Erbe ERBEJET 2 User Manual
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Erbe ERBEJET 2 User Manual

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USER MANUAL
ERBEJET
2
®
V 1.1.x
HYDROSURGERY
80110-801_V23493
2022-03

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  • Page 1 USER MANUAL ERBEJET ® V 1.1.x HYDROSURGERY 80110-801_V23493 2022-03...
  • Page 3 USER MANUAL ERBEJET ®...
  • Page 4 Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or dissemi- nated 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.

  • Page 5: Table Of Contents

    Safety information for use of ERBEJET 2 ........
  • Page 6 ERBEJET 2 example accessories........

  • Page 7: General Instructions For Use

    The water jet can be used for marking, rinsing, lifting and dissecting tissues. Compatibility You can connect ERBEJET 2 with the Erbe ESM 2 suction module via an ECB cable. The functions of the ESM 2 suction module are then shown on the ERBEJET 2 display. You obtain a mutually communicating system.

  • Page 8: Qualification Of User

    1 • General Instructions for Use Qualification of user For the intended use, the unit may only be operated by medical professionals who have been trained in the use of the unit or combination of units on the basis of the User Manual.

  • Page 9: Safety Instructions

    2 • Safety Instructions Chapter 2 Safety Instructions 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. CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

  • Page 10: Compliance With Safety Information

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

  • Page 11: Risks Due To The Environment

    2 • Safety Instructions Risks due to the environment Unsuitable temperature or level of humidity during operation If you operate the unit at an unsuitable temperature or level of hu- midity, it may sustain damage, fail, or not perform properly. ...

  • Page 12: Caused By Other Equipment

    "Notes on electromagnetic compatibility (EMC)".  If you are using accessories from other manufacturers, check whether the Erbe unit is interfering with other units or being af- fected by interference itself. You cannot use the unit if there is any interference.

  • Page 13: Electric Shock

     Only connect the unit to a power supply network with proper grounding.  Use the compatible Erbe power cord (see the Accessories, Com- patible power cords chapter).  Check the power cord for damage. You must not use a damaged power cord.
  • Page 14 2 • Safety Instructions WARNING Non-sterile infusion set The patient may become infected if a non-sterile infusion set is used.  Use aseptic techniques when connecting the infusion set to a bot- tle or a bag of separating medium.  Use aseptic techniques when connecting the infusion set to the pump cartridge.

  • Page 15: Fire / Explosion

    2 • Safety Instructions Fire / explosion WARNING Ignition of anesthetics, skin cleansers, and disinfectants in poten- tially explosive atmospheres If you place the unit in a potentially explosive atmosphere, anesthet- ics, skin cleansers, and disinfectants can ignite. Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.

  • Page 16: Damage To The Unit And Accessories

     For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will in- validate liability on the part of Erbe Elektromedizin GmbH. Tension on the suction hose If you subject the suction hose to tension, secretion can escape from the branch (1).

  • Page 17: Notes

    2 • Safety Instructions 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.
  • Page 18 2 • Safety Instructions Activation under visual inspection Note: Only activate the water jet under visual inspection. Use of dyes Note: If you want to use a dye, please observe the instructions in the notes on use for the pump cartridge and instruments. / 66...

  • Page 19: Description Of The Controls

    3 • Description of the Controls Chapter 3 Description of the Controls Controls on the front panel ERBEJET 2 Fig. 3-1 Symbol Indicates that the safety instructions in the User Manual must be read before switch- ing the unit on.

  • Page 20: Controls On The Back

    Connect the unit to a properly installed, grounded power outlet. Use the compatible Erbe power cord (see the Accessories, Compatible power cords chapter). If the unit is installed on the Erbe VIO CART, connect to the power supply using the VIO CART’s pow- er cord.

  • Page 21: Working With Erbejet 2

     For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will in- validate liability on the part of Erbe Elektromedizin GmbH. Connecting suction module ESM 2, connecting the applicator to the...
  • Page 22 4 • Working with ERBEJET 2 Fig. 4-2  Hang the suction container on the mounting bracket. Inserting the suction bag Fig. 4-3  Insert the suction bag into the suction container. Connecting ESM 2 with the suction Note: Use a new membrane filter in the following cases: container •...
  • Page 23 4 • Working with ERBEJET 2 Fig. 4-5 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 WARNING pump unit, replacing the applicator A pump unit is used for several patients Risk of cross-infection.

  • Page 24: Selecting Program, Inserting Pump Unit, Connecting Separating Medium, Priming Pump Unit And Applicator

    4 • Working with ERBEJET 2 Fig. 4-7 The pump unit is intended for the treatment of one patient. The applicators can be re- placed any number of times during the treatment of this one patient.  Press the release mechanism (1) to release the applicator.
  • Page 25 4 • Working with ERBEJET 2 Fig. 4-9 2. You will then see a selection list of programs. 3. Select a program with the selection buttons R1, R3. Example setting: BASIC PRO- GRAM. 4. Confirm your selection. Press the selection button next to the menu item OK.
  • Page 26 4 • Working with ERBEJET 2 Fig. 4-12 2. As soon as the pump unit has been connected, the ERBEJET prompts you to prime the pump unit and applicator with separating medium. Connecting the separating medium WARNING Unsuitable separating medium The use of an unsuitable separating medium can change the effect of the water jet.
  • Page 27 4 • Working with ERBEJET 2 Fig. 4-13 2. Remove the protective cap from the pump unit. Connect the infusion tube to the Luer-Lock adapter (1) on the pump unit. Priming the pump unit and applicator Fig. 4-14 Fig. 4-15...

  • Page 28: Mounting Suction Hose Of Applicator To Suction Container

    (1).  Do not subject the suction hose to tension. Fig. 4-16 Note: The ESM 2 may be operated only in combination with a suction hose that is in- tegrated in an applicator of the ERBEJET 2. / 66...

  • Page 29: Window Settings, Selecting Effect, Setting Suction

    4 • Working with ERBEJET 2 Fig. 4-17 1. Attach the adapter to the connection for the suction hose. Fig. 4-18 2. Attach the suction hose to the adapter. Window settings, Selecting effect, Setting suction Window settings Fig. 4-19 The following parameters are stored in each program: •...
  • Page 30 Select an Effect with the selection buttons R2, R3. Example setting: Effect 45. Setting suction Fig. 4-21 If ERBEJET 2 is connected to an ESM 2 suction module, you can also apply suction with a suitable applicator, as well as cut. Press the selection button next to the menu item Suction.

  • Page 31: Activation

    Press the selection button R3 to set the suction mode. • Off: Suction is off. • Cont: Suction works continuously, independent of activation of ERBEJET 2. • Pedal: Suction works with pedal activation. In the example display, this setting is active.

  • Page 32: Saving A Modified Basic Program As A New Program, Selecting Program, Saving Programs For The Remode Function

    1- 60 sec. Note: When activating ERBEJET 2, the set effect is shown inverted on the display (white numbers on blue background). Note: During suction, the set maximum vacuum is shown inverted on the display of ERBEJET 2 (white numbers on blue background).
  • Page 33 4 • Working with ERBEJET 2 In the preceding stages of the tutorial you made changes to the settings of the basic program. The modified basic program is marked with a * in the display. The settings will be lost if they are not saved. You cannot overwrite the basic program with your settings.
  • Page 34 4 • Working with ERBEJET 2 Fig. 4-27 3. Select a program with the selection buttons R1, R3. Example: BASIC PROGRAM. 4. Confirm your selection. Press the selection button next to the menu item OK. Saving programs for the ReMode With the footswitch ReMode switch you can change between two program levels a and b of a program.

  • Page 35: Deleting A Program, Overwriting A Program

    4 • Working with ERBEJET 2 1. Change the settings of program 2 EXAMPLE. 2. Press the selection button next to the menu item Program / Setup. 3. Press the selection button next to the menu item SAVE / ERASE program.

  • Page 36: Ml-Signal

    4 • Working with ERBEJET 2 ml-Signal You can turn on the ml-Signal in Setup of ERBEJET 2 (see also Setup). A tone sounds after the emission of every ml separating medium. Displaying used separating medium, Resetting display Displaying used separating medium Fig.

  • Page 37: Having The Unit Of Pressure Set

    4 • Working with ERBEJET 2 Resetting display When inserting a new pump unit, the display of the liquid volume is automatically reset to 0. You can also manually reset the display of the liquid volume to 0. This is possible with every pump unit as often as one likes.
  • Page 38 4 • Working with ERBEJET 2 You can perform the following settings: • Contrast: Contrast in 10 levels. • Display brightness: Brightness in 10 levels. • Volume of button sound: Volume of button sound in 10 levels. • Volume of ml-Signal: Volume of the ml-Signal in 10 levels. When you turn on the ml-Signal, a tone sounds after the emission of every ml separating medium.

  • Page 39: Status Messages, Error Messages

    The pump unit drives have reached the reference position. Error messages An error message consists of an error code (EC.) and an error text. The ERBEJET 2 dis- play shows two different types of error messages. a) Error messages that prompt you to take action and remedy the error. You will find these error messages in the table.

  • Page 40: Error Messages With Error Codes In Numerical Order

    Service. Suction OFF You have attempted to activate the ESM 2 suction Set the suction mode to PEDAL. module, but the suction is deactivated in the Suc- tion window of the ERBEJET 2 display. Suction mode: OFF / 66...
  • Page 41 Switch on the ESM 2 suction module  with the power switch.    b) There is no connection between ERBEJET 2 b) Check the connection between ERBE- and the ESM 2 suction module. JET 2 and the ESM 2 suction module ...
  • Page 42 Keyboard error Various causes are possible:     a) You pressed a button when starting. a) Restart ERBEJET 2 without pressing a  button.   b) Button jammed. b) Inform Technical Service. Two switches simultane- You have pressed both footswitch pedals at the Press just one pedal.

  • Page 43: Installation

    6 • Installation Chapter 6 Installation Ambient conditions WARNING Ignition of anesthetics, skin cleansers, and disinfectants in poten- tially explosive atmospheres If you place the unit in a potentially explosive atmosphere, anesthet- ics, skin cleansers, and disinfectants can ignite. Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.

  • Page 44: Electrical Installation

     Only connect the unit to a power supply network with proper grounding.  Use the compatible Erbe power cord (see the Accessories, Com- patible power cords chapter).  Check the power cord for damage. You must not use a damaged power cord.

  • Page 45: Installing Erbejet 2

    • Connect the unit to a properly installed, grounded power outlet. Use the compati- ble Erbe power cord (see the Accessories, Compatible power cords chapter). If the unit is installed on the VIO CART, connect to the power supply using the VIO CART’s power cord.
  • Page 46 6 • Installation / 66...

  • Page 47: Disassembly, Cleaning And Disinfection

    7 • Disassembly, Cleaning and Disinfection Chapter 7 Disassembly, Cleaning and Disinfection Removal of separating medium; disassembly of ESM 2 suction unit, applicator, and pump unit WARNING Contaminated accessories Risk of infection for the medical staff.  Wear gloves when dismantling the accessories Removing separating medium Remove the separating medium from the pump unit.

  • Page 48: Safety Instructions For Cleaning And Disinfection

    7 • Disassembly, Cleaning and Disinfection Removing the pump unit with applicator Fig. 7-3  Press the selection button next to the menu item EJECT. The pump unit unlocks. Observe the instructions on the display. Remove the pump unit. Dispose of the pump unit and applicator.

  • Page 49: Wipe Disinfection

    You can only start using the unit again once it has been checked by a service technician. Wipe disinfection For cleaning and disinfecting the surfaces of the unit or of the cart, Erbe recommends wipe disinfection. Use only disinfectant which complies with the relevant national standards.

  • Page 50: Instructions For Cleaning And Disinfection

    7 • Disassembly, Cleaning and Disinfection Instructions for cleaning and disinfection 1. Mix the disinfectant in the concentration specified by the manufacturer. 2. Clean any visible contamination before disinfecting (e.g. blood) from the surfaces using the disinfectant. Otherwise the efficacy of the subsequent disinfection may be impaired.

  • Page 51: Technical Data

    Activation Footswitch Separating medium Sterile, physiological saline solutions Suction as a separate module (Erbe ESM 2) adjustable -100 to -800 mbar (± 50 mbar) Applicators Sterile single-use applicators, rigid and flexible for open, lap- aroscopic, endoscopic, microsurgical, minimal-invasive and micro-invasive applications, from 1.3 mm outer diameter.
  • Page 52 8 • Technical Data Ambient conditions for operation of the unit Temperature +10 °C to +40 °C Relative humidity 15% – 80%, noncondensing Acclimatizing If the unit has been stored or transported at temperatures below +10 °C or above +40 °C, the unit will require approx. 3 hours to acclimatize at room temperature.

  • Page 53: Notes On Electromagnetic Compatibility (Emc)

    "Notes on electromagnetic compatibility (EMC)".  If you are using accessories from other manufacturers, check whether the Erbe unit is interfering with other units or being af- fected by interference itself. You cannot use the unit if there is any interference.
  • Page 54 9 • Notes on electromagnetic compatibility (EMC) WARNING 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 unit. Risk of injury to the patient. The unit may fail or not perform properly. ...
  • Page 55 9 • Notes on electromagnetic compatibility (EMC) Guidance and manufacturer's declaration - electromagnetic immunity Voltage dips, short- 0% U for 0.5 cycle, 0% U for 0.5 cycle, Mains power quality should be term interruptions and at 0, 45, 90, 135, 180, 225, at 0, 45, 90, 135, 180, 225, that of a typical commercial or voltage fluctuations on...
  • Page 56 9 • Notes on electromagnetic compatibility (EMC) Electromagnetic immunity against high-frequency wireless communication units as per IEC 61000-4-3 Frequency band (MHz) Test frequency (MHz) Modulation Compliance level (V/m) 380 - 390 Pulse (18 Hz) 430 - 470 FM ± 5 kHz deviation or pulse (18 Hz) 704 - 778...
  • Page 57 9 • Notes on electromagnetic compatibility (EMC) Essential performance characteristics The unit does not have any essential performance characteristics within the meaning of IEC 60601-1. / 66...
  • Page 58 9 • Notes on electromagnetic compatibility (EMC) / 66...

  • Page 59: Maintenance, Customer Service, Warranty, Disposal

    Modifications and repairs may only be undertaken by Erbe or by persons expressly au- thorized by Erbe. Erbe accepts no liability if modifications and repairs to the unit or accessories are made by unauthorized persons. This will also invalidate the warranty.

  • Page 60: Disposal

    EU Directive 2012/19/EU of 07/04/2012, WEEE. In non-EU countries the local regulations must be observed. If you have any questions about disposal of the product, please contact Erbe Elektro- medizin or your local distributor. / 66...

  • Page 61: Accessories

    Chapter 11 Accessories Introduction The following offers an overview of example accessories for each accessory category. A complete overview is available in the Erbe accessories catalog and on the Erbe web- site. We recommend the use of Erbe accessories. / 66...

  • Page 62: Erbejet 2 Example Accessories

    11 • Accessories ERBEJET 2 example accessories HybridKnife Accessories for ERBEJET 2 Applicators and probes ESM 2 (suction module for liquids) Cart and accessories / 66...

  • Page 63: Compatible Units

    11 • Accessories Compatible units You can connect ERBEJET 2 with the Erbe ESM 2 suction module via an ECB cable. In this case, the units communicate with each other. You cannot connect suction systems from other manufacturers to ERBEJET 2 using an ECB cable.
  • Page 64 11 • Accessories REF no.  REF no. Length, Power plug (type) (supplied with the (spare part) amperage unit) 51704-053 52704-053 4 m, 10 A 51704-054 52704-054 4 m, 10 A BR/3 51704-057 52704-055 5 m, 10 A 51704-058 52704-058 2.5 m, 10 A IL/3G / 66...

  • Page 65: Symbols

    Serial number Manufacturer Date of manufacture Keep away from sunlight Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation Quantity (x) Follow instructions for use Warning; Electricity Foot switch Erbe Communication Bus Used to exchange data between Erbe units. / 66...
  • Page 66 12 • Symbols Symbol Explanation Equipotentiality Refers to the grounding terminal. Off, On Defibrillation-proof type CF applied part The applied parts of the unit (e.g. instrument sockets) are pro- tected against the effects of defibrillator discharge. Computer network Refers to the computer network itself or the network connections. Input HF isolated patient circuit The danger of leakage currents and therefore the danger of burns...

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