Zimmer ergo k Скачать руководство пользователя страница 32 | Manualshive

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Conformity Declaration

11

This product bears the CE marking

0123

in accordance with the CE Council Directive 93/42/EEC.

Zimmer Elektromedizin GmbH hereby declares, that the ergometer

Ergo K / Ergo K with Blood Pressure Module

conforms to the standards in accordance with the CE Council Directive 93/42/EEC
concerning medical devices.

The device belongs to Class IIa according to Annex IX / 3.2.

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Содержание ergo k

Страница 1: ...Zimmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 0731 9761 291 Fax 0731 9761 299 www zimmer de ergo k User Manual ...

Страница 2: ......

Страница 3: ... 3 3 Operating the Unit Load Profiles Profile Screens 9 4 Ergometric Session Preparation Remarks Performing 13 5 Blood Pressure Module optional Positioning the Cuff Procedure 15 6 Safety Warnings 19 7 Cleaning and Disinfection 22 8 Rear Panel Connections 23 9 Service Menu Entering Settings Testing Calibration Test 24 10 Accessories 29 11 Conformity Declaration 30 12 Technical Data Ergometer Blood ...

Страница 4: ...ndependent load regulation from 10 to 1000 Watts Patient weight capacity up to 150 kg Stable chassis with stable dual tube front frame Smooth seat height adjustment Horizontal seat adjustment Universal mounting for commercially available seats Serial interface and remote start for interconnection with ECG recorders and PC EKG units Handling Features Simple and self explanatory operation Control pa...

Страница 5: ...Select load cycle program using the arrow on the cockpit Start Load Start load by pressing the START STOP button Stop Monitor patient during load cycle Should problems arise stop load cycle immediately Recovery Phase Once the START STOP button is pressed the load cycle switches automatically to a recovery phase Cycle Termination Pressing START STOP button again terminates the load cycle program Wa...

Страница 6: ...ich could causes irreparable damage near vicinity of x ray or diathermic systems motors or transformers explosive environments Ensure that the ergometer is placed horizontally The slope of the floor should never exceed 10 Otherwise the stability of the unit of reduced The ergometer can be transported by lifting both front tubes and pushing or pulling the ergometer using the back rollers 1 5 ...

Страница 7: ...zontal Seat Position The seat can be moved horizontally Release the lock by turning the knob under the seat 6 and slide the seat to the desired position Then re secure the seat by turning the knob Handle Bar Adjustment The handle bar can be tilted up and down to adapt to the different arm lengths of the various patients Release the lock by turning the lever 7 ccw After tilting the handle bar to th...

Страница 8: ... normal operating mode It indicates the load profile used last before the unit was turned off Function Test Select program Level Test ST1 using the arrow keys Start ergometry by pressing the START STOP key A load should now be detected when the pedals are pressed The load can be increased in 25W steps by using the key The increase should be detectable when pedals are pushed End the test by pressin...

Страница 9: ...en shows the achieved results Program Display The LEDs light emitting diodes indicate the load program just selected Details can be obtained from the LCD screen Program Selection These two arrow keys are used for selecting the load program The program currently selected is indicated by the LEDs described above Programming Use the PROG button to scroll through the various points of the presently ac...

Страница 10: ...C or an ECG recorder Please remember that not all ECG units take over the results of such manually initiated measurements and present them on the screen or on paper Speed Range Display The speed of the tread crank is shown on the digital LED display As soon as you leave the regulated load range the display starts to flash In addition the speed of the crank is indicated by an LED trend indicator Th...

Страница 11: ...pilot light signals that the load is determined by an external unit like an ECG recorder or a PC ECG Explanation Load profile Profile Screens One of the available profiles should be selected prior to having the patient begin exercise under load Press the arrow button or until the lamp of the desired load profile lights up The indicated values can still be altered individually Square load NIBP OFF ...

Страница 12: ...he recovery phase 100 sec are adjustable A recovery phase follows with a reduced load i e 25 W that is maintained for a certain duration i e 5 min The blood pressure measurement is not activated in this example NIBP OFF External This program cannot be varied This display always appears when the ergometer is controlled by an ECG recorder or a PC ECG In this operating mode the ergometer controls are...

Страница 13: ... Result Screen Following the successful measurement the systolic and diastolic pressures are indicated The heart rate HR is shown only if an ECG source e g amplifier is installed NIBP Measurement Failed If for some reason the blood pressure measurement fails a message indicates that the measuring cycle was unsuccessful This failure message remains on the screen for about 2 5 seconds Please check t...

Страница 14: ... in minutes after which another blood pressure measurement is performed automatically by the unit In programs with changing loads the blood pressure measurement is triggered one full minute prior to the next change of the load The adjusted measuring interval always relates to this moment Example With an adjusted time interval of 2 min the blood pressure measurements take place at 7 5 3 1 minutes p...

Страница 15: ...lever can be altered after pulling it out Ensure the clamping lever has clicked into a locked position Adjusting the saddle horizontally Normally the seat rests on an extension centered above the seat support In cases where it is not possible to have the patient s arms fully extended by adjusting the handle bar the seat can be moved back and forward horizontally Release the rotating knob underneat...

Страница 16: ... PC Performing the exercise After the preparation of patient and equipment is completed the patient may start the exercise Press the START STOP button to start the load profile shown on the LCD display The preset values are adjusted automatically Press the START STOP button again to end the load and automatically initiate the recovery phase Press the START STOP button once more to terminate the pr...

Страница 17: ...ter is ready for operation when the device is turned on Make sure that cuff and microphone are properly connected Microphone Connect the tube on the microphone to the connection tube on the cuff Lead the microphone through the red strap on the inner side of the cuff and place it into the red pocket with the flat side of the microphone facing the red pocket the artery Microphone Flat side Back side...

Страница 18: ...t during the measurement Locate the brachial artery Position the cuff so that the microphone rests over the brachial artery To be sure of the correct location first feel for the artery Positioning the microphone Avoid Interference Secure the tube to prevent it from being kicked by the knee during movement Ensure that the cuff tube is not under tension but has a slight slack Ensure that the tube an...

Страница 19: ...ement during the ergometry program Manual intermediate measurement during the ergometry program Starting the Procedure Generally the ergometer or the controlling unit ECG recorder or PC triggers the measuring procedure However you can always make single or intermediate measurements Manual Single Measurement Pressing the NIP button starts the measuring procedure The determined results are displayed...

Страница 20: ...orrect microphone position etc The error message appears for about 2 5 sec Please check the following Position of the microphone Position of the cuff Position of the air tube Other potential interfering causes Refer to information in this chapter Then restart the program Interval Measurement After the successful completion of the Analytical measurement the Interval measurement patient may start th...

Страница 21: ...each use the operator must ensure that the equipment is safe to use A comprehensive technical check should be carried out in adequate intervals in order to detect mechanical deficiencies of the unit and the cables Maintenance Equipment maintenance must be performed by Zimmer Elektromedizin GmbH or personnel authorized by Zimmer Elektromedizin GmbH in compliance with generally accepted technical st...

Страница 22: ...ients with insufficient blood coagulation the positioning of the cuff on the arm or leg could result in a haematoma The decision regarding an automatic blood pressure measurement should be made carefully prior to any measurements In order to ensure that the blood circulation is sufficient it is necessary to monitor the limb supporting the cuff Warning Ergo K Ergometry system is intended to be used...

Страница 23: ...cumulated charged currents Safety Warnings Explosive outdoor environments direct sunlight or use near high voltage systems are prohibited Devices imitting electromagnetic fields must be a minimal of 5 meters from device i e x ray machines diathermy devices mobile telephones or magnetic cresonance scanners The 5 meter special limit can be reduced by using schielding protectors such as shielding cur...

Страница 24: ...quipment components or accessories in cleaning or disinfecting solutions is not permissible since it may result in malfunction or destruction of such parts Liquid penetrations into the device must be checked by customer service Following cleaning and or disinfection all cleaned or disinfected parts must be sufficiently aired out before the power cable is reconnected and the unit is turned on Risk ...

Страница 25: ...ling unit Wiring of the DSUB9 socket The dielectric strength of input and output is 24 VDC When the ergometer is controlled by an analog voltage pin 7 the additional serial start of the blood pressure module is possible protocol 1 Symbols Various symbols are used on the rear panel of the ergometer for easy recognition of unit properties They are described below Warning This symbol alerts you to fo...

Страница 26: ...system only with blood pressure option During the calibration test this is the reference load on which the test is based During the calibration test this is the speed for which the mean load is calculated During the calibration test this is the effective actual load Selecting the Language S This indicates the selected language The language can be changed by pressing the or button 0 German 1 Englis...

Страница 27: ...P10 Ergoline P1 Polymed Selecting the Baud Rate B In order to have the ergometer controlled by a connected ECG recorder or PC ECG it is necessary to set the correct baud rate for the communication This indicates the selected protocol You can alter the setting by pressing the button The following baud rates are available 2 2400 Bd 4 4800 Bd Heart Rate hhh Indication This shows the momentary heart r...

Страница 28: ...neral functional test of the ergometer This may be done with a test person or in a suitable test stand or with a simulator Perform the test as described in the Operating Instructions Checking the Speed Indicator First test the speed as it is a very important parameter to determine the load With no load turn the crank by hand so that the indicator shows 60 rpm Use a stopwatch to measure the time re...

Страница 29: ...tem Art Nr 53 800 102 Attach the test weight to the sensor rod Make sure the weight does not swing Check the load reading on the screen Pist i i i W The recorded Pist Value See 2 must increase by 258 Watt after attaching the test weight Refer to the MTK Instructions Exit the Service Menu by pressing the START STOP button Note If the indicated load deviates from the setpoint value by more than 5 th...

Страница 30: ... screen is displayed 3 Build up pressure with the hand pump The pressure within the system is displayed as ppp Compare the displayed value with the reading of the mercury pressure gauge at several pressure levels but at least in intervals of 50 mmHg 4 After completion of the test press the NIP button again to exit the calibration mode Press the START STOP button to close the service screen 5 Recon...

Страница 31: ...t Tube for cuff incl Microphone Tube Holder Unit book Operation Instructions Information Sheet Ergometric Blood Pressure Measurement 118 83 080 140 84 208 001 99 800 050 53 800 400 53 809 110 53 804 850 Accessories Art Nr Description 118 Power cable 503 Connection cable Ergo K PC 5 m long Other cables Remote cable Remote control and Custom lengths upon reqest 53 800 102 Calibration set sensor exte...

Страница 32: ...Council Directive 93 42 EEC Zimmer Elektromedizin GmbH hereby declares that the ergometer Ergo K Ergo K with Blood Pressure Module conforms to the standards in accordance with the CE Council Directive 93 42 EEC concerning medical devices The device belongs to Class IIa according to Annex IX 3 2 ...

Страница 33: ... 0 250 1 min Load Programs 7 load programs freely programmable external Display LED Display for load speed and time LCD for load profiles blood pressure and Program progress Interfaces Serial analog load floating relay contact Patient Weight max 150 kg Saddle Height 680 1050 mm above the crank axis continuously adjustable Horizontal Saddle Position Continuously adjustable Protection Class I Protec...

Страница 34: ...easuring Range 20 280 mmHg Accuracy 3 mmHg Measuring Time Approx 25 50 Sec Measuring Interval 1 to 99 minutes or determined by the controlling unit Note When using the blood pressure module in high elevations the measuring time should be extended as the pump may be slower Norms The Blood pressure module conforms DIN EN 1060 1 Edition 1995 12 Storage and Transport Keep original packaging for transp...

Страница 35: ...ective Ensure proper connection between connection cable RS 232 and ergometer Ensure proper positioning of the control device Ensure that controlling device is in the ergometry mode and is started Ensure correct baud rate and correct protocol selection Refer to Chapter 9 Service NIBP Measurement Error Error in blood pressure measurment Error message is displayed for approx 2 5 seconds Blood pressu...

Страница 36: ...Zimmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 0731 9761 291 Fax 0731 9761 299 www zimmer de ergo k User Manual ...

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