GE eBike BASIC User manual

2018112-003 Rev J eBike, eBike L, eBike EL - I -
eBike / eBike L / eBike EL
Service Manual
2018112-003 Revision J

- II - eBike, eBike L, ebike EL 2018112-003 Rev J
The Service Manual eBike is valid for the following devices:
2017911-001 ERGOMETER EBIKE BASIC PC-CTRL
2017911-002 ERGOMETER EBIKE BASIC PCPLUS-CTRL
2017911-003 ERGOMETER EBIKE BASIC PC-CTRL & BP
2017911-004 ERGOMETER EBIKE BASIC PCPLUS-CTRL & BP
2017911-005 ERGOMETER EBIKE COMFORT PC-CTRL
2017911-006 ERGOMETER EBIKE COMFORT PCPLUS-CTRL
2017911-007 ERGOMETER EBIKE COMFORT PC-CTRL & BP
2017911-008 ERGOMETER EIBKE COMFORT PCPLUS-CTRL&BP
2017911-020 ERGOMETER EBIKE L 240V
2017911-021 ERGOMETER EBIKE L & BP 240V
2017911-022 ERGOMETER EBIKE L EXT TRMNL 240V
2017911-023 ERGOMETER EBIKE L & BP EXT TRMNL 240V
2017911-024 ERGOMETER EBIKE L 120V
2017911-025 ERGOMETER EBIKE L & BP 120V
2017911-026 ERGOMETER EBIKE L EXT TRMNL 120V
2017911-027 ERGOMETER EBIKE L & BP EXT TRMNL 120V
2017911-028 ERGOMETER EBIKE EL 240V
2017911-029 ERGOMETER EBIKE EL & BP 240V
2017911-030 ERGOMETER EBIKE EL EXT TRMNL 240V
2017911-031 ERGOMETER EBIKE EL & BP EXT TRMNL 240V
2017911-032 ERGOMETER EBIKE EL 120V
2017911-033 ERGOMETER EBIKE EL & BP 120V
2017911-034 ERGOMETER EBIKE EL EXT TRMNL 120V
2017911-035 ERGOMETER EBIKE EL & BP EXT TRMNL 120V
optional with Module "N I B P" and all Supply and Service Items
and Software Version FW 1.8
Caution:
During repairs/service interventions, observe the protective measures against
damage due to ESD.
••
••
•GE Medical Systems Information Technologies GmbH considers itself responsible for the effects on safety,
reliability, and performance of the equipment, only if:
- assembly operations, extensions, readjustments, modifications, or repairs are carried out
by GE Medical Systems Information Technologies GmbH or by persons authorized by
GE Medical Systems Information Technologies,
- the electrical installation of the relevant room complies with the applicable national and local
requirements, and
- the instrument is used in accordance with 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.
••
••
•All rights are reserved for instruments, circuits, techniques, and names appearing in the manual.
Manufacturer:
ergoline GmbH
Lindenstraße 5
D-72475 Bitz
Tel.: [phone] - 0
Fax: [phone] - 127
e-mail: [email protected]
internet: http://www.ergoline.com
Manual Information
©Copyright 2003, 2008. General Electric Company. All rights reserved.
Distributor:
GE Medical Systems
Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223 USA
Tel. [phone]
888.558.5120 (USA only)
Fax [phone]

2018112-003 Rev J eBike, eBike L, eBike EL - III -
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 letterA.
Part No. Revision Code Date Comment
2018112-003 Rev A 2003-11 Initial Release
2018112-003 Rev B 2004-04 076092
2018112-003 Rev C 2004-08 077414
2018112-003 Rev D 2005-01 079503: eBike L&EL added
2018112-003 Rev E 2005-03 079947: V1.4 PC/PCplus
2018112-003 Rev F 2005-09 081381
2018112-003 Rev G 2006-12 ECO 085810: V1.6
2018112-003 Rev H 2007-10 ECO 089049:
V1.6 replaced by V1.7
Revised pages: II, 3, 4, 5, 55, 56, 57,
60, 68
2018112-003 Rev I 2008-03 V1.7 replaced by V1.8
Revised pages: II, III, 3-6, 17, 25, 26,
32, 33, 47, 57-59, 85, 86, 93, 94
2018112-003 Rev J 2008-06 Blood-pressure module (pump)
updated
Images replaced on pages 30, 87, 90,
94
Revision History

- IV - eBike, eBike L, ebike EL 2018112-003 Rev J
CONTENTS
Contents
A-1 Safety Information .................................................................................................. 1
Inspection according to German Medical Device Operator Ordinance............................. 2
A-2 Final Checkout Procedure / Functional Test ........................................................ 3
A-2.1.Final Checkout Procedure and Functional Test of eBike Basic, eBike Comfort ...... 3
A-2.2. Final Checkout Procedure and Functional Test of eBike L ..................................... 4
A-2.3. Final Checkout Procedure and Functional Test of eBike EL .................................. 5
Part B. Mechanical Design ............................................................................................ 9
B.1 Operating Controls and Connections of eBike............................................................ 9
B.1.a Operating Controls .................................................................................................. 9
B.1.b Operating Controls and Connections of eBike L .................................................... 10
B.1.c Operating Controls and Connections of eBike EL .................................................. 11
B.1.d Connections and Data Ports of the eBike .............................................................. 12
B.2 Overview: Mechanical Design eBike ........................................................................ 13
B-2.1 Overview: Disassembling the eBike basic/comfort ............................................... 14
B-3. Overview: Mechanical Design eBike L ................................................................... 21
B-3.1 Overview: Disassembling eBike L ........................................................................ 22
B-3.1.1 eBike L: Remove Connection Box ................................................................................................ 22
B-3.1.2 eBike L: Remove Casing .............................................................................................................. 22
B-3.1.3 eBike L: Replace Saddle Motor .................................................................................................... 24
B-3.1.4 eBike L: Install Power Supply Module for eBike L (P/N 2018111-142) ............................................ 25
B-3.1.5 eBike L: Replace Lift Motor for Couch Adjustment ........................................................................26
B-3.1.6 eBike L: Replace Motor Control Unit ............................................................................................. 27
B-3.1.7 eBike L Basic: Replace Control Panel .......................................................................................... 27
B-3.1.8 eBike L External: Replace External Speed Indicator......................................................................27
B-4.Overview: Mechanical Design eBike EL .................................................................. 28
B-4.1 Overview: Disassembling eBike EL ...................................................................... 29
B-4.1.1 eBike EL: Remove Connection Box .............................................................................................. 29
B-4.1.2 eBike EL: Remove Casing ............................................................................................................ 29
B-4.1.3 eBike EL: Replace Saddle Motor .................................................................................................. 31
B-4.1.4 eBike EL: Install Power Supply Module for eBike EL (P/N 2018111-142) ....................................... 32
B-4.1.5 eBike EL: Replace Lift Motors for Couch Adjustment .................................................................... 33
B-4.1.6 eBike EL: Replace Motor Control Unit ........................................................................................... 34
B-4.1.7 eBike EL Basic: Replace Control Panel ........................................................................................ 35
B-4.1.8 eBike EL External: Replace External Speed Indicator ................................................................... 35
Part C. Electrical Design ............................................................................................. 37
C-1.1 Block Diagram eBike Basic / eBike Comfort for RPM Board 1 ............................. 37
C-1.2 Block Diagram eBike Basic / eBike Comfort for RPM Board 2 ............................. 38
C-1.3 Block Diagram eBike L for RPM Board 1 ............................................................. 39
C-1.4 Block Diagram eBike L for RPM Board 2 ............................................................. 40
C-1.5 Block Diagram eBike EL for RPM Board 1 ........................................................... 41
C-1.6 Block Diagram eBike EL for RPM Board 2 ........................................................... 42
C-2.1 Wiring Diagram eBike Basic / eBike Comfort ....................................................... 43
C-2.2 Wiring Diagram eBike L ....................................................................................... 44

2018112-003 Rev J eBike, eBike L, eBike EL - V -
Contents
C-2.3 Wiring Diagram eBike EL .................................................................................... 45
C-3 Overview: PCBs eBike ............................................................................................ 46
C-4 Overview: DIP Switch and Jumper Settings ............................................................. 48
Part D: Service Menu for eBike Basic / Comfort / L / EL ........................................... 49
Part E: Drive Unit ......................................................................................................... 65
E-1. Drive Unit - Mechanical Design ............................................................................... 65
E-2. Troubleshooting and Repairs .................................................................................. 67
E-2.1 Replace Strain Gauge........................................................................................... 67
E-2.2 Replace PCB RPM............................................................................................... 67
E-2.3 RPM Board : Replacement and Adjustment Procedure ......................................... 68
Part F: Servicing Instructions .................................................................................... 71
F-1. Spare Parts for Repair of eBike .............................................................................. 71
F-2. Spare Parts for Repair of eBike L / eBike EL .......................................................... 72
F-3. Add-on “BP Module eBike“ ..................................................................................... 73
F-4. Add-on “BP Module eBike L“ & “BP Module eBike EL“ ........................................... 74
Appendix A: Interfaces ................................................................................................ 75
A.1 Digital Interfaces PORT 1 and PORT 3 .................................................................... 75
A.1 a Setup for: Digital ECG Unit ................................................................................... 76
A.2 Digital Interface PORT 2: For SERVICE PURPOSES only ....................................... 77
A.3 Analog Interfaces With Digital Data Transfer............................................................. 78
Appendix B: Spare Parts / Service Kits for eBike ..................................................... 79
Appendix B.2: Spare Parts / Service Kits for eBike L / eBike EL ............................. 90
Appendix C.1: Technical Specifications eBike Basic / eBike Comfort.................. 103
Appendix C.2: Technical Specifications eBike L .................................................... 105
Appendix C.3: Technical Specifications eBike EL.................................................. 106

- VI - eBike, eBike L, ebike EL 2018112-003 Rev J
For your notes

2018112-003 Rev JeBike, eBike L, eBike EL -1-
A:Safety Information
A-1. Safety Information
Electrical Safety During Service Interventions (IEC 60601-1)
IEC 60601-1 requirements must be satisfied during repair, modifications and inspections of medical
electricalequipment.
Under the regulations of the product liability act, equipment manufacturers must ensure that their
product does not present any hazard to the user in normal use.
The potential hazards must be considered in particular when handling mains operated devices.
To ensure that equipment functions faultlessly and without presenting any hazard after service
interventions,it must besubjected tothetest proceduresstipulated for thedifferent device categories.
Requirements for Persons stipulated in the German Medical Device Operators Ordinance:
The requirements of §11 section 6, §11 section 5 sentence 1 and §6 section 4 of the MPBetreibV
(German Medical Device Operator Ordinance) must be satisfied.
The regulations abouthandling ESD sensitive components mustbe observed.
1. Protection class I equipment (connected to protective earth conductor)
max. resistance of the protective earth conductor
R protective earth conductor
(with connection cable with max. length of 5 m) 0.100 Ohm
max.equivalent enclosure leakage current for portable equipment.
max. equivalent enclosure leakage current 0.500 mA
Themeasuring equipmentused forthe testsmustbe inspectedand calibratedat regularintervals.As
perthe GermanMedical Device Operator Ordinance, the measurement results must be documented
in the medical device book.
Note
Suitable common ground terminal:
- Bicycle ergometer eBike Basic / Comfort: screw of the levelling device
- ErgometereBikeL/EL:screwhead of theprotectiveearthconnectionbetweenswivelling section
andergometer base
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
informedinwritingofthehazardpresentedbythedevice.Thesameremarkmustbeannotated
on the service report and on the service invoice.
Important information for service interventions:
- Use original spare parts only.
- For information about product changes, refer to the manufacturer’s original documentation
only.
- Observe the fuses’ original ratings, characteristics andAmpere interrupting capacity.
- Parts of the device that ensure its safe operation must be neither damaged nor obviously
unsuitable.Thisappliesto insulationand insulatingcomponentsinparticular.
- Power cords must be visually inspected for signs of damage before connecting them to the
powerline.
:

-2-eBike, eBike L, eBike EL 2018112-003 Rev J
Inspection according to German Medical Device Operator Ordinance:
• Technical Safety Inspections and Inspections of the Measuring Systems:
According to §6 and §11 of the German Medical Device Operator Ordinance, the load unit must be
inspectedto theapproved rulesof the art at intervals of 2years bya GEMedical SystemsInformation
Technologies authorized Service technician, and repaired if necessary.
Themeasurement results must be documentedin the medical device book.
According to the German Medical Device Operator Ordinance, the next due inspection is indicated
on the Test Sticker next to the ergometer’s nameplate.
If unauthorized personnel opens the control terminal, destroying the calibration sticker (production
date), any warranty claim shall become void.
• Maintenance:
Dependingon the applicationpurpose, all clampinglevers of thedevice mustbeinspected atintervals
of6months to checkthatthethread and tipofthe clamping leverareadequately greased. Ifnecessary,
theclamping levers must be greased.
We recommend using a universal high-performance lubricant such as OKS 470.
Note
§11 of the German Medical Device Operator Ordinance demands that ergometers used in
medicine, i.e., ergometers for exercising patients with a defined and reproducible physical load,
be calibrated with a dynamic load.
Thetechnical inspectionof the measuring system isnot requiredfor ergometersused for training
purposes only and where the tests are not documented. The restricted applicability must be
identified by a suitable marker on the ergometer and it must be documented in the medical
devicebook.
Automatic Sphygmomanometer
Calibration instructions for the NIBP module can be found in the Servicing Instructions. Follow these
instructions to display the BP values with the test setup according to DIN EN 1060-1 and DIN EN
1060-3.
Ergometer
Static and dynamic inspections of the ergometer must be performed according to DIN VDE 0750-
238.
A:Safety Information

2018112-003 Rev JeBike, eBike L, eBike EL -3-
A-2. Final Checkout Procedure / Functional Test
These tests must be performed as the final checkout and test procedure after every safety
inspection, maintenance and repair of the product.
A-2.1. Final Checkout Procedure and Functional Test of eBike Basic,
eBike Comfort
1. Visually inspect the device
- Inspectcoat oflacquer,cables/power cord, bellows on steering column andsaddle.
- Inspectcuff, tubing and tubing connection.
- Checkthe setupfor stability, adjust with levelling deviceif required.
Expected result: Nodamage, instabilityor weardetected Pass/Fail
2. Check cranks, pedals and Velcro strips
- Cranks,pedals and Velcro stripsproperly fixed.
- Greasethe threads oftheclamping levers(every6 months, dependingon application purpose).
Expected result:Allthreads properly greased, cranks and pedals OK Pass/Fail
3. Power on
- Using the power cord, connect the device to the power line and turn it on with the power switch.
- Wait for self-test to end: Check LCD, e.g. for error messages.
- Check in the software if the firmware version is OK.
Expected result: Device powers on without errors and FW is OK Pass/Fail
4. Adjustments
eBike Basic:
- Checksaddle(height) and handlebar(angle)adjustment.
- Checkthat the clampinglevers (saddle (height)and handlebar (angle)adjustment) are tight.
eBike Comfort:
- Check electrical saddle adjustment: adjust minimum and maximum saddle height;
thenreturn saddle tomid-level.
- Checkhandlebar adjustment (heightand angle).
- Checkthat the clampinglevers (handlebarheight and angle)are tight.
Expected result:Adjustmentsworkandlevers aretight Pass/Fail
5. Speed and Noise
- Check speed indication on LCD and additional speed indication for test subject.
- Checknoise level ofidling driveunit (e.g., forgrinding noisesor noise fromthe bearing).
Expected result: Speed displayed on both displays and no noticeable noise Pass/Fail
6. NIBP module (ifapplicable)
- Check blood pressure measurement on test subject at rest.
- Checkbloodpressure readingsonLCD.
Expected result: BPvalues aredisplayed and inproper range Pass/Fail
A:FinalCheckout Procedure /FunctionalTest

-4-eBike, eBike L, eBike EL 2018112-003 Rev J
A-2.2 Final Checkout Procedure and Functional Test of eBike L
1. Visually inspect the device
- Inspectcoat oflacquer,cables/power cord, bellows on steering column andsaddle.
- Inspectfootboard for stability.
- Inspectcuff, tubing and tubing connection.
- Inspectcouch adjustment motorfor damage.
- Check the setup for stability, lock castor brakes, if required.
Expected result: No damage,instability or wear detected Pass/Fail
2. Check rests, cranks, pedals and Velcro strips
- Check that all clamping levers and star grips are firmly seated.
- Check that cranks, pedals, Velcro strips and pedal shoes are properly fixed.
- Inspect leg rests and their attachment, if leg rests are installed.
- Inspect head and arm rests as well as handgrips.
- Greasethe threads oftheclamping levers(every6 months, dependingon application purpose).
Expected result:All threads properly greased, cranks, rests and pedals OK Pass/Fail
3. Power on
- Using the power cord, connect the device to the power line and turn it on with the power switch.
- Wait for self-test to end: Check LCD, e.g. for error messages.
- Check in the software if the firmware version is OK.
Expected result: Device powers on without errors and FW is OK Pass/Fail
4. Couch adjustment motor
- Set motor to both stop positions.
- Changecouch positionfrom horizontal (0°) to semi-recumbent(45°) andthen backto the
horizontalposition(0°).
Expected result: Couch position changes to the expected positions Pass/Fail
5. Saddle adjustment motor
- Check all possible positions by moving the saddle to the top and to the bottom position.
- Return saddle to the middle position.
Expected result: Saddle position changes to the expected positions Pass/Fail
A:FinalCheckout Procedure /FunctionalTest
7. Exercise test
- Start manual exercise test, e.g. initial load of 50 Watts / load change of 25 Watts.
- Checkload level andload indication.
Expected result: Load changesas expected Pass/Fail
8. Communication (if applicable)
- If ergometer is remote-controlled from EKG unit or PC-ECG system, check connection cable.
- Check load control vial EKG unit or PC ECG system.
- Check remote start if applicable.
Expected result: Ergometer can be controlled by external unit Pass/Fail

2018112-003 Rev JeBike, eBike L, eBike EL -5-
A-2.3 Final Checkout Procedure and Functional Test of eBike EL
1. Visually inspect the device
- Inspectcoat oflacquer,cables/power cord, bellows on steering column andsaddle.
- Inspectfootboard for stability.
- Inspectcuff, tubing and tubing connection.
- Inspectcouch adjustment motorfor damage.
- Check the setup for stability, lock castor brakes, if required.
- Inspectoutrigger.
Expected result: Nodamage, instabilityor weardetected Pass/Fail
2. Check rests, cranks, pedals and Velcro strips
- Check that all clamping levers and star grips are firmly seated.
- Check that cranks, pedals, Velcro strips and pedal shoes are properly fixed.
- Folddown drop section.
- Inspect leg rests and their attachment, if leg rests are installed.
- Adjust and inspect hip support.
- Inspect head and arm rests as well as handgrips.
- Greasethe threads oftheclamping levers(every6 months, dependingon application purpose).
Expected result:All threads properly greased, cranks, rests and pedals OK Pass/Fail
3. Power on
- Using the power cord, connect the device to the power line and turn it on with the power switch.
- Wait for self-test to end: Check LCD, e.g. for error messages.
- Check in the software if the firmware version is OK.
Expected result: Device powers on without errors and FW is OK Pass/Fail
A:FinalCheckout Procedure /FunctionalTest
6. Speed and Noise
- Check speed indication on LCD and additional speed indication for test subject.
- Checknoise level ofidling driveunit (e.g., forgrinding noisesor noise fromthe bearing).
Expected result: Speed displayed on both displays and no noticeable noise Pass/Fail
7. NIBP module (ifapplicable)
- Check blood pressure measurement on test subject at rest.
- Checkbloodpressure readingsonLCD.
Expected result: BPvalues aredisplayed and inproper range Pass/Fail
8. Exercise test
- Start manual exercise test, e.g. initial load of 50 Watts / load change of 25 Watts.
- Checkload level andload indication.
Expected result: Loadchanges asexpected Pass/Fail
9. Communication(ifapplicable)
- If ergometer is remote-controlled from EKG unit or PC-ECG system, check connection cable.
- Check load control vial EKG unit or PC ECG system.
- Check remote start if applicable.
Expected result: Ergometer can be controlled by external unit Pass/Fail

-6-eBike, eBike L, eBike EL 2018112-003 Rev J
4. Both couch adjustment motors
- Set both motors to both stop positions.
- Changecouch positionfrom horizontal (0°) to semi-recumbent(45°) andthen backto the
horizontalposition(0°).
- Checkadjustment rangefor lateraltilt from the horizontal position (0°).
Expected result: Couch position changes to the expected positions Pass/Fail
5. Saddle adjustment motor
- Check all possible positions by moving the saddle to the top and to the bottom position.
- Return saddle to the middle position.
Expected result: Saddle position changes to the expected positions Pass/Fail
6. Speed and Noise
- Check speed indication on LCD and additional speed indication for test subject.
- Checknoise level ofidling driveunit (e.g., forgrinding noisesor noise fromthe bearing).
Expected result: Speed displayed on both displays and no noticeable noise Pass/Fail
7. NIBP module (if applicable)
- Check blood pressure measurement on test subject at rest.
- Checkbloodpressure readingsonLCD.
Expected result: BP valuesare displayed andin proper range Pass/Fail
8. Exercise test
- Start manual exercise test, e.g. initial load of 50 Watts / load change of 25 Watts.
- Checkload level andload indication.
Expected result: Load changesas expected Pass/Fail
9. Communication (if applicable)
- If ergometer is remote-controlled from EKG unit or PC-ECG system, check connection cable.
- Check load control vial EKG unit or PC ECG system.
- Check remote start if applicable.
Expected result: Ergometer can be controlled by external unit Pass/Fail
A:FinalCheckout Procedure /FunctionalTest

2018112-003 Rev JeBike, eBike L, eBike EL -7-
Prüfprotokoll gemäß MPBetreibV
§6 Sicherheitstechnische Kontrolle
§11 Messtechnischen Kontrolle
Ergometer eBike, eBike L, eBike EL
Blatt 1 von 1
Prüfprotokollnr.:
_______________
Die durchgeführten und nachfolgend dokumentierten Prüfungen sind das Ergebnis einer messtechnischen
Kontrollegemäß MPBetreibV ergänztdurch gerätespezifische Zusatzanforderungenvon GEMSIT.
Geprüftes Ergometer: Type: ________________ Serien Nr.: _________________
Letzte Überprüfung: Datum: ________________ Software: _________________
SEV: (VDE0751)
SL-Widerstand <0,3 Ohm
gemessen: ________ Ohm
Ersatzgeräteableitstrom <0,75mA
gemessen: _________ mA
MessgerätType: ________
Serien Nr.: _____________
MessgerätType: ________
Serien Nr.: _____________
MessgerätType: ________
Serien Nr.: _____________
MessgerätType: ________
Serien Nr.: _____________
Drehzahl[min-1] Leistung [W] Befund
Soll Ist [±1] Soll max.Abw. Ist
30
40
50
100
120
Regelverhalten < 3 Watt oder ± 5%
40 25 ± 3 Watt
40 50 ±3 Watt
40 100 ±5Watt
70 200 ±10 Watt
90 500 ±25 Watt
100 600 ±30 Watt
Prüfstand Type: SN: geprüft bis: Prüf ID.Nr.:
SeparatesProtokoll
Jahr der nächsten notwendigen messtechnischen Kontrolle: 20_ _
Datum: ______________________ Unterschrift : __________________________
GE Medical Systems Information Technologies GmbH, Munzinger Str. 3, D-79111 Freiburg, Germany
Only valid for Germany!
bestanden nichtbestanden Bemerkungen:
7-Segment-Anzeigevollständig? Ergometergehäuseunbeschädigt?
LCD-KontrastinOrdnung? SpannungsführendeTeilenicht berührbar?
LenkerstangeBefestigung/unbeschädigt? Messkopf unbeschädigt?
Sattelstange Befestigung/unbeschädigt? Tastaturunbeschädigt/Funktionok?
MechanischeSattelverstellung ok? Sattel-undLenkerklemmunggefettet?
ElektrischeSattelverstellung ok? (nurComfort/L/EL) Elektrische Liegenverstellungok(nur L/EL)?
MechanischeGerätestütze ok (nurEL)? ElektrischeSeitenverstellung ok(nurEL)?
Bedienungsanleitungvorhanden? Medizinproduktebuch vorhanden?

-8-eBike, eBike L, eBike EL 2018112-003 Rev J
Prüfprotokoll über die Ergebnisse
der messtechnischen Kontrolle
gemäß §11, MPBetreibV
Blutdruckmessgerät im Ergometer
Blatt 1 von 1
Prüfprotokollnr.:
_______________
Die durchgeführten und nachfolgend dokumentierten Prüfungen sind das Ergebnis einer messtechnischen
Kontrollegemäß DIN EN1060-1 undDINEN 1060-3,ergänzt durch gerätespezifischeZusatzanforderungen
vonGEMSIT.
Geprüftes Ergometer:Typ: ___________ Serien Nr.: ___________
Letzte Kalibrierung: Datum: ___________


Da bei der messtechnischen Kontrolle Ihres Medizinproduktes das Medizinproduktebuch nicht vorlag,
werden Sie gebeten, die nachstehenden Angaben für Ihre Dokumentation zu verwenden.
eingesetzte Prüf-/Messmittel Bezeichnung, Typ Seriennummer
-Kalibriertes Druckmessgerät
-Patientensimulator für Blutdruck
-Sonstige
-Sonstige
-Sonstige
Jahr der nächsten turnusmäßigen messtechnischen Kontrolle: 20_ _
Datum: ______________________ Unterschrift : __________________________
Durchgeführte Prüfung Prüfergebnis/ermittelte Werte Bemerkungen
1. Sichtprüfung: i.O. n.i.O.
2.Funktionsprüfung: BDM-Werte:
systolisch: _________ mmHg Proband
diastolisch: _________ mmHg
Pulsrate: _________ min-1 Patientensimulator
3.Luftundichtheits-
prüfung Druckabfall (50 mmHg): _______ mmHg/min.
[< 6 mmHg/min.]Druckabfall(300 mmHg): _______mmHg/min.
4. Anzeigefehlerdes
Manschettendrucks [ ± 3 mmHg]
(nachAufpumpen mmHg 0 50 100 150 200 250 300
ca. 3 Sek. abwarten)
Only valid for Germany!
bestanden nichtbestanden Bemerkungen:
GE Medical Systems Information Technologies GmbH, Munzinger Str. 3, D-79111 Freiburg, Germany

2018112-003 Rev JeBike, eBike L, eBike EL -9-
B:Mechanical Design
Part B. Mechanical Design
B.1 Operating Controls and Connections of eBike
B.1.a Operating Controls
eBike basic eBike comfort
with control terminal PC with control terminal PCplus
1Power input with mains fuse (section 2.3.1)
2Interfaces (on bottom of ergometer)
3Powerswitch
4Nameplatewithserialnumber
5Controlterminal withLCD and operating
controls
6Speed indication for patient
7Handlebar
8Bellowsonsteering column
9a eBike basic: Steering column (fixed height)
9b eBike comfort: Steering column, height
adjustable
10 eBike comfort: Clampinglever forheight
adjustmentofthe handlebar
11 Clampingleverfor angle adjustment
ofthe handlebar
12 Castors
13 Saddle
14 Steering tube withbellows for saddle
15 LED indicating saddle height
16a eBike basic: Clampinglever forsaddle
adjustment
16b eBike comfort:Motor-driven saddle
adjustment
17 Pedal
18 Levellingdevice for optimumstability
Figure B-1: Operating controls of bicycle ergometers eBike basic / comfort
6
7
13
14
16b
16a
15
3
4
17
18
1, 2
3
5
11
8
9b
10
12
5
11
8
9a
12

-10 -eBike, eBike L, eBike EL 2018112-003 Rev J
B:Mechanical Design
B.1.b Operating Controls and Connections of eBike L
NIBP
eBike
6
5
9
4
7
8
3
2
1
11
11
10
12
13
14
Figure B-2: Operating controls of bicycle ergometers eBike L
1Clampinglever for adjustment of thehead
support
2Armrest forblood pressuremeasurements
(right or left, on systems with blood pressure
moduleonly)
3Handgrip (prop for mounting the bed and
dismounting)
4Speed readout for patient
5Controlterminal
6Powerswitch
7Connector panel (power input, fuses, etc.)
8Leg rest (option)
9Castors,locking
10 Paperroll
11 Remotecontrol for adjustmentof bed
surface and saddle
12 Connector for blood pressure cuff, on both
sides of the bed, type B applied part ( )
(onsystems with blood pressure module
only)
13 Nameplate
14 Footboard

2018112-003 Rev JeBike, eBike L, eBike EL -11 -
B:Mechanical Design
B.1.c Operating Controls and Connections of eBike EL
NIBP
eBike
6
5
9
4
7
8
3
2
1
11
12
13
10
14
15
16
17
18
19
Figure B-3: Operating controls of bicycle ergometers eBike EL
1Clampinglever for adjustment of thehead
support, release button for drop section 14
2Armrest forblood pressuremeasurements
(on stress-echo beds with blood pressure
moduleonly)
3Handgrip (prop for mounting the bed and
dismounting)
4Speed readout for patient
5Controlterminal
6Powerswitch
7Connector panel (power input, fuses, etc.)
8Leg rest (option)
9Castors,locking
10 Paperroll
11 Upperhandgrip,adjustable
12 Remotecontrol for adjustment of bedsurface
andsaddle
13 Armpitsupport,adjustable
14 Drop section
15 Connector for blood pressure cuff, on both
sides of the bed, type B applied part ( )
(on stress-echo beds with blood pressure
moduleonly)
16 Hipsupport,adjustable
17 Nameplate
18 Outrigger
19 Footboard

-12 -eBike, eBike L, eBike EL 2018112-003 Rev J
B:Mechanical Design
B.1.d Connections and Data Ports of the eBike
3
25
1b 6
1a
4Underside of ergometer baseplate Underside of control terminal
Figure B-2: Connections and Data Ports of the eBike
3
2
1b
1a 6
5
4
eBike L / EL connection panel eBike L / EL cuff connection
Figure B-3: Connections and data ports of systems eBike L and eBike EL
1a PORT 1: Digital RS232 interface (9-pin Sub-D) for data communication with PC and EKG
unit and output for remote start of the EKG unit.
1b PORT 3: Digital RS232 interface (5-pin DIN connector) for data communication with PC
and EKG unit.
2 PORT 2:Additional digital RS232 interface, e.g., for software updates
3 ANALOG:Analog I/O port (8-pin DIN connector) for analog control and analog data
communication.
4 SERVICE notused.
optional: NIBP module
5Connector for jack plug of the microphone cable.
6Connector for cuff tubing.
Note: For pin configurations, refer toAppendixA: Interfaces.

2018112-003 Rev JeBike, eBike L, eBike EL -13 -
B:Mechanical Design
B.2 Overview: Mechanical Design eBike
B4-2
B4-1
Figure B-4: Mechanical design of bicycle ergometers eBike basic
Item No. Part No. Description
B4-1 Ergometer base
B4-2 Load unit, fully assembled for eBike
B4-3 Powersupply withpower switch
B4-4 Control terminal PC (B2-4a) and control terminal PCplus (B2-4b)
B4-5 Casing eBike basic (B2-5a) and casing eBike comfort (B2-5b)
B4-6 Cover, grey (B2-6a) and cover, blue (B2-6b)
B4-7 PCB Interface in base assembly
B4-8 Pump unit for BP module in base assembly (optional)
B4-9 Saddle motor (eBike comfort only)
B4 -4 B4-9 B4-3 B4-4a B4-4b
B4-6a B4-5a B4-6b B4-5b B4-7 B4-8

-14 -eBike, eBike L, eBike EL 2018112-003 Rev J
B:Mechanical Design
B-2.1 Overview: Disassembling the eBike basic/comfort
We recommend using the following tools to disassemble the device:
Flat bladed screwdrivers:Philips screwdrivers:
1 pc. 1.0x0.18 1 pc. PH1
1 pc. 4.0x 0.8 1 pc. PH2
1 pc. 6.0x 1.2 1 pc. PH3
Fork wrenches: Allankeys:
1 pc. 5.5 mm 1 pc. 2.5 mm straight
2 pc. 7 mm 1 pc. 3 mm straightand elbow
1 pc. 13 mm 1 pc. 4 mm straightand elbow
1 pc. 17 mm 1 pc. 5 mm straight
1 pc. 19 mm 1 pc. 6 mm straightand elbow
Socket wrenches : Pliers
1 pc. 5.5 mm 1 pc. sidecutter
1 pc. 13 mm 1 pc. flatnose pliers
1 pc. multigrippliers
Special tools
1 pc. crankextractor
2 pc. round pin, max. 3 mm, minimum length 15 mm
NOTE: Use the same tools to disassemble eBike L and eBike EL. Two wide metal angles may be required to
remove the ergometer casing (side length approx. 1.5 cm x 15 cm).