 11.

Safe handling Safe for use in conformance with IEC regulations Safety information regarding XBO reflector lamps Product description Scope of supply Components required for operation Intended use Operating principle Preparation and setup First use Presetting the correct voltage Working with the xenon light source System set-up Function checks Safe operation Validated reprocessing procedure General safety instructions General information Dismantling prior to carrying out the reprocessing procedure Preparations at the place of use Preparation before cleaning Cleaning/disinfection Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Maintenance Replace xenon lamp Troubleshooting list Fuse replacement Technical Service Accessories/Spare parts Optical cable accessories Optical cable connection accessories Accessories for power cord Other accessories Spare parts Technical data Ambient conditions Disposal

1. 3 4 4 4 4 4 4 5 5 5 5 6 6 7 7 7 7 8 8 8 8 8 9 9 9 9 11 12 12 12 12 12 12 12 12 13 13 13

Safe handling

DANGER

Risk of injury to patients due to inappropriate application! ► The product and accessories should only be operated by qualified or trained and experienced personnel.

► Transport the product only in its original box. ► 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. – Adhere to application instructions according to relevant norms, see Safe for use in conformance with IEC regulations. ► Inspect the accessories regularly: Electrode cables and endoscopic accessories, in particular, must be checked for possible damage to the insulation. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► 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 xenon light sources in areas where there is a risk of explosion.

3

Aesculap® Xenon Light Source OP932

1.1

Safe for use in conformance with IEC regulations

2.

Product description

2.1

Scope of supply

The operating environment

DANGER

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

► Do not use the xenon light source at more than 2 500 meters above sea

level. ► 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 CF requirements. ► To avoid failure of the xenon lamp during an operation: Make certain that the xenon lamp is replaced after 700 hours of operation (i.e., its guaranteed service life). Check the operating time counter.

1.2

Safety information regarding XBO reflector lamps

WARNING

WARNING

Caution: Risk of injury from explosion! ► Exercise caution when working with the xenon lamp. The permissible inner pressure of the xenon lamp when cold is ca. 20 bar. ► Do not use the xenon lamp more than 1.25 times longer than its average service life. During operation, the inner pressure of the lamp increases threefold. Risk of injury to eyes from strong ultraviolet radiation and high luminance! ► Do not look directly into or at the xenon lamp.

► Make certain that xenon lamps are operated only with enclosed xenon

light sources. ► Only operate XBO lamps with the safety cladding and protecting cap. ► When performing maintenance or repairs, always wear protective garb

(safety glasses and gloves). ► When doing maintenance or repair work, make certain that the reflec-

tor opening is not pointing towards any persons.

4

Note The xenon light source OP932 does not have a spare lamp. As the xenon lamp may fail before the guaranteed operating period has elapsed, always have a spare lamp available, see Accessories/Spare parts. Art. no.

Designation

OP932

Xenon light source

OP935

Aesculap-Storz optical cable connection

TA022011

Xenon light source OP932 instructions for use

TA022130

Notes on electromagnetic compatibility (EMC)

2.2

Components required for operation

Art. no.

Designation

OP932

Xenon light source

TE730 to TE785

Power cord

OP906 OP913 OP914

Optical cable

2.3

Intended use

The xenon light source OP932 is used to illuminate the operative field and body cavities during medical applications.

2.4

Operating principle

When the device is switched on, a xenon lamp is ignited. The xenon lamp is operated under output control. The xenon lamp generates free-burning discharge arcs between two electrodes in pure xenon gas. The small gap between the electrodes allows for creation of a source of illumination closely resembling that of a spotlight. The light is filtered through the cold light reflector, propagated through the optical cable and directed to the field of view (operative field). Monitoring the operating time of the xenon lamps The xenon light source OP932 is fitted with an operating time counter that registers the number of hours the lamp has been in operation. During operation, the xenon lamp OK indicator 4 is illuminated. If a lamp operating period of 700 hours is exceeded, the change lamp indicator 8 comes on. Monitoring temperature In order to safeguard the xenon light source against overheating, the operating temperature of the power supply unit and xenon lamp are continuously monitored. If the limiting temperature is exceeded, the xenon lamp switches off. The fan is activated during the cooling phase. The xenon light source can be used again after a brief period.

3.

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.

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. ► 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.

Brightness control The desired brightness can be continuously adjusted with the brightness control 5.

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

3.1

First use

WARNING

3.2

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.

Presetting the correct voltage

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

5

Aesculap® Xenon Light Source OP932

4.

Working with the xenon light source

Connecting the endoscope ► Connect the endoscope to the instrument connection 12.

4.1

System set-up

WARNING

WARNING

Risk of burns from excessively high operating temperatures! The xenon lamp, 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.

Connecting the optical cable The endoscope must be connected to the instrument connection 12. ► Insert the optical cable 11 into the optical cable connection 6 until it snaps into place. ► Do not crush or crimp the optical cable 11 or wind it too tightly (minimum diameter 150 mm). Keep the xenon light source separated from the optical cable ► Separate the xenon light source from the optical cable after use. ► In order to prevent the xenon light source from slipping, hold the xenon

light source firmly in one hand and pull out the optical cable 11 with the other hand.

► 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,

medical cart or similar) is sufficiently stable. ► Make certain that the device is safeguarded against vibration during

operation.

Changing the optical cable connection The xenon light source OP932 is delivered with a Aesculap-Storz fiberoptic connection. Where necessary, this can be replaced with the fiberoptic connection systems Wolf (article no. OP936), Olympus (article no. OP937) and ACMI (article no. OP938), see Accessories/Spare parts.

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 (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. 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.

6

DANGER

DANGER

Risk of fatal injury from electric shock! ► Before dismantling the fiber-optic connection system, disconnect the mains plug. ► Do not insert anything into the device opening. Risk of burns! ► Only replace the fiber-optic connection system after the device has completely cooled down. ► Do not insert anything into the device opening. ► Do not activate device without a fiber-optic connection system fitted.

If a fiber-optic cable is plugged in, remove it: ► Rotate the optical cable connection 6 in a counterclockwise direction

and then remove it. ► Mount the other optical cable connection 6 by rotating it as far as it

will go in a clockwise direction. Always ensure that the fiber-optic connection is firmly connected to the housing.

Connecting the power supply

DANGER

Risk of fatal injury from electric shock! ► Connect the product only to a grounded power supply. ► Set up the device in such a way that a separation from the network cable is straightforwardly possible.

Note Before operating the device, make certain that the supply voltage marked on the plug of the device matches that of the supply voltage being used. ► Plug the power cord 13 into the power socket 14 at the back of the control unit. ► Plug in the mains plug at a socket of the building mains. ► Turn on the control unit with the power ON switch 2. The power ON indicator 3 lamp shows that the device is activated. ► When operating multiple devices concomitantly, connect the devices to the potential equalization terminal.

4.2

Function checks

► Prior to each use, perform a functionality test for the xenon light

Switching the device on and off ► Turn on the control unit with the power ON switch 2. ► Turn off the control unit with the power OFF switch 1.

Brightness control The desired brightness can be continuously adjusted with the brightness control 5. Note If the cold light source is switched on and off frequently, the xenon lamp will wear out more quickly. During brief interruptions, instead of switching the device off, lower the brightness with the brightness control.

5.

Validated reprocessing procedure

5.1

General safety instructions

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

source. ► Make certain that the self-test runs in accordance with legal regula-

tions. If the device is functioning properly, the xenon lamp 9 will be ignited after the device is switched on. After the device is switched on, the power ON indicator 3 on the front of the device is activated. After the self-test has been successfully performed, the lamp OK indicator 4 also comes on. When the change lamp indicator 8 is illuminated: – The xenon lamp is malfunctioning – Maximum permissible operating time has been exceeded ► Replace the xenon lamp, see Replace xenon lamp.

4.3

Safe operation

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Automatic self-test After being switched on, the device automatically carries out a self-test lasting approximately 3 seconds. During this self-test, all display elements on the front panel are illuminated. After performance of the test, either the lamp OK indicator 4 or the change lamp indicator 8 are activated, depending upon the length of period during which the lamp has been operated. If a malfunction is detected during the self-test, the lamp OK indicator 4 and change lamp indicator 8 are illuminated simultaneously. If this happens, the device must be restarted.

Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. 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. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

7

Aesculap® Xenon Light Source OP932

5.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

5.4

Preparations at the place of use

► Remove any visible surgical residues to the extent possible with a

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

disinfection within 6 hours.

5.5

Preparation before cleaning

► Keep the product separate from the power supply. ► Remove accessories. ► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

5.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

DANGER

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.

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.

CAUTION

5.3

Dismantling prior to carrying out the reprocessing procedure

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

respective instructions for use.

8

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. ► Observe specifications regarding concentration, temperature and exposure time.

Validated cleaning and disinfection procedure Validated procedure

Special features

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.

5.7

Wipe disinfection for electrical devices without sterilization

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Wipe disinfection

RT

≥1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

RT:

Room temperature

6.

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. ► Observe the specified application time (1 min minimum).

5.8

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.

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. The guaranteed service life of the xenon lamp is 700 hours of operation. Note Maintenance must only be carried out by authorized personnel. If necessary, the circuit diagrams and the service manual, which contains all the necessary documents, are provided for this.

► Check the product for any damage, abnormal running noise, overheat-

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

6.1

Replace xenon lamp

DANGER

DANGER

DANGER

Risk of fatal injury from electric shock! ► Pull out the power plug before opening the device. Danger of explosion due to incorrect handling! ► The xenon lamp should only be operated by qualified personnel. ► Always wear protective gloves and safety glasses. Danger of burns from a hot xenon lamp! ► Only replace the xenon lamp after the device has completely cooled down.

9

Aesculap® Xenon Light Source OP932

Opening the device

Install xenon lamp

► Rotate the fast-action locks 17 90° in a counterclockwise direction. ► Pull the cover slightly outwards and raise it. ► Make certain that the ground cable is not under any strain by being

D

pulled on. Remove xenon lamp

B

A

A

A

B E

C

C

F

Fig. 2

D E Fig. 1 Legend A Wire loop B Plug tabs C Lamp connector D Ceramic socket E Lamp body ► Loosen lamp connector C: – Squeeze the laterally mounted plug tabs B together. – Withdraw lamp connector C at the same time. ► Release the wire loop A on either side and fold them back. ► Grasp the xenon lamp by its ceramic socket D and push it backwards. At the same time incline the xenon lamp slightly downwards and open the two fastening brackets.

10

Legend A Bushing B Bushing flange C Positioning flange D Lamp connector E Ceramic socket F Groove ► Grasp the xenon lamp by its ceramic socket E. ► Incline the xenon lamp and its underside forwards. ► Insert the positioning flange C of the xenon lamp in the groove F of the lamp holder and push it forward. Make certain that the lower edge of the reflector touches the lamp holder. ► Push the xenon lamp forward until the upper segment of the edge of the reflector touches the xenon lamp holder and the lamp snaps into the two fastening brackets. ► Suspend the wire loop. The xenon lamp is now fixed in place. ► Plug lamp plug D into bushing A. Ensure that the plug tabs snap into place in the bushing flange B. ► Setting back the operating time counter, see Setting back the operating time counter

Close device

Setting back the operating time counter

Note Before putting the device cover in place, the connection between the cover and the ground cable must be present and intact.

The xenon light source is equipped with an integrated operating time counter that registers the number of hours the xenon lamp has been in operation. If the xenon lamp exceeds the maximum permissible number of hours in operation of 700 hours, the lamp change lamp indicator 8 lights up. After inserting the new xenon lamp, the operating time counter must be reset. ► Switch on the device. ► Press on the two the lamp OK indicator 4 and change lamp indicator 8 displays for approximately 3 seconds. This sets the counter back. The lamp OK 4 and change lamp 8 indicators flash alternately four times. Then the lamp OK indicator light 4 is illuminated.

► Pull the device cover slightly outwards, by its lower edge. ► Set the cover on the device. ► Make certain that no wires are caught. ► Press the fast-action locks 17. ► Rotate the fast-action locks 17 clockwise 90° with a screwdriver until

it snaps into place.

7.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Xenon lamp 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 xenon light source repaired by manufacturer

No light comes out of the end of the optical cable

Power ON switch not activated

Activate power ON switch

The xenon lamp is malfunctioning

Replace the xenon lamp

Malfunction in power supply unit

Have xenon light source repaired by manufacturer

Xenon lamp overheated

Wait a few moments until the xenon lamp is ignited

Xenon lamp does not come on

Fan does not work

No air comes out of right grating

Malfunction in fan

Have xenon light source repaired by manufacturer

Brightness noticeably poorer

The optical cable cannot be removed

Optical cable not completely inserted

Use the correct optical cable connection

Visual check of filter

Thermal protection filter dirty

Clean the thermal protection filter

Visual check of filter

Malfunction in thermal protection filter

Have xenon light source repaired by manufacturer

11

Aesculap® Xenon Light Source OP932

7.1

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

9.

Accessories/Spare parts

9.1

Optical cable accessories

DANGER Specified fuses that can be used with this unit: TA021473 (T 6.3 AH / 250 V) ► Use a small screwdriver to release the clip on the fuse holder 16. ► Remove fuse holder 16. ► Replace both fuses. ► Reinsert fuse holder 16 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.

8.

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

Art. no.

Designation

OP906

Optical cable ∅ = 4.8 mm, 1 800 mm long

OP913

Optical cable ∅ = 4.8 mm, 2 500 mm long

OP914

Optical cable ∅ = 4.8 mm, 3 500 mm long

9.2

Optical cable connection accessories

Art. no.

Designation

OP936

Optical cable connection system: Wolf

OP937

Optical cable connection system: Olympus

OP938

Optical cable connection system: ACMI

9.3

Accessories for power cord

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

Aesculapagency. 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.

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

9.4

Art. no.

Designation

TE736

Plug for isolation transformer

TA022012

Service manual

9.5

12

Other accessories

Spare parts

Art. no.

Designation

OP933

Xenon lamp (300 W / 16 V)

TA021473

Fuses that can be used with this unit

10. Technical data

10.1 Ambient conditions Operation

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

Designation

Class

OP932

Xenon light source

I

Storage and transport

Temperature

Relative humidity Model

OP932

Voltage range (current con- 100 V to 240 V (5.5 A to 2.3 A) sumption) Frequency

50 Hz to 60 Hz

Safety rating

I

Device protection Time-Current characteristic Breaking capacity Construction

T 6.3 AH / 250 V T (time lag) H (1 500 A) 5 mm x 20 mm

Weight

7.6 kg

Dimensions L x W x H

305 mm x 305 mm x 125 mm

Applied part

Type CF

Xenon lamp

300 W xenon Short-arc reflector lamp (16 V)

EMC

IEC 60601-1-2

Norms applied

IEC 60601-1

Atmospheric pressure

Note The atmospheric pressure of 770 hPa corresponds to a maximum operating altitude of 2 500 m.

11. 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.

13

- DIR 93/42/EEC

Technical alterations reserved

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

TA-Nr. 022011 Änd.-Nr. 45894

07/13

V6