User Guide
16 Pages
Preview
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User Guide
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Urodyn 1000 User Guide
Copyright © 2000 Medtronic Functional Diagnostics A/S. All rights reserved. The contents of this manual are the property of Medtronic Functional Diagnostics A/S. Any reproduction in whole or in part is strictly prohibited. At the time of printing / transfer to the CD-ROM, this manual correctly described the device and its functions. However, as modifications may have been carried out since the production of this manual, the system package may contain one or more addenda to the manual. This manual including any such addenda must be thoroughly read, before using the device.
2 Contents
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Urodyn 1000 User Guide
Contents Contents ... 3 Safety Information... 5 Product Description... 5 Intended Use... 5
Symbols ... 6 Setup Keys... 6 Parts List ... 6
Routine use of system ... 7 Prepare Equipment ... 7 Operation modes ... 7 Start up the System... 7 Device Verification ... 7 Standard Settings ... 7 Change Settings ... 8 Description of factory settings ... 8 Print Recording ... 8 Report ... 8
Troubleshooting... 9 Out of Paper... 9 Secure Printer Arm ... 9 No Sensor Connected... 9 Calibration Failed ... 9 Printer too hot... 9 Technical failure ... 9
Device description... 10 System ... 10 Legend... 10
Maintenance ... 11 Cleaning... 11
Calibration ... 12 Device Calibration... 12
Technical Data... 13 Model ... 13 Number of Channels ... 13 Filters... 13 Power Supply ... 13 Languages:... 13 Operating Conditions... 13 Accuracy ... 13 Measures and weights ... 13 Contents 3
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Urodyn 1000 User Guide
Sensor... 14 Sensor type:... 14 Recording method ... 14 Parameters ... 14
Classification ... 15 Authorized Service Centers... 16
4 Contents
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Urodyn 1000 User Guide
Safety Information This product is CE marked in conformity with the requirements of the Medical Device Directive 93/42/EEC. Adhere to the following recommendations for safe operation of the device: Never use the device near X-rays, mobile telephones, CB radios or other forms of radio communication, and/or electromagnetic fields. These may affect the performance of the device. To avoid hazards, only use sensors that have been designed for use with the system (see Sensor section). Do not attempt to open the case. Do not immerse the device in water or any other liquid. Do not change printer paper during an investigation. Do not allow patients to connect a sensor themselves. Do not connect the sensor to anything other than the appropriate input on the device. Never attempt to connect a sensor to any electrical outlet apart from the one specified on the device (see Device description). You should observe the specific safety standards and regulations of your own country, regarding electrical connections to the main supply in hospitals and wet environments. Note: To disconnect the mains from the device, remove the plug from the power socket. Do not keep non-compliant equipment in the patient environment. If in doubt contact your authorized service center for further information.
Intended Use The Urodyn® 1000 is intended to acquire and analyze data and to provide post acquisition analysis of voiding and voiding disorders. WARNING Only professional users should use this device.
Medtronic Functional Diagnostics A/S is only responsible for the reliability and performance of the device if the following are strictly observed: Authorized personnel (see back of guide for
authorized service centers) carry out all repairs and modifications. The device must be used in accordance with the instructions given in this section. The device must be used only for its intended use. If the above points are not strictly observed, the warranty will be considered invalid. WARNING Danger of electrical ignition. The device is not intended for use with anesthetic gases mixed with air, oxygen or nitrous oxide.
CAUTION In the United States, Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner. WARNING The instructions in this manual are meant for recommendation only. They are not intended to replace or negate hospital patient care policy.
Product Description The Urodyn® 1000 is a stationary medical device used to record physiological data, such as those associated with voiding disorders.
Safety Information 5
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Urodyn 1000 User Guide
Symbols Explanations of the symbols found on the device:
Attention, see accompanying documents. Body Floating safety rating ! Input Standby/Manual start/stop
$ CE mark with notified body ID Setup Keys
C
Cancel, returns you to the previous location without saving any changes Down, moves the selection bar to the next item down Up, moves the selection bar to the next item up Enter button, executes the current selection
6 Symbols
Parts List The package should contain the following items: 1 Urodyn® 1000 1 Power cord 3 Paper rolls 1 Registration Card 1 Urodyn® 1000 User Guide (This manual) 1 Changing the language of Urodyn® 1000 1 Cleaning Instructions 1 Wall Mounting Instruction
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Urodyn 1000 User Guide
Routine use of system Prepare Equipment Operation modes The Urodyn® 1000 has three different operation modes: 1. Power save: a number of functions are automatically deactivated by the system in order to save power. The mode is changed to standby either by pressing the Standby button or automatically by the built-in On period function, if selected. 2. Standby: all functions are enabled and the device is ready to record. Recording starts when the Standby button is pressed or when a flow is detected. 3. Recording: data is being recorded.
Start up the System Connect the system, as described in Device description. The device will start up in power save or, if within the designated On period, in standby mode. If the device starts in power save mode, to begin using it press the Standby button. When this screen is displayed, the system is ready for use.
This is done as follows: 1. When prompted by the device, or during the installation, pour the contents of the calibration bottle into the Flow Transducer. This provides a known volume (e.g. 400ml), pour at 10-40 ml/second. 2. Wait for the test report to be printed. 3. Validate the device result against the poured volume. If the difference between the result obtained and the actual volume is greater than the volume accuracy figure (see the Technical Data section), then the device should be calibrated, as described in the Calibration section. 4. Empty the beaker /pot. NOTE The device will prompt you to verify at regular intervals (weekly), to ensure optimal performance. This interval can be changed in the Setup Menu under Verification.
Standard Settings The device is set up to use factory settings at delivery. This can be changed in the Setup menu, using Modify existing. Use Factory settings will clear any customer settings and return the device to its factory settings.
Recording starts when the Standby button is pressed or when a flow is detected.
Device Verification
The device is factory calibrated, but to ensure optimal performance it is recommended that it should be verified, before the system is used. Routine use of system 7
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Urodyn 1000 User Guide
Change Settings To use the factory settings, provided with the device, no changes are necessary. If you wish to modify the factory settings, select Setup from the main menu then Modify existing from the Setup screen. The configurable items are displayed in a list with the optional settings underneath. Use Up and Down keys to scroll between items and Enter to select the preferred setting. Press Cancel to return to the previous item.
Description of factory settings NOTE In the following items the system's default settings (where applicable) are underlined.
Time format/Date format: are determined by
the system's language setting. When this is English (U.S.), the system will use the 12hour (a.m./p.m.) and Month/Day/Year formats. If the language is set to English (U.K.), the system will use the 24-hour and Day/Month/Year formats. For all other languages the system will use the 24-hour and Day/Month/Year formats. Set time: the system's internal clock can be set up. Select Time then Change Hours/Change Minutes Use the Up/Down controls to increase/decrease the values displayed. Set date:the system's internal date can be setup. Select Date then Change Months/Change years Use the Up/Down controls to increase/decrease the values displayed. Language settings: the user can select the relevant local language. For a complete list of available languages, see Technical Data. The default language is English (U.S.). Verification interval: can be set to prompt the user to verify the accuracy of the devices. The interval between verifications can be: a week, a month, six months or a year. Filter settings: the user can choose between the Standard or Thompson settings. 8 Troubleshooting
Printer settings: the user can choose between
printing 0, 1 or 2 additional copies of the recording. The user can also switch on or off an option to enter patient information before the recording starts. Sensitivity: allows the selection of the sensitivity (ml/s) for the recording. Values available are: 50, 25 and 10 ml/s. On period: allows the user to set the start and stop times for the on period. No flow time: this is the period of time, after a recording, that the device continues to record data after the flow has fallen to zero. Fixed values from 10 seconds to 2 minutes are available. The default value is 20 seconds.
Print Recording The default is to print during each study. To obtain an additional copy of the study, press the Start/Standby button before the time limit is exceeded. The device will maintain up to 20 studies for safekeeping and for printing out copies later. Patients can be found in the Previous Patients menu. Using the arrows (Up and Down keys), select the patient, then press Enter to print. Note when the memory is full the oldest data will be erased, one entry at a time.
Report IMPORTANT: Exercise diligence in the interpretation of results from this system. It is always advisable to check the program analysis results against the signal tracing when a major consequence such as surgery occurs as a result of an investigation.
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Urodyn 1000 User Guide
Troubleshooting The device has an error detection system that, in the event of a failure, will suggest an action or display an error code. If an error code is shown always note it down, as this will help your service representative to solve the problem.
Out of Paper
there is a build-up of residue. If there is, then clean the device and try to calibrate again. WARNING If you choose to ignore this message by pressing ENTER standard calibration values will be used instead of the real ones. This may produce incorrect results!
Printer too hot If this screen is displayed: The printer motor has overheated. Load paper into the device. Instructions on how to do this can be found on the inside of the device lid.
Secure Printer Arm
Open the device's lid and secure the printer arm.
This can happen if there is a high turnover of patients, where all the studies are printed out. To avoid damaging the device, allow it to cool down before reuse.
Technical failure If this screen is displayed:
No Sensor Connected &RQQHFW VHQVRU
Ensure that the Flow Transducer is connected to the device.
Note down the error code and call your service representative.
Calibration Failed
If this screen appears, there may be a calibration/ sensor problem. Ensure that all connections are secure. If the screen is still displayed, check whether the sensor is obstructed or if Troubleshooting 9
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Urodyn 1000 User Guide
Device description System
Legend
10 Device description
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.
Urodyn® 1000 Display Power on indicator Standby, start/stop switch IrDA Port Lid Lid catch Set up keys Printer Secure screw to wall bracket Paper location Printer lever Paper output Power input connector Power supply cable Electrical outlet Flow Transducer input Flow Transducer connector Flow Transducer Flow Transducer stand
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Urodyn 1000 User Guide
Maintenance On a weekly basis, test the device for proper function and inspect cables and sensor for cuts and other signs of damage. If in doubt, replace the relevant parts. The device should be cleaned routinely, as described below. No additional maintenance is required.
Do not immerse the device in any liquid. To clean accessories, follow the cleaning in-
structions as described in their individual User Guides, provided with those accessories.
Cleaning The Urodyn® 1000 should be cleaned once a month. Clean the device as follows: Turn off the device by unplugging it from the
power socket. Wipe the device with a damp cloth and mild detergent.
Maintenance 11
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Urodyn 1000 User Guide
Calibration Device Calibration The device is factory calibrated, but to ensure optimal performance it is recommended that it should be calibrated regularly. This is done as follows:
1. Using the control keys, select Test from the main menu. 2. Select Calibration 3. The device should be calibrated using a known volume of 400ml, measured using the calibration bottle. When prompted by the device, pour the contents of the calibration bottle into the Flow Transducer (pour at 10-40 ml/second). 4. Wait for the test report to be printed. 5. Empty the beaker /pot.
12 Calibration
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Urodyn 1000 User Guide
Technical Data 5VQTCIG%QPFKVKQPU 6TCPURQTVCVKQP 4GSWKTGOGPVU
Model ®
Urodyn 1000
Temperature -40°C to +70°C (-40°F to 158°F) Humidity 10% - 100%rh (including condensation) Atmospheric pressure 700hPa - 1060hPa
Number of Channels 1 channel
Filters Standard (0-1 Hz –3dB) Thompson (0-0.25 Hz –3dB)
Operating Conditions
Power Supply Power Supply: Mains Input: 110-240V, 50-60Hz Power consumption: max. 100 VA Type of Protection: Safety Class I
Temperature +10°C to +40°C (50°F to 104°F) Humidity 30% - 75%rh Atmospheric pressure 700hPa - 1060hPa
Languages:
Accuracy
English (U.S.), English (UK), Danish, Dutch, French, German, Greek, Italian, Portuguese, Spanish, Swedish and Finnish.
Flow Transducer
Flow: Volume:
+/-3% (relative) +/- 0.2 ml/s (absolute) +/-3% (relative) +/- 1.0 ml (absolute)
Note: Accuracy is dependent on calibration.
Measures and weights Width
Depth
Height
Weight
Metric
320 mm
210 mm
70 mm
Maximum 1.7kg
U.S.
12.5 ”
8.0 ”
3.0 ”
Maximum 3.8lbs.
All values are approximate.
Technical Data 13
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Urodyn 1000 User Guide
Sensor The device supports a Flow Transducer sensor. The device has 2 channels (internally) with different filtering (Standard and Thompson). The amplifier is controlled by the device’s software.
Sensor type: Flow Transducer: REF 9034K010.
Recording method Continuous on demand or automatic detec-
tion of flow. Sampling rate: 16Hz. Resolution: 12 bit A/D. Measuring range: 0-1000 ml @ 0-50 ml/s.
14 Sensor
Parameters The device, together with the sensor supports the following parameter: Flow.
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Urodyn 1000 User Guide
Classification Type of protection against electric shock: Class I. Degree of protection against electric shock: Type BF (Body Floating): Applied part provides a specific degree of protection against electric shock, particularly in regard to the amount of current leakage that is allowed. The applied part is mechanically isolated
Not intended for direct cardiac application.
Degree of protection against ingress of water: IP 20. Degree of safety in presence of inflammable anesthetics: The device is not intended for use with anesthetic gases mixed with air, oxygen or nitrous oxide. Danger of electrical ignition.
(floating). Mode of operation: Continuous or intermittent operation.
Classification 15
Authorized Service Centers Denmark
USA
Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde Denmark Tel. +45 44 57 90 00 Fax +45 44 57 90 10 E-mail [email protected] Http://www.mfd.medtronic.com
Medtronic Functional Diagnostics, Inc. 3850 Victoria Street North MS v215 Shoreview, MN 55126-2978 USA Tel. +1-612-514-1700 Fax +1-612-514-1710 Toll-free in the USA: 1-800-227-3191
Manufactured by:
Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde Denmark Tel. +45 44 57 90 00 Fax +45 44 57 90 10 E-mail: [email protected] http://www.mfd.medtronic.com Printed in Denmark, March, 2000 Reg. No 9034M1041
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