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Summary of Contents for mbnet Engineering ergo vac compact
- Page 1 Control with Keyboard Height-adjustable Internal Cable Telescopic Arm Feed 300° Pivot Range ergo vac compact Operating Manual Trolley optional (standard version w/o trolley)
- Page 2 The latest version of this instruction of use can be found at www.mbnet.de. Sales information can also be obtained from: info@mbnet.de ergo vac compact bears the mark, indicating its compliance with the essential general Safety and Perfo- mance requirements of Annex I of the Medical Device Regulation 2017/745/EU. The requirements apply to pa- tients, users and third persons who come into contact with this device within the scope of its intended use.
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Page 3: Table Of Contents
User guide ergo vac compact Table of Contents Safety Notes ................4 Application ................20 Responsibility of the User ............4 Operating Conditions ............20 Organisational Measures............4 Starting a Recording .............. 20 Indications for Use ..............4 Contra-indication ..............4 Maintenance and Care ............ -
Page 4: Safety Notes
User Guide ergo vac compact Safety Notes Responsibility of the User The device must be used only by qualified physicians or trained medical professionals. The responsibilities of the staff for operating and maintaining the device must be speci- fied by the operator. -
Page 5: Safety-Conscious Operation
Operation with other Devices If the device is part of a medical system, only the original suction hoses from mbnet Engineering GmbH must be connected to the device. Portable communication devices, HF radios and devices labelled with the symbol: (non-ionic electromagnetic radiation) can affect the operation of this device. -
Page 6: Terms Of Warranty
The warranty is void if unauthorised or unqualified persons attempt to make repairs. In case the device is defective, send it to your local mbnet Engineering GmbH representative or directly to the manufacturer. The manufacturer can only be held responsible for the safety,... -
Page 7: Symbols And Pictograms
User guide ergo vac compact 1.10 Symbols and Pictograms 1.10.1 Symbols Used in this Document The safety level is classified according to ISO 3864-2. The following overview shows the safety symbols and pictograms used in this user guide. For general safety notes as listed in this section. -
Page 8: Symbols Used On The Device
User Guide ergo vac compact 1.10.2 Symbols Used on the Device BF-symbol, no protection against defibrillation current Dispose of as electronic waste Manufacturer Date of manufacture CE label Refer to instruction manual Serial number Catalogue number Seite 8... -
Page 9: Introduction
Introduction The ergo vac compact is an ECG suction device for recording heart potentials during resting and stress ECGs and sending the data to the ECG device. The built-in control panel allows for easy operation and efficient configuration of the device. -
Page 10: Patient Module With Control Panel
User Guide ergo vac compact Patient module with Control Panel What makes the patient module stand out is its optimal user ergonomics. It consists of a control panel, control electronics and defibrillation protection. The control panel features white and green backlighting as well as push buttons. The control panel is easy to operate and to clean. -
Page 11: Cable Arm
User guide ergo vac compact Cable Arm The cable arm has a special feature on a hidden cable management as well as a movable and horizontal telescopic arm. Telescopic Arm Closure Telescopic Arm Patient Module Jjoint Telescopic arm Closure Opening and closing to insert and remove the telescopic arm. -
Page 12: Fixation Of Cable Arm
User Guide ergo vac compact Fixation of Cable Arm Standard-Fixation ITD (accessory option, must be ordered separately) Label 2021-05 Scope of Delivery Cable arm with patient module Electrode suction hose (6 x 1.10 m / 4 x 1.30 m) Spacers (2 pcs with 3 rows / 2 pcs with 2 rows) Medical grade power supply ECG connection cable 3.7m (15-pin D-Sub) -
Page 13: Operation
User guide ergo vac compact Operation Getting Started Electric shock hazard. The device must not be used if it is not properly grounded or the pow- HAZARD er cable is damaged or suspected to be damaged. Location The device must not be stored or operated in a wet, humid or dusty area. -
Page 14: Power Supply
Power Supply and Battery Level Indicators The device can either receive power from the mains or via the integrated rechargeable battery. Use only the power supply provided by mbnet Engineering GmbH to power and charge the Warning device, don‘t plug the device to other power supplies or USB ports! Battery capacity The integrated battery provides power for up to 2.5 hours of continuous ope-... - Page 15 User guide ergo vac compact Low battery level: 1 green LED will light up Critical battery level (max. remaining operating time: 10 minutes): green LED will start to flash! Once the minimum battery level has been reached, the device will automatically switch to battery...
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Page 16: Isolating The Device From The Mains
User Guide ergo vac compact If the device is in operation: during operation, the LEDs will not light up to indicate the battery level. 3.3.2 Isolating the device from the mains To isolate the device and the power adapter from the mains, simply pull out the adapter plug. -
Page 17: Suction Levels
User guide ergo vac compact Suction Levels The system‘s suction lines can be individually adjusted for each patient using 5 suction levels. When the unit is turned on, it activates an average default level (about -170 mbar). The current suction level is indicated by the green LEDs on the control panel. The highest level is about -250 mbar and should only be used in extreme cases (a lot of body hair). -
Page 18: Possible Errors During The Suction Process
Therefore, please note the following points: 1 Only use electrodes that are recommended by mbnet Engineering GmbH. 2 To increase the electrode's conductivity and adherence: Shave the areas where the electrodes are to be placed, if necessary. -
Page 19: Possible Sources Of Errors During The Suction Process
User guide ergo vac compact Possible Sources of Errors during the Suction Process 5.2.1 Preparation If you are using new electrodes or those, which have not been used for a long time and have there- fore dried out, first stabilise the electrodes by placing them for at least three hours in a 1% salt solution (NaCl solution). -
Page 20: Application
User Guide ergo vac compact Application Do use this device until you have read and understood the safety instructions at the beginning of these instructions for use. Caution The device is a BF type device. During operation, make sure that neither the patient- nor the conductive parts of the patient connec- tion or the electrodes (including the neutral ones) come into contact with other persons or conducti- ve parts (even if they are grounded). -
Page 21: Maintenance And Care
User guide ergo vac compact Maintenance and Care The device requires regular checks (Chapter 7.5, page 31). The test results must be recorded in writing and compared to the values in the accompanying documents. Maintenance work not described in this section may only be performed by a qualified, authorised technician. -
Page 22: Cleaning The Housing And Cables
User Guide ergo vac compact Cleaning the Housing and Cables Switch off the device before cleaning and disconnect it from the mains. Do not, under any circum- Warning stances, immerse the device in cleaning liquid and do not sterilise it with hot water, steam or air. -
Page 23: Cleaning And Storing The Electrodes
User guide ergo vac compact 7.2.1 Cleaning and Storing the Electrodes NEVER use metallic or sharp items to clean the electrodes. This could damage them Caution irreparably. Make absolutely sure that the suction unit is operating in cleaning mode when you immerse... -
Page 24: Recommended Cleaning And Disinfection Methods For Electrodes
User Guide ergo vac compact 7.2.2 Recommended Cleaning and Disinfection Methods for Electrodes Wiping disinfection / cleaning: to be carried out after every use Intensive wiping disinfection / c leaning: 1x daily after the last use (OR: when required) Immersion disinfection, cleaning / d rying: 1x weekly after the last use (OR: when required) This cleaning method can damage the suction unit if not carried out correctly. - Page 25 User guide ergo vac compact Diagram 4: Diagram 5: Impurities (electrode) Check the position of the suction dome on the electrode housing After cleaning, check the optimal fit of the suction dome on the electrode housing to ensure the suction electrode functions optimally.
- Page 26 User Guide ergo vac compact Pull off the silicone suction dome from the electrode housing (in the direction of the arrow). Then clean the inside of the suction dome and the electrode housing. Pull off the suction dome Diagram 9: Remove the suction dome Replace the suction dome after it has been cleaned back on the electrode housing.
- Page 27 User guide ergo vac compact Immersion Disinfection and Subsequent Cleaning and Drying This cleaning method can damage the suction unit if not carried out correctly. Caution 1. Switch off the suction unit 2. Position the container for the cleaning liquid in such a way that no medical equipment can be become wet from drops of liquid.
- Page 28 User Guide ergo vac compact Activate this function twice in a row. If the blow-out function is not activated correctly, it cannot be ruled out that cleaning liquid will flow over the electrode suction hose into the suction device. Diagram 13: Blow-out/ cleaning key 7.
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Page 29: Cleaning The Suction Hoses
User guide ergo vac compact 7.2.3 Cleaning the Suction Hoses UNDER NO CIRCUMSTANCES pull on the suction hoses during cleaning (risk of breaking the cable)! You MUST also instruct your temporary staff and the responsible cleaning staff on this matter! 7.2.4... -
Page 30: Disinfection
User Guide ergo vac compact Disinfection Disinfection removes certain bacteria and viruses. Please refer to the manufacturer’s information. Use commercially available disinfectants intended for clinics, hospitals and medical practices. Disinfect the device in the same way as described for cleaning the device in Chapter 7.2, page 22. -
Page 31: Battery Disposal
Recurrent test in line with the information from the ECG manufacturer Inspection carried out by: In case of a defect, please contact the service department of your hospital, your mbnet Engineering GmbH representative or the local after-sales service: (Name) (Telephone) -
Page 32: Replacement Of Parts With A Limited Life, Every 3 - 5 Years
Replaced on: The controller Accessories and Consumables Always use mbnet Engineering GmbH spare parts and disposables or products approved by Warning mbnet Engineering GmbH. Failure to do so may invalidate the warranty. Your local representative stocks all the disposables and accessories available for the ergo vac compact. -
Page 33: Replacement Of Ecg Leads
Contact customer service doesn‘t work Should these tips be of no help in fixing the problem, please call your mbnet Engineering GmbH dealer or directly contact mbnet Engineering GmbH. Please have your model name and serial number ready. They are listed on the type label on the pump housing. - Page 34 User Guide ergo vac compact Transmitter Testing max. power Distance d HF source frequency frequency P (W) Wireless (MHz) [MHz] communications devices Various radio services (TETRA 400) 380-390 Walkie-talkie (FRS) 430-470 Rescue service, police, fire brigade, servicing (GMRS) L TE band 13/17 704 – 707...
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Page 35: Technical Data
User guide ergo vac compact Technical Data 9.1. Power Supply Power supply GlobTek GMT 96180-1807-2.0-T3 Input 100 – 240 VAC, 50-60Hz, 0.6A Output 5V, 3.6A, 18.0W Input Protecion Internal fuse in line Protection This device is not designed for outdoor use (IPX0) -
Page 36: Emc Information
Guidance and manufacturer’s declaration – electromagnetic emissions The ergo vac compact is intended for use in the electromagnetic environment specified below. The customer or the user of the ergo vac compact should assure that it is used in such an environment. Compliance... - Page 37 Guidance and manufacturer’s declaration – electromagnetic immunity The ergo vac compact is intended for use in the electromagnetic environment specified below. The customer or the user of the ergo vac compact should assure that it is used in such an environment. IEC 60601...
- Page 38 Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ergo vac compact, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 39 The ergo vac compact is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ergo vac compact can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ergo vac compact as recommended below, according to the maximum output power of the communication equipment.
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