Erbe ESM 2 User Manual
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Erbe ESM 2 User Manual

Erbe ESM 2 User Manual

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USER MANUAL
ESM 2
V 1.0.x
HYDROSURGERY
80110-701_V25208
2024-01

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Summary of Contents for Erbe ESM 2

  • Page 1 USER MANUAL ESM 2 V 1.0.x HYDROSURGERY 80110-701_V25208 2024-01...
  • Page 3 USER MANUAL ESM 2...
  • 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

    Compatible power cords ..........24 Operating principle of the ESM 2 ......25...
  • Page 6 Working with the ESM 2 ........27...

  • Page 7: General Instructions For Use

    Member State. Intended Use / Indications for Use The suction module ESM 2 draws air through a vacuum hose out of a suction container. Compatibility The ESM 2 is used with the Erbe hydrosurgical unit ERBEJET 2, instruments and ac- cessories.

  • Page 8: Performance Characteristics

    1 • General Instructions for Use Performance characteristics Performance characteristics relating to the intended use are: • Suction of fluids • Collection of fluids in a suction bag / 64...

  • 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: Observation Of Further User Manuals

    2 • Safety Instructions Observation of further User Manuals The ESM 2 is operated together with an ERBEJET 2. The User Manual of the ESM 2 contains information about the ERBEJET 2 only if this is necessary for the operation of the ESM 2.

  • Page 11: Risks Due To The Environment

     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 12: Caused By Other Equipment

    Risk of injury to patient and medical personnel. Units may fail or not function properly.  Place the unit where possible only near Erbe units or stack the unit where possible only on Erbe units.  If it is necessary to operate the unit near or stacked together with units from other manufacturers, keep as much distance as possi- ble between the units.

  • 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: Risk Of Infection

    2 • Safety Instructions Risk of infection WARNING The unit is contaminated Risk of infection to the patient and medical personnel.  Follow the instructions for cleaning and disinfecting the unit. WARNING Contaminated accessories Risk of infection to the patient and medical personnel. ...

  • Page 15: Defective Unit, Defective Accessories

     Blown power fuses may only be replaced by a competent techni- cian.  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. / 64...

  • Page 16: Damage To The Unit And Accessories

    2 • Safety Instructions Tension on the suction tubing If you subject the suction tubing to tension, secretion can escape from the branch (1).  Do not subject the suction tubing to tension. Fig. 2-1 Damage to the unit and accessories WARNING Use of non-approved internal cables by Technical Service This can result in the increased emission of electromagnetic waves or...

  • Page 17: Installation Of The Unit

    Suction mode "Pedal": End activation of the pedal. Suction mode "Cont.": Pull the suction tubing off from the suction container. The vacuum built up by the ESM 2 is reduced in a short time by this measure. Installation of the unit...

  • Page 18: Safety Features

    The vacuum tube may be connected to the unit only through the membrane filter. The protection membrane filter prevents that air or fluid contaminated with germs enters the ESM 2. Coding of the connections The unit and the accessories are equipped in a well thought out way with female and male connections, so that the user is assisted to connect the accessories correctly.

  • Page 19: Description Of The Controls

    (6) Suction category The ESM 2 is a suction module in the “High vacuum/high flow” suction category (as per ISO 10079-1). The maximum vacuum that can be generated is -800 mbar / -80 kPa /-12 psi.

  • Page 20: Controls On The Back

    Controls on the back Fig. 3-2 (1) ECB socket Connect the ECB socket of the ESM 2 with the ECB socket of the ERBEJET 2. The ECB (Erbe Communication Bus) is responsible for the communication of the units with one another.

  • Page 21: Accessories

    The suction fluid passes from the applicator to the suction bag (9) through the suction tubing. The ESM 2 may be operated only in combination with a suction tubing that is integrat- ed in an applicator of the ERBEJET 2.

  • Page 22: Overview 2 (Fitting With 2 Suction Containers And Switch Valve)

    The suction fluid passes from the applicator to the suction bag (9) through the suction tubing. The ESM 2 may be operated only in combination with a suction tubing that is integrat- ed in an applicator of the ERBEJET 2.

  • Page 23: Compatible Units

    Compatible units The ESM 2 must only be used together with a Erbe ERBEJET 2 hydrosurgical unit. The ESM 2 must be connected to the ERBEJET 2 with an ECB cable.

  • Page 24: Compatible Power Cords

    4 • Accessories Compatible power cords Use the following compatible Erbe power cords. REF no.  REF no. Length, Power plug Power plug (supplied (spare amperage Erbe international with the part) designation designation unit) 51704-039 52704-039 4 m, 10 A...

  • Page 25: Operating Principle Of The Esm 2

    Chapter 5 Operating principle of the ESM 2 The ESM 2 draws air through the vacuum tube out from a suction container and in this way generates a vacuum. A suction bag connected with the suction tubing of the ap- plicator is located in the suction container.
  • Page 26 5 • Operating principle of the ESM 2 / 64...

  • Page 27: Working With The Esm 2

    The ESM 2 is operated together with an ERBEJET 2. This chapter contains information Manuals about the ERBEJET 2 only if this is necessary for the operation of the ESM 2. In any event you should also observe the User Manual of the ERBEJET 2.

  • Page 28: Setting Options For The Unit

    6 • Working with the ESM 2 Setting options for the unit The following parameters can be set on the ESM 2 via the user interface of the ERBEJET 2: Suction mode The suction mode determines whether the ESM 2 aspirates in continuous operation or whether the suction runs only if the waterjet pedal or (if present) the suction pedal is operated.

  • Page 29: Programs

    Factory unit settings The ERBEJET 2 is delivered from the factory with a preset, not changeable basic pro- gram. The following settings are made in this basic program for the ESM 2: • Suction mode: "Pedal" • Maximum vacuum: -100 mbar (or -10 kPa or -1.5 psi) •...

  • Page 30: Checking The Unit And Accessories

    Erbe Elektromedizin GmbH. Connecting suction accessories The configuration with the ESM 2 and the ERBEJET 2 installed on a VIO CART and 1 suction container is described below as an example. If 2 suction containers are used together with the switch valve, also note the overview illustration on page 22 for the connection.
  • Page 31  Never attempt to connect the ESM 2 directly with the suction tubing of the applicator or to aspirate fluid directly. The ESM 2 is intended exclusively for generating a vacuum in the suction con- tainer by aspirating air.
  • Page 32 • If the membrane filter has absorbed moisture. Fig. 6-5 1. Connect the vacuum tube with the membrane filter. Fig. 6-6 2. Use the vacuum tube to connect the ESM 2 to the suction container directly. Plug the membrane filter onto the ESM 2. / 64...
  • Page 33  Do not subject the suction tubing to tension. Fig. 6-7 Note: The ESM 2 may be operated only in combination with a suction tubing that is integrated in an applicator of the ERBEJET 2. Note: Observe at this place the User Manual of the ERBEJET 2 for the connection of the applicator to the ERBEJET 2.

  • Page 34: Connect Unit And Switch On

    1. Check that all relevant program settings are correct and have not been acciden- tally changed since the unit was last used. 2. You change the settings for the ESM 2 as required before or during the applica- tion (see also page 38).
  • Page 35 6 • Working with the ESM 2 Suction You must also observe the notes on use of the applicator used. If you have selected the "Pedal" suction mode, suction starts as soon as you activate the waterjet on the ERBEJET 2 via the waterjet footswitch or directly activate suction via the suction footswitch (if present).

  • Page 36: Dismantling Suction Accessories

    Note: The vacuum tube can remain attached to the suction container for the next ap- plication. ESM 2 1. Disconnect the vacuum tube (together with the membrane filter) from the ESM 2. 2. Separate the membrane filter from the vacuum tube and dispose of the mem- brane filter is a suitable way.

  • Page 37: Disposal Of Disposable Accessories

    6 • Working with the ESM 2 Dismantling the suction container 1. Separate the vacuum tube from the suction container and pull the suction con- tainer out of the mounting bracket. and mounting bracket 2. Remove the mounting bracket from the side rail.

  • Page 38: Changing And Saving Settings

    The following settings are possible for the suction mode: • "Off": The suction function is deactivated. • "Cont.": If there is an ECB connection between ESM 2 and ERBEJET 2 and both units are switched on, the suction runs without interruption as soon as a program has been selected or the start settings have been operated.
  • Page 39 6 • Working with the ESM 2 Setting the run-on time After you let the waterjet pedal go the suction still runs for the set run-on time, pro- vided you have set a run-on time greater than 0. Suction stops immediately when you let the suction pedal of the 2-pedal footswitch go.
  • Page 40 6 • Working with the ESM 2 / 64...

  • Page 41: Cleaning And Disinfection

    7 • Cleaning and disinfection Chapter 7 Cleaning and disinfection Safety Instructions WARNING The unit is contaminated Risk of infection to the patient and medical personnel.  Follow the instructions for cleaning and disinfecting the unit. WARNING Contaminated accessories Risk of infection to the patient and medical personnel. ...

  • Page 42: Dismantling, Field Of Application Of The Processing Information

    7 • Cleaning and disinfection WARNING Flammable detergents and disinfectants used on the unit/cart Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.  Use products that are not flammable. If the use of flammable products is unavoidable, proceed as fol- lows: ...

  • Page 43: Supplies

    7 • Cleaning and disinfection These substances may attack metal parts due to their corrosive effect. • Quaternary ammonium cations, phenolic compounds (e.g., phenoxyethanol) • Solvents and benzine These substances cause damage to plastics. Supplies • Ready-for-use wipes with a cleaning agent or disinfectant solution. •...

  • Page 44: Validated Procedure For Cleaning And Disinfection

    Germany. Leave the disinfection solution to work for one minute, making sure it is vis- ibly wetted. Erbe recommends this processing procedure for the unit, the cart, and the mounting bracket. Other equivalent procedures are possible. The user must ensure that the pro- cedures used are suitable by means of suitable measures (e.g., validation, routine...

  • Page 45: Troubleshooting

    Status messages, error messages The ERBEJET 2 can indicate on the display during operation (apart from different op- erating instructions) a number of status and error messages for the ESM 2. 3 different types of messages are possible: • Status messages: show a change in the operating state of the system. Status messages are for information purposes only.
  • Page 46 If necessary, switch the unit back on or re- interrupted. establish the ECB connection. The message also occurs if the ESM 2 is switched off during activation or the ECB Reactivate the unit. connection to the ERBEJET 2 is discon- With more frequent, untraceable occur- nected.
  • Page 47 The message also occurs if the unit has to Switch unit off and back on. If the error aspirate against a larger resistance. Pos- persists, inform the Erbe service depart- sible causes: Vacuum tube or suction tub- ment. ing is plugged, kinked or crimped; suction With more frequent, untraceable occur- bag is full;...
  • Page 48 8 • Troubleshooting / 64...

  • Page 49: Installation

    9 • Installation Chapter 9 Installation Safety Instructions 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 50 9 • Installation WARNING Unsuitable temperature or humidity in transit or storage If you transport or store the unit at an unsuitable temperature or level of humidity, it may sustain damage and fail. Risk of electric shock to the medical personnel. Risk of injury to the patient! ...

  • Page 51: Installation Of The Unit On A Vio Cart

     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 52: Installation Of The Unit Independently Of The Vio Cart

    9 • Installation Installation of the unit independently of the VIO CART CAUTION Unsuitable base Danger of injury due to unit dropping down.  Place the unit on a stable, level, and vibration-free base. Fig. 9-1 1. Connect as required the grounding terminal pin (1) through a grounding cable with the grounding system of the operating room.

  • Page 53: Technical Data

    10 • Technical Data Chapter 10 Technical Data Power connection Rated supply voltage 100 V to 240 V (± 10 %) Rated supply frequency 50 / 60 Hz Line current 0.4 A to 0.8 A Power input in standby mode 25 watts Maximum power consumption 100 watts...
  • Page 54 10 • Technical Data 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. Standards Classification according to EC Directive 93/42/EEC Classification according to Regulation (EU) 2017/745 Protection class as per EN 60 601-1 Type as per EN 60 601-1...

  • Page 55: Notes On Electromagnetic Compatibility (Emc)

    Risk of injury to patient and medical personnel. Units may fail or not function properly.  Place the unit where possible only near Erbe units or stack the unit where possible only on Erbe units.  If it is necessary to operate the unit near or stacked together with units from other manufacturers, keep as much distance as possi- ble between the units.
  • Page 56 11 • Notes on electromagnetic compatibility (EMC) CAUTION Unit interference from magnetic resonance imaging equipment The field of magnetic resonance imaging equipment can affect the unit. Risk of injury to the patient. The unit may fail or not perform properly. ...
  • Page 57 11 • Notes on electromagnetic compatibility (EMC) Guidance and manufacturer's declaration - electromagnetic immunity Surge IEC 61000-4-5 ±1 kV differential mode ±1 kV differential mode Mains power quality should be that of a typical commercial or ±2 kV common mode ±2 kV common mode hospital environment.
  • Page 58 11 • Notes on electromagnetic compatibility (EMC) Guidance and manufacturer's declaration - electromagnetic immunity Note: These guidelines may not apply in all cases. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a)  The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.7 MHz.
  • Page 59 11 • Notes on electromagnetic compatibility (EMC) Operating environment For the intended use, the unit may only be operated in premises used for medical pur- poses. The unit may be operated in the vicinity of an electrosurgical unit. The safety instruc- tions for the unit and the electrosurgical unit must be observed.
  • Page 60 11 • Notes on electromagnetic compatibility (EMC) / 64...

  • Page 61: 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 62: 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. / 64...

  • Page 63: Symbols

    13 • Symbols Chapter 13 Symbols Individual details of the symbols in this chapter may deviate from your product. Not all symbols may necessarily appear on your unit or its packaging. Symbol Explanation Caution: Before switching the unit on or performing another action related to the unit, read the safety instructions in the User Manual.
  • Page 64 13 • Symbols Symbol Explanation Foot switch Erbe Communication Bus Used to exchange data between Erbe units. 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.

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