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Custo Med Bicycle Ergometer ec3000e, Руководство по эксплуатации

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- 5 -

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

D

eClaration

 

of

 C

onformity

Содержание Bicycle Ergometer ec3000e

Страница 1: ...GEB 0179 DK 1334 Version 001 12 09 2013 Operating manual Bicycle Ergometer ec3000e...

Страница 2: ...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 wi...

Страница 3: ...ting the Blood Pressure Cuff 17 Preparing the Patient 18 Adjusting the Saddle and the Handlebar 18 Preparing the Patient for Blood Pressure Measurements 19 Checking the Cuff Tubing 20 Attaching the Sp...

Страница 4: ...4...

Страница 5: ...ind 17008 HF Empf nger POLAR 17009 HF Empf nger Digital bmi 17010 Puls Brustgurt Digital bmi 17011 Pedalkurbeln verstellbar mit den Anforderungen der Richtlinie bereinstimmt is in conformity with the...

Страница 6: ...6...

Страница 7: ...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 ter...

Страница 8: ...ermany Tel 49 0 7431 9894 0 Fax 49 0 7431 9894 128 Email info ergoline com Internet www ergoline com Distributed by custo med GmbH Leibnizstra e 7 85521 Ottobrunn Germany Tel 49 89 710 98 00 Fax 49 89...

Страница 9: ...rning Shock Hazard When the ergometer is connected to other equipment or if a medical system is created it must be ensured that the added leakage currents do not present a hazard In case of questions...

Страница 10: ...easurement will be aborted and the cuff deflated If a valid measurement cannot be completed within 120 seconds the measurement will be aborted and the cuff deflated If the cuff pressure remains consta...

Страница 11: ...11...

Страница 12: ...Adjustment of the handlebar height ec3000e only 6 Castors 7 Speed display RPM for patient 8 Adjustment of the saddle height 9 Digital saddle height indication option 10 Power switch green button 11 S...

Страница 13: ...sp the handlebar and tilt the ec3000e towards you until it is standing on the castors only and is balanced It is now possible to transport the ec3000e When you have reached the new location lower the...

Страница 14: ...patient Connecting the Power Cord Set the handlebar to the front upper position and secure Tilt the ec3000e carefully towards you until it rests on the handlebar Assembly position of the ec3000e ergom...

Страница 15: ...connection to the protective ground system power cords of type hospital only or hospital grade have to be used Power cord with installed strain relief The connection panel is located on the underside...

Страница 16: ...og remote start etc The appropriate cable is plugged into the corresponding socket on the connection panel Port 1 USB and secured with the strain relief Hint connecting cables Only use connecting cabl...

Страница 17: ...le while the blood pressure is being taken Therefore do not forget to attach the cuff tubing to the handlebar with the supplied Velcro tape Open the large Velcro tape and wrap around handlebar Secure...

Страница 18: ...ting upright on the saddle can reach it easily To do so open clamping lever 1 and set the handlebar to a suitable angle On the ec3000e 200 the height of the handlebar can ad ditionally be adjusted wit...

Страница 19: ...e must be located exactly on the brachial artery Locate the artery by palpation if required The red tab identifies the position of the micro phone The accurate placement of the microphone is the prima...

Страница 20: ...e the cuff immediately from the arm or disconnect the cuff tubing from the control terminal The same measures are recommended if the cuff does not deflate correctly When you close the Velcro strap che...

Страница 21: ...O2 Sensor Place the index finger into the SoftTip sensor The cable should run on top of the hand After some seconds the actual SpO2 value is displayed on the recorder display SpO2 Sensors option Attac...

Страница 22: ...ted the initial screen of the selected operating mode e g Ergometry will be displayed instead of the main menu With the key you can display the main menu If an error message e g E 01 appears immediate...

Страница 23: ...SETTINGS Used to configure the ergometer Speed readout At the top of the control terminal there is a speed readout for the patient as well as three LEDs that inform the patient of the speed too slow...

Страница 24: ...the corresponding values will be displayed The exercise test can only be terminated with the corre sponding command from the controlling ECG unit Note All functions are locked while the ergometer is...

Страница 25: ...cursor on one of the protocols and confirm the selec tion with SELECT The exercise test is started with the Start key a blood pressure measurement at rest may precede the test see Settings When the b...

Страница 26: ...be selected manually It is recommended that the patient continues to pedal in the recovery phase The END key in the middle will terminate the test End Note The saddle height ec3000e 200 can be changed...

Страница 27: ...easurements The exercise test is started with the Start key afterwards the load can be set and changed with the 5 W and 5 W keys in increments of 1 W up to 25 W as config ured Blood pressure measureme...

Страница 28: ...the ergometer will display this menu Use the softkeys on the right and left to position the bar cursor on your preferred default mode and save the selection with SELECT Protocols Protocols 6 15 are us...

Страница 29: ...le in the range from 0 to 100 Load Change Here you determine the increments for each load change Depending on your choice each key press will change the load by 1 5 10 und 25 Watts Selecting the param...

Страница 30: ...in with you select DATE or TIME and confirm the selection Then the value displayed in reverse video can be edited with the keys and saved with SELECT The time is adjusted in the same way You exit the...

Страница 31: ...be initiated with digital commands Digital default The communication with the ergo meter is entirely controlled with digital commands Analog IN OUT The entire communication load control and BP mea sur...

Страница 32: ...ipping wet If the cleaning agents and disinfectants used are caustic or contain alcohol they may damage and or discolor the upholstery Only the following disinfectants are approved Sch lke Mayr GmbH A...

Страница 33: ...or soap water Allow the microphone to dry before reinserting it in its pocket For disinfection spray a disinfectant sparingly on the cuff the tubing and the microphone After the contact time indicated...

Страница 34: ...of SoftTip Sensor 1 The sensor must be carefully cleaned or disinfected after every use and before use with a different pa tient It is recommended that sensors be prepared for reuse immediately after...

Страница 35: ...dried with sterile compressed air Inspection and function test Visually inspect the sensors for damage Worn deformed porous or otherwise damaged sensors must not be reused Cleaning of cables Disconne...

Страница 36: ...o years according to the rules of the art by a Service Engineer authorized by custo med Similarly the automatic sphygmomanometer in the control terminal must be checked and calibrated by an authorized...

Страница 37: ...ured Load to DIN VDE 0750 0238 Load Increments user programmable Internal Protocols Control Terminal 5 fixed incremental exercise test protocols e g WHO 10 user programmable protocols manual load cont...

Страница 38: ...30 to 75 no condensation atmospheric pressure 700 to 1060 hPa transport and storage temperature 20 to 70 C 40 to 158 F rel humidity 10 to 90 no condensation atmospheric pressure 500 to 1060 hPa Blood...

Страница 39: ...n and comparison of the rest ing BP readings from both methods for plausibility Exercise Test Protocols Protocol initial load W time in stage min load increment W recovery load W recovery time min 1 W...

Страница 40: ...range black speed independent range to DIN VDE 0750 0238 black grey speed independent range of the ec3000e ergometer Family of characteristics of the load periods according to IEC 60601 1 Under perman...

Страница 41: ...operation in the configuration in which it is being used Guidance and Manufacturer s Declaration Electromagnetic Emissions The ergoselect ergometer is intended for use in the electromagnetic environme...

Страница 42: ...differential mode 2 kV common mode 1 kV 2 kV Mains power should be that of a typical commer cial or hospital environment Voltage dips short interrup tions and voltage variations on power supply input...

Страница 43: ...from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment mark...

Страница 44: ...t Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0...

Страница 45: ......

Страница 46: ...custo med GmbH Leibnizstra e 7 85521 Ottobrunn Germany Phone 49 89 710 98 00 Fax 49 89 710 98 10 Email info customed de Internet www customed de...

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