ERBEJET 2 User Manual V1.1.x Oct 2015

USER MANUAL ERBEJET® 2

Registered trademarks of Erbe Elektromedizin GmbH: AXUS®, BICISION®, BiClamp®, classicCOAG®, classicCUT®, CLEVERCAP®, DeCo®, dryCUT®, endoCUT®, endoCOAG®, ERBE®, ERBECRYO®, ERBEFLO®, ERBEFLO AeroRinse®, ERBEJET®, ERBELift®, ERBOKRYO®, FIAPC®, forcedAPC®, forcedCOAG®, Hybrid knife®, HybridKnife®, Hydro-Jet®, ICC 200®, ICC 80®, KYRON®, NESSY®, NESSY Ω®, PLURA®, preciseAPC®, Preflow®, pulsedAPC®, ReMode®, REMODE®, softCOAG®, sprayCOAG®, swiftCOAG®, The Color Blue®, thermoSEAL®, twinCOAG®, VIO®.

MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 (2008) 19NA

EN ISO 9001 EN ISO 13485 User Manual Art. No. 80110-801 Product Art. No. 10150-000 All rights to this User Manual, in particular rights of duplication, dissemination and translation, are reserved. No part of this User Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or disseminated by the use of electronic systems without the written consent of Erbe Elektromedizin GmbH. The information contained in this User Manual can be changed or expanded without prior notice and without obligation on the part of Erbe Elektromedizin GmbH. Printed by Erbe Elektromedizin Printed in Germany Copyright © Erbe Elektromedizin GmbH, Tübingen 2015

Table of Contents

Table of Contents 1

Safety Instructions... 7 Intended purpose... 7 Safety notations... 7 Meaning of the note... 7 Who must read this User Manual?... 8 Compliance with safety information... 8 Structure of safety instructions... 8 Operating errors and incorrect installation by persons without training... 8 Risks due to the environment... 9 Electric shock... 10 Risk of infection... 11 Fire / explosion... 12 Defective unit, defective accessories... 12 Interference caused by the unit... 13 Safety information for use of ERBEJET 2... 13 Notes... 14

2

Description of the Controls... 17

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Controls on the front panel... 17 Controls on the back... 18

3

Working with ERBEJET 2... 19 Connecting suction module ESM 2, Connecting applicator to the pump unit... 19 Selecting program, Inserting pump unit, Connecting separating medium, Priming pump unit and applicator... 22 Mounting suction hose of applicator to suction container... 25 Window settings, Selecting effect, Setting suction... 26 Activation... 28 Saving a modified basic program as a new program, Selecting program, Saving programs for the ReMode function... 29 Deleting a program, Overwriting a program... 32 ml-Signal... 33 Displaying used separating medium, Resetting display... 33 Having the unit of pressure set... 34 Accessing Setup... 34

4

Status Messages, Error Messages... 37 Status messages... 37 Error messages... 37 Error messages with error codes in numerical order... 38 Error messages... 39

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Table of Contents

5

Installation... 41 Ambient conditions...41 Electrical installation...43 Installing ERBEJET 2...44

6

Disassembly, Cleaning and Disinfection... 45 Removal of separating medium; disassembly of ESM 2 suction unit, applicator, and pump unit...45 Wipe disinfection...46 Instructions for cleaning and disinfection...47

7

Technical Data... 49

8

Information on electromagnetic compatibility (EMC)... 51

9

Maintenance, Customer Service, Warranty, Disposal... 55 Maintenance...55 Customer service...55 Warranty...55 Disposal...56

10 Combination with other equipment, Third-party accessories... 57

Introduction...59 ERBEJET 2 example accessories...60

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11 Accessories... 59

1 • Safety Instructions

Chapter 1 Safety Instructions Intended purpose The ERBEJET 2 water jet surgical unit is intended for applying a high pressure water jet. The water jet can be used for marking, rinsing, lifting and dissecting tissues.

Safety notations

DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

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

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CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE indicates a potentially hazardous situation which, if not avoided, may result in property damage.

Meaning of the note "Note:" Refers a) to manufacturer's information that relates directly or indirectly to the safety of people or protection of property. The information does not relate directly to a risk or dangerous situation. Refers b) to manufacturer's information that is important or useful for operating or servicing the unit.

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1 • Safety Instructions

Who must read this User Manual? Knowledge of the User Manual is absolutely essential for correct operation of the unit. The User Manual must therefore be read by everyone who works with the equipment. Anyone who prepares, sets, disassembles, cleans and disinfects the unit must also read the User Manual. Please pay particular attention to the safety instructions in each chapter.

Compliance with safety information Working with medical equipment is associated with certain risks to patients, medical personnel and the environment. Risks cannot be entirely eliminated by design measures alone. Safety does not depend solely on the equipment. Safety depends to a large extent on the training of medical personnel and correct operation of the equipment. The safety instructions in this chapter must be read, understood and applied by everyone who is working with the equipment.

Structure of safety instructions The safety instructions are structured according to the following risks: • Operating errors and incorrect installation by persons without training • Risks due to the environment 80110-801 10.15

• Electric shock • Risk of infection • Fire / explosion • Defective unit, defective accessories • Interference caused by the unit • Safety information for use of ERBEJET 2 • Notes

Operating errors and incorrect installation by persons without training

WARNING Operating errors and incorrect installation by persons without training Persons without training can operate or install the unit incorrectly. Risk of injury or death for patients and medical staff! Risk of damage to property.  The equipment may only be used and installed by persons who have been trained on how to use and install it properly according to this User Manual.  Training may only be carried out by persons who are suitable on the basis of their knowledge and practical experience.

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1 • Safety Instructions

 In the event of uncertainties or if you have any questions, please contact Erbe Elektromedizin. You will find the addresses in the address list at the end of this User Manual.

Risks due to the environment

NOTICE Interference with the unit by portable and mobile HF communication devices (e.g. mobile phones, WLAN equipment) Electromagnetic waves emitted by portable and mobile HF communication devices can effect the unit. The unit may fail or not perform properly.  Please see the table "Recommended separation distances between portable and mobile HF communications equipment and the equipment" at the end of this User Manual.

NOTICE Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity, it may sustain damage, fail, or not perform properly.  Operate the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.

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 If other ambient conditions must be observed for operation of the equipment, you will also find them in the Technical Data.

NOTICE Unsuitable temperature or humidity in transit or storage If you transport or store the equipment at an unsuitable temperature or level of humidity, it may sustain damage and fail.  Transport and store the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.  If other ambient conditions must be observed for transport and storage of the equipment, you will also find them in the Technical Data.

NOTICE Insufficient acclimatization time, unsuitable temperature during acclimatization If the device was stored or transported below or above a certain temperature, it will take a certain time and temperature to acclimatize. If you do not observe the rules, the device can sustain damage and fail.  Acclimatize the device according to the rules in the Technical Data.

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1 • Safety Instructions

NOTICE Overheating of the device due to poor ventilation If ventilation is poor, the device can overheat, sustain damage, and fail.  Install the device in such a way that there is an unobstructed circulation of air around the housing. Installation in confined wall recesses is prohibited.

NOTICE Penetration of liquid into the device The housing is not absolutely watertight. If liquid penetrates, the device can sustain damage and fail.  Make sure no liquid can penetrate the device.  Do not place vessels containing liquids on top of the device.  Take care when connecting the separating medium to the pump unit that the unit does not come into contact with the separating medium. The same applies when removing the separating medium.

Electric shock

Defective grounded power outlet, power supply network without proper grounding, inferior-quality power cord, incorrect line voltage, multiple power outlets, extension cords Risk of electric shock and other injuries to the patient and medical personnel! Risk of damage to property.  Connect the unit / the equipment cart to a properly installed grounded power outlet.  Only connect the unit to a power supply network with proper grounding.  Only use the Erbe power cord or an equivalent power cord for this purpose. The power cord must bear the applicable national test symbol.  Check the power cord for damage. You must not use a damaged power cord.  The supply voltage must match the voltage specified on the unit's rating plate.  Do not use multiple power outlets.  Do not use extension cords.

WARNING Incorrect line fuse, defective device Risk of electric shock to the patient and medical personnel! Risk of damage to property.  Blown line fuses may only be replaced by a competent technician. Only replacement fuses that have the same rating as the one specified on the unit’s rating plate may be used.

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WARNING

1 • Safety Instructions

 When a fuse has been changed, the function of the unit must be verified. If the unit does not function properly or if there are any concerns, please contact Erbe.

WARNING Connection of unit / equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel!  Switch off the device. Unplug the power cord of the device/equipment cart.

Risk of infection

WARNING Non-sterile applicator connector The patient can be infected by the use of a non-sterile applicator connector.  Use aseptic techniques when you connect the applicator connector with the pump unit.

WARNING Non-sterile separating medium The patient can be infected by the use of a non-sterile separating medium. 80110-801 10.15

 Only use sterile, physiological saline solutions.

WARNING Contaminated separating medium Separating medium splash over the medical staff. Risk of infection for the medical staff.  Avoid the accumulation of separating medium in the operating area. Ensure adequate suction.  Use personal protective equipment, e.g. a face mask and splash guard. The protective equipment must be appropriate for the risk arising from the patient.

WARNING Contaminated accessories Risk of infection for the medical staff.  Wear gloves when dismantling the accessories

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1 • Safety Instructions

Fire / explosion

WARNING Ignition of anesthetics, skin cleansers, and disinfectants in potentially explosive atmospheres If you place the device in a potentially explosive atmosphere, anesthetics, skin cleansers, and disinfectants can ignite. Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.  Do not place the device in potentially explosive atmospheres.

Defective unit, defective accessories

WARNING Technical safety checks not being done Risk of injury or death for patients and medical staff! Risk of damage to property.  Have the device checked for safety at least once a year.  You must not use a device that is not safe.

Damaged device, damaged accessories, modified device, and modified accessories Risk of injury to the patient and medical personnel! Risk of damage to property.  Check the unit and accessories (e.g. footswitch, cables, tubes from instruments) for damage every time before use.  You must not use damaged equipment or damaged accessories. Replace defective accessories.  If the unit or accessories are damaged, please contact our customer service.  For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will invalidate liability on the part of Erbe Elektromedizin GmbH.

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WARNING

1 • Safety Instructions

NOTICE Tension on the suction hose If you subject the suction hose to tension, secretion can escape from the branch (1).  Do not subject the suction hose to tension.

1

Fig. 1-1

Interference caused by the unit

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NOTICE Use of non-approved internal cables by Technical Service This can result in the increased emission of electromagnetic waves or reduce the immunity of the device. The unit may fail or not perform properly.  Technical Service may only use the internal cables that are listed in the service manual for the device.

NOTICE Stacked devices If you stack the device next to other equipment or with other equipment, the devices can affect each other. The unit may fail or not perform properly.  The device may only be stacked next to or with VIO series units.  If it is necessary to operate the device near other equipment or stacked together with other equipment, check whether the devices are affecting each other: Are the devices behaving unusually? Do errors occur?

Safety information for use of ERBEJET 2

WARNING Unsuitable separating medium The use of an unsuitable separating medium can change the effect of the water jet. Risk of injury to the patient.  Only use sterile, physiological saline solutions.

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1 • Safety Instructions

WARNING Effect set too high The higher the effect, the greater the risk of accidental tissue damage.  Set effect as low as possible relative to the required surgical effect.

WARNING Activation of the unit with no knowledge of active settings If the user does not understand the active settings of the unit, he can cause the patient accidental tissue damage.  Check the active settings on the unit display after setting the unit, changing a program, or changing a setting.

CAUTION Uncontrolled water jet Depending on the effect setting, the water jet can damage skin or the eyes.  Never point the water jet at medical personnel. Do not point the water jet at the patient accidentally.  Wear goggles for your own safety.  Point the tip of the applicator at the operating field. Only press the pedal when you want to cut.

During the priming process, separating medium can escape from the applicator. Depending on the effect setting, the water jet can damage skin or the eyes.  Never point the applicator at medical personnel. Never point the applicator at the patient during the priming process.  Wear goggles for your own safety.  If separating medium escapes from the applicator, stop the priming process. Press the Selection button next to the menu item. STOP.

NOTICE Applicator pressure hose kinked If you kink the pressure hose you will obtain an error message in critical cases and have to replace the applicator and pump unit.  Do not kink the pressure hose.

Notes Grounding

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Note: If necessary, the equipment can be connected to the external grounding system of the room with the grounding pin on the back of the unit and/or Cart using a connecting cable designed for this purpose. Affects of low frequency leakage currents due to a defective grounding system within the room may be eliminated through external grounding.

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CAUTION

1 • Safety Instructions

Note: The equipment conforms to the requirements of Type CF and is protected against the effects of a defibrillator discharge.

Membrane keyboards

Note: If alcohol-based disinfectants are used on units with membrane keyboards, this remove the anti-glare finish. However, the user surfaces remain fully functional. This does not present a hazard.

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Use of a defibrillator

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1 • Safety Instructions

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2 • Description of the Controls

Chapter 2 Description of the Controls Controls on the front panel

ERBEJET 2

L1

R1

L2

R2

L3

R3

1 4 2 3

Fig. 2-1

Symbol

(1)

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Read the user manual before switching on and using the unit.

Power

(2) Power switch Unit on / off. The unit is completely disconnected from the power supply only when the power connector is unplugged.

Symbol

(3) The equipment conforms to the requirements of Type CF (Cardiac Float) and is protected against the effects of a defibrillator discharge.

Pump shaft

(4) Accommodates the pump unit.

Selection buttons

(L1) (L2) (L3) (R1) (R2) (R3) The buttons have a different function depending on which window is shown on the display. Take note of the function the button refers to.

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2 • Description of the Controls

Controls on the back

6 7

Fig. 2-2

Sockets

(1) Footswitch socket You can connect a single-pedal or a dual-pedal footswitch to this socket. (2) (3) ECB sockets (ECB means Erbe Communication Bus) Other compatible units can be connected to ERBEJET 2. The ECB ensures communication between the units. Connect an ECB cable with these sockets and with one of the other units. (4) Potential equalization terminal Attach a potential equalization line and connect this to the potential equalization system of the operating room. If you are using the Erbe VIO-CART, connect the potential equalization line to the potential equalization pin of the VIO-CART.

Power fuses

(5) Power fuses The unit is protected with power fuses. If one of these power fuses has blown, the unit may not be used on the patient again until it has been checked by a competent technician. The values of the power fuses are specified on the unit's rating plate. Only spare fuses with these values may be used.

Power connection

(6) Power connection Connect the unit to a properly installed grounded outlet. Only use the Erbe power cord or an equivalent power cord for this purpose. The power cord must bear the national test symbol. If the unit is installed on the Erbe VIO-CART, make the power connection with the power cord of the VIO-CART.

Symbol

(7) Read the user manual before switching on and using the unit.

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Potential equalization

3 • Working with ERBEJET 2

Chapter 3 Working with ERBEJET 2 Connecting suction module ESM 2, Connecting applicator to the pump unit If you use an applicator with suction hose you can use the suction module ESM 2 for suction.

WARNING Damaged device, damaged accessories, modified device, and modified accessories Risk of injury to the patient and medical personnel! Risk of damage to property.  Check the unit and accessories (e.g. footswitch, cables, tubes from instruments) for damage every time before use.  You must not use damaged equipment or damaged accessories. Replace defective accessories.  If the unit or accessories are damaged, please contact our customer service.

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 For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will invalidate liability on the part of Erbe Elektromedizin GmbH.

Attaching the mounting bracket

Fig. 3-1

 Equip the bracket with a mounting bracket. Hanging the suction container

Note: The suction container must be positioned lower than the operating field so that no fluid can flow back from the suction hose into the operating field.

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3 • Working with ERBEJET 2

Fig. 3-2

 Hang the suction container on the mounting bracket. Inserting the suction bag

 Insert the suction bag into the suction container. Connecting ESM 2 with the suction container

Note: Use a new membrane filter in the following cases: • For each new application (new operation). • If the membrane filter has been unpacked for longer than 7 days. • If the membrane filter has absorbed moisture.

Fig. 3-4

1. Connect the vacuum hose with the membrane filter.

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Fig. 3-3

3 • Working with ERBEJET 2

Fig. 3-5

2. Use the vacuum hose to connect the ESM 2 to the suction container directly. Plug the membrane filter onto the ESM 2.

Connecting the applicator to the pump unit

WARNING Non-sterile applicator connector The patient can be infected by the use of a non-sterile applicator connector.

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 Use aseptic techniques when you connect the applicator connector with the pump unit.

Fig. 3-6

1. Connect the applicator connector with the pump unit. The applicator connector locks firmly into the pump unit and can no longer be detached.

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