Daum electronic ergo_bike medical8 Operating Instruction
medical
Operating Instructions
0650682e.0004
0297
Miscellaneous
2
Table of Contents
The ergometer ergo_bike medical8 is designed to apply a defined physical load
to a test person irrespective (independently) of the pedalling speed. It is very
well suited for diagnostic and therapeutic utilisation and for ergometry and
rehabilitation.
All ergo_bike medical8 ergometers are equipped with standard interface protocols
and can thus be used in conjunction with ECG printers or personal computers
of various manufacturers.
Please note that only properly educated and qualified staff (personnel) may
proceed with the installation and utilisation of the ergo_bike medical8.
Please read this operating instructions carefully!
Keywords Glossary / Info Texts
Please refer to the information concerning each operation status stored in the
dashboard. Use the Info-key to display this information.
The keywords glossary provides additional information and explanations.
The keywords glossary and the info-texts are an essential part of this
operating instructions.
Miscellaneous
- Introduction ................................................................................................... 2
- Keywords Glossary / Info Texts .................................................................... 2
- Data Interface ............................................................................................... 2
Safety Notes
- Using the Device in Compliance with the Recommendations ...................... 3
- Personal ........................................................................................................ 3
- Patient Safety ............................................................................................... 3
- Patient Treatment.......................................................................................... 3
- Notes From the Manufacturer to the User .................................................... 3
- Accessories ................................................................................................... 3
- Software ........................................................................................................ 3
- Documentation .............................................................................................. 3
- Installation / Update ...................................................................................... 4
- Potential Equalisation ................................................................................... 4
- Other Notes .................................................................................................. 4
Setting Up
- Control Elements and Connections .............................................................. 5
- Switching On / Off ......................................................................................... 6
- Saddle adjustment ........................................................................................ 6
- Handlebars adjustment ................................................................................. 6
- Wireless Pulse Rate Measure ...................................................................... 6
The Dashboard
- Top panel - Overview of the control elements ............................................... 7
- Underside - Overview of the connectors ....................................................... 7
Dashboard User Guide
- Switching On ................................................................................................. 8
- Starting Training Without Selecting a Program ............................................. 8
- Setting Personal Data ................................................................................... 8
- Starting Training by Selecting a Program ..................................................... 9
- Training Programs ................................................................................... 9 - 10
- Setting Limit Values ................................................................................ 10- 11
- Reviewing Stored Training Data ................................................................... 11
- MP3 Player ................................................................................................... 12
- Keywords Glossary ....................................................................................... 12
General Notes
- Important Notes ............................................................................................ 13
- Training Hints ............................................................................................... 13
- Environmental Conditions ............................................................................. 13
- Used Symbols .............................................................................................. 13
- Compliance to Standards ............................................................................. 13
Application Domains ....................................................................................... 13
Maintenance ................................................................................................... 13
EC - declaration of conformity ........................................................................ 14
Specifications .................................................................................................. 16
Service
- Testing according to the prescriptions of the by-law for operating medical
products ....................................................................................................... 16
- Liability ......................................................................................................... 16
- Replacement of the Dashboard Battery ....................................................... 16
-
What is to be noted in the handling of SD cards ......................................... 16
Ergometry test ................................................................................................ 16
Testing / Placing into service ................................................................... 17 - 18
Service Operation ........................................................................................... 19
GNU General Public License ..................................................... 20 - 22
Data Interface
You can use a ECG machine or a personal computer (PC) to control the ergo_bike
medical8. A special data cable is needed to this effect, which you can order from
daum electronics gmbh. The data transmission protocols of the controlling device
(apparatus) and of the ergo_bike medical8 must be configured to recognise each
other. Please contact daum electronic gmbh, or a company authorised by it, if
needed.
Warning:
- Optional equipements, that are connected to the digital interfaces of the
ergo_bike medical8, must provably comply with the EN specifications (e.g. EN
60950 for data processing devices and EN 60601 for electromedical devices).
Furthermore, all the configurations must comply with the system standard of the
GEF (German Electrotechnology Federation) 0750 part 1-1. Whoever connects
optional devices to the signal input or output line, configures a system and is
consequently responsible of maintaining the compliance to the GEF 0750 part
1-1 system standard. Please if you have any questions contact the provider of
the device in question.
- You must never touch device parts that are conducting very low safety voltage
and patients simultaneously.
Safety Notes
3
Using the Device in Compliance with the Recommendations
The ergometers of the ergo_bike medical8 series may be used exclusively for
ergometry, cardiovascular rehabilitation and for kinesitherapy.
Their use is only allowed in compliance with the directions of the operating
instructions.
The manufacturer will not be held liable if the ergometer is not used in compliance
with the provided instructions and consequently causes injury to persons or
other severe consequences, as well as material damages.
The ergo_bike medical8 carries the CE label CE 0297 according to the councils
directive for medical products 93/42 EEC and complies with the basic requirements
of appendix 1 of this directive.
The CE label covers only the accessories included in the package.
Every user of this device and everyone who is concerned with assembling,
maintaining, testing or troubleshooting it, must read and understand the contents
of this operating instructions before starting to work on the device.
The quality assurance system used at daum electronic gmbh complies with the
DIN EN ISO 13485:2003 standard.
The ergo_bike medical8 are designed according to the MPG, group IIa and
comply with the corresponding type B, according to DIN EN 60601-1:1996.
The devices comply to the safety and health requirements according to:
93/42/EEC of the council of June 14, 1993 about medical products,
DIN EN 60601-1-2:2001 (EU directive about electromagnetic compatibility).
daum electronic gmbh considers itself to be liable for the safety, reliability and
functionality of the device only if:
- Modifications and repairs to the device are carried out by daum electronic
gmbh or by a service provider formally authorised by daum electronic gmbh
to do this work.
- the device is used in compliance with the directions of the operating instructions.
Personnel (Staff)
The ergo_bike medical8 may only by operated by educated personnel (staff).
The personnel must read and understand this operating instructions before
operating the device.
The operating instructions must be kept in the direct vicinity of the ergo_bike
medical8.
Patient Safety
According to the prescriptions of the by-law (order) for operating medical products
(MP by-law §5) the users must
- be educated in operating the ergometer.
- master the necessary sequences for handling and assembling the device.
- know the applicable safety regulations for operating this type of devices, and
act accordingly.
- know about any additional regulations that may apply (e.g. safety facilities).
- know about possible risks (hazards) that may arise from using this type of
devices.
In order to maintain the safety of the patients, it must be avoided that conductive
parts and the connectors connected to them, including the neutral electrode,
come into contact with others conductive parts (including the grounding), while
getting on the ergo_bike medical8.
Please do never touch device parts conducting very low safety voltage and the
patient simultaneously.
When coupling with other devices or with a combination of medical systems
care must be taken to prevent any danger arising from the summation of the
leakage currents. If you have any questions please ask your dealer or the service
department of daum electronic gmbh. In particular, when coupling many devices
to a test site care must be taken to ensure that the potential equalisation is
effected through a common power supply (e.g. a wall socket-outlet).
If a socket with multiple outlets is installed after the initial start-up, no other
device may be connected to this socket. (use covers on the multiple sockets)
An electrical shock hazard exists when touching non-medical devices, and
devices that are not separately grounded.
Defective or faulty devices and accessories may not be used.
The personal computer and all other connected non-medical devices (e.g.
monitor, printer, etc) must be installed at least 1.5m away from the patient place,
because leakage currents could be generated on the housing (or use separate
grounding, housing leakage current).
Patient Treatment
All the devices and the related components and parts must every time be
checked for functionality and defects before they are used with the patient.
Notes From the Manufacturer to the User
The device is not protected against the infiltration of liquids.
Direct contact with humidity or liquids must absolutely be avoided.
Care must be taken to wipe out sweat drops after training (sweat attacks paint
and plastic parts)
Damages caused by sweat are not covered by the warranty.
The ergometer should be installed on a level, firm floor (e.g. concrete
floors). For other floor surfaces we recommend to use the device over a
protective underlay. Appropriate underlays for the protection of the floor
can be ordered from daum electronic gmbh.
The manufacturer will not be held liable for damages to the floor.
Order No. 0810401
Accessories
The device may only be used with the accessories prescribed and distributed
by daum electronic gmbh.
Every accessory item and every device connected must be manufactured in
conformity with the corresponding standard, e.g. DIN EN 60950 for computer
devices, DIN EN 60601-1 for electromedical devices.
Software
The supplied software may only be copied and archived for safety and functional
reasons. In special cases a request must be addressed in writing to daum
electronic gmbh. Releasing it to non-authorised persons in not allowed. The
ergo-bike medical8 may only be used with the internal and external softwares
supplied and authorised by daum electronic gmbh.
Documentation
The documentation supplied is an integral part of the ergo_bike medical8 and
may only be copied or distributed with the authorisation of daum electronic
gmbh.
GB
4
Safety Notes
Installation / Update
New installations, updates as well as major interventions on the configuration
of the ergo_bike medical8 may only be carried out by authorised personnel.
Potential Equalisation
Connecting of electronic devices through V 24 / RS232 / USB / LAN, for instance,
or other interfaces of a computer, or of another independent measuring device
may only be carried out by authorised personnel and in rooms intended for
medical use according to DIN VDE (German Electrotechnology Federation)
0100 / Part 710.
Parallel connection over potential equalisation makes sure that in the case of
an eventual insulation breakdown none of the networked devices will develop
on its housing a voltage in excess of 10mV, and thus harm the patient. For this
purpose all the medical devices of daum electronic gmbh are equipped with a
connector for potential equalisation; this connector must be connected by means
of a potential equalisation cable to all the other devices in this system and to
the potential equalisation bus of the room.
Other Notes
All the diagrams and evaluations are to be considered as a suggestion from the
device. When providing a diagnosis the results must always be controlled and
evaluated by a qualified physician.
The electronic installations of the rooms where the device will be used must
absolutely comply with the requirements of directive DIN VDE (German
Electrotechnology Federation) 0100 / Part 710.
The device is not suited for operation in rooms and / or areas with explosion
risks.
All the interventions in the device, modifications to system components, extensions
to the system, as well as needed internal cleaning and repairs may only be
carried out by personnel authorised by daum electronic gmbh.
When using the device you must absolutely follow (respect) the instructions in
the user manual for the load-applying unit, particularly with respect to the safety
of the patient.
Cellular telephones may not be used in the direct vicinity of the device, otherwise
they may interfere with its functionality.
Wireless telephones may be used.
Electromagnetic interference are primarily characterised by the oscillation of the
displayed load value. If the displayed value varies uncontrollably frequently,
even when the speed is higher than 30 /min, this can be an effect of electromagnetic
compatibility (EMC).
Only cables certified by daum electronic gmbh may be used to connect the
device with other devices.
5
Setting Up
Control Elements and Connections
1 Dashboard
2 Interfaces and connectors
3 Handlebars continuously adjustable over 360°
4 Clamp screw for the handlebars
5 Roller casters
6 Name plate
7 Potential equalisation
8 On/Off switch
9 Height adjustment for the saddle
10 Saddle column
11 Horizontal adjustment of the saddle
12 Saddle
2
3
4
1
5
6
8
9
10
11
12
7
GB
Setting Up
6
ergo_memo-card2
Protection
slider
Safety button
18 levels
Vertical adjustment
Loosen the spring loaded tommy head button 2 by one to two turns, and then
pull it out. Move the saddle column up or down to the required height. Release
the tommy head button and move the saddle column a little bit up or down until
the protruding red safety button on the tommy head button locks in. Then tighten
the tommy head button.
For safety reasons height adjustment is only possible up to level 18!
360° continuous
Switching ON / Off
Please read the safety notes before switching the ergo_bike premium8 on, and
follow the installation and assembly instructions.
Insert the ergo_memo-card2 in the dashboard before switching the device on.
Use the On/Off switch " I " on the lower rear section of the device to switch it
on and off.
3
2
13cm
1
Handlebars adjustment
Loosen the star knob 3 adjust the handlebars to the required position and
tighten the star knob back.
On / Off power switch
Saddle adjustment
Horizontal adjustment
Loosen the lever 1 slide the saddle to the required position and then tighten
the lever again.
The lever should point to the rear after tightening. Pull and turn the lever to point
to the rear.
- risk of injury.
When switched on, the system takes about 1 minute to load the software. The
colour screen displays during this time a software load progress bar.
Wait for the beep signal before using the dashboard.
If the memory card is inserted after the Premium device is switched on, then
you must wait for the beep signal. This can take about 5 seconds. (if the card
is empty it will be initialised)
In principle the memory card should be pulled out while you are not pedalling
or only after the beep signal!
The protection slider on the ergo_memo-card2 must point to the bottom when
the card is inserted into the dashboard. This will make it possible to write to the
card.
If the slider points upward the card is locked/write protected.
If the card is empty it will be initialised. Only then can you use a computer to
save e.g. mp3 files (in the \mp3 folder) or update files (in the \update folder) on
the card.
The maximal cards size is to 1GByte.
Notes to the handling of SD cards (page 16)
In the case of a commercial use (whenever the device is used frequently on a
daily basis) we recommend switching it ON in the morning and then switching
it OFF once at evening.
Wireless Pulse rate Measure
The ergo_bike medical8 is equipped with a Polar receptor module, and can thus
receive coded pulse rate signals only.
The Dashboard
7
12
Front side of the console
2
3
4
10
5
6
7
9
8
11
1
Top panel
1. Colour screen
2. Volume (up)
3. MP3-Player
4. Volume (down)
5. Function keys
6. Menu
Calls the main menu
7. Info
Displays detailed information about the current situation
8. Control button
By turning and pressing this button you can select and open menu items
9. -/+ Dumbbell
Decrease or increase the load
10. -/+ Values
Decrease or increase the pulse rate, RPM, torque and gear
The value that can be actually modified will be colour-highlighted in the
training view.
11. Audio connector
Used to connect a headphone
12. Card reader for the ergo_memo-card2
Underside
13. Reset key
14. USB-Host
15. USB-Slave
16. Light-emitting diode (LED) for network connector
17. Network connector (Ethernet)
18. Audio connector L/R to external amplifier (Line Out)
19. Battery 3.3 V
Battery replacement
The button cell battery (CR 2032) is located on the underside of the circuit board
of the dashboard. Replace this battery when you notice a loss of time and date
on the system clock. (See the maintenance section)
13
14
15
19
16
17
18
GB
Dashboard User Guide
8
Start
pedalling
Press the
function key
under End
Press the
Menu key
Turn and
press control
button to
select
Setting
Turn and
press control
button to
select Name
& Addr.
Turn and
press control
button to
select Name
Slider switch
lower position:
write protection
is deactivated.
Turn and
press control
button to
select
Personal data
Please use the ergo_memo-card2 with every training session to store your
personal settings and actual training data. This card is user related. It is not
possible to store the personal settings of a second user on the same card.
Note:
When you train without ergo_memo-card2 you will not have the possibility to
store training results.
The user controls the dashboard by means of the control button, the Menu
key, the Info key and two function keys.
Use the info key to obtain more information about the individual menu
items.
If the requested information spans many pages, you can leaf through the pages
by turning the control button. Press the Info key to display the keywords glossary
(page 12).
Note:
We reserve the right to modify the figures!
Insert the ergo_memo-card2 in the card reader before turning the device on.
Setting Personal Data
Before training you should enter your personal data and limit values under menu
item Setting.
User and device data can be set here.
Starting Training Without Selecting a Program
You can start training immediately with this screen displayed.
Switching ON (with ergo_memo-card2)
You can enter all the characters and special characters by turning and
pressing the control button. Use the position Small to switch between
capital and small characters as well as special characters. Use the <-
position to delete and correct your entry
Use the Info key to obtain more information about the individual menu items.
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