ASPEL CRG 200, Operation Manual

Page 1: ...Zabierzów 19 05 2020 Edition I ASPEL S A PL 32 080 Zabierzów os H Sienkiewicza 33 tel 48 12 285 22 22 fax 48 12 285 30 30 www aspel com pl Operation Manual Ergometer CRG 200 v 5xx ...

Page 2: ...o proposes a wide variety of medical equipment for ECG Holter Systems as well as blood pressure meters ABPM Systems spirometers Exercises Stress Test Systems electrocardiographs with accessories such as trolleys carry bags ECG cables electrodes and ECG paper You are gladly invited to visit our website www aspel com pl Please read the following manual carefully as it contains important guidelines o...

Page 3: ...METERS 14 2 6 EQUIPMENT 15 2 7 MANUFACTURER AND DESIGNATION 16 3 OPERATION OF ERGOMETER 17 3 1 START UP OF THE DEVICE 17 3 2 PATIENT PREPARATION 19 3 2 1 Electrode placement for an exercise test 20 3 2 2 Electrode placement for cardiological rehabilitation 21 3 3 USING ERGOMETER 21 4 MAINTENANCE AND TECHNICAL SERVICE 25 4 1 CLEANING DISINFECTION MAINTENANCE AND SERVICE 25 BEFORE DISINFECTION THE D...

Page 4: ...ion of qualified and properly trained medical staff Patient Using the device with artificial cardiac pacemaker or other electric stimulator does not cause danger neither for patient nor for operator Ergometer CRG 200 v 5xx Ergometer meets appropriate safety requirements and can be placed near a patient in an area of 1 5 m of free space surrounding a patient Time of proper work of the device mainly...

Page 5: ...lectromagnetic immunity of Ergometer and cause malfunctions Usage Inappropriate use of the device may be the cause of an accident The device is not suitable to direct usage on open heart The device is not adapted to interaction with surgical equipment of high frequency Conductive parts of electrodes including neutral electrode should not touch neither metal parts nor grounding Operator cannot touc...

Page 6: ...sk unidentified before for patients operators or third parties Therefore it has to be checked identified analyzed estimated and controlled before every single connection Moreover every changes made in connections to RS 232 connector could cause new risk and need additional analysis When Ergometer and PC computer are working at the same time and ECG analysis is performed it is necessary for such co...

Page 7: ...Ergometer CRG 200 v 5xx IU AT 77 C_I_ENG ASPEL S A 19 05 2020 Strona 7 z 31 using parts and accessories which are not authentic or not recommended by the manufacturer operation of the device in inappropriate conditions ...

Page 8: ...n stored or transported at temperatures exceeding the operating conditions then after unpacking leave it for a period of time necessary for the device to adapt to the conditions and temperature of the room in which it will be used Before moving the device make sure it is switched off and disconnected from the power supply and control computer In order to move the device take the handlebars with bo...

Page 9: ...address Application part type CF defibrillation resistant Proceedings instruction Transportation packaging should be kept dry Indicates proper vertical position of transportation packaging Transportation packaging contains fragile materials and it should be moved carefully Indicates maximum number of identical packages that can be placed on one another Indicates temperature range in which transpor...

Page 10: ...feet in rehabilitation centres etc where an authorised person governs access and supervises the tests Accurate cardiologic supervision of patients is conducted during physical effort Ergometer CRG 200 can operate in the following systems AsTER rehabilitation trainings CardioTEST exercise stress tests 2 2 General description Ergometer has been designed according to modern technologies Microprocesso...

Page 11: ...I_ENG ASPEL S A 19 05 2020 Strona 11 z 31 2 3 Ergometer s appearance Fig 1 Ergometer CRG 200 1 Handlebar adjustment knob 2 Control board 3 Saddle adjustment knob 4 Saddle height adjustment knob 5 Wheels for moving the Ergometer 6 Socket panel 1 2 3 4 5 6 ...

Page 12: ...ter CRG 200 v 5xx IU AT 77 C_I_ENG ASPEL S A 19 05 2020 Strona 12 z 31 Fig 2 Ergometer CRG 200 control board 1 Patient s cable socket 2 Signalling LEDs Fig 3 Ergometer CRG 200 socket panel 1 DC socket 2 RS 232 socket 1 2 1 2 ...

Page 13: ...cy and the risk of myocardial infarction A complete system contains 1 Ergometer CRG 200 acc to EN 60601 1 with accessories 2 PC compatible with IBM acc to EN 60950 3 LCD monitor 4 CD with software Fig 4 Recommended arrangement of CRG 200 and PC In the patient s environment only an Ergometer CRG 200 can be installed Devices which are not part of the system shall not be connected to it Patient s env...

Page 14: ... Weight 41 kg Supply External power supply CRG 200 M24 integral part of Ergometer CRG 200 Supply voltage 100 240V AC 47 63 Hz Max current consumption 2A for 100 120V 1A for 220 240V DC socker 24V 2A max Braking processor controlled brake with torque measurement load does not depend on speed Communication interface RS 232 Load level 25 1001 W Load accuracy 5 W to the power level 50W and 10 above 50...

Page 15: ... 50 100 mm s 5 Frequency range 0 05 150 Hz HR measuring range 15 240 bpm HR measuring error 2 HR resolution 1 bpm Digital filters 25 Hz 35 Hz 50 Hz anti drift filter Monitoring range of ST section 3 mm 10mm mV ST measuring error 0 2 mm 10mm mV ST resolution 0 1 mm 10mm mV Applied part EN 60601 1 defibrillation resistant type CF Input circuit is secured against defibrillating impulse After the impu...

Page 16: ...5xx IU AT 77 C_I_ENG ASPEL S A 19 05 2020 Strona 16 z 31 2 7 Manufacturer and designation ASPEL S A os H Sienkiewicza 33 PL 32 080 Zabierzów tel 48 12 285 22 22 fax 48 12 285 30 30 sprzedaz aspel com pl www aspel com pl Fig 5 Rating plate ...

Page 17: ...supply should be connected to Ergometer s DC socket and power supply network Moving the seat s pillar post beyond marked regulation range is forbidden Electrical system of a room where cyclometer is to be installed should fulfill IEC requirements for electrical system safety Connect data cable to the Ergometer and to PC s USB RS 232 port Installation and start up should be performed according to t...

Page 18: ...r the Ergometer CRG 200 and computer set and relevant declarations of conformity It is forbidden to conduct any modifications of location and composition of the devices without prior written consent of the manufacturer After any modification in terms of device composition compliance with EN 60601 1 section 16 standard should be verified again Free space required for safe use of Ergometer should no...

Page 19: ...n cream do not use spirit use gauze not a compress due to better abrasive properties o The middle of the site where a contact part of an electrode will be in contact with the skin should be wiped with gauze with abrasive cream so as to remove the superficial layer of dead epithelial cells epithelial abrasion Before sticking electrodes remove the remains of abrasive cream and exfoliated epithelial ...

Page 20: ...ardiac electrodes V1 white red fourth intercostal space on the right of the sternum V2 white yellow fourth intercostal space at the left edge of the sternum V3 white green in the mid distance between V2 and V4 V4 white brown fifth intercostal space in the left midclavicular line V5 white black along the straight line from V4 vertically to the left anterior axillary line at the cross section with t...

Page 21: ...ent of the handlebars and saddle of the Ergometer o attachment of the pedal crank and pedals Incorrect mounting tightening the steering wheel saddle crank and pedals can cause damage to the patient s health and mechanical damage to the above mentioned components of the ergometer R red intercostal space below right collarbone L yellow intercostal space below left collarbone F green left space below...

Page 22: ... Ergometer is in control of rotation speed When a patient s speed is proper the middle green diode is lit If a necessity of increasing or decreasing speed appears it is signaled by turning on lower or upper red diode together with intermittent audio signals Use the device only according to its indications and operation conditions Training sessions can be conducted only when qualified medical perso...

Page 23: ...g 9 darker colour shows recommended rotation speed During work it is necessary to maintain the constant rotation speed so that green LED on Ergometer s control panel is on recommended rotation speed Load level Recommended rotation speed 25 100 W 50 rpm 80 rpm 101 200 W 60 rpm 80 rpm 201 300 W 65 rpm 85 rpm 301 400 W 80 rpm 100 rpm 401 500 W 90 rpm 110 rpm 501 600 W 100 rpm 120 rpm 601 700 W 105 rp...

Page 24: ...ow LED medium sound signal rotation speed is much lower than the recommended yellow LED long sound signal rotation speed too low to achieve requested power To end training stop pedaling disconnect ECG cable from patient and unplug power Ergometer if it is not to be used for a long time Cycle Ergometer CRG 200 has an option which allows to switch the audio signalling system into rotation rhytm mode...

Page 25: ... a cleaning agent on the device Information regarding cleaning a PC computer and LCD monitor are specified in the documentation of the foregoing devices Before disinfection the device and accessories should be cleaned To disinfect the device use commercially available specialist disinfecting agents indicated for the disinfection of medical products e g BACILLOL DESCOSEWPT SEKUSEPT ALDEWIR HEXAQUAR...

Page 26: ...acturer or one should contact a specialist electronic and electromechanic waste company 4 3 Customer service If you need help in diagnosing any problems with work of the device please contact ASPEL S A service 4 4 Dealing with common problems PROBLEM SOLUTION No contact with a PC Restart PC Restart Ergometer unplug wait few seconds plug again Check the cable connection between the Ergometer CRG 20...

Page 27: ...c environment specified below The customer or the user of the Ergometer CRG 200 should assure that the device is used in such an environment Immunity test EN 60601 1 2 test level Compliance level Electromagnetic environment advices Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 2 kV 4kV 8 kV 15 kV air 8 kV contact 2 kV 4 kV 8 kV 15 kV air Floors should be made of wood concrete or ceramic t...

Page 28: ...28 V m 450 MHz 28 V m 9 V m 710 745 780 MHz 9 V m 28 V m 810 870 930 MHz 28 V m 28 V m 1720 1845 1970 MHz 28 V m 28 V m 2450 MHz 28 V m Near field free of radio devices EN 61000 4 3 9 V m 5240 5500 5785 MHz 9 V m Portable RF communication equipment e g phones including peripheral devices such as antenna cable and external antennas should be used no closer than 30 cm 12 in to any part of Ergometer ...

Page 29: ...to connect electromedical equipment and other medical or non electromedical devices to multiple sockets creating electromedical system in this way devices don t need to be coupled with a combination of hardware For example connection of Ergometer CRG 200 with PC to multiple sockets creates electromedical system A2 General requirements for electromedical systems Electromedical system should ensure ...

Page 30: ...at electromedical system installations and its modifications during the usage period are the subject to EN 60601 1 standard requirements Responsible division may be hospital single doctor or unprofessional person In the private usage patient operator and responsible division may be in one person All non medical devices complied with safety standards proper to its original purposes and placed in th...

Page 31: ...surrounding which is a part of medical space Device B s touch current should be limited by using additional protecting grounding or isolation transformer for device B but only if any single ground conductor or equivalent conductor in the device is cut off Device A placed in a patients surrounding device B placed outside patients surrounding Example Ergometer CRG 200 connected by its RS 232 socket ...