ENDOGATOR EGP-100 series Instruction Manual Rev AD July 2013

Instruction Manual

CAUTION: Federal (USA) law restricts this device to sale by or on the order of physician. The ENDOGATOR™ irrigation pump provides GI Endoscopy professionals with an innovative way to irrigate during procedures. The ENDOGATOR irrigation pump was developed to assist nursing staff and doctors in the most demanding cases.

SIGNAL WORDS:

WARNING: Indicates a potentially hazardous situation which if not avoided, could result in death or serious injury.

CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

EXPLOSION: Indicates potential for violent chemical reactions which, if not avoided, may result in moderate or serious injury.

DO NOT allow fingers to contact moving parts.

MR MR Unsafe

These instructions should be stored and used for reference as needed. If there are any questions, please contact Customer Service - Service Department at 800-490-9869 / International: 01-782-594164

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Table of Contents

I.

Important Safety Precautions... 4

II.

Product Features... 5

III.

Pump Specifications... 6

IV.

Instructions For Use for the EGP-100/EGP-100A/EGP-100E GI Endoscopy irrigation pump... 7

V.

Troubleshooting... 9

VI.

Care and Maintenance... 9

VII. Warranty and Service...11

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I. Important Safety Precautions A. To reduce the risk of electrical shock, do not remove pump cover. Refer servicing to qualified personnel. B. Never install or operate the ENDOGATOR™ irrigation pump in an area where there is risk of flammable gases. Possible explosion hazard if used in the presence of flammable anesthetics or other flammable mixtures. C. Only qualified medical personnel in an acceptable medical facility should operate the ENDOGATOR irrigation pump. D. The ENDOGATOR irrigation pump should be connected to a properly grounded 120v (EGP-100/EGP-100A) or 240v (EGP-100E) receptacle marked “Hospital Grade” or “Hospital Only,” otherwise grounding reliability cannot be achieved. E. Extreme caution must be taken when handling liquids around electrical equipment. DO NOT operate the ENDOGATOR irrigation pump if liquid has been spilled on the unit. F. Never place the ENDOGATOR irrigation pump on other electrical equipment. Electromagnetic or other interference may occur between the ENDOGATOR irrigation pump and other electronic devices. G. The ENDOGATOR irrigation pump should only be used in conjunction with other equipment whose safety against leakage has been established. H. The instructions contained in the operating manuals of any equipment to be used in conjuction with the ENDOGATOR irrigation pump must be followed to avoid any possible hazard from incompatibility. I. The instructions for use described in this manual MUST be followed. Otherwise, comprised safety, malfunction, injury to the operator and / or patient, or costly damage to the unit and other equipment may occur. J. Repairs to the ENDOGATOR irrigation pump should only be performed by an authorized representative.

Electromagnetic Compatibility (EMC) Information Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section. Portable and mobile RF Communications Equipment can affect medical electrical equipment. The use of accessories, transducers and/or cables other than those specified, with the exception of those sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system. The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The EGP-100 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The EGP-100 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. The EGP-100 is not suitable for interconnection with other equipment.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least30% Mains power quality should be that of a typical commercial or hospital environment. Separation between portable and mobile RF communications equipment and the Medical Electrical Equipment that are not LIFE-SUPPORTING The EGP-100 is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the EGP-100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the EGP-100.

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II. Product Features • Compact design • Easy loading pump head and self-contained footswitch eliminate maintenance costs • Pump safety system • Disposable ENDOGATOR™ irrigation tubing for safety and compliancy

Product Contents

Quantity

EGP-100 ENDOGATOR irrigation pump unit (Model EGP-100)

1

Footswitch (EGP-041)

1

Power Cord (EGP-012)

1

Water Bottle Holder (200270)

1

Pump Head (EGP-014)

1

EGP-100A ENDOGATOR irrigation pump unit (Model EGP-100A)

1

Footswitch (EGP-009)

1

Power Cord (EGP-052)

1

Water Bottle Holder (200270S)

1

Pump Head (EGP-014)

1

EGP-100E ENDOGATOR irrigation pump unit (Model EGP-100E)

1

Footswitch (EGP-041)

1

Power Cord (U.K.) (EGP-042)

1

Power Cord (E.U.) (EGA-7017)

1

Water Bottle Holder (200270)

1

Pump Head (EGP-014)

5

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III. Pump Specifications A. Electrical Voltage / Current Requirement

120v / 240v ~ 50-60 Hz

30VA

B. Pump Flow Rate Auxiliary Water Channel Biopsy Channel

0 - 200 ml / min 0 - 500 ml / min

C. Physical Dimensions Height Width Depth Weight

6 inches 7 inches 8 inches 5 pounds

D. Ideal Flow Settings Auxiliary Water Channel Biopsy Channel

40 - 70 70 - 100

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IV. Instructions For Use for the EGP-100/EGP-100A/EGP-100E GI Endoscopy irrigation pumps WARNING: The ENDOGATOR™ GI endoscopy irrigation pump is designed specifically to be operated by a medical professional. Any person using this equipment must read the following instructions for use before operating the irrigation pump. In addition, medical staff must distinctively determine the necessity of use on all patients. ONLY staff trained in use of the GI Endoscopy irrigation pump may make this determination.

Indications for Use: GI endoscopic irrigation for use with washing catheters, integral GI endoscope water jet channels and GI endoscope working channels. A. Place the ENDOGATOR irrigation pump on a flat surface near your choice of GI endoscope. Press down on the pump to engage the suction cup feet. Surface must be smooth for feet to stick. B. Position the footswitch on the floor. Insert footswitch tubing into designated footswitch connection port on front of the pump. C. Confirm that the power switch is in the “OFF” position. Attach the female plug of the power cord into the power input module on the back of the pump. Attach the male end into the wall outlet. D. Take the pump head unit and align the shaft hole on the pump head unit with the shaft on the pump. Rotate the pump head unit until it is pointing up and to the left. Push the pump head unit all the way back so that it seats flush against the pump. Rotate the pump head unit until it is upright and tightly secured. E. Attach the (supplied) ENDOGATOR water bottle holder to the metal bracket attached to the side of the pump.

CAUTION: Use of irrigation fluid other than sterile water may cause an infection risk to patients. F. It is recommended that when using the ENDOGATOR irrigation pump, sterile water should be used. Therefore, open a bottle of sterile water, 500cc or 1000cc. Place the sterile bottle of water in the water bottle holder. Open the sterile peel pack and remove the ENDOGATOR disposable irrigation tubing and tightly secure the cap onto the sterile bottle of water. G. Open the pump head. Place the pump head tubing into the pump head so that the water flow is in the direction of the arrow on the pump head. Water flow is right to left facing the pump. H. Ensure that tubing is lying in the center of pump head opening and gently close pump head. I. Before turning pump on, ensure that the flow rate indicator is at the lowest speed setting.

CAUTION: Improper installation of pump head tubing during a procedure may compromise the sterility of the tubing. If this occurs, immediately replace with new tubing. CAUTION: NEVER allow the sterile water to run out. Otherwise, air will be supplied to the patient.

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J. Push power switch to the “ON” position.

K. Prior to attaching tubing to GI endoscope, prime the irrigation tubing by pressing the footswitch and make flow rate adjustments as needed. (Ensure that the end of the tubing is placed over a receptacle to catch the expelled water). L. Release the footswitch to stop the water flow.

M. Attach ENDOGATOR™ irrigation tubing and proper adapter to GI endoscope.

N. When procedure is finished, turn the power switch to the “OFF” position. After all procedures are completed for the day , remove tubing from the pump head and discard disposable water bottle, disposable tubing and GI endoscope connector.

NOTE: ENDOGATOR irrigation tubing may be used for 24 hours (discard daily).

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V. Troubleshooting CONDITION Green light is not on

POSSIBLE PROBLEM

RESOLUTION

Power cord not connected

Verify that the power cord is fully inserted. With main power switch OFF, check plug at wall outlet and at rear

Internal problem

of pump.

(No Power)

Call customer service to schedule service on the pump. Green light is on, but no pump motion when footswitch is depressed

Pump motion but no irrigation

Footswitch not properly connected

Ensure footswitch is connected to port on front of pump.

Defective footswitch and/or connecting cable

With the power OFF, press the footswitch and listen for an audible click at the pump where the footswitch connects. If there is an audible sound, the footswitch is working.

Internal problem

Call customer service to schedule service on the pump.

Incorrect installation of tubing

If air bubbles are forming in the water bottle when footswitch is depressed, the tubing was incorrectly installed. Place the pump head tubing into pump head so that the flow is from right to left. Refer to the Instructions For Use section. Call customer service to schedule service on the pump.

Internal problem

Pump shuts off during procedure

The Pump safety system monitors the flow rate setting which dictates the amount of electrical current and motor torque. The system shuts down the pump when the maximum current is exceeded for 5 seconds. This feature protects the pump components from damage and repair expenses. If pump safety system is activated, first turn pump off and on again and resume normal use. Call customer service to schedule service on the pump.

Pump safety feature activated

Internal problem

VI. Care and Maintenance 1. Before cleaning, disconnect the power cord from the outlet. 2. The ENDOGATOR™ irrigation pump may be cleaned with a soft cloth or gauze. Wipe down with a cloth dampened with Isopropyl alcohol. 3. Inspect the pump before each use. 4. All ENDOGATOR irrigation tubing must be discarded 24 hours after initial use. 5. Device should never be sterilized by any method.

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Replacement Parts EGP-100 ORDER NUMBER 200270 200230 EGP-041 EGP-012 EGP-014

DESCRIPTION Water Bottle Holder ENDOGATOR™ irrigation tubing Footswitch Power Cord Pump Head

EGP-100A ORDER NUMBER 200270S 200230 EGP-009 EGP-052 EGP-014

DESCRIPTION Water Bottle Holder ENDOGATOR irrigation tubing Footswitch Power Cord Pump Head

EGP-100E ORDER NUMBER 200270 200230 200230U EGP-041 EGP-042 EGA-7017 EGP-014

DESCRIPTION Water Bottle Holder ENDOGATOR irrigation tubing ENDOGATOR irrigation tubing Footswitch Power Cord (U.K.) Power Cord (E.U.) Pump Head

Accessory Items EGP-100/EGP-100A/EGP-100E ORDER NUMBER 100115 (24 Hr Use) 100126 (Single Use) 100135 (Single Use) 100136 (Single Use) 100241 (Single Use) 100242 (Single Use) 100303 (Single Use)

DESCRIPTION ENDOGATOR auxiliary water jet connector for OLYMPUS® GI endoscopes ENDOGATOR backflow valve ENDOGATOR irrigation tubing channel ENDOGATOR channel adapter ENDOGATOR single use auxiliary water jet connector for OLYMPUS GI endoscopes ENDOGATOR single use auxiliary water jet connector for PENTAX® GI endoscopes DEFENDO™ Y-OPSY® biopsy valve irrigator for OLYMPUS and FUJINON® GI endoscopes

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VII. Warranty and Service Limited Warranty Materials and workmanship of this product, MODEL EGP-100 will be warranted for a period of one (1) year from the original date of purchase. If this product should become inoperable due to a defect in materials or workmanship during this one (1) year warranty period, the product will be repaired or replaced. This limited warranty does NOT include replacement or service due to an accident, natural disaster, use of the product other than specified, external electrical error, improper installation, negligence, modification, unauthorized service or normal wear. No one person, agent, distributor, dealer or company is authorized to modify or change the terms of this warranty.

Servicing Please contact the Customer Service Department and obtain a Return Material Authorization (RMA) Number. The RMA number must accompany all units and paperwork for proper service or warranty work.

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™

™ Spülpumpe

MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODÈLE : EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELLO: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E МОДЕЛЬ: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E

GI Endoscopy Irrigation Pump Instruction Manual

GI-Endoskopie-Spülpumpe Bedienungsanleitung Manuel d’instructions de la pompe d’irrigation pour endoscopie GI Manual de instrucciones Bomba de irrigación para endoscopia GI Manuale di istruzioni Pompa di irrigazione per endoscopia GI Irrigatiepomp voor GI endoscopie Instructiehandleiding Brugsanvisning for skyllepumpe til brug i forbindelse med gastrointestinal endoskopi Instruksjonshåndbok for skyllepumpe til GI-endoskopi Manual de instruções da bomba de irrigação endoscópica gastrointestinal Instruktionsbok för spolpump för magtarmendoskopi Инструкция по эксплуатации ирригационного насоса для выполнения эндоскопии ЖКТ Manual de instruções da bomba de irrigação endoscópica gastrointestinal Manual de instrucciones Bomba de irrigación para endoscopia GI

0050

Hergestellt in den USA von: MEDIVATORS 3150 Pollok Drive Conroe, TX 77303 USA Tel.: +1.973.890.7220

MEDIVATORS Inc. Headquarters 14605 28th Avenue North Minneapolis, MN 55447 USA Tel. (gebührenfrei): +1.800.444.4729

MEDIVATORS BV Sourethweg 11 64422PC Heerlen Niederlande Tel.: +31,45.6.471.471

EC

REP

www.medivators.com

C.R. KENNEDY & COMPANY PTY LTD 300 LORIMER STREET PORT MELBOURNE 3207 VICTORIA AUSTRALIEN TEL.: +61 3 9823 1555 FAX: +61 3 9823 1591

FUJINON® ist eine eingetragene Marke der Fujinon Corporation. OLYMPUS® ist eine eingetragene Marke der Olympus Corporation. PENTAX® ist eine eingetragene Marke der Hoya Corporation. MEDIVATORS™, DEFENDO™, Y-OPSY® und ENDOGATOR™ sind Marken und eingetragene Marken von MEDIVATORS Inc.

Ausgabedatum: 18.03.2013

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IFU-EGPMA/REV AD

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MODE D'EMPLOI-EGPMA/RÉV AC

™

™ bomba de irrigación

MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODÈLE : EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELLO: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E МОДЕЛЬ: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E

GI Endoscopy Irrigation Pump Instruction Manual

GI-Endoskopie-Spülpumpe Bedienungsanleitung Manuel d’instructions de la pompe d’irrigation pour endoscopie GI Manual de instrucciones Bomba de irrigación para endoscopia GI Manuale di istruzioni Pompa di irrigazione per endoscopia GI Irrigatiepomp voor GI endoscopie Instructiehandleiding Brugsanvisning for skyllepumpe til brug i forbindelse med gastrointestinal endoskopi Instruksjonshåndbok for skyllepumpe til GI-endoskopi Manual de instruções da bomba de irrigação endoscópica gastrointestinal Instruktionsbok för spolpump för magtarmendoskopi Инструкция по эксплуатации ирригационного насоса для выполнения эндоскопии ЖКТ Manual de instruções da bomba de irrigação endoscópica gastrointestinal Manual de instrucciones Bomba de irrigación para endoscopia GI

0050

Fabricado en EE. UU. por: MEDIVATORS 3150 Pollok Drive Conroe, TX 77303 EE. UU. Tel.: +1.973.890.7220

Oficina central de MEDIVATORS, Inc. 14605 28th Avenue North Minneapolis, MN 55447 EE. UU. Línea gratuita: +1.800.444.4729

MEDIVATORS BV Sourethweg 11 CE 64422PC Heerlen Países Bajos Teléfono: +31,45.6.471.471

REP

www.medivators.com

C.R. KENNEDY & COMPANY PTY LTD 300 LORIMER STREET PORT MELBOURNE 3207 VICTORIA AUSTRALIA TEL.: +61 3 9823 1555 FAX: +61 3 9823 1591

FUJINON® es una marca registrada de Fujinon Corporation. OLYMPUS® es una marca registrada de Olympus Corporation. PENTAX® es una marca registrada de Hoya Corporation. MEDIVATORS™, DEFENDO™, Y-OPSY® y ENDOGATOR™ son marcas comerciales y marcas registradas de MEDIVATORS Inc.

Fecha de publicación: 18/03/2013

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™

™ Pompa di irrigazione

MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODÈLE : EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELLO: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E МОДЕЛЬ: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E

GI Endoscopy Irrigation Pump Instruction Manual

GI-Endoskopie-Spülpumpe Bedienungsanleitung Manuel d’instructions de la pompe d’irrigation pour endoscopie GI Manual de instrucciones Bomba de irrigación para endoscopia GI Manuale di istruzioni Pompa di irrigazione per endoscopia GI Irrigatiepomp voor GI endoscopie Instructiehandleiding Brugsanvisning for skyllepumpe til brug i forbindelse med gastrointestinal endoskopi Instruksjonshåndbok for skyllepumpe til GI-endoskopi Manual de instruções da bomba de irrigação endoscópica gastrointestinal Instruktionsbok för spolpump för magtarmendoskopi Инструкция по эксплуатации ирригационного насоса для выполнения эндоскопии ЖКТ Manual de instruções da bomba de irrigação endoscópica gastrointestinal Manual de instrucciones Bomba de irrigación para endoscopia GI

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Fabbricato negli USA da: MEDIVATORS 3150 Pollok Drive Conroe, TX 77303 USA Tel.: +1.973.890.7220

MEDIVATORS BV Sourethweg 11 64422PC Heerlen Paesi Bassi Tel.: +31.45.6.471.471

MEDIVATORS Inc. Headquarters 14605 28th Avenue North Minneapolis, MN 55447 USA Numero verde: +1.800.444.4729

EC

www.medivators.com

REP

C.R. KENNEDY & COMPANY PTY LTD 300 LORIMER STREET PORT MELBOURNE 3207 VICTORIA AUSTRALIA TEL.: +61 3 9823 1555 FAX: +61 3 9823 1591

FUJINON® è un marchio registrato di Fujinon Corporation. OLYMPUS® è un marchio registrato di Olympus Corporation. PENTAX® è un marchio registrato di Hoya Corporation. MEDIVATORS™, DEFENDO™, Y-OPSY® e ENDOGATOR™ sono marchi e marchi registrati di MEDIVATORS Inc.

Data di pubblicazione: 18/03/2013

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™

™ irrigatiepomp

MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODÈLE : EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELLO: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODEL: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELL: EGP-100/EGP-100A/EGP-100E МОДЕЛЬ: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E MODELO: EGP-100/EGP-100A/EGP-100E

GI Endoscopy Irrigation Pump Instruction Manual

GI-Endoskopie-Spülpumpe Bedienungsanleitung Manuel d’instructions de la pompe d’irrigation pour endoscopie GI Manual de instrucciones Bomba de irrigación para endoscopia GI Manuale di istruzioni Pompa di irrigazione per endoscopia GI Irrigatiepomp voor GI endoscopie Instructiehandleiding Brugsanvisning for skyllepumpe til brug i forbindelse med gastrointestinal endoskopi Instruksjonshåndbok for skyllepumpe til GI-endoskopi Manual de instruções da bomba de irrigação endoscópica gastrointestinal Instruktionsbok för spolpump för magtarmendoskopi Инструкция по эксплуатации ирригационного насоса для выполнения эндоскопии ЖКТ Manual de instruções da bomba de irrigação endoscópica gastrointestinal Manual de instrucciones Bomba de irrigación para endoscopia GI

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Vervaardigd in de VS door: MEDIVATORS 3150 Pollok Drive Conroe, TX 77303 VS Tel.: +1.973.890.7220

MEDIVATORS BV Sourethweg 11 EG 6422 PC Heerlen Nederland Telefoon: +31,45.6.471.471

MEDIVATORS Inc. Headquarters 14605 28th Avenue North Minneapolis, MN 55447 VS Gratis nummer: +1800444.4729

www.medivators.com

VERT.

C.R. KENNEDY & COMPANY PTY LTD 300 LORIMER STREET PORT MELBOURNE 3207 VICTORIA AUSTRALIË TEL : +61 3 9823 1555 FAX : +61 3 9823 1591

FUJINON® is een wettig gedeponeerd handelsmerk van Fujinon Corporation. OLYMPUS® is een wettig gedeponeerd handelsmerk van Olympus Corporation. PENTAX® is een wettig gedeponeerd handelsmerk van Hoya Corporation. MEDIVATORS™, DEFENDO™, Y-OPSY® en ENDOGATOR™ zijn handelsmerken en wettig gedeponeerde handelsmerken van MEDIVATORS Inc.

Uitgavedatum: 18-3-2013

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