mbnet Engineering ergo basic Bedienungsanleitung
Art.-Nr.: 360 711 Ver.: a
ergo basic
Operating Manual
internal cable feed
300° pivot range
height-adjustable
telescopic arm
ergo basic 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
The basic bears the mark (IEC 60601-1, Class I, Type BF with 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: 12.06.2020
mbnet Engineering GmbH
Kirschauer Straße 37a
OT Callenberg
D-02681 Schirgiswalde-Kirschau
Telephone +49 (0)3582 34 83 0 and 54 25 47
Telefax +49 (0)3592 34 34 4 and 54 25 49
E-Mail [email protected]
Internet www.mbnet.de
Art.-no.: 360 711 Ver.: a
Date of issue: 12.06.2020
Original
User Guide ergo basic
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 ............................................................................ 8
2.2 Patient module..................................................................... 9
2.3 Joint...................................................................................... 9
2.4 Telescopic arm closure ...................................................... 10
2.5 Leads................................................................................... 10
2.6 Fixation of cable arm.......................................................... 10
2.7 Serial Number .................................................................... 11
2.8 Supplied accessories for ergo basic .................................. 11
3 Operation ........................................................................... 11
3.1 Getting Started and Location ............................................ 11
4 ECG Recording ................................................................... 12
4.1 Placement of Electrodes ................................................... 12
4.2 Possible Sources of Errors with the ECG Recording ......... 13
4.2.1 Preparation ................................................................................... 13
4.2.2 Application of Electrodes ........................................................... 13
4.2.3 Before the Recording ................................................................... 13
4.2.4 During the Recording ................................................................... 13
4.2.5 Removal of Electrodes from the Skin........................................ 13
4.3 Electrode Identification and Colour Code ........................ 14
4.4 Resting ECG with 10-lead Patient Cable
Electrode Placement for Standard Leads .................. 14 – 15
4.5 Right Precordial (C4r).................................................. 15 – 16
5 Application .......................................................................... 16
5.1 Operating Conditions ........................................................ 16
5.2 Starting a Recording .......................................................... 17
6 Maintenance and Care ........................................................ 17
6.1 Visual Inspection........................................................................... 17
6.2 Cleaning the Housing and Cables ............................................ 18
6.2.1 Cleaning the ECG-leads .............................................................. 19
6.2.2 Cleaning Connection Cables...................................................... 19
6.2.3 Admissible Detergents................................................................. 19
6.2.4 Non-admissible Detergents ........................................................19
6.3 Disinfection ........................................................................ 20
6.3.1 Admissible Disinfectants ............................................................ 20
6.3.2 Non-admissible Disinfectants .................................................... 20
6.4 Inspection Report .............................................................. 21
6.5 Accessories and Consumables .......................................... 22
6.6 Replacement of ECG Leads ............................................... 22
7 Troubleshooting................................................................. 22
7.1 Possible Errors ................................................................... 22
7.2 Preventing Electromagnetic Interference ........................ 23
7.3 Warranty ............................................................................. 24
7.4 Accessories and Disposables ............................................. 24
8 Technical Data ................................................................... 25
8.1 Device ................................................................................. 25
8.2 System Cable ..................................................................... 25
8.3 Cable Arm ........................................................................... 25
8.4 Safety Standards ............................................................... 25
ergo basic User Guide
Seite 4
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
specified 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 6: “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 cable arm 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 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 flammable
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 ergo basic
Seite 5
1.5 Safety-conscious Operation
Make sure that the staff have read and understood the operating instructions,
in particular 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 with defective cables constitutes a danger to the life and limb of the patient.
Therefore take note of the following:
Damaged cable connections and connectors must be replaced immediately.
1.7 Operation with other Devices
If the device is part of a medical system, only the original ECG cables 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
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.
Do not use high-temperature sterilisation processes (such as autoclaving).
Do not use e-beamor gamma radiation sterilisation.
Do not use aggressive or abrasive cleaners.
Do not, under any circumstances, immerse the device or cable assemblies in cleaning liquid.
ergo basic User Guide
Seite 6
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 6: “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
User Guide ergo basic
Seite 7
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
ergo basic User Guide
Seite 8
2 Introduction
The ergo basic is an ECG cable for recording heart potentials during resting and stress ECGs
and sending the data to the ECG device.
2.1 Elements of the Suction Device
2.1.1 Overview
internal cable feed
height-adjustable
telescopic arm
300° pivot range
2.1.2 Scope of Delivery
Standard Model
Banana plug or Clipcable
Options
Trolley
User Guide ergo basic
Seite 9
2.2 Patient module
What makes the patient module stand out is its optimal user ergonomics.
The control panel is easy to clean.
2.3 Joint
The joint has a locking screw.
The joint is set from factory! Adjust only when necessary!
patient module
ECG-leads
Caution
ergo basic User Guide
Seite 10
2.4 Cable Arm
The cable arm has a special feature on a hidden cable management as well as a movable and
horizontal telescopic arm.
telescopic armtelescopic arm closure
joint
patient module
Telescopic arm closure
Open and close to extend and retract of the telescopic arm.
2.5 Leads
The tenshielded, interference-free electrode lines are trouble-free and standout by virtue of
their low abrasion and high flexibility.
Please pay attention on the careful handling of ECG-leads (see page 19, chapter 6.2)
2.6 Fixation of cable arm
Standard-Fixation ITD (accessory option, must be ordered separately).
Caution
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