Daum electronic ergo_bike medical8 User manual

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
ell suited for diagnostic and therapeutic utilisation and for ergometry and
rehabilitation.
All ergo_bike medical8 ergometers are equipped ith standard interface protocols
and can thus be used in conjunction ith ECG printers or personal computers
of various manufacturers.
Please note that only properly educated and qualified staff (personnel) may
proceed ith 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 key ords glossary provides additional information and explanations.
The keywords glossary and the info texts are an essential part of this
operating instructions.
Miscellaneous
- Introduction ................................................................................................... 2
- Key ords Glossary / Info Texts .................................................................... 2
- Data Interface ............................................................................................... 2
Safety Notes
- Using the Device in Compliance ith the Recommendations ...................... 3
- Personal ........................................................................................................ 3
- Patient Safety ............................................................................................... 3
- Patient Treatment.......................................................................................... 3
- Notes From the Manufacturer to the User .................................................... 3
- Accessories ................................................................................................... 3
- Soft are ........................................................................................................ 3
- Documentation .............................................................................................. 3
- Installation / Update ...................................................................................... 4
- Potential Equalisation ................................................................................... 4
- Other Notes .................................................................................................. 4
Setting Up
- Control Elements and Connections .............................................................. 5
- S itching On / Off ......................................................................................... 6
- Saddle adjustment ........................................................................................ 6
- Handlebars adjustment ................................................................................. 6
- Wireless Pulse Rate Measure ...................................................................... 6
The Dashboard
- Top panel - Overvie of the control elements ............................................... 7
- Underside - Overvie of the connectors ....................................................... 7
Dashboard User Guide
- S itching 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
- Revie ing Stored Training Data ................................................................... 11
- MP3 Player ................................................................................................... 12
- Key ords 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-la 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, hich 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 ith the EN specifications (e.g. EN
60950 for data processing devices and EN 60601 for electromedical devices).
Furthermore, all the configurations must comply ith 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 lo 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 allo ed in compliance ith the directions of the operating
instructions.
The manufacturer ill not be held liable if the ergometer is not used in compliance
ith the provided instructions and consequently causes injury to persons or
other severe consequences, as ell as material damages.
The ergo_bike medical8 carries the CE label CE 0297 according to the councils
directive for medical products 93/42 EEC and complies ith 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 ho is concerned ith assembling,
maintaining, testing or troubleshooting it, must read and understand the contents
of this operating instructions before starting to ork on the device.
The quality assurance system used at daum electronic gmbh complies ith the
DIN EN ISO 13485:2003 standard.
The ergo_bike medical8 are designed according to the MPG, group IIa and
comply ith 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 ork.
- the device is used in compliance ith 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-la (order) for operating medical products
(MP by-la §5) the users must
- be educated in operating the ergometer.
- master the necessary sequences for handling and assembling the device.
- kno the applicable safety regulations for operating this type of devices, and
act accordingly.
- kno about any additional regulations that may apply (e.g. safety facilities).
- kno 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 ith others conductive parts (including the grounding), hile
getting on the ergo_bike medical8.
Please do never touch device parts conducting very lo safety voltage and the
patient simultaneously.
When coupling ith other devices or ith 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, hen coupling many devices
to a test site care must be taken to ensure that the potential equalisation is
effected through a common po er supply (e.g. a all socket-outlet).
If a socket ith 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 hen 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 a ay 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 ith the patient.
Notes From the Manufacturer to the User
The device is not protected against the infiltration of liquids.
Direct contact ith humidity or liquids must absolutely be avoided.
Care must be taken to ipe out s eat drops after training (s eat attacks paint
and plastic parts)
Damages caused by s eat are not covered by the arranty.
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 ith the accessories prescribed and distributed
by daum electronic gmbh.
Every accessory item and every device connected must be manufactured in
conformity ith the corresponding standard, e.g. DIN EN 60950 for computer
devices, DIN EN 60601-1 for electromedical devices.
Software
The supplied soft are may only be copied and archived for safety and functional
reasons. In special cases a request must be addressed in riting to daum
electronic gmbh. Releasing it to non-authorised persons in not allo ed. The
ergo-bike medical8 may only be used ith the internal and external soft ares
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 ith the authorisation of daum electronic
gmbh.
GB

4
Safety Notes
Installation / Update
Ne installations, updates as ell 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 breakdo n none of the net orked devices ill 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 ith 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 al ays be controlled and
evaluated by a qualified physician.
The electronic installations of the rooms here the device ill be used must
absolutely comply ith the requirements of directive DIN VDE (German
Electrotechnology Federation) 0100 / Part 710.
The device is not suited for operation in rooms and / or areas ith explosion
risks.
All the interventions in the device, modifications to system components, extensions
to the system, as ell 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 follo (respect) the instructions in
the user manual for the load-applying unit, particularly ith respect to the safety
of the patient.
Cellular telephones may not be used in the direct vicinity of the device, other ise
they may interfere ith 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 hen 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 ith other devices.

5
Setting Up
Control Elements and Connections
1 Dashboard
2 Interfaces and connectors
3 Handlebars continuously adjustable over 360°
4 Clamp scre for the handlebars
5 Roller casters
6 Name plate
7 Potential equalisation
8 On/Off s itch
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 t o turns, and then
pull it out. Move the saddle column up or do n to the required height. Release
the tommy head button and move the saddle column a little bit up or do n 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 s itching the ergo_bike premium8 on, and
follo the installation and assembly instructions.
Insert the ergo_memo-card2 in the dashboard before s itching the device on.
Use the On/Off s itch " I " on the lo er rear section of the device to s itch 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 po er s itch
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 s itched on, the system takes about 1 minute to load the soft are. The
colour screen displays during this time a soft are load progress bar.
Wait for the beep signal before using the dashboard.
If the memory card is inserted after the Premium device is s itched on, then
you must ait for the beep signal. This can take about 5 seconds. (if the card
is empty it ill be initialised)
In principle the memory card should be pulled out hile you are not pedalling
or only after the beep signal!
The protection slider on the ergo_memo-card2 must point to the bottom hen
the card is inserted into the dashboard. This ill make it possible to rite to the
card.
If the slider points up ard the card is locked/ rite protected.
If the card is empty it ill 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 ( henever the device is used frequently on a
daily basis) e recommend s itching it ON in the morning and then s itching
it OFF once at evening.
Wireless Pulse rate Measure
The ergo_bike medical8 is equipped ith 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
79
8
11
1Top 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 ill be colour-highlighted in the
training vie .
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 hen 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
lo er position:
rite protection
is deactivated.
Turn and
press control
button to
select
Personal data
Please use the ergo_memo-card2 ith 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 ithout ergo_memo-card2 you ill 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 key ords 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 ith 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 s itch bet een
capital and small characters as ell 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.

Dashboard User Guide
9
Press the menu
key
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Press control
button
Elevation Profile Training Programs (distance programs)
The distance programs are varied, efficient, and simulate a realistic biking tour. Only here you have the possibility to use
the gearshift (for instance by turning the control button during the training).
RPM Training Programs (revolutions per minute)
With the RPM controlled programs the heel speed in revolutions per minute is maintained at a level defined by the user.
Training Programs
Pulse Rate Training Programs
With the pulse rate programs the heart pulse rate is controlled and adjusted automatically by means of the braking po er.
Starting Training by Selecting a Program
You can choose from various program types.
Watt Training Programs
With the att controlled programs the braking po er is adjusted according to the set up att value.
Use the Info key to obtain more information about the individual menu
items.
Cardio Plus Training Programs
The device set the load value in att for the first program step and ait until the prescribed heart rate is exceeded "from
belo ". Then the next step is activated and its load value is set.
GB

Dashboard User Guide
10
Press control
button
Press control
button
Press the
Menu key
Turn and
press control
button to
select
Setting
Turn and
press control
button to
select Limit
values
Turn and
press control
button to
select
Personal data
Turn and
press control
button to
select Watt
Turn control
button to
select the att
limit-value and
press
Confirm
Turn and
press control
button to
select
Dynamic limit
values
Setting Limit Values
In order to protect the user against overloading or physical injuries the training
intensity can be controlled by various adjustable limit values. These should be
set in menu Setting before starting training or before setting the loading values
after a fe training units.
Dynamic Limit Values and Static Limit Values can be set.
- Due to their natural variability, dynamic limit values are continually exceeded.
- Static limit values are reached only once per training.
Setting the Dynamic Limit Value for "Watt"
Watt limit value reached while training
The field displaying the att value ill be highlighted in red hen the set Watt
limit value is reached or exceeded during training. If the loading is reduced and
thus falls belo the limit value the arning is removed.
Strength Training Programs (pedalling speed dependent programs)
With the strength programs a pre-selected constant pedalling resistance is applied. The
effort produced by the user is a function of the pedalling speed.
Use the info key to obtain more information about the individual menu
items.

Dashboard User Guide
11
Press control
button
Press the
Menu key
Turn and press
control button
to select
Training Data
Press function
key under
Options
Turn and
press control
button to
select Limit
Values
Turn and
press control
button to
select Time
Turn control
button to select
the time limit-
value and
press the
function key
under Confirm
Press function
key under
Yes
Turn and
press control
button to
select Static
Limit Values
Setting the Static Limit Value for Time
Press the
Menu key
Turn and
press control
button to
select
Setting
Turn and
press control
button to
select
Personal data
Turn and
press control
button to
Select
Training Unit
Turn and
press control
button to
Select
Diagram
Reviewing Stored Training Data
Recalling stored training data.
e.g. Individual Training
The individual training units can be recalled under several specific performance
diagrams.
Time limit value reached while training
When the Time limit value is exceeded during training the braking load is
automatically reduced to a minimal value. Simultaneously the system displays
a arning message that must be ackno ledged. The training can then be
terminated or continued.
Use the Info key to obtain more information about the individual menu
items.
GB

Dashboard User Guide
12
Press control
button to start
playing
selected title
Press the
MP3 key
Turn control
button to
select a title
Press the
follo ing key
to increase the
volume
Press function
key under
Stop
Press the
follo ing key to
decrease the
volume
Press function
key under
Back
MP3 Player
Listen to your favourite music hile training.
Save mp3 files on the ergo_memo-card2.
To do this you need a USB card reader connected to your computer, then save
the mp3 files in the /mp3 folder on the ergo_memo card2.
Insert the memory card in the dashboard at the front side of the device.
Starting the MP3 Player
Press the mp3 player key, the system ill display a list ith the music titles
saved on the card.
Select a title by turning the control button.
Press the control button to start playing the selected title.
The system continues ith playing all the music titles eventually follo ing the
selected one in the list.
The volume is controlled by means of the 2 dedicated keys.
Press the stop key (left function key) to stop the music.
If you exit the MP3 player hile the music is playing by pressing the Back key,
you can continue listening to your music hile training.
Use the Info key to obtain more information about the individual menu
items.
Press the Info
key
Turn control
button to
select the
key ord
Press the
function key
under
Key ords
Keywords Glossary
The ergo_bike medical8 contains a glossary of key ords for the concepts
related to the utilisation of the dashboard that need a further explanation.
A short description is provided for each one of these key ords.
Viewing the Keywords Glossary
Please note that you should not fill up the card with mp3 files,
otherwise the system will not save any training data on the
card!
!

Maintenance
General Notes
13
Fig. A Fig. B
Outside Cleaning
Clean the outside surfaces ith a etted soft cloth. Do not use any strong or
corrosive cleaning solution, or one containing solvents, (e.g., alcohol, stain
remover, etc).
Care should be taken to ipe out s eat drops after training (s eat attacks paint
and plastic parts).
Damage caused by s eat is not covered by the arranty.
You can clean the coating of the handlebars ith a mild detergent, applying
appropriate caution.
Noises
ergo_bike medical8 ergometers are equipped ith quality ball bearings and
silent belt drive. Still, it is unavoidable that you hear a fe remaining noises in
the range of up to LpA 52 dB (decibel).
Fastening Screws
All the fastening scre s must be tightened up from time to time. We recommend
tightening them at least after the first 50 km and then once every 500 km.
About the V belt
The driving surfaces of the drive pulley and the V-belt pulley are covered ith
a rubber layer by the manufacturer.
This favours the development of an optimal fitting of the V belt into the
grooves of the driving pulley during the first 500 to 1000 kilometres.
During the first 500 to 1000 km the belt ill loose some excess rubber, hich
ill appear in the form of black po der deposits. You can remove these deposits
using a small brush or a vacuum cleaner.
V-belts are earable parts and as such are not covered by the arranty.
Important Notes
Mains Voltage 230 Volt
Because of ne regulations the mains voltage must be specified in the form of
a definite value. Consequently, the mains voltage values indicated ith a tolerance
from 220 to 240 Volt ill be restricted for all the ergometers of daum electronic
to the single mains voltage value of 230 Volt.
Mains Power Supply
In order to avoid all hazards any damages to the connection cable to the mains
po er supply or to the On/Off s itch must immediately be repaired, or replaced
ith ne parts, by the manufacturer, the customer service department of the
manufacturer, or similarly qualified service personnel.
Trainings Hints
A comfortable and relaxed sitting posture is of great significance for the efficiency
and the benefit of the training ith the ergo_bike medical8 as ell as an
appropriate shoe (sport shoe). The handlebars, saddle height, and saddle
inclination should be adjusted to the personal requirements of the test person.
The back should be straight and the legs should still be slightly bent at the lo er
pedal position (Fig. A) as for normal biking, as opposed to the racing posture
(Fig. B).
Environmental Conditions
Ergometers are not suited for operation in areas of medical rooms ith explosion
hazards, or in a combustive atmosphere. The devices may not be operated in
the near vicinity of e.g. X-ray devices, motors or transformers ith big electrical
connections because electric or magnetic fields may disturb or deactivate some
measurements. The vicinity of high voltage cables is also to be avoided.
Unless other ise specified in the accompanying documentation and delivery
documents, all the devices are designed to be used in the usual indoor conditions
under the climate conditions considered normal (DIN IEC 601-1):
Temperature range: -10°C .....+40°C
Relative air humidity: 30 ...75%
Air pressure: 700... 1060 mBar
The devices must therefore be protected against particular humidity effects.
Ventilation opening must not be covered in order to avoid restricting the circulation
of air. Storage temperature range: -20°C .....+50°C
All the devices may be stored for a maximum period of 6 to 9 months ithout
being connected to an electrical po er supply. Beyond this period the rechargeable
batteries may loose their charge as a consequence of the lack of electrical po er
supply. If the storage period of the device exceeds this period, it ill eventually
need to be reprogrammed.
Dispose of the packaging material safely. Keep foil sheets and plastic bags a ay
from children.
Risk of suffocation
Used Symbols
The symbols used on the ergo_bike medical8 comply ith the IEC 417 and IEC
878 standards (table D1/D2).
Follo the Warnings / Danger Notices
Accompanying documents / instructions.
Device of type B
Dangerous electrical voltage
Alternating current
Protective cable connection
Ground
Potential equalisation
Recycling of old electric and electronic devices
read the operating instructions
Compliance to Standards
The ergo_bike-medical8 may not be used if the certifications/approval and the
defined safety standards (according to the table of the technical specifications)
do not comply ith the local prescriptions. The local country specifications must
be compared ith those of the device before using the device and the device
may only be used if they comply ith each other.
Domains of application
Ergometer bikes, ith a declaration of conformity related to the medical domain,
are suited for medical applications.
You may use these models in the follo ing domains:
- Endurance training
- Performance (capacity) tests
- Biking ergometry
- Development training for rehabilitation
!
GB

14
EC manufacturer's declaration of conformity
EC manufacturer's declaration of conformity
For the following designated product
Product: ergo_bike
Model: ergo_bike medical
We hereby declare that the aforementioned product complies with the following prescriptions:
EC-directive 93/42EEC of the council of June 14, 1993 about medical products
The following standards and prescriptive provisions were used to evaluate the product :
Standard description Issue
EN 1041 Informationen supplied by the manufacturer 199
with medical devices
EN 60601-1 + A1 + A2 Medical electrical equipment Part 1  General 1996
requirements for safety
EN 60601-1-2 Medical electrical equipment Part 1  General 2001
requirements for safety
2. additional form : electromagnetic compatibility -
requirements and tests
The quality assurance system of daum electronic gmbh is certified by the DQ GmbH according to the
representation models I O 13485:2003 and according to 93/42EEC annexe II item 3, (CE 0297)
daum electronic gmbh
Flugplatzst. 100
D-90768 Fürth
Tel.: ++49 (0)911 / 9 75 36-0
Fax: ++49 (0)911 / 9 75 36-96
Fürth, November 30, 2006
0297

Specifications
EC manufacturer's declaration of conformity
15
Safety Requirements
daum electronic gmbh hereby declares that this product complies ith the
follo ing provisions regarding electromagnetic compatibility and electrical safety:
- EN 957-5 Additional specific safety requirements and test methods
- EC directive 93/42EEC of the council of June 14, 1993 about medical products
- 89 / 336 / EEC of May 3, 1989 including subsequent changes (Recommendation
92 / 31 / EEC of April 28, 1992 and recommendation 93 /68 / EEC of July 22,
1993)
- 73 / 23 / EEC of February 19, 1973 including subsequent changes
(Recommendation 93 / 68 / EEC of August 30, 1993)
- 02 / 96 / EG of January 27, 2003 about Recycling of old electic and electronic
devices
- 03 / 108 / EG of December 8, 2003 of changes (Recommendation)
2002 / 96/ EG about Recycling of old electic and electronic
- EN 60601-1-2 (EMC, Generic Emission Standard, Part 1: Residential commercial
and light industry)
Technical Safety Recommendations:
Compare the supply voltage indicated on the nameplate located on the housing
ith your local supply voltage prior to plugging the po er cord to the po er
supply. Please contact you dealer if the values are not the same.
The device is completely disconnected from the po er supply by pulling out the
po er cord, therefore it should al ays be plugged into an easily accessible
socket.
Braking system: Computer-controlled, full electronic eddy current
brake (operating in the speed ranges sho n
in the diagram on page 16)
Load range: 20 to 1000 Watt
Speed range: 0 to 200 RPM
Load precision: Conform to DIN VDE 0750-238 (German
Electrotechnology Federation)
Loading levels: In 1-Watt increments, manually adjustable
Drive:
T o-stage, maintenance-free V-ribbed belt drive.
Saddle height adjustment: fast setting in 18 levels
Handlebars setting: approx. 360° continuous
Displays: Colour screen
256 Colours
320 x 240 / 76800 Pixels
Pulse rate measurement: Measuring range 40 to 200 beats per minute
Telemetric using the Cardio sensor chest strap
(available as an optional accessory)
Alarm signals: Acoustic and optical
Weight: approx. 45 kg
Dimensions: L 97 cm, W 54 cm, and H 125 cm
Po er supply: 230 V alternating current, 50 Hz, 50 VA
protective signs: CE - 0297
Safety class: 1
GB

Ergometry Test
16
Maintenance
rotation speedl
po er Watt
160
150
140
130
120
110
100
90
80
70
60
50
40
30
20
10
25 100 200 300 400 500 600
Replacements of the Dashboard Battery
CAUTION! Failure to correctly replace the battery may create
an explosion risk.
A button cell battery (CR 2032) is located on the underside of the dashboard
circuit board. This battery must be replaced hen the time and date keeping
function fails. Problems hen turning on the machine and display failures are
also signs of an empty battery.
Ergometry operation
- Adjust the saddle position to the size of the body (see page 6). At the lo est
position of the pedal the heel of the extended leg must still rest on that pedal.
- Adjust the handlebars (see page 6)
- Prepare the test person. Explain to the patient hat the test is about and the
importance of pedalling at a prescribed speed. The ergo_bike medical8 ill
maintain the set load constant under variable pedalling speed in the follo ing
speed range:
- Connect the pulse rate sensor or ECG electrodes
- Enter the patient data
- set the remaining profile data, e.g. the cool do n load duration and value
- Select load profile
- Start the ergometry process
- Watch the pedalling speed (RPM) under load and instruct the patient to correct
his pedalling speed if needed (a green bar is displayed to the left of the RPM
display, this bar ill turn red if the pedalling speed is not ithin the tolerance
domain).
Caution:
Non-supervised ergometry sessions must be strictly avoided. During the ergometry
test the patient must be visually observed. The ergometry test must be interrupted
immediately in the case of any complication (exhaustion, excessive s eating,
skin discoloration, etc.).
All maintenance and repair works may only be carried out by
specifically authorised personnel.
Note: In the case of repair or service works, authorised personnel may
order needed service documents from daum electronic gmbh.
Testing according to the prescriptions of the by law for
operating medical products ( MP by law)
Technical Safety and Measurements tests:
Every t o years or after executing repair orks including interventions on the
electronic system, the device must undergo a check by a service technician
authorised by daum electronic gmbh according to §6 and §11 of the by-la for
operating medical products and the kno n technical regulations, and be repaired
as needed.
Technical safety tests may only be executed by persons (technicians) ith the
proper education and kno ledge.
According to §11 of the by-la for operating medical products, technical metrology
tests may only be executed by the authorities or persons, ho comply ith the
applicable requirements and are certified to carry-out this activity by the competent
national authority.
Liability
The manufacturer ill not be held liable if the ergometer is not used in compliance
ith the provided instructions and recommendations and if the prescription are
ignored.
Handlebars rappings are earable parts. These parts are not covered by the
arranty.
Warning: The device must be switched OFF when replacing the battery.
Afterward you must set the date and time.
Unscre and remove the 4 scre s on the lo er part of the dashboard. Then
tilt the upper part of the dashboard up carefully.
Take care not to separate any cable connection.
Never touch the electronic parts of the dashboard with your fingers!
Charges of static electricity can destroy the sensitive parts.
Press the clip holder out ard ith a pin to replace the battery, remove the battery
and insert a ne one ith the plus symbol up.
Reassemble the upper part of the dashboard carefully.
Caution! Do not pinch any cable!
Notes about used button cell batteries
- Keep batteries a ay from children, and do not s allo them!
- Do not recharge empty batteries and do not thro them in fire.
Please recycle used batteries by bringing them to the appropriate collect point,
or return them to your dealer.
What is to be noted in the handling of SD cards?
1. Electrostatic Discharge (ESD) can damage electronic components. Before
touching the memory card, ensure that you are free of static electricity by
first touching a grounded metal object.
2. Avoid touching the golden fingers (pins) of the memory card.
3. Keep the memory card a ay from heat, direct sunlight and moisture.
4. Do not bend, flex, or drop the memory card.
5. To prevent data loss and/or damage to a memory card. NEVER remove the
card from an electronic device hile data is being transferred. NEVER pull
out the card out of the device if data is being ritten, e. g. if training or cycling.
6. Backup your SD card in regulare intervals in the PC.
Range independent of the speed
ergo_bike medical8
Range independent of the speed according to
DIN VDE 0750-238 (German Electrotechnology Federation)
!
!

Testing /Placing Into Service
17
Model
Serial No.
=> Note: All the following issues must be considered to complete the reception.
Issue Status
I afety notese
Protected individual electric socket-outlet (16 A) verified
Equipotential bonding verified
Installation notes / clearance space verified
Cable routing verified
upervision duty verified
II Functions
ON / OFF switch verified
EMERGENCY TOP device verified
Controls  mechanical verified
Controls  dashboard / console verified
III User manual
The user manual was read and understood.verified
The user manual must be stored in the direct vicinity of the device.
=> The reception has been completed in accordance with the Medical
Devices Law (MPG) and the additional directions of the manufacturer.
Received by
Name
Date Signature
Client
Name
Date Signature
Reception report
verified
GB

Testing /Placing Into Service
18
Enclosed sheet for the testing (before placing into service) and repeat testing of medical electrical devices or systems according to GEF (German Electrotechnology
Federation) 0751-1
Next test date Remark Tester Signature Date
Placing into service
(start up)

Any failure of the medical device and the precise description of its cause must be reported to the person in charge of the safety of medical products
at daum electronic gmbh.
The device must be tested according to GEF (German Electrotechnology Federation) 0751 1 before it is put back into service.
Failure description Spare part / Item number Tester Signature Date
19
Service Case
Flugplatzstr. 100
D-90768 Fürth
Tel. ++49 (0) 911/9 75 36-0
Fax ++49 (0) 911/9 75 36-96
GB

GNU General Public License
20
restricted, and the output from the Program is covered only if its contents
constitute a ork based on the Program (independent of having been made by
running the Program). Whether that is true depends on hat the Program does.
1. You may copy and distribute verbatim copies of the Program's source code
as you receive it, in any medium, provided that you conspicuously and appropriately
publish on each copy an appropriate copyright notice and disclaimer of arranty;
keep intact all the notices that refer to this License and to the absence of any
arranty; and give any other recipients of the Program a copy of this License
along ith the Program.
You may charge a fee for the physical act of transferring a copy, and you may
at your option offer arranty protection in exchange for a fee.
2. You may modify your copy or copies of the Program or any portion of it, thus
forming a ork based on the Program, and copy and distribute such modifications
or ork under the terms of Section 1 above, provided that you also meet all of
these conditions:
a) You must cause the modified files to carry prominent notices stating
that you changed the files and the date of any change.
b) You must cause any ork that you distribute or publish, that in hole
or in part contains or is derived from the Program or any part thereof,
to be licensed as a hole at no charge to all third parties under the
terms of this License.
c) If the modified program normally reads commands interactively hen
run, you must cause it, hen started running for such interactive use
in the most ordinary ay, to print or display an announcement including
an appropriate copyright notice and a notice that there is no arranty
(or else, saying that you provide a arranty) and that users may
redistribute the program under these conditions, and telling the user
ho to vie a copy of this License. (Exception: if the Program itself is
interactive but does not normally print such an announcement, your
ork based on the Program is not required to print an announcement.)
These requirements apply to the modified ork as a hole. If identifiable sections
of that ork are not derived from the Program, and can be reasonably considered
independent and separate orks in themselves, then this License, and its terms,
do not apply to those sections hen you distribute them as separate orks. But
hen you distribute the same sections as part of a hole hich is a ork based
on the Program, the distribution of the hole must be on the terms of this License,
hose permissions for other licensees extend to the entire hole, and thus to
each and every part regardless of ho rote it.
Thus, it is not the intent of this section to claim rights or contest your rights to
ork ritten entirely by you; rather, the intent is to exercise the right to control
the distribution of derivative or collective orks based on the Program.
In addition, mere aggregation of another ork not based on the Program ith
the Program (or ith a ork based on the Program) on a volume of a storage
or distribution medium does not bring the other ork under the scope of this
License.
3. You may copy and distribute the Program (or a ork based on it, under Section
2) in object code or executable form under the terms of Sections 1 and 2 above
provided that you also do one of the follo ing:
a) Accompany it ith the complete corresponding machine-readable
source code, hich must be distributed under the terms of Sections 1
and 2 above on a medium customarily used for soft are interchange;
or,
b) Accompany it ith a ritten offer, valid for at least three years, to
give any third party, for a charge no more than your cost of physically
performing source distribution, a complete machine-readable copy of
the corresponding source code, to be distributed under the terms of
Sections 1 and 2 above on a medium customarily used for soft are
interchange; or,
c) Accompany it ith the information you received as to the offer to
distribute corresponding source code. (This alternative is allo ed only
for noncommercial distribution and only if you received the program in
object code or executable form ith such an offer, in accord ith
Subsection b above.)
The source code for a ork means the preferred form of the ork for making
modifications to it. For an executable ork, complete source code means all the
1. Information
Some sections of the soft are used on your Daum premium 8(i) or medical 8(i)
training device are covered by the GNU Public General License (see 1.1ff) or
other Open-Source licences and can be do nloaded from the eb site of the
Daum Company free of charges.
To do this please point your bro ser to the eb page http:// .daum-
electronic.de/de/support/opensource.html and select the soft are you hish to
do nload.
1.1. GNU General Public License
Version 2, June 1991
Copyright (C) 1989, 1991 Free Soft are Foundation, Inc.
51 Franklin Street, Fifth Floor, Boston, MA 02110-1301, USA
Everyone is permitted to copy and distribute verbatim copies
of this license document, but changing it is not allo ed.
1.2. Preamble
The licenses for most soft are are designed to take a ay your freedom to share
and change it. By contrast, the GNU General Public License is intended to
guarantee your freedom to share and change free soft are--to make sure the
soft are is free for all its users. This General Public License applies to most of
the Free Soft are Foundation's soft are and to any other program hose
authors commit to using it. (Some other Free Soft are Foundation soft are is
covered by the GNU Lesser General Public License instead.) You can apply it
to your programs, too.
When e speak of free soft are, e are referring to freedom, not price. Our
General Public Licenses are designed to make sure that you have the freedom
to distribute copies of free soft are (and charge for this service if you ish), that
you receive source code or can get it if you ant it, that you can change the
soft are or use pieces of it in ne free programs; and that you kno you can
do these things.
To protect your rights, e need to make restrictions that forbid anyone to deny
you these rights or to ask you to surrender the rights. These restrictions translate
to certain responsibilities for you if you distribute copies of the soft are, or if
you modify it.
For example, if you distribute copies of such a program, hether gratis or for
a fee, you must give the recipients all the rights that you have. You must make
sure that they, too, receive or can get the source code. And you must sho them
these terms so they kno their rights.
We protect your rights ith t o steps: (1) copyright the soft are, and (2) offer
you this license hich gives you legal permission to copy, distribute and/or
modify the soft are.
Also, for each author's protection and ours, e ant to make certain that everyone
understands that there is no arranty for this free soft are. If the soft are is
modified by someone else and passed on, e ant its recipients to kno that
hat they have is not the original, so that any problems introduced by others
ill not reflect on the original authors' reputations.
Finally, any free program is threatened constantly by soft are patents. We ish
to avoid the danger that redistributors of a free program ill individually obtain
patent licenses, in effect making the program proprietary. To prevent this, e
have made it clear that any patent must be licensed for everyone's free use or
not licensed at all.
The precise terms and conditions for copying, distribution and modification follo .
1.3. TERMS AND CONDITIONS FOR COPYING,
DISTRIBUTION AND MODIFICATION
0. This License applies to any program or other ork hich contains a notice
placed by the copyright holder saying it may be distributed under the terms of
this General Public License. The "Program", belo , refers to any such program
or ork, and a " ork based on the Program" means either the Program or any
derivative ork under copyright la : that is to say, a ork containing the Program
or a portion of it, either verbatim or ith modifications and/or translated into
another language. (Hereinafter, translation is included ithout limitation in the
term "modification".) Each licensee is addressed as "you".
Activities other than copying, distribution and modification are not covered by
this License; they are outside its scope. The act of running the Program is not