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1 - Intended Use

This device is intended to be used as a stress test device in a medical environment. The main goal of
the use of the devices is to create reproducible stress tests. With cycling ergometers typically workload
(watt) is imposed. With treadmills typically speed (km/h) and inclination (% grade) are imposed. This
product is designed both for manual operation and for control by external ECG-, pulmonary
equipment. Most likely this device will be used in conjunction with another medical device to obtain
other important physiological data, allowing a physician to evaluate a test subjects physical status. 
The product may also be used for rehabilitation or active aging therapy. 
As such the intended use of the device solely cannot be defined specifically. 

The device has to be operated under the supervision of well-trained medical specialists in the field of
use. 
The ultimate judgment whether a test subject should undertake a stress test with the device must be
made by the responsible medical specialist, based on the limitations of each individual, the medical
history and all other applicable circumstances. Neither the manufacturer nor its distributors assume
any responsibility for the final use of its equipment.

2 - Precautions

Read this manual before using the device and follow it
carefully.

The operator should instruct the test subject prior to
performing an exercise protocol. If, at any time during
exercise, the test subject feels faint, dizzy, or experiences
pain, stop the test and he or she should be consulted by the
physician.

Care should be taken in mounting or dismounting the
ergometer. Be aware of feet when replacing the ergometer.

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M960900 / VERSION: 1.0 - 2014-09-24

Summary of Contents for 960900

Page 1: ...M9609XX Manual Corival 2015 Cardio Pulmonary Lode BV Zernikepark 16 NL 9747 AN Groningen The Netherlands t 31 50 571 28 11 f 31 50 571 67 46 ask lode nl www lode nl M960900 VERSION 1 0 2014 09 24...

Page 2: ...ice 5 2 Connecting cables 5 3 Cable Management 6 Preparation 6 1 Adjusting the saddle position 6 2 Adjust the handlebar 7 List of symbols used 8 Control with the Lode Ergometry Manager LEM 9 Control w...

Page 3: ...specifically The device has to be operated under the supervision of well trained medical specialists in the field of use The ultimate judgment whether a test subject should undertake a stress test wi...

Page 4: ...while using the device Service of this device is restricted to factory trained personnel only The operator should not touch accessible parts and the patient simultaneously Read all warnings posted on...

Page 5: ...in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation The operator should clean the device handgrips cushions after each exer...

Page 6: ...subject should keep the feet in the pedals or hold the hand grips during the total duration of the exercise test Portable RF communications equipment including peripherals such as antenna cables and e...

Page 7: ...SpO2 blood saturation measurement These measurements may be inaccurate depending on use circumstances These measurements are indicative and cannot be used for diagnostic purposes 3 Contra Indication...

Page 8: ...mergency dismount Where equipment is positioned adjacent to each other the value of the free area may be shared 4 Validity This manual covers all Corival versions starting with the following serial nu...

Page 9: ...9 Type plate Note that if the bloodpressure option is included the cuff is also an APPLIED PART Note that if the SpO2 option is included the sensor is also an APPLIED PART Note that a A USB A B cable...

Page 10: ...e on off button and wait until the self test is carried out The product is ready for use after you have heard a series of beeps Use the on off button in order to switch the ergometer off 5 2 Connectin...

Page 11: ...holes in the strain relief as shown in the picture and place it back in the ergometer Note There is place for the thick AC cord in the middle and 2 other thinner cables on the sides 4 Put the ergomete...

Page 12: ...ition Lift the lever under the saddle The saddle can now be moved up and down Release the lever to lock the saddle in position Note the patient should not sit on the saddle while adjusting it 12 24 M9...

Page 13: ...dlebar Unlock the handlebar by moving the lever away from the ergometer Position the handlebar in de preferred position by rotating it Lock the handlebar by bringing the lever back to the original pos...

Page 14: ...uipment WEEE as set out in Directive 2002 96 EC of 27 January 2003 of the European Parliament and of the Council on waste electrical an electronic equipment are necessary to reduce the waste managemen...

Page 15: ...external commands When the device does not have a control unit the terminal mode is automatically selected See for detailed instructions the user manual of your external device 10 Maintenance Mainten...

Page 16: ...th a soft cloth moistened with soap water The cloth should only be moist and not dripping wet If the cleaning agents and disinfectants used are caustic or contain alcohol they may damage and or discol...

Page 17: ...suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes...

Page 18: ...exceed 3 meters Immunity Test Surge EN 61000 4 5 IEC 60601 Test Level Not applicable Compliance Level Not applicable Electromagnetic Environment Guidance Conducted only on ports interfacing with cable...

Page 19: ...sed no closer to any part of the Lode equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended sepera...

Page 20: ...output power of the communications equipment For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation ap...

Page 21: ...for children Partnumber 401066 Versatile ergometry Saddle for children Ambient sensor pack Partnumber 945827 Check environmental conditions during test Ambient sensor pack for ergometers Adjustable c...

Page 22: ...sy connection RS232 cable USB to Serial converter Partnumber 226012 Easy connection USB to Serial converter Arm support Partnumber 906814 Arterial line possible Arm support SpO2 for control unit with...

Page 23: ...t 180 kg 396 8 lbs Handlebar adjustment angle 360 Adjustability range seat 300 mm 11 8 inch User Interface English user interface Norwegian user interface Czech user interface Danish user interface Du...

Page 24: ...class of product with optional SpO2 IIa CE class of product with optional BPM IIa CB according to IECEE CB Environmental conditions Maximum operational temperature 35 C Minimum operational temperatur...

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