mbnet Engineering ergo basic User manual

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
Sales information can also be obtained from: inf[email protected]
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 [phone] and 54 25 47
Telefax [phone] 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

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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
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

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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.

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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 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

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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 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

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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

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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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2.7 Serial Number
2.8 Supplied accessories for ergo basic
Cable arm with patient module
Electrode suction hose (6 x 1 m / 4 x 1.30 m)
Standard bracket
Operation manual
3 Operation
3.1 Getting Started
The device must not be used if it is suspected to be damaged.
Location
The device must not be stored or operated in a wet, humid or dusty area.
It must also not be exposed to direct sunlight or heat from other sources.
The device must not come into contact with acids or acidic fumes.
The device should not be placed in the vicinity of X-ray, hf surgical equipment,
diathermy units, large transformers or electric motors.
DANGER

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4 ECG Recording
Ensure that neither the patient nor the leading parts of the patient connection nor the electrodes
(including the neutral electrodes) come in contact with other persons or conductive objects
(even when these are earthed).
4.1 Placement of Electrodes
Careful application of the electrodes and good electrode contact is important for a good recording
(see electrode positioning on page 14, chapter 4.4).
A minimal resistance between skin and electrode is required to obtain the best ECG signal and ensure the
highest quality ECG recording. 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.
Thoroughly clean the areas with alcohol or soapy water (skin cream is often applied
above all during the winter as this will increase electrode resistance enormously(!) –
Always COMPLETELY remove skin cream at the application sites!).
Let the skin dry thoroughly before you apply the electrodes.
3 Check the electrode resistance.
4 If the electrode contact is higher than the acceptable level:
Remove the electrode and use an abrasive cleaning pad or abrasive cleaning gel
to remove the uppermost layer of epidermis.
Apply the electrode.
5 Ensure that the patient is warm and relaxed before you start the recording.
6 After the recording, remove the electrodes.
* Dedicated abrasive cleaning gel gives very good results in reducing the skin-electrode resistance.
Warning

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4.2 Possible Sources of Errors with the ECG Recording
4.2.1 Preparation
With adhesive electrodes, observe their shelf-life - They should not beexpired!
Should you use suction bulbs and clams, always check wether they are cleaned before usage.
4.2.2 Application of Electrodes
The areas of skin to which the electrodes will be applied must be clean and dry.
Use an electrolyte ECG spray, which contains soluble chloride.
Do not use ECG gel! Only ECG spray!
Remove any skin cream!
4.2.3 Before the Recording
Inform the patient about the procedure so that they are not frightened.
The patient must:
be lying down relaxed (attention: hands must be on the couch, not in the air)!
not be cold (above all for resting ECG recordings)!
No powerful devices must be in operation close by at the same time.
The couch should not be touching the walls!
4.2.4 During the Recording
Suction hoses must under no circumstances pull / tear / stretch the electrodes, but must hang freely!
Wait with the recording of the ECG until you can see a good ECG recording on the screen.
Under no circumstances press the recording button beforehand!
Under no circumstances must the electrodes be applied on the patient‘s skin for longer than 25 minutes
(risk of blisters forming)!
4.2.5 Removal of Electrodes from the Skin
Do not pull on the electrode cables.

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4.3 Electrode Identifi cation and Colour Code
The electrode colour codes in this section correspond to Code 1 (IEC).
Below you will find the corresponding colour codes in accordance with Code 2 (AHA).
IEC AHA
IEC
label Colour AHA label Colour
Extremity R
L
F
red
yellow
green
RA
LA
LL
white
black
red
Chest
according
to Wilson
C1
C2
C3
C4
C5
C6
white / red
white / yellow
white / green
white / brown
white / black
white / purple
V1
V2
V3
V4
V5
V6
brown / red
brown / yellow
brown / green
brown / brown
brown / black
brown / purple
Neutral N black RL green
4.4 Resting ECG with 10-lead Patient Cable
Electrode Placement for Standard Leads
C1 red
R red
C2 yellow
C3 green
C4 brown
C5 black
C6 purple
L yellow
F green
N black
C1 red
C2 yellow
C3 green
C4 brown
C5 black
C6 purple
F green
N black
It is sometimes difficult
with a child to apply all
the electrodes. In this
case electrode C4 can be
placed on the right side
of the chest and the setting
“Recording display”
programmed to V4r.n.

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IEC label AHA label Connecting the ECG patient cable
C1, red V1, red Fourth intercostal space at the right sternal border
C2, yellow V2, yellow Fourth intercostal space at the left sternal border
C3, green V3, green Midway between C2 and C4
C4, brown V4, blue Fifth intercostal space on the mid-clavicular line
C5, black V5, orange Anterior axillary line on the same horizontal level as C4
C6, purple V6, purple Mid-axillary line on the same horizontal level as C4
L, yellow LA, black Left arm (resting ECG)
R, rot RA, white Right arm (resting ECG)
F, green LL, red Left foot (resting ECG)
N, black RL, green Right foot (resting ECG)
4.5 Right Precordial (C4r)
The ACC /AHA guidelines recommend that in all patients with myocardial infarction with inferior
ST elevation, an investigation into a possible RV ischemia or a RV infarction is carried out;
this investigation is undertaken with a right precordial C4r recording.
C2 yellow
C3 green
C5 black
C6 purple
L yellow
F green
C1 red
R red
N black
C4 brown
C2 yellow
C3 green
C5 black
C6 purple
F green
N black

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4.5 Right Precordial (C4r)
IEC label AHA label Connecting the ECG patient cable
C1, white / red V1, brown / red Fourth intercostal space at the right sternal border
C2, white / yellow V2, braun / yellow Fourth intercostal space at the left sternal border
C3, white / green V3, brown / green In the middle between C2 and C4
C4, white / brown V4, brown / blue Fifth intercostal space right on the mid-clavicular line.
C5, white / black V5, brown / orange Anterior axillary line on the same horizontal level as C4
C6, white / purple V6, brown / purple Mid-axillary line on the same horizontal level as C4
L, yellow LA, black Left arm
R, red RA, white Right arm
F, green LL, red Left foot
N, black RL, green Right foot
5 Application
Do not take an ECG picture until you have read and understood the safety instructions at
the beginning of these instructions for use.
The device is a BF type device.
During ECG recording, make sure that neither the patient- nor the conductive parts of the
patient connection or the electrodes (including the neutral ones) come into contact with other
persons or conductive parts (even if they are grounded).
The device must not be used if there is a suspicion of damage.
5.1 Operating Conditions
The device is not suitable for continuous operation.
High-frequency fields and radiation can influence the quality of ECG leads.
The device can be operated under the following environmental conditions:
Ambient temperature: +10 °C and +50 °C
Relative humidity: between 30 % and 75 % (non-condensing)
Air pressure: between 700 hPa and 1060 hPa
Caution
Caution

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6.1 Visual Inspection
Visually inspect the unit and cable assemblies for the following:
Device, housing and mains cable (not damaged or cracked)
Electrode cable sheathing and connectors (undamaged)
No cracks, abrasion or wear in any cable assembly
Defective units or damaged cables must be replaced immediately.
Warning
5.2 Starting a Recording
1Preparing the patient
2Apply electrodes
3Ask the patient about their well-being
4Performing a measurement
5In case suction pulbs and extremity electrodes are applied: Clean them before next use
6 Maintenance and Care
The device requires regular checks (see page 21, Chapter 6.4). 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.
The following table indicates the intervals and responsibilities of the maintenance work required.
Local regulations in your country may stipulate additional or different inspection intervals and tests.
Interval Maintenance step Responsible
Before every use Visual inspection of the device and ECG electrodes User
Every 6 months
Visual inspection of the device
(see page 21, 6.4 Inspection report)
- Cables and accessories
Functional tests according to the instructions
(see page 21, 6.4 Inspection report)
User
Every 12 months Safety test according to § 11 MPBetreibV qualified staff

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6.2 Cleaning the Housing and Cables
Do not, under any circumstances, immerse the device in cleaning liquid and do not sterilise it with hot water,
steam or air.
Do not autoclave the unit or any accessories.
Do not immerse the device in liquid.
The use of detergents with a high acid content or detergents that are otherwise
unsuitable can damage the device (i.e. cracks and wear of the plastic housing).
Always follow the dilution instructions provided by the manufacturer of the cleaning solution.
Never use any of the following or similar cleaning products: Ethyl alcohol,
ethanol, acetone, hexane, abrasive or scouring powder or material, any cleaning
material that damages plastic.
The patient cable and other cable assemblies must not be exposed to excessive
mechanical stress. Whenever disconnecting the leads, hold the plugs and not the
cables. Store the leads in such a way as to prevent anyone stumbling over them
or any damage being caused by the wheels of medical equipment carts.
When cleaning, ensure that all labels and safety statements, whether etched, printed or stuck to the device,
remain in place and readable.
Thoroughly inspect the device and the accessories before cleaning.
Look for any signs of damage.
Gently bend and flex cables, inspecting them for damage or extreme wear, exposed
wires and bent connectors.
Confirm that all connectors engage securely.
The housing of the device and the cable assemblies can be cleaned with a cloth slightly
moistened (not wet) on the surface only. If necessary, a domestic non-caustic cleaner or a
70 % alcohol solution can be used to remove grease stains and finger prints.
Wipe the equipment with a cloth slightly moistened (not wet) with one of the approved
cleaning solutions (see page 19, chapter 6.2.3). Thoroughly wipe off any excess cleaning
solution. Do not let the cleaning solution run into or accumulate in connector openings,
switches, or gaps. If liquid gets into connectors, dry the area with warm air and then check
that the device operates properly.
Warning
Caution

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6.2.1 Cleaning the ECG-leads
UNDER NO CIRCUMSTANCES pull on the ECG-leads during cleaning (risk of breaking the cable)!
You MUST also instruct your temporary staff and the responsible cleaning staff on this matter!
6.2.2 Cleaning Connection Cables
1Check the cable before cleaning for any damage. Gently bend all the parts of the cable.
Inspect the cable insulation for cracks, damage or extreme wear, exposed wires and
bent connectors.
2Wipe the equipment with a cloth slightly moistened (not wet) with one of the approved
cleaning solutions; the approved cleaning solutions are listed below.
3Hold the cable with the cloth in the middle of the cable; wipe 20 cm of the cable at a
time with the cloth until the entire cable is clean. Never clean the cable along its entire
length at once as this can lead to damage to the cable insulation.
4Thoroughly wipe off any excess cleaning solution. Do not let the cleaning solution run
into or accumulate in connector openings, switches or gaps. If liquid still reaches the
connector openings, dry them with hot air.
6.2.3 Admissible Detergents
50 % isopropanol (Isopropyl alcohol)
neutral, mild detergent
(for example: “SaniCloth®“ and “mikrozid universal wipers®“)
all products designed for cleaning plastic
6.2.4 Non-admissible Detergents
Never use products containing the following:
Pure, 100% aliphatic, monovalent alcohols, such as ethylalcohol, ethanol, ethylalcohol
Acetone
Hexane
Abrasive cleaning powder
Plastic-dissolving products

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6.3 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 (see page 18, chapter 6.2)
6.3.1 Admissible Disinfectants
Isopropanol (50 %)
Propanol (70 – 80%)
Aldehyde (2 – 4 %)
Ethanol (70 – 80%)
all products that are suitable for sensitive surfaces,
such as:
Bacillol® 30 foam / Bacillol® 30 Tissues
(10 % Propanol-1, 15% Propanol-2, 20% Ethanol)
Mikrozid® AF (25% Ethanol, 35 % 1Propanol-1)
6.3.2 Non-admissible Disinfectants
Organic solvents
Ammonia-based detergent
Abrasive cleaning agents
100 % alcohol, Virex, Sani-Master
HB Quat®
Conventional detergents (e.g. Fantastic®, Tilex® etc.)
Conductive solutions
Solutions or products containing the following ingredients:
Acetone
Ammonium chloride
Betadine
Chlorine, wax or wax compoundn
Ketone
Sodium salt