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Testing /Placing Into Service

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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)

Summary of Contents for ergo_bike medical8

Page 1: ...medical Operating Instructions 0650682e 0004 0297 ...

Page 2: ...etting 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 Servi...

Page 3: ...ode 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 qu...

Page 4: ...gestion 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 Al...

Page 5: ...ors 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 ...

Page 6: ...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 se...

Page 7: ...nd 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...

Page 8: ...eys 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 t...

Page 9: ...te With the RPM controlled programs the wheel 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 power Starting Training by Selecting a Program You can choose from various program types Watt Training Programs Wit...

Page 10: ... or before setting the loading values after a few 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 watt value will be highlighted in red w...

Page 11: ...tton 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 ...

Page 12: ...trol button to start playing the selected title The system continues with playing all the music titles eventually following 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 while the music is playing by pressing the Back key you can continue listening to your music while training...

Page 13: ...s should still be slightly bent at the lower 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 with 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 with big electrical connections b...

Page 14: ...on Issue EN 1041 Informationen supplied by the manufacturer 1998 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 b...

Page 15: ...eplate located on the housing with your local supply voltage prior to plugging the power cord to the power supply Please contact you dealer if the values are not the same The device is completely disconnected from the power supply by pulling out the power cord therefore it should always be plugged into an easily accessible socket Braking system Computer controlled full electronic eddy current brak...

Page 16: ... for operating medical products and the known technical regulations and be repaired as needed Technical safety tests may only be executed by persons technicians with the proper education and knowledge According to 11 of the by law for operating medical products technical metrology tests may only be executed by the authorities or persons who comply with the applicable requirements and are certified...

Page 17: ...Supervision duty verified II Functions ON OFF switch verified EMERGENCY STOP 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...

Page 18: ...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 ...

Page 19: ...ety 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 0 911 975 36 0 Fax 49 0 911 97536 96 GB ...

Page 20: ... and only if you received the program in object code or executable form with such an offer in accord with Subsection b above The source code for a work means the preferred form of the work for making modifications to it For an executable work complete source code means all the 1 Information Some sections of the software used on your Daum premium 8 i or medical 8 i training device are covered by th...

Page 21: ...l distribution limitation excluding those countries so that distribution is permitted only in or among countries not thus excluded In such case this License incorporates the limitation as if written in the body of this License 9 The Free Software Foundation may publish revised and or new versions of the General Public License from time to time Such new versions will be similar in spirit to the pre...

Page 22: ...if any to sign a copyright disclaimer for the program if necessary Here is a sample alter the names Yoyodyne Inc hereby disclaims all copyright interest in the program Gnomovision which makes passes at compilers written by James Hacker signature of Ty Coon 1 April 1989 Ty Coon President of Vice This General Public License does not permit incorporating your program into proprietary programs If your...

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Page 24: ...daum electronic gmbh Flugplatzstr 100 D 90768 Fürth Tel 49 0 911 97536 0 Fax 49 0 911 7537 14 www daum electronic de Stand 25042007 ...

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