Custo Med Bicycle Ergometer ec3000e User manual

GEB-0179 / DK-1334
Version 001 - 12.09.2013
Operatng manual
Bcycle Ergometer ec3000e

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.
custo med GmbH
Leibnizstraße 7
85521 Ottobrunn
Germany
Tel: [phone]
Fax: [phone]
Email: [email protected]
Internet: www.customed.de
Printed in Germany

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Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Mounting the Control Terminal (P or K) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Connecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Connecting the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Adjusting the Saddle and the Handlebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Preparing the Patient for Blood Pressure Measurements . . . . . . . . . . . . . . 19
Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Attaching the SpO2-Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Operation Control terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 32
Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . .41
CONTENTS

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EG-KONFORMITÄTSERKLÄRUNG/
DECLARATIONOFCONFORMITY
Wir / We ergolineGmbH
Lindenstr.5
72475Bitz(Germany)
erkläreninalleiniger
Verantwortung,dassdas
Medizinprodukt/
declare on our own responsibility that
the medical device
ec3000e
Modelle/Models 17000 ec3000e
unddasZubehör/andthe
accessories
17001 SattelverstellungmitMotor
17002 Autom.Blutdruckmessung
17003 SpO2-Messung
17004 Sattelverstellung,horizontal
17005 Manschette,Zugbügel,Standard
17006 Manschette,Zugbügel,XL
17007 Manschette,Zugbügel,Kind
17008 HF-EmpfängerPOLAR
17009 HF-EmpfängerDigital(bmi)
17010 Puls-BrustgurtDigital(bmi)
17011 Pedalkurbeln,verstellbar
mitdenAnforderungender
Richtlinieübereinstimmt
is in conformity with the Directive
93/42/EWGund2007/47/EG
93/42/EECand2007/47/EC
UMDNS-Code/
UMDNS-Code
10383
BenannteStelle / Notified Body: TÜVSÜDProductServiceGmbH
Ridlerstr.65
80339München
Germany
Konformitätsbewertungsverfahren
Conformity assessment procedure:
AnhangII
Appendix II
Klasse/Class IIa
Klassifizierungnach/
Classification according to:
AnhangIX/Regel10
Appendix IX / rule 10
Beginn der Gültigkeit / Begin of the validity:
Datum/Date: 28.05.2003
Ort/City:
Bitz den, 10.09.2013 Axel Bodmer
DECLARATION OF CONFORMITY