mbnet Engineering ergo vac User manual

Art.-Nr.: 360 188 Ver.: c
Operating Manual
internal cable
feed
pump module:
small, quiet, powerful suction
300° pivot range
height-adjustable
telescopic arm
suspension for suction leads
Trolley optional (standard version w/o trolley)

ergo vac
User guide
Sales and Service Information
mbnet Engineering GmbH has a network of customer service, sales and advisory centres.
Contact your nearest mbnet Engineering GmbH subsidiary to obtain the address of your
local distributor.
You can find a full list of all subsidiaries and distributors on our website: www.mbnet.de
Sales information can also be obtained from: [email protected]
mbnet Engineering GmbH
Kirschauer Straße 37a
D-02681 Callenberg
Telephone [phone] u. 54 25 47
Fax [phone] u. 54 25 49
E-Mail [email protected]
Internet www.mbnet.de
Ergo vac bears the mark (IEC 60601-1, Class I, Type BF without defibrillation protection), indicating its compliance
with the essential requirements regarding safety, functionality and labelling of Annex I of the Medical Device Directive
93/42/EEC. The requirements apply to patients, users and third persons who come into contact with this device within
the scope of its intended use.
Date of issue: 30.05.2019
Art.-no.: 360 188 Ver.: c
Date of issue:: 30.05.2019
Original

ergo vac
User guide
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 ................................................ 6
1.10.1 Symbols Used in this Document ...................................... 6
1.10.2 Symbols Used on the Device............................................ 7
2 Introduction .................................................................... 8
2.1 Elements of the Suction Device ...................................... 8
2.1.1 Overview ......................................................................... 8
2.1.2 Scope of Delivery ............................................................. 9
2.2 Control Box with Control Panel ...................................... 9
2.3 Suction Electrode Leads ................................................ 9
2.4 Cable Arm ..................................................................... 10
2.5 Pump Module ............................................................... 10
2.6 Fixation Pump Module ................................................. 11
2.7 Serial Number .............................................................. 11
2.8 Supplied accessories ................................................... 11
3 Operation ..................................................................... 12
3.1 Getting Started ............................................................. 12
3.2 On / Off .......................................................................... 12
3.3 Power Supply................................................................ 13
3.3.1 Displays for Mains or Battery Power .............................. 13
3.3.2 Isolation from Power Grid .............................................. 13
4 Controls ........................................................................ 13
4.1 Suction Levels .............................................................. 14
4.2 Blowing out Air ............................................................. 14
4.3 Cleaning ....................................................................... 14
5 ECG Recording ............................................................14
5.1 Placement of Electrodes ......................................... 14/15
5.2 Possible Sources of Errors with the ECG Recording ... 15
5.2.1 Preparation..................................................................... 15
5.2.2 Application of Electrodes................................................ 15
5.2.3 Before the Recording ..................................................... 16
5.2.4 During the Recording ..................................................... 16
5.2.5 Removal of Electrodes from the Skin ............................. 16
5.3 Electrode Identification and Colour Code ................... 16
5.4 Resting ECG with 10-lead Patient Cable
Electrode Placement for Standard Leads .................... 17
5.5 Right Precordial (C4r) ................................................... 18
6 Application .................................................................... 19
6.1 Operating Conditions ................................................... 19
6.2 Starting a Recording .................................................... 19
7 Maintenance and Care ................................................. 20
7.1 Visual Inspection ........................................................... 20
7.2 Cleaning the Housing and Cables................................. 21
7.2.1 Cleaning and Storing the Electrodes............................... 22
7.2.2 Recommended Cleaning and
Disinfection Methods for Electrodes ........................ 23 - 27
7.2.3 Cleaning the Suction Hoses ........................................... 28
7.2.4 Cleaning Connection Cables .......................................... 28
7.2.5 Admissible Disinfectants................................................. 28
7.2.6 Non-admissible Detergents ............................................ 28
7.3 Disinfection.................................................................... 29
7.3.1 Admissible Disinfectants................................................. 29
7.3.2 Non-admissible Disinfectants ......................................... 29
7.4 Battery .......................................................................... 29
7.4.1 Charging the Battery ...................................................... 29
7.4.2 Battery Disposal ............................................................. 30
7.5 Inspection Report ......................................................... 30
Replacement of Parts with a Limited Life,
every 3 – 5 years ............................................................ 31
7.6 Accessories and consumables ....................................... 31
7.7 Replacement of ECG Leads ........................................... 32
8 Troubleshooting ............................................................ 32
8.1 Possible Errors ............................................................. 32
8.2 Preventing Electromagnetic Interference ................ 32/33
8.3 Warranty ....................................................................... 34
8.4 Accessories and Disposables ...................................... 34
9 Technical Data .............................................................. 34
9.1 Pump Module ............................................................... 34
9.2 Preventing Electromagnetic Interference ..................... 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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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 have 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 5: “Maintenance and Care” are observed.
Do not modify this equipment without authorization of the manufacturer.
1.2 Organisational Measures
Before using the device, ensure that a medical product representative has
explained its functions as well as the safety requirements.
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 direct cardiac application.
The device is not for use in an MRI suite.
Warning

User guide
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1.5 Safety-conscious Operation
Make sure that the staff have 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.
Fuses must only be replaced with the same type and rating as the
original.
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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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 liabil-
ity 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 representa-
tive 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 5: “Maintenance and Care” have been
complied with.
No further guarantees are assumed. mbnet Engineering GmbH makes no warranty of
merchantability or fitness for a particular purpose with respect to the product or parts
thereof.
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.
Reference to other instructions.
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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1.10.2 Symbols Used on the Device
BF-symbol, no protection against defibrillation current.
Dispose of as electronic waste.
Attention: consult accompanying documents.
Manufacturer
Date of manufacture
CE label
Follow the manufacturer’s instructions

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2 Introduction
The ergo vac 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
2.1.1 Overview
suction electrode
leads with colour
code
fixation pump module
pump module:
small, quiet, powerful
suction
internal cable
feed
Trolley optional
(standard version w/o trolley)
suspension for suction leads
height-adjustable
telescopic arm

User guide
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Standard Model
Resting and stress ECGs
Mains operation
Options
Battery operation
Trolley (with grounding cable)
Fixation pump module on trolley
2.1.2 Scope of Delivery
2.3 Suction Electrode Leads
The ten shielded, interference-free electrode lines are trouble-free and stand out by virtue of
their low abrasion and high flexibility.
2.2 Control Box with Control Panel
What makes the control box 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.
Control
Box
ON / OFF
Suction Power
Stop ECG
Clean
Caution Please pay attention on the careful handling of suction leads (see 7.2.2 page 23)

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User Guide
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2.5 Pump Module
pump module
Power
Power Switch
Fuse
2.4 Cable Arm
The special feature of the cable arm is its hidden cable routing as well as its movable and
horizontal telescopic arm.
height-adjustable
telescopic arm
Joint
Control
The unit may only be connected to the following devices:
ECG devices that meet IEC 60601-1 standards.
ECG monitors that meet IEC 60601-1 standards.
The unit must not be connected to Class B ECG devices.
Any connection to unauthorized hardware is at your own risk.
It may also void the warranty.
Caution