ergoline ergoselect 1000 User manual

Manual
ergoselect 1000
Couch Ergometer
Operator's Manual
2010000070000 • Version 06/2009 • English

This manual was written with the utmost care. Should you still nd details that do not correspond with the system,
please let us know and we will correct the issue as soon as possible.
We reserve the right to modify the design and technical features of the device and are not bound by the information and
illustrations provided in this manual.
All trademarks appearing in this document are trademarks of their respective owners. Their protection is acknowledged.
No part of this manual may be reprinted, translated or reproduced without the manufacturer's written permission.
This manual is not subject to any change order service. Please contact the manufacturer for the latest document
revision.
ergoline GmbH
Lindenstraße 5
72475 Bitz
Germany
Tel.: [phone] - 0
Fax: [phone] - 128
e-mail: [email protected]
http: www.ergoline.com
Printed in Germany

- 3 -
Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Ergometer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Adjusting the Couch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Preparing the Couch with the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Preparing the Patient for Blood Pressure Measurements. . . . . . . . . . . . . . 14
Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Control terminal P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Control Terminal K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Operating Modes with Control Terminal K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Speed readout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Reha Ergometer in PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Training with Chip Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Settings for Control Terminals K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 45
Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Elektromagnetische Verträglichkeit EN 60601-1-2 . . . . . . . . . . . . . . . . 52
Contents

- 4 -

- 5 -
DeClaration of Conformity

- 6 -
General information
• TheproductergoselectbearstheCEmarkingCE‑0123
(NotiedBody:TÜV),indicatingitscompliancewith
theprovisionsoftheCouncilDirective93/42/EEC
aboutmedicaldevicesandfulllstheessential
requirementsofAnnexIofthisdirective.
TheCEmarkingcoversonlytheaccessorieslistedin
theOrderInformationchapter.
TheergometerisanMDDclassIIaproduct.
• Thedevicefulllstherequirementsofstandard
EN60601‑1"MedicalElectricalEquipment,Part1:
GeneralRequirementsforSafety"aswellasthe
interferenceprotectionrequirementsofstandard
EN60601‑1‑2"ElectromagneticCompatibility–
MedicalElectricalDevices".
Theradio‑interferenceemittedbythisproductis
withinthelimitsspeciedinEN55011,classB.
• Thismanualisanintegralpartoftheequipment.It
shouldbeavailabletotheequipmentoperatoratall
times.Closeobservanceoftheinformationgivenin
themanualisaprerequisiteforproperdeviceperfor‑
manceandcorrectoperationandensurespatientand
operatorsafety.Pleasenotethatinformationpertinent
toseveralchaptersisgivenonlyonce.Therefore,read
themanualoncecarefullyinitsentirety.
• Thesymbols  mean:

Consultaccompanyingdocuments.
Itindicatespointswhichareofparticularimportance
intheoperationofthedevice.
• Observanceofthesafetyinformationprotectsfrom
injuriesandpreventsinappropriateuseofthedevice.
Allequipmentusersandpersonsresponsiblefor
assembly,maintenance,inspectionandrepairofthe
devicemustreadandunderstandthecontentofthis
manual,beforeusingorworkonit.
Paragraphswithspecialsymbolsareofparticular
importance.
• Ifunauthorizedindividualsopenthecontrolterminal,
damagingthecalibrationsticker,anywarrantyclaim
shallbecomevoid.
• Thismanualreectstheequipmentspecications
andapplicablesafetystandardsvalidatthetimeof
printing.Allrightsarereservedfordevices,circuits,
techniques,softwareprograms,andnamesappearing
inthismanual.
• OnrequestERGOLINEwillprovideaFieldService
Manual.
• TheERGOLINEqualitymanagementsystemcomplies
withthestandardsISO9001:2000andENISO13485:
2003.
• Thesafetyinformationgiveninthismanualisclassi‑
edasfollows:
• Toensurepatientsafety,thespeciedmeasuringac‑
curacy,andinterference‑freeoperation,werecom‑
mendusingonlyoriginalERGOLINEaccessories.The
userisresponsibleifnon‑ERGOLINEaccessoriesare
used.
• ERGOLINEisresponsibleforthesafety,reliability,and
performanceoftheequipment,onlyif
‑ modicationsandrepairarecarriedoutby
ergolineGmbHorbyanorganizationexpressly
authorizedbyergolineGmbH
‑ theequipmentisusedinaccordancewiththe
instructionsgiveninthisoperator'smanual.
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Phone:[phone] - 9894 -0
Fax: [phone]
e-mail: [email protected]
http: www.ergoline.com / www.ergoline.eu
Danger
indicates an imminent hazard. If not avoided, the hazard will
result in death or serious injury.
Caution
indicates a potential hazard. If not avoided, the hazard may
result in minor injury and/or product/property damage.
Warning
indicates a hazard. If not avoided, the hazard may result in minor
injury and/or product/property damage.

- 7 -
Danger
• Explosion Hazard •
The device is not designed for use in areas where an explosion
hazard may occur.
Explosion hazards may result from the use of ammable anes-
thetics, skin cleansing agents or disinfectants.
Warning
• Patient Hazard, Equipment Damage •
Do not expose the ergoselect to direct sunlight to prevent system
components from reaching inadmissible high temperatures.
Do NOT use the ergoselect outdoors (medical device). Furthermore
the device has no additional protection against the ingress of hu-
midity. Humidity inside the device may cause equipment malfunc-
tions and increases the risk of an electric shock.
Additionally, the device should not be operated in the vicinity of
electric power plants, because they may impair equipment func-
tions.
The ergoselect ergometer may only be used in combination with
accessories approved by ergoline GmbH.
• Risk to Persons •
Before using the ergometer, the operator must ascertain that it is
in correct working order and operating condition. The cables and
connectors, in particular, must be checked for signs of damage.
Damaged parts must be replaced immediately, before use.
• Equipment Malfunction •
Only the special shielded cables supplied by ERGOLINE may be
used to connect the device to other pieces of equipment.
• Equipment Malfunction •
Cellular telephones may not be used in the immediate vicinity
of the ergometer, because they might interfere with the proper
functioning of the ergometer.
Electromagnetic interference most probably exists when the watt
reading is unstable. If the displayed value changes frequently even
though the speed is above 30 RPM, this may be due to electro-
magnetic interference.
Warning
• Shock Hazard •
When the ergometer is connected to other equipment or if a medi-
cal system is created, it must be ensured that the added leakage
currents do not present a hazard.
In case of questions, please contact your ERGOLINE dealer or the
ergoline GmbH Service Department.
For use, the ergometer must always be connected to electric
installations that fulll the local requirements.
• Patient Hazard •
The German Medical Device Operator Ordinance (MPBetreibV, § 5)
demands that users
• must be trained in the use of the ergometer
• must be familiar with the routines for handling and
assembly of the ergometer
• must be familiar with and observe the safety rules and regu-
lations for operation of this type of equipment
• must be informed about any other pertinent rules and regu-
lations (e.g. safety features)
• must be informed about the potential hazards arising from
the use of this type of equipment.
safety information
Hint
Removing the power cord results in complete disconnection from
mains (all poles)..
Danger
Additionalequipmentconnectedtomedicalelectrical
equipmentmustcomplywiththerespectiveIECorISO
standards(e.g.IEC60950fordataprocessingequipment).
Furthermoreallcongurationsshallcomplywiththere‑
quirementsformedicalelectricalsystems(seeIEC60601‑
1‑1orclause16ofthe3Ed.ofIEC60601‑1,respectively).
Anybodyconnectingadditionalequipmenttomedical
electricalequipmentconguresamedicalsystemandis
thereforeresponsiblethatthesystemcomplieswiththe
requirementsformedicalelectricalsystems.Attentionis
drawntothefactthatlocallawstakepriorityoverthe
abovementionedrequirements.Ifindoubt,consultyour
localrepresentativeorthetechnicalservicedepartment.
• IEC60601‑1+Al+A2:1995:6.8.2.c,19.2.b,19.2.c,
• IEC60601‑1:2005:7.9.2.5,8.1,16.2.d,
• MDD93142lEEC:AnnexIclause13.6.c

- 8 -
safety information for
non‑invasive BlooD Pressure
measurement
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cu on pa-
tients suering from sickle cell anemia or where skin lesions are
likely to occur.
The cu may cause hematomas in patients with severe blood
coagulation disease. In these instances, the user must take a
decision for or against automatic blood pressure measurements.
Caution
• Compromised Measuring Accuracy •
Arrhythmias occurring frequently during a measurement may
compromise the accuracy of the measurement.
In certain cases, a valid measurement will not be possible.
Electromagnetic elds are also capable of impairing the measur-
ing accuracy.
Note
• The blood pressure module and the approved accessories
are debrillation-proof and may remain attached to the
patient during debrillation.
• If the cu pressure exceeds the maximum value of
300 mmHg during ination, the ination procedure will be
aborted and the cu deated.
As a redundant safety precaution, the cu is immediately
deated when the cu pressure exceeds 320 mmHg.
You can check the proper functioning of this safety precau-
tion by abruptly bending your arm while the cu is being
inated, causing a brief overpressure in the cu. The cu
must deate immediately.
• Measurements that did not yield a valid measurement will
not be repeated during the exercise test.
• If the ination phase takes longer than 40 seconds or if an
adequate pressure does not build up in the cu within a
reasonable period of time, the measurement will be aborted
and the cu deated.
• If a valid measurement cannot be completed within
120 seconds, the measurement will be aborted and the cu
deated.
• If the cu pressure remains constant for some time, the
measurement will also be aborted and the cu deated.
intenDeD use
Theergoselectisacomputer‑controlledmedicalergometer.
Atpedalspeedsbetween30and130RPMandloads
between6and999watt,theergometeroperatesindepen‑
dentofthepedalspeed.
Thespeed‑independentrangeisshownintheAppendix
(TechnicalSpecications).
Theergoselectergometermayonlybeusedinexercise
testingaswellasforrehabilitationofcardiacandcardio‑
vascularpatientsaccordingtotheinstructionsgivenin
thismanual.Iftheergometerisusedforotherpurposes,
themanufacturercannotbeheldliableforpersonalinju‑
riesorpropertydamageresultingfromtheunintendeduse
oftheequipment.
BioComPatiBility
Thepartsoftheproductdescribedinthismanual,includ‑
ingallaccessoriesthatcomeincontactwiththepatient
duringtheintendeduse,fulllthebiocompatibility
requirementsoftheapplicablestandardsifappliedas
intended.
Ifyouhavequestionsinthismatter,pleasecontact
ERGOLINEorarepresentative.
aPPliCaBle laws, reGulations anD
DireCtives
• 93/42/EEC(MedicalDeviceDirectiveoftheEU)
• 89/336/EEC(ElectromagneticCompatibilityDirective
oftheEU)
• EN1060‑1Non‑invasivesphygmomanometers,Part1:
Generalrequirements
• EN1060‑3Non‑invasivesphygmomanometers,Part3:
Supplementaryrequirementsforelectro‑mechanical
bloodpressuremeasuringsystems

- 9 -
Additionalequipmentconnectedtomedicalelectrical
equipmentmustcomplywiththerespectiveIECorISO
standards(e.g.IEC60950fordataprocessingequipment).
Furthermoreallcongurationsshallcomplywiththere‑
quirementsformedicalelectricalsystems(seeIEC60601‑
1‑1orclause16ofthe3Ed.ofIEC60601‑1,respectively).
Anybodyconnectingadditionalequipmenttomedical
electricalequipmentconguresamedicalsystemandis
thereforeresponsiblethatthesystemcomplieswiththe
requirementsformedicalelectricalsystems.Attentionis
drawntothefactthatlocallawstakepriorityoverthe
abovementionedrequirements.Ifindoubt,consultyour
localrepresentativeorthetechnicalservicedepartment.“
(Standard/directivereferences:
· IEC60601‑1+Al+A2:1995:6.8.2.c,19.2.b,19.2.c,
· IEC60601‑1:2005:7.9.2.5,8.1,16.2.d,
· MDD93142lEEC:AnnexIclause13.6.c

- 10 -
Setup and MainS ConneCtion
ControlS and indiCatorS
1 Clamping lever for head rest adjustment
2 Arm rest for blood pressure measurement
(right or left; on systems with automatic blood
pressure measurement only)
3 Handgrip (mounting and dismounting aid)
4 Speed indication for patient
5 Control terminal (model P or model K)
6 Power switch (green button)
7 Connectors for power cord and connection cables
8 Leg rest (option)
9 Castors, locking
10 Tissue roll
11 Remote control for couch and saddle adjustment
12 Connection for blood pressure cuff on either side of
the couch (on systems with automatic blood pres-
sure measurement only)
13 Type plate
14 Footboard
ergoMeter Setup
The ergoselect 1000 is mounted on a wooden pallet for
shipment.
You need a wrench (SW 17) or a ratchet and the corre-
sponding socket to detach the ergometer from the pallet
and for all other mounting operations described below.
Mounting the CaStorS
The four castors are mounted to the base plate with the
enclosed screws.
ergoselect 1000 - controls, connections and indicators
Caution
• Equipment Damage •
Avoid strong vibrations of the ergometer during transport.
• Patient Hazard / Equipment Damage •
During assembly, the ergometer must be disconnected from the
power line.