Lode Brachumera Sport User manual

m965911/21 - Manual Brachumera
Sport
Sports Medicine
Lode BV
Zernikepark 16
NL 9747 AN
Groningen
The Netherlands
t: [phone]
f: [phone]
@: [e-mail]
www.lode.nl
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Table of contents
1 - Intended Use1 - Intended Use
2 - Precautions2 - Precautions
3 - Contra Indication3 - Contra Indication
4 - Validity4 - Validity
4.1 - Description of Parts
5 - Installation5 - Installation
5.1 - Install the device
5.2 - Free Area
5.3 - Connecting Cables
5.4 - Moving the Ergometer
6 - Preparation6 - Preparation
7 - Controlling the Ergometer7 - Controlling the Ergometer
7.1 - Manual Control Ergometer
7.2 - External Control with ECG or Ergospirometry System
7.3 - External control with Lode Ergometry Manager
8 - Exchange Parts of the Brachumera8 - Exchange Parts of the Brachumera
8.1 - Exchange Handgrips/Pedals
8.2 - Change Crank Position
9 - Brachumera with Stand (965840)9 - Brachumera with Stand (965840)
10 - Brachumera PFM (965921)10 - Brachumera PFM (965921)
11 - Maintenance11 - Maintenance
12 - Cleaning12 - Cleaning
13 - Calibration13 - Calibration
14 - List of symbols used14 - List of symbols used
15 - Accessories15 - Accessories
16 - Specifications16 - Specifications

1 - Intended Use
This device is intended to be used as a stress test device in a medical environment, primarily to create
reproducible stress tests and measuring the effect. With this device typically workload is imposed.
The intended use is further enhanced to monitor:
- the diastolic and systolic blood pressure, and/or
- oxygen saturation of the blood, and/or
- pulse rate of the test subject,
when the measurement is executed with blood pressure and SpO2 measurement.
This device is designed for both manual control and external control by means of ergometry software,
external ECG and pulmonary equipment.
The device has to be operated under the supervision of well-trained medical specialists1 in the field of
use.
All users should read the IFU (available in corresponding language) and should have knowledge and/or
experience of exercise protocols, contra indications for exercise test, knowledge of stop criteria and
cleaning of the device.
The maintenance and service of the medical device has to be done by a well-trained service engineer
who is working for a Lode distributor and is specifically trained regarding the MD by the International
Service Coordinator of Lode.
1These specialists hold a bachelor and/or master degree in the medical field, they can be sport
physicians, exercise physiologists, or (specialized) physical therapists.
2 - Precautions
Read all warnings posted on the device.
Inspect the device for worn or loose components prior to
use. Tighten / replace any loose or worn components prior to
use.
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The operator should not touch accessible parts and the
patient simultaneously.
Read this manual before using the device and follow it
carefully.
The operator should instruct the test subject prior to
performing an exercise protocol. If, at any time during
exercise, the test subject feels faint, dizzy, or experiences
pain, stop the test and he or she should be consulted by the
physician.
Replacement of parts can only be done by the manufacturer
or designated service personnel.
Set up and operate the device on a solid level surface.
The equipment has a safety earth (ground) connection and
must be connected to a (grounded) wall socket with
protective earth to avoid the risk of electric shock. The
functional earth connection is for potential equalisation only.
(Adjustable) Cranks and pedals extend beyond the housing
of the brachumera, be carefull that your face is not too close.
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Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
Be aware that during extreme exercise testing the head of
the participant can hit the housing of the Brachumera.
Be sure that no cables are in the area of the crank shaft.
Carefully read the instruction prior removing or placing the
Brachumera from/to the stand.
Check for completeness of all warning labels on the
equipment.
A regular check of the fixation and guiding of the power cord
is needed.
Do not use when damaged.
Due to mass of inertia the cranks keep turning as long as the
flywheel is spinning, ensure the participant keeps a safe
distance
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In case of heavy loads, always check if the Brachumera is
properly fixated.
The installation should only be done by authorized persons
who follow the installation instructions.
Do not spill any liquid over the device.
Only use the device at normal operating temperature and air
pressure (see specification).
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the ergometer, including cables specified by the
manufacturer. Otherwise, degradation of the performance of
this equipment could result.
Any serious incident that has occurred in relation to this
device should be reported to the manufacturer and the
competent authority of your Member State.
The ergometer is to be operated by classified personnel only.
The medical device is heavy: take care for clamping of foot or
hands when moving or tilting the device.
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Your device may be executed with heart rate measurement,
blood pressure measurement, and / or SpO2 (blood
saturation) measurement. These measurements may be
inaccurate, depending on use circumstances. These
measurements are indicative and cannot be used for
diagnostic purposes.
When replacing cranks, pedals or handle bar be sure to
mount the parts in the correct position and tighten the
connection firmly.
3 - Contra Indication
The device is to be operated by classified personnel only. As stated in the intended use, the device is
intended to be used in a medical environment. During the intended use the test subject will deliver
energy. Application of the wrong dosis of energy could lead to permanent damage of the test subject
health. Only use this device under supervision of a medical physician.
Although the ergometer does not have any contra indication other than the maximum weight and
length of the test subject, in respect of exercise testing the following contra indication should taken
into account:
-Acute myocardial infarction (within 2 days)
-Unstable angina not previously stabilized by medical therapy
-Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
-Symptomatic severe aortic stenosis
-Uncontrolled symptomatic heart failure
-Acute pulmonary embolus or pulmonary infarction
-Acute myocarditis or pericarditis
-Acute aortic dissection
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4 - Validity
This manual covers all Brachumera versions starting with the following serial number:
965911 Brachumera Sport: S/N 20220001 -
965921 Brachumera Sport PFM: S/N 20220001 -
Date of first issue: 2022-11-18
4.1 - Description of Parts
1. Handgrips for transport
(APPLIED PART)
2. Handpedals (APPLIED PART)
3. 7" Control Unit
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4. Type plate
5. Symbol plate
6. Communication Interface
Module
7. Network Module
8. Service port (not to use)
9. Power inlet and On/Off
switch
10. Potential Equalization
Conductor
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Be careful for toes and back when moving the ergometer, the device is heavy.
In case of a Brachumera in combination with Stand the installation will be done by a
trained service engineer.
5 - Installation
5.1 - Install the device
- Unpack the device while leaving the transport straps in place.
- Place the device in the location where it will be used.
- Remove transport straps and remaining packaging materials.
- Connect the power cord to the line output at the required voltage (see type plate).
- Remove all objects from the device.
- Switch on the unit with the on/off button and wait until the self-test is carried out. The product is
ready for use after you have heard a series of “beeps”.
- Use the on/off button in order to switch the ergometer off.
5.2 - Free Area
The free area around the
ergometer shall be not less than
0,6 m greater than the training
area in the directions from
which the equipment is
accessed. The free area must
also include the area for
emergency dismount. Where
equipment is positioned
adjacent to each other the
value of the free area may be
shared.
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Free area when used with
stand.
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5.3 - Connecting Cables
The connection for the power
cord and optional connectors
for external devices are placed
at the backside of the
ergometer, so they are easy to
reach.
1 - connector control unit
2 - connector communication
module
3 - connector network module
4 - connector power cord
The operator is instructed not to connect any device to the optional connectors unless it possesses an
approval to 60601-1 or 60950 issued by an independent third party.
5.4 - Moving the Ergometer
The Brachumera is a heavy device and should always be moved with two persons. If the Brachumera is
fixated on the stand, it is recommended to remove the Brachumera from the stand before moving the
ergometer and the stand to another location.
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6 - Preparation
The Brachumera can be positioned vertical (on the stand) or horizontal (on a table), in either position it
is important to have the correct position of the crank axis in respect to the shoulders of the participant
before the test starts. This is not typically one position since it depends on the participant, the goal of
the test or the sport of the participant. Changes during the test can affect the test results and should
therefor be avoided.
When the Brachumera is fixated on the stand you can use the pneumatic spring to change the height
of the Brachumera. When the Brachumera is used in horizontal position the customer is responsible
for table or other solution to place the ergometer in the correct position.
If the Brachumera is in the correct position, the cables are connected and the ergometer is switched
on, you are ready to measure.
7 - Controlling the Ergometer
7.1 - Manual Control Ergometer
Your device is executed with a 7" Control Unit, which makes it possible to control the ergometer
manually.
In order to use and a create protocol with the Control Unit, you need to upgrade to an 7"
Programmable Control unit.
The Brachumera PFM is standard executed with an 3.5" display, since the Brachumera PFM standard
comes with the Lode Ergometry Manager to control the ergometer and collect the PFM data. The 3.5"
display only shows data (load, RPM and time) and cannot be used to steer the ergometer.
For the functioning of the display and/or control units, we refer to the manuals M945810, M945834
and M945835. The most recent version in many other languages can always be downloaded from Lode
website.
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The RS232 connection and the USB connection on the Excalibur/Brachumera can only
be used for external CPET devices. Never use those when the Excalibur/Brachumera
should be connected with LEM.
7.2 - External Control with ECG or Ergospirometry System
Your device is enabled with a communication module to connect to many external devices:
1. Connect the device with the supplied USB cable to the external device (optionally RS232 cable can
used). You can control the device with e.g. an exercise ECG device or Metabolic Cart.
2. Download the interfacing instructions from the internet at www.lode.nl after you have registered
your device.
3. Select “Terminal mode” and "Communication Module" on the control unit to allow external
commands (see for detailed instructions the user manual of your external device).
7.3 - External control with Lode Ergometry Manager
Your device is enabled to communicate with the Lode Ergometry Manager (LEM). LEM gives the
opportunity to work with a database, create protocols and to perform a variety of tests:
1. Use the network module connection cable (930930, UTP cable) to connect your device to the pc, plug
the RJ45 connector in the ergometer and the USB in an USB port of your pc.
2. Start the LEM Software on your PC.
3. Select on the display of the ergometer “Terminal” mode and "Network Module" to allow external
commands. The terminal mode is automatically recognized by LEM (see for detailed instructions the
user manual of LEM).
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8 - Exchange Parts of the Brachumera
8.1 - Exchange Handgrips/Pedals
Based on the athlete or type of
test it is possible to change
handgrips. As long as the
thread of the handgrip fits the
cranks (standard size) you can
attach the handgrip to the
Brachumera crank.
Depending on the use of the
Brachumera it is also possible
to attach pedals in stead of
handrips to the Brachumera.
Tool: wrench 15
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Be careful with the placement of the crank pulley. If the crank pulley is not complete
place straight on the thread, the thread of the crank axis will be damaged and not
useful anymore.
8.2 - Change Crank Position
The cranks of the Brachumera
can be placed asymmetrical as
well as symmetrical, depending
on the sport of the participant.
Always reposition the left crankleft crank,
leave the right side fixated on
the Brachumera, in this case
you always know the correct
position of the left crank.
To remove the crank:
- use the allen key to loose the
screw (crank bolt and cover will
come loose) (2, 3);
- use the crank pully and wrench 16 to release the crank of the Brachumera (4);
- reposition the crank and secure the crank again with the allen key.
Tools:
- Wrench 16
- Allen key 8
- Crank pully (see picture below)
If necessary it is also possible to exchange the cranks for another pair of cranks. As long as the cranks
have the standard thread to connect to the crank axis the crank can be used. Follow the same steps as
described above.
Crank pully to release the crank of the Brachumera.
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The position of the cranks with a Brachumera PFM is very important. Please contact
your local distributor if you want to change the cranks of the Brachumera PFM.
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9 - Brachumera with Stand (965840)
With the stand for the
Brachumera, the Brachumera
can be used in vertical position
and the height of the
Brachumera can be adjusted.
This creates the possibility to
easily set the height of the
Brachumera needed for the
participant.
A trained service engineer will
install the Brachumera inclusive
stand. The Brachumera can be
removed from the stand when
it should be used in horizontal
position. Please read carefully
the manual how to safely
dismount and mount the
Brachumera to the stand.
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10 - Brachumera PFM (965921)
In case your Brachumera is a Brachumera with Pedal Force Measurement (Brachumera PFM (965921)),
you have to use the Lode Ergometry Manager (LEM) software to collect and analyse the PFM data. In
the manual Manual LEM 10 PFM all information about the use of the PFM is described.
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11 - Maintenance
Maintenance should be carried out on a regular and planned basis. We recommend to check the unit
annually. This may be done by your local dealer. It is also recommended that a record of the service
history is kept for all activities relating to service and maintenance.
Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will
not be held responsible for the results of maintenance or repairs by unauthorized persons.
The check up and/or technical maintenance must be carried out conform the procedure described in
the service manual of the unit.
Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to
warranty.
Lode will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, or other information that will assist authorized service personnel to repair those parts of
the ergometer that are designated by Lode as repairable by authorized service personnel.
12 - Cleaning
Before cleaning and other maintenance of any part of the device, first switch off the device and
disconnect it from the mains. The surfaces can be cleaned with a damp cloth and a liquid (non-
abrasive) cleaning product.
General Cleaning
Wipe the device surface down with a cloth moistened with soap water or a disinfectant. The cloth
should not be dripping wet; do not allow liquids to enter the device.
Cleaning the Saddle
Clean the saddle with a soft and dry or moist cloth. Disinfectants used should not contain any alcohol.
Cleaning the Upholstery (e.g. couch ergometer)
Wipe the upholstery down with a soft cloth moistened with soap water. The cloth should only be moist
and not dripping wet. If the cleaning agents and disinfectants used are caustic or contain alcohol, they
may damage and/or discolor the upholstery.
If you are not certain about the discolouring effect of a cleaning agent, you may try a little on a part of
the product that is not visible during normal use.
Lode cannot advise a specific cleaning agent, since local recipes may differ.
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