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

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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

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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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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

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Cable arm with patient module
Electrode suction hose (6 x 1.30 m / 4 x 1.50 m)
Spacers (2 pcs with 3 rows / 2 pcs with 2 rows)
Pump unit, large
Power cable for mains connection
ECG Spray 250 ml
Standard bracket
Screw set consisting of:
2 x cable ties 200mm
1 x D-sub connection kit
1 x cable clip, small
1 x 5 mm and 1 x 2.5 mm Allen key
4 x each of M6x12 / M6x16 / M6x20 Allen screw
4 x each of M6 nut / M6 self-locking / M6 square nut
4 x 6.3 washer / 4 x 6.37 spring washer / 4 x rubber feet
Operation manual
2.6 Fixation module pump
2.7 Serial Number
2.8 Supplied accessories for ergo vac (mains) or (battery)
Bracket for pump module ergo vac with Trolley vexio-cart.
Comment: We have a large selection of brackets (bracket can be
created according to customer requirements), incl. table and wall
mounts
cable arm pump module pump module with accumulator
fixation
pump module

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Turn off the unit when not in use for a longer time.
Never apply suction when the electrodes are in a cleaning fluid.
When pressing the button, the suction pump creates a vacuum for about
5 seconds and then turns off automatically.
3 Operation
3.1 Getting Started
Electric shock hazard. The device must not be used if it is not properly grounded or
the power cable is damaged or suspected to be damaged.
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.
Location
3.2 On / Off
The unit is switched on and off with the button. When pressing the ON button,
the electrode can be sucked to the skin of the patient by applying light pressure with
the fingers.
HAZARD
ON / OFF
Warning

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3.3 Power Supply
The unit can be connected to the mains or be supplied from the built-in battery (option).
In both modes the button on the control panel will light up.
Battery Life (Option):
The internal battery provides power for up to two hours of
continuous use.
Battery being charged:
A completely depleted battery takes about 3.5 hours to fully charge
(when power is off). If the device is switched on during charging, the
charging time may be longer.
The battery is charged when the device is connected to the mains. The
device can remain connected to the power grid without causing damage
to the device or battery.
The device can remain connected to the power grid without risk for
the battery.
Recharging Times:
Battery recharging time if depleted: about 3.5 hours if the unit is
not in use
Charging time when in use: about 10 hours
To isolate the device and the power supply from the mains, pull the power plug.
3.3.2 Isolation from Power Grid
3.3.1 Displays for Mains or Battery Power
4 Controls
The controls are located on the front of the control box and control the entire
suction system.
regulate suction power
clean / blow out air
suction levels

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4.1 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 -150 mbar).
The current suction level is indicated by the green LEDs on the control panel. The highest
level is about -220 mbar and should only be used in extreme cases (a lot of body hair).
The suction level must in each case be adjusted to the patient‘s skin type!
The device must not be used if the skin is broken. Strong suction or long-term
exposure to suction may result in hematomas! Particular caution is especially required
with older patients. The operator of the unit should ask the patient how he or she feels!
The electrodes should not be applied to the skin of the patient for more than
25 minutes.
4.2 Blowing out Air
When pressing the button, the suction unit will be blown out with compressed air for
about 5 seconds and then turned off automatically.
4.3 Cleaning
When the system is in standby mode, it can blow out the air from the suction lines by
pressing the cleaning button. The cleaning is stopped by pressing the button. The
system then reverts back to standby mode.
Never apply suction when the electrodes are in a cleaning fluid.
5 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.).
5.1 Placement of Electrodes
Careful application of the electrodes and good electrode contact is important for a
good recording (see electrode positioning on pages 13 - 15).
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:
Warning
Warning
Warning

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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 by pressing on the cleaning button.
Clean the suction or vacuum electrodes according to the manufacturer's instructions.
* Dedicated abrasive cleaning gel gives very good results in reducing the skin-electrode resistance.
5.1 Placement of Electrodes
5.2.2 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!
IMPORTANT: Use only pure NaCl and distilled or deionised water for this. No tap water!
Do not use physiological salt solution from a pharmacy! This contains additives, which can
damage the electrodes!
5.2 Possible Sources of Errors with the ECG Recording
5.2.1 Preparation
If you are using new electrodes or those, which have not been used for a long time and have
therefore dried out, first stabilise the electrodes by placing them for at least three hours in a
1% salt solution (NaCl solution).

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5.2.3 Before the Recording
5.2.4 During 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!
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)!
5.2.5 Removal of Electrodes from the Skin
Do not pull on the electrode cables, but touch the electrode carefully at the edge or activate
the blow-out function at the suction unit ( The electrodes will then fall off on their own
accord)!
5.3 Electrode Identification 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
5.2 Possible Sources of Errors with the ECG Recording

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5.4 Resting ECG with 10-lead Patient Cable
Electrode Placement for Standard Leads
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 set-
ting “Recording display”
programmed to V4r.
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
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, red RA, white Right arm (resting ECG)
F, green LL, red Left foot (resting ECG)
N, black RL, green Right foot (resting ECG)

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5.5 Right Precordial (C4r)
The ACC/AHA guidelines recommend that in all patients with myocardial infarction with in-
ferior 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
Explanations see
table on page 18
C2 yellow
C3 green
C5 black
C6 purple
F green
N black
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, brown / 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

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1 Preparing the patient
2 Switch on device and apply electrodes
3 Ask the patient about their well-being (note the suction strength of the electrodes)
4 Determine and adjust suction strength /
The lower the pressure level, the better the skin tolerance!
Étape 1 & 2: for smooth skin Étape 4: for medium-hairy skin
Étape 3: for lightly-hairy skin Étape 5: for very hairy skin
5 Performing a measurement
6 Switch off the vacuum pump with the button, the electrodes detach from the patient
7 The system switches off automatically after 10 seconds.
8 (Optional) After long periods of use and/or heavy perspiration by patients, the system can blow
out air by the pressing of the cleaning button.
9 Cleaning the electrodes (See. Chapter 7.2.1)
2
4
6, 8
6 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 the mains connection cable is damaged or there is a
suspicion of damage.
6.1 Operating Conditions
The device is not suitable for continuous operation; switch off again after use.
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 +40 °C
Relative humidity: between 30 % and 75 %
Air pressure: between 700 hPa and 1060 hPa
6.2 Starting a Recording
Caution
Caution

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7 Maintenance and Care
The device requires regular checks (Chapter 7.5). 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, 7.5 Inspection report)
- Cables and accessories
- Mains cable
Functional tests according to the instructions
(see page 30, 7.5 Inspection report)
User
Every 12 months Safety test according to § 11 MPBetreibV qualified staff
The useful life of the device electrodes is estimated to be 2 years.
7.1 Visual Inspection
Visually inspect the unit and cable assemblies for the following:
Device, housing and mains cable (not damaged or cracked)
Keypad (not damaged or cracked)
Electrode cable sheathing and connectors (undamaged)
No cracks, abrasion or wear in any cable assembly
Input/output connectors (not damaged or cracked)
In addition to the visual inspection, the device should be switched on and the functions of
the operating field should also be checked. In this way, you can check that:
the device performs faultlessly
the display works
Defective units or damaged cables must be replaced immediately.
Warning