mbnet Engineering ergo vac compact User manual

Art.-no.: 360904 Ver.: c
Operating Manual
ergo vac compact
300° Pivot Range
Internal Cable
Feed
Height-adjustable
Telescopic Arm
Trolley optional (standard version w/o trolley)
Control with Keyboard

Sales and Service Information
The latest version of this instruction of use can be found at www.mbnet.de.
Sales information can also be obtained from: [e-mail]
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.
Date of issue: 26.05.2021
ergo vac compact
User Guide
mbnet Engineering Gmbh
Kirschauer Strasse 37a
OT Callenberg
D-02681 Schirgiswalde-Kirschau
Telephone [phone]
Fax [phone]
E-Mail [email protected]
Internet www.mbnet.de
Art.-no.: 360901 Ver.: c
Date of issue:: 26.05.2021
Original

User guide ergo vac compact
Table of Contents
1 Safety Notes ............................................................................. 4
1.1 Responsibility of the User ....................................................... 4
1.2 Organisational Measures.......................................................... 4
1.3 Indications for Use ................................................................... 4
1.4 Contra-indication ..................................................................... 4
1.5 Safety-conscious Operation .................................................... 5
1.6 Safe Use with Electronics ........................................................ 5
1.7 Operation with other Devices .................................................. 5
1.8 Maintenance ............................................................................ 5
1.9 Terms of Warranty ................................................................... 6
1.10 Symbols and Pictograms ......................................................... 7
1.10.1 Symbols Used in this Document ............................................. 7
1.10.2 Symbols Used on the Device.................................................... 8
2 Introduction ............................................................................. 9
2.1 Elements of the Suction Device ............................................... 9
2.2 Patient Module with Control Panel ....................................... 10
2.3 Joint ....................................................................................... 10
2.4 Cable Arm ............................................................................... 11
2.5 Suction Electrode Leads ........................................................ 11
2.6 Fixation of Cable arm ............................................................ 12
2.7 Label ....................................................................................... 12
2.8 Scope of delivery ................................................................... 12
3 Operation ............................................................................... 13
3.1 Getting Started ...................................................................... 13
3.2 On/Off .................................................................................... 13
3.3 Power Supply.......................................................................... 14
3.3.1 Power Supply and Battery Level Indicators .................. 14 – 16
3.3.2 Isolating the Device from the Mains ..................................... 16
4 Controls .................................................................................. 16
4.1 Suction Levels ........................................................................ 17
4.2 Blowing out Air ...................................................................... 17
4.3 Cleaning ................................................................................. 17
5 Possible Errors during the Suction Process ........................... 18
5.1 Placement of Electrodes ....................................................... 18
5.2 Possible Sources of Errors during the Suction Process ....... 19
5.2.1 Preparation............................................................................. 19
5.2.2 Application of Electrodes....................................................... 19
5.2.3 During the Recording ............................................................. 19
5.2.4 Removal of Electrodes from the Skin ................................... 19
5.3 Electrode Identification and Colour Code ........................... 19
6 Application ............................................................................. 20
6.1 Operating Conditions ............................................................ 20
6.2 Starting a Recording .............................................................. 20
7 Maintenance and Care ........................................................... 21
7.1 Visual Inspection .................................................................... 21
7.2 Cleaning the Housing and Cables.......................................... 22
7.2.1 Cleaning and Storing the Electrodes..................................... 23
7.2.2 Recommended Cleaning and
Disinfection Methods for Electrodes .............................. 24 - 28
7.2.3 Cleaning the Suction Hoses................................................... 29
7.2.4 Cleaning ECG Connection Cables .......................................... 29
7.2.5 Admissible Disinfectants........................................................ 29
7.2.6 Non-admissible Detergents ................................................... 29
7.3 Disinfection............................................................................. 30
7.3.1 Admissible Disinfectants........................................................ 30
7.3.2 Non-admissible Disinfectants................................................ 30
7.4 Battery .................................................................................... 30
7.4.1 Charging the Battery .............................................................. 30
7.4.2 Battery Disposal ..................................................................... 31
7.5 Inspection Report .................................................................. 31
7.5.1 Inspection Protocol ................................................................ 31
7.5.2 Replacement of Parts with a Limited Life,
every 3 – 5 Years...................................................................... 32
7.6 Accessories and Consumables............................................... 32
7.7 Replacement of ECG Leads .................................................... 33
8 Troubleshooting .................................................................... 33
8.1 Possible Errors ....................................................................... 33
8.2 Preventing Electromagnetic Interference ....................... 33-34
9 Technical Data ....................................................................... 35
9.1 Power Supply ......................................................................... 35
9.2 Patient Module ....................................................................... 35
9.3 System Cable ......................................................................... 35
9.4 Electrodes .............................................................................. 35
9.5 Cable Arm ............................................................................... 35
9.6 Safety Standards ................................................................... 35
10 EMC information..................................................................... 36
10.1 Table1: Immunity (all devices):
electromagnetic emissions ................................................... 37
10.2 Table 2: Immunity: electromagnetic immunity..................... 38
10.3 Table 3: electromagnetic immunity....................................... 39

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ergo vac compact User Guide
1 Safety Notes
1.1 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.
Ensure that the staff has read and understood the user guide. This applies in particular
to this section Safety notes.
The device must not be stacked at any moment.
Damaged or missing parts must be replaced immediately.
The safety, reliability and performance of the device can only be guaranteed when the
maintenance intervals as stated in Chapter 7: “Maintenance and Care” are observed.
Do not modify this equipment without authorization of the manufacturer.
1.2 Organisational Measures
Keep this user guide in an accessible place for reference purposes.
Make sure that it is always complete and legible.
Observe the operating and maintenance instructions.
1.3 Indications for Use
The device is an ECG vacuum and is operated in combination with normal ECG
devices. The device is suitable for both recording resting as well as exercise ECG and
is used for patients of both genders as well as all ancestries and age groups (preferably
as of the age of seven, also dependent on body size).
The device is only to be operated in a professional healthcare environment.
The device is suitable for use inside hospitals, cardiology centres,
outpatient clinics and medical practices.
The device can safely be used with pacemaker patients.
Always operate the device in line with the technical data indicated.
The device is not intended for sterile use or use outdoors.
This is a device of type BF. It is not defibrillation protected. As a safety precaution,
remove the electrodes before defibrillation!
1.4 Contra-indication
The device is not intended for sterile use.
The device must not be used in potentially explosive areas or in the presence of flam-
mable gases such as anaesthetic agents.
The device is not for use in an MRI suite.

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User guide ergo vac compact
1.5 Safety-conscious Operation
Make sure that the staff has read and understood the operating instructions, in par-
ticular this section Safety Notes.
Do not touch the housing of the device during defibrillation.
To ensure patient safety, none of the electrodes, including the neutral electrode, nor the
patient or any person with simultaneous patient contact, must come in contact with
conductive parts, even when these are earthed.
Immediately report any changes that impair safety (including operating behaviour) to the
responsible person.
Only use accessories and disposables recommended or supplied by mbnet
Engineering GmbH. The use of accessories or disposables from other manufacturers
may result in injury, inaccurate information and/or damage to the unit.
1.6 Safe Use with Electronics
Operating the device without the correctly rated fuse or with defective cables
constitutes a danger to the life and limb of the patient or the operator!
Therefore take note of the following:
The device must not be used if the power cable is damaged or
suspected of being damaged.
Damaged cable connections and connectors must be replaced imme-
diately.
Electrical safety devices, such as fuses, must not be modified.
1.7 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.
1.8 Maintenance
Danger of electric shock - do not open the device! It contains no parts, which can be
repaired by the user. Servicing must only be performed by qualified technicians
authorised by mbnet Engineering GmbH.
Switch off the device before cleaning and disconnect it from the mains.
Do not use high-temperature sterilisation processes (such as autoclaving). Do not use e-beam
or gamma radiation sterilisation.
Do not use aggressive or abrasive cleaners.
Do not, under any circumstances, immerse the device or cable assemblies in cleaning
liquid.

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ergo vac compact User Guide
1.9 Terms of Warranty
Your device is warranted against defects in material and manufacture, as stated in the Terms
and Conditions. Excluded from this warranty is damage resulting from negligence or improper
use. The warranty covers the free replacement of the defective part. Any liability for subsequent
damage is excluded. 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,
reliability and performance of the apparatus if:
assembly operations, extensions, readjustments or repairs are carried out by persons
authorized by the manufacturer, and
the device and approved attached equipment is used in accordance
with the manufacturer’s instructions, and
the maintenance intervals as stated in Chapter 7: “Maintenance and Care” have been complied
with.
No further guarantees are assumed. mbnet Engineering GmbH makes no warranty of mer-
chantability or fitness for a particular purpose with respect to the product or parts thereof.

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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.
For electrical hazards, warnings or precautionary measures when dealing with electricity.
For possibly dangerous situations which could lead to damage to property or system failure.
Important or helpful user information.
For a possibly dangerous situation which could lead to severe personal injury or to death.
For a direct danger which could lead to severe personal injury or to death.
For a possibly dangerous situation which could lead to slight personal injuries. This symbol is also
used to indicate possible damage to property.
DANGER
Warning
Caution

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ergo vac compact User Guide
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

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User guide ergo vac compact
2 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.
2.1 Elements of the Suction Device
Joint
Suction Leads
Height-adjustable
Telescope Cable Arm
Distributor with Keyboard
Trolley optional
Suspension
for Suction Leads

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ergo vac compact User Guide
Patient Module
ON/OFF
Regulation of Suction Power
Stop /Clean ECG
(blow out function)
Suction Power Display
(5 levels: 100, 130, 170, 210, 250 mbar)
Suction Leads
2.2 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.
The joint is set from factory! Adjust only when necessary!
2.3 Joint
The joint has a locking screw.
Caution