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URODYN 1000 System

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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 repro-
duction 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 man-
ual, 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
 ®
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
 ®
Urodyn 1000 User Guide

Sensor..................................................................................................................... 14
Sensor type:........................................................................................................................... 14
Recording method ................................................................................................................. 14
Parameters ............................................................................................................................ 14
Classification ......................................................................................................... 15
Authorized Service Centers................................................................................................... 16

4 Contents

Safety Information
This product is CE marked in conformity with
the requirements of the Medical Device Direc-
tive 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 inves-
tigation.
 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 stan-
dards 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 de-
vice, 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 infor-
mation.
Product Description
The Urodyn® 1000 is a stationary medical de-
vice used to record physiological data, such as
those associated with voiding disorders.
®
Urodyn 1000 User Guide
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 ob-
served:
 Authorized personnel (see back of guide for
authorized service centers) carry out all re-
pairs 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.
Safety Information 5
 ®
Urodyn 1000 User Guide

Symbols Parts List

The package should contain the following
Explanations of the symbols found on the de-
items:
vice:
1 Urodyn® 1000
1 Power cord
 Attention, see accompanying documents. 3 Paper rolls
1 Registration Card
1 Urodyn® 1000 User Guide (This manual)

 Body Floating safety rating

1 Changing the language of Urodyn® 1000
1 Cleaning Instructions
1 Wall Mounting Instruction

! Input

Standby/Manual start/stop

$ CE mark with notified body ID

Setup Keys

C Cancel, returns you to the previous loca-

tion 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 selec-

tion

6 Symbols

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 but-
ton or automatically by the built-in On pe-
riod 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 de-
scription. 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.
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.
®
Urodyn 1000 User Guide
This is done as follows:
1. When prompted by the device, or during the
installation, pour the contents of the calibra-
tion 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 set-
tings.
Routine use of system 7
 ®
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 dis-
played in a list with the optional settings under-
neath. 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 de-
fault 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 12-
hour (a.m./p.m.) and Month/Day/Year for-
mats. If the language is set to English (U.K.),
the system will use the 24-hour and
Day/Month/Year formats. For all other lan-
guages 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 dis-
played.
 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 dis-
played.
 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 re-
cording. The user can also switch on or off
an option to enter patient information before
the recording starts.
 Sensitivity: allows the selection of the sensi-
tivity (ml/s) for the recording. Values avail-
able 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 rec-
ord data after the flow has fallen to zero.
Fixed values from 10 seconds to 2 minutes
are available. The default value is 20 sec-
onds.
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 inter-
pretation of results from this system. It is always
advisable to check the program analysis results
against the signal tracing when a major conse-
quence such as surgery occurs as a result of an
investigation.

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
Load paper into the device. Instructions on how
to do this can be found on the inside of the de-
vice lid.
Secure Printer Arm
Open the device's lid and secure the printer arm.
No Sensor Connected
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Ensure that the Flow Transducer is connected to
the device.
Calibration Failed
If this screen appears, there may be a calibra-
tion/ sensor problem. Ensure that all connec-
tions are secure. If the screen is still displayed,
check whether the sensor is obstructed or if
®
Urodyn 1000 User Guide
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 mes-
sage 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.
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:
Note down the error code and call your service
representative.
Troubleshooting 9
 ®
Urodyn 1000 User Guide

Device description
System Legend
 1. Urodyn® 1000

 2. Display
3. Power on indicator
 4. Standby, start/stop switch
  5. IrDA Port
6. Lid

 7. Lid catch
 8. Set up keys


 9. Printer
 10. Secure screw to wall bracket

11. Paper location

 12. Printer lever
13. Paper output
 14. Power input connector

15. Power supply cable
16. Electrical outlet
 17. Flow Transducer input
 18. Flow Transducer connector
 19. Flow Transducer
20. Flow Transducer stand

10 Device description
 ®
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 accesso-
ries.

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
 ®
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 de-
vice, pour the contents of the calibration bot-
tle 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
 ®
Urodyn 1000 User Guide

Technical Data
Model 5VQTCIG%QPFKVKQPU
®
Urodyn 1000 6TCPURQTVCVKQP
4GSWKTGOGPVU
Number of Channels Temperature -40°C to +70°C
(-40°F to 158°F)
1 channel
Humidity 10% - 100%rh
(including condensation)
Filters Atmospheric pressure
Standard (0-1 Hz –3dB) 700hPa - 1060hPa
Thompson (0-0.25 Hz –3dB)
Operating Conditions
Power Supply Temperature +10°C to +40°C
Power Supply: Mains (50°F to 104°F)
Input: 110-240V, 50-60Hz Humidity 30% - 75%rh
Power consumption: max. 100 VA Atmospheric pressure
Type of Protection: Safety Class I 700hPa - 1060hPa

Languages: Accuracy
English (U.S.), English (UK), Danish, Dutch, Flow Transducer
French, German, Greek, Italian, Portuguese, Flow: +/-3% (relative)
Spanish, Swedish and Finnish. +/- 0.2 ml/s (absolute)
Volume: +/-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
 ®
Urodyn 1000 User Guide

Sensor
The device supports a Flow Transducer sensor. Parameters
The device has 2 channels (internally) with dif-
The device, together with the sensor supports
ferent filtering (Standard and Thompson). The
the following parameter:
amplifier is controlled by the device’s software.
 Flow.

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

Classification
Type of protection against electric shock:
 Class I.
Degree of protection against electric shock:
 Type BF (Body Floating): Applied part pro-
vides 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
(floating).
®
Urodyn 1000 User Guide
 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 an-
esthetic gases mixed with air, oxygen or ni-
trous oxide. Danger of electrical ignition.
Mode of operation:
 Continuous or intermittent operation.
Classification 15
Authorized Service Centers

Denmark USA
Medtronic Functional Diagnostics A/S Medtronic Functional Diagnostics, Inc.
Tonsbakken 16-18 3850 Victoria Street North MS v215
DK-2740 Skovlunde Shoreview, MN 55126-2978
Denmark USA
Tel. +45 44 57 90 00 Tel. +1-612-514-1700
Fax +45 44 57 90 10 Fax +1-612-514-1710
E-mail uro.mfd@medtronic.com Toll-free in the USA: 1-800-227-3191
Http://www.mfd.medtronic.com

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: uro.mfd@medtronic.com
http://www.mfd.medtronic.com

Printed in Denmark, March, 2000 Reg. No 9034M1041 

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