• GE Medical Systems Information Technologies GmbH considers itself responsible for the eects on safety,reliability, and
performance of the equipment, only if:
- assembly operations, extensions, readjustments, modications, or repairs are carried out by ergoline GmbH or by
persons authorized by GE Medical Systems Information Technologies GmbH,
- the electrical installation of the relevant room complies with the applicable national and local requirements,
- and the instrument is used in accordance with the intended use and the instructions for use.
• This manual contains service information; operating instructions are provided in the operator’s manual of the
instrument.
• This manual is in conformity with the instrument at printing date.
• The Service Manual eBike III is valid for the following devices:
2017911-301 EBIKE III BASIC
2017911-303 EBIKE III BASIC WITH NIBP
2017911-305 EBIKE III COMFORT
2017911-307 EBIKE III COMFORT WITH NIBP
Software Version GF 1.x and optional with Module “NIBP“ and Supply and Service Items.
Manufacturer: Distributor:
ergoline GmbH GE Medical Systems Information Technologies, Inc
Lindenstraße 5 8200 West Tower Avenue
D-72475 Bitz Milwaukee, WI 53223 USA
Germany Tel. +1 414 355 5000 1 800 437 1171 (US only)
Tel.: +49 (0) 7431 98 94 - 0 1 800 668 0732 (Canada only)
Fax: +49 (0) 7431 98 94 - 128 Fax +1 414 355 3790
e-mail: info@ergoline.com
internet: http://www.ergoline.com
2018111-336 Rev. B eBike III basic / comfort - 3 -
revIsIon HIstory
This manual is subject to the GE Medical Systems Information Technologies change order service.
The revision code, a letter that follows the document part number, changes with every update of the manual.
The initial version of the manual has the letter B.
Part No.Revision CodeDateComment
2018111-336Rev A2016-03Engineering Release
2018111-336Rev B2016-04Initial Release
- 4 - eBike III basic / comfort 2018111-336 Rev. B
- 6 - eBike III basic / comfort 2018111-336 Rev. B
eleCtrICal safety
leakageCurrents
MeasurIngequIpMent
The measuring equipment used for the electrical safety
tests must be inspected and calibrated at regular intervals
(refer to manufacturer of measuring equipment).
The measurement results must be documented.
eBIke III BasIC / CoMfort
The eBike III basic/comfort ergometers are protection
class II equipment (no connection to protective ground).
The necessary electrical safety tests for these devices
together with the limit values are listed in the
chapter titled “eBike III basic/comfort - Preventive
maintenance“.
teCHnICal safety InspeCtIonsand
nspeCtIonsoftHe MeasurIng systeMs
I
The load unit is recommended to be inspected to the
approved regional standards at intervals of 2 years by a
GE Medical Systems Information Technologies authorized
service technician, and calibrated or repaired if necessary.
Calibration instructions for the NIBP module can be found
in this Service manual. Follow these instructions to display
the BP values with the test setup according to
EN 1060-1 and EN1060-3 or appropriate regional standard.
Warning
• Equipment Damage •
• The regulations about handling ESD sensitive components
must be observed.
Warning
• Patient Hazard, Equipment Damage
• EN 62353 and/or IEC 60601-1 requirements must be
satised during repair, modications and inspections of
medical electrical equipment.
• To ensure that equipment functions faultlessly and
without presenting any hazard after service interventions,
it must be subjected to the test procedures stipulated for
the dierent device categories.
• A device is considered to be unsafe, when:
- it cannot be repaired
- the user does not wish to have the device repaired.
In this case, the operator must be informed in
writing of the hazard presented by the device.
The same remark must be annotated on the
service report and on the service invoice..
The measurement results must be documented.
Warning
• Patient Hazard, Equipment Damage
• Use original spare parts only.
• For information about product changes, refer to the
manufacturer’s original documentation only.
• Observe the fuses’ original ratings, characteristics and
Ampere interrupting capacity.
• Parts of the device that ensure its safe operation must be
neither damaged nor obviously unsuitable. This applies to
insulation and insulating components in particular.
• Power cords must be visually inspected for signs of
damage before connecting them to the power line.
2018111-336 Rev. B eBike III basic / comfort - 7 -
eBIke III BasIC / CoMfort
veryIMportantservICenote
Warning
• Hazard, Equipment Damage
• When work at the bottom of the eBike III is required (e.g. access to electronic moduls, exchange
of load unit or installation of COM module) the eBike III should be carefully placed on one side
by grabbing it at the handlebar and the saddle.
• DO NOT tilt the eBike III forward to stand on the handlebar - this is an unsecure and instable
position!
preventIve MaIntenanCe
Note
• eBike III basic / comfort is a protection class II device (no connection to protective ground).
• Preventive maintenance is recommended to be performed every 2 years.
fInalCHeCkoutproCedure / funCtIonaltest
1. Check the setup for stability, adjust with leveling device if required.
Expected result: No instability Pass/Fail
2. Visually inspect the device:
- inspect cables / power cord
Expected result: No damage or wear detected Pass/Fail
- 8 - eBike III basic / comfort 2018111-336 Rev. B
- Check bellow on saddle for damage / wear / cracks
- Check handlebar adjustment (angle)
- Check saddle height adjustment
- Check that the clamping levers (saddle [height] and handlebar [angle] adjustment) are tight.
Grease the thread of the saddle clamping lever.
(Use of an universal high-performance lubricant such as OKS 470 is recommended.)
eBike III comfort
- Check handlebar adjustment (angle)
- Check that the clamping lever is tight.
- Check electrical saddle adjustment: adjust minimum and maximum saddle height;
then return saddle to mid-level
- Check correct indication of saddle height display
- Check that the clamping lever for handlebar adjustment (angle) is tight
Expected result: Adjustments work and levers are tight, thread properly greased Pass/Fail
4. Using the power cord, connect the device to the mains power line and place the power switch in the ON position
Wait for self test to end:
- check LCD for error messages (refer to „Turning the System On“ on page 60)
- check the software version in the service menu for correct version GF 1.x
(refer to „Software update“ on page 78)
- check the “error log le“ in service menu (refer to „Error log“ on page 67)
Expected result: Device powers on without errors, FW is correct version, no errors logged Pass/Fail
5. Check speed indication (rpm) is displayed on LCD and the additional speed indication on the patient display.
Check noise level of idling drive unit (for example, for grinding noises or noise from the bearing)
Expected result: Speed displayed on both displays and no noticeable noise Pass/Fail
6. Units with NIBP module:
- Check cu tubing and tubing connections, microphone connectors
- Check blood pressure measurement on test subject at rest (refer to the „eBike III operators manual“)
- Check blood pressure readings are displayed on LCD
Expected result: BP values are displayed and in proper range Pass/Fail
7. Set manual load (see „Manual Load“ on page 66), change load (for example, 50 W, 100 W)
- Check load level and load indication
Expected result: Load is set and changes as expected Pass/Fail
8. If ergometer is remote controlled from ECG recorder or PC-ECG system:
- Check connecting cable
- Check load control via ECG recorder or PC ECG system
- Check remote start if applicable
Expected result: Ergometer can be controlled by external unit Pass/Fail
2018111-336 Rev. B eBike III basic / comfort - 9 -
eleCtrICal safety
Perform electrical safety checks when indicated - current leakage test results meet requirements.
All indicated electrical safety checks require a pass/fail indication for steps performed.
Record the measurement values in your debrief.
1.AC mains power cord ground prong to
exposed metal surface (ground lug)
(1) NC = Normal Condition
SFC = Single Fault Condition
N/A = Not Applicable
(2) UUT = Unit Under Test
(3) Test applies for eBike III with blood pressure unit only - measuring point is the microphone connector
N/A
- 10 - eBike III basic / comfort 2018111-336 Rev. B
CHeCkoutproCedureafterrepaIr
After replacing a FRU or performing certain tasks, it is necessary to also inspect the unit and perform a series of checks to
ensure the unit is functioning properly. The following tables identify the inspections and checkout procedures to perform.
To use the tables, locate the relevant FRU or task in the rst column and note the required checkout procedure(s) for the
item(s). Then locate the corresponding instructions in the sections following the tables.
19. eBike III comfort only: Check correct indication of saddle height display pass/fail
20. eBike III comfort only: Check if saddle tube moves tightly and without any mechanical wobble
in saddle tube guidance. pass/fail
21. Check software (rmware) is at correct version GF 1.x
(refer to „Software update“ on page 78) pass/fail
22. Check and clear the “error log le“ in service menu
(refer to „Error log“ on page 67) pass/fail
23. Check stable position on oor, check leveler adjustment pass/fail
Operational Checks
24. Power-up self-test passed (no error messages on LCD)? pass/fail
25. LCD contrast ok?
(refer to „Contrast“ on page 62) pass/fail
26. eBike successfully communicates with ECG device?
(refer to „Connectivity and installation eBike III to GE ECG devices“ on page 81) pass/fail
27. Check load level and load indication on LCD pass/fail
28. Set manual load (see „Manual Load“ on page 66),
change load (for example, 50 W, 100 W)
Check noise level of idling drive unit (for example, for grinding noises or noise from the bearing) pass/fail
29. Check speed indication (rpm) displayed on LCD and the additional speed indication
on the patient display. pass/fail
30. Blood pressure measurement successfully initiated by ECG device? pass/fail
31. Blood pressure values successfully communicated to ECG device pass/fail
32. Check cu tubing and tubing connections, microphone connectors pass/fail
33. Check blood pressure measurement on test subject at rest pass/fail
34. Check blood pressure readings on LCD pass/fail
Tests and Calibration Checks
35. System conguration and settings correct?
(refer to „System Cong.“ on page 66) pass/fail
36. NIBP test successfully passed?
(refer to „NIBP Test“ on page 76) pass/fail
37. NIBP calibration successfully performed?
(refer to „NIBP Calibration“ on page 77) pass/fail
2018111-336 Rev. B eBike III basic / comfort - 13 -
38. Check and clear the “NIBP error log le“ in service menu
(refer to „Error log“ on page 67) pass/fail
39. Dynamic load calibration with test bench successfully performed?
(refer to „Dynamic Load Calibration“ on page 72) pass/fail
40. Electrical saddle adjustment: adjust minimum and maximum saddle height
(refer to „Saddle Calibration“ on page 64) pass/fail
41. Check torque values for screws pass/fail
Electrical Safety Checks
42. Current leakage and ground continuity test results meet requirements?
Perform electrical safety checks when indicated (refer to „Electrical Safety“ on page 10).
All indicated electrical safetychecks require a pass/fail indication for steps performed.
Record the measurement values. pass/fail
- 14 - eBike III basic / comfort 2018111-336 Rev. B
testproCedure “rpM / load“
Note
• Unless regulatory requirements of the country dene a dierent test procedure or test intervall, it is recommended to perform the
test “RPM / load“ at least every 2 years.
Note
• An external calibration device for dynamic load testing is needed to perfom the following test procedures
(“ergoline ergotest 550“ - order direct from Ergoline P/N 705890) or equivalent device.
• Please refer to the operator manual of the used calibration device.
testpreparatIon
1. Dismount BOTH (!) pedal cranks of the eBike III - see “Dismount pedal cranks“ under section „Dismount pedal cranks“
on page 41.
2. Follow the operator manual from the manufacture of calibration device being used to connect the calibration device
with the axis of the eBike III.
3. If supported by the calibration device, connect the eBike III interface (RS-232 or USB) with the calibration device.
4. Connect the calibration device to the PC / notebook setup containing the software and conguration to work with the
device.“
5. Start the test software of the calibration device.
rpM testprotoCol
1. Apply a load of 100 W to the eBike III
(-either by command of the test software or manually on the eBike III (see „Manual Load“ on page 66).
2. Perform the following RPM tests step by step. Note the results in the table or use the printed protocol of the
calibration device to document the test.
StepTarget RPMActual RPMDeviation max.Pass / Fail
#130± 1 rpm
#240± 1 rpm
#350± 1 rpm
#4100± 1 rpm
#5120± 1 rpm
2018111-336 Rev. B eBike III basic / comfort - 15 -
loadtestprotoCol
1. Perform the load test (RPM is set by the calibration device / load of the eBike III is set either by command of the test
software or manually on the eBike III -see „Manual Load“ on page 66) step by step.
2. The actual load is measured and displayed by the calibration device software. Note the results in the table or use the
printed protocol of the calibration device to document the test.
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testproCedure “Bloodpressure (nIBp)“
Note
• Unless regulatory requirements of the country dene a dierent test procedure or test interval, it is recommended to perform the
test “Blood pressure (NIBP)“ at least every 2 years.
Note
• A calibrated NIBP measure instrument set is needed to perfom the following test procedures.
• Please refer to the operator manual of the used device.
testpreparatIon
1. Power eBike III on and enter service menu / NIBP test (-see „Calibration of Blood pressure unit“ on page 75).
2. Connect the calibration equipment with the eBike III cu connector.
leak-tIgHtnesstest
1. Use the connected test equipment to apply the target pressure (see table below) to the eBike III cu connector, wait
until the pressure in the system has stabilized (approx. 5 sec).
2. After 1 min check the actual pressure and note the pressure drop in the table
StepTarget PressureActual pressure dropPressure drop max.Pass / Fail
#150 mmHgmmHg / min< 6 mmHg / min
#2300 mmHgmmHg / min< 6 mmHg / min
aCCuraCytest
1. Use the connected test equipment to apply the target pressure (see table below) to the eBike III cu connector, wait
until the pressure in the system has stabilized (approx. 5 sec).
2. Check the actual pressure displayed on the eBike III display and note the value in the table.