45009019
User Manual
UROMIC Jive
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Urodynamic system
UROMIC Jive
User Manual
45009019 - User manual UROMIC Jive 08-2018.odt
Page 2 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Contents
1. Function and Use of UROMIC Jive....................................................................................4
1.1. Technical data of UROMIC Jive......................................................................................5
1.2. Device Label and Explanation of Symbols......................................................................6
1.3. Connecting Other Devices................................................................................................7
1.4. Connecting to Electrical Installation................................................................................7
1.5. Replacement of Fuses.......................................................................................................8
1.6. Input Power Cable Exchange............................................................................................8
2. Device Description.................................................................................................................9
2.1. Accessories.....................................................................................................................11
2.1.1. Bridge Circuit Type Pressure Transducers...............................................................11
2.1.2. Cystometric Pump (MU5004)..................................................................................12
2.1.3. Wireless Uroflowmeter (MU5013)..........................................................................13
2.1.4. Uroflowmeter (MU5003).........................................................................................14
2.1.5. Examining Chair for Uroflowmetry in Paediatric and Female Patients (MU9009).14
2.1.6. Catheter Puller (MU5005)........................................................................................15
2.1.7. Infusion Sensor (MU7102).......................................................................................15
2.1.8. EMG Pre-amplifier (PEMG)....................................................................................16
3. Preparation and Commissioning of the Device................................................................17
3.1. Preparation of the Device before Switching on..............................................................17
3.2. Switching the Device ON...............................................................................................17
3.3. Switching the Device OFF..............................................................................................17
4. Setup and Calibration of the Device..................................................................................18
4.1. Uroflowmetry Calibration..............................................................................................18
4.2. Calibration of Pressure Channels CH1 to CH3 (CH4)...................................................18
4.3. EMG Calibration............................................................................................................19
4.4. Cystometric Pump Calibration.......................................................................................19
4.5. Calibration of the Puller..................................................................................................20
5. Uromic Measurement Software.........................................................................................21
6. Basic Troubleshooting........................................................................................................22
7. Repairs and Warranty........................................................................................................24
8. Optional Accessories of the Measure Apparatus.............................................................24
9. Preventive Checks and Periodical Maintenance..............................................................25
10. Disinfection and Maintenance..........................................................................................26
10.1. Single-use Items............................................................................................................26
10.2. Disinfection of Components Possibly Contacting the Patient......................................26
10.3. Maintenance of the Device...........................................................................................26
11. Consumables......................................................................................................................27
11.1. Consumables Usage Guide...........................................................................................27
11.2. Risks Caused by Reusing the Disposable Items...........................................................28
11.3. Risks Involved in Manipulation with Infectious Materials..........................................29
12. Instructions for Waste Disposal.......................................................................................30
13. Contact Addresses.............................................................................................................31
Appendix A – EMC information...........................................................................................32
45009019 - User manual UROMIC Jive 08-2018.odt
Page 3 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
1. Function and Use of UROMIC Jive
UROMIC Jive is a medical device for complete urodynamic examination performed in
urological examination rooms. It can be used for diagnostics of urinary tract using standard
measuring methods stated by ICS. The following measurement methods are implemented:
uroflowmetry, cystometry, miction cystometry, profilometry, VLPP, EMG, anorectal
manometry.
The urodynamic measurement method provides gradual measuring by individual methods
into one record.
The pressure is measured by pressure transducers, the filling of bladder is measured by the
cystometric (peristaltic) pump, the flow rate and volume of urine is measured by the
uroflowmeter, the defined travel of the measuring catheter is measured by the catheter puller
and the electric potential of muscles is measured by the EMG probe.
All these devices are controlled by a built-in measuring unit that co-operates with a built-in
computer equipped with a control programme and the measurement is displayed on an
embedded monitor.
The device can be used for examining patients aged 5 years and older.
Patients suffering from urinary tract infection should not be examined because of possible
distortion of the measurement caused by the bladder irritation.
The device may be operated only by professionals that are perfectly familiar with the
operating instructions and whose qualification conforms to the requirements of the applicable
local regulations. Operators’ training should be carried out during installation by the vendor's
personnel or by a representative authorised by the manufacturer.
UROMIC Jive is an ordinary device, without any protection against water ingress. It is
intended for ordinary environment and for a continuous operation. It must be connected to a
stable mains distribution system.
The device does not contain any harmful substances which makes possible its safe disposal
after its lifetime expiration.
The UROMIC Jive device is classified as a Medical Electrical Equipment. It requires special
safety precautions related to EMC (electromagnetic compatibility) and must be installed and
commissioned in accordance with information about EMC stated in Appendix A of this
manual.
Portable and mobile RF communication equipment and other RF sources may have negative
impact on UROMIC Jive performance.
UROMIC Jive should not be used adjacent or on top of other equipment.
In case of adjacent or layered usage in necessary, this device should be monitored for its
normal performance in the arrangement in which it will be used.
!
Caution!
The device should be serviced solely by a person trained by the manufacturer.
Removing of covers and any manipulation, repairs and modifications inside the device
are forbidden.
There is a risk of electric shock when the covers are removed from the device!
45009019 - User manual UROMIC Jive 08-2018.odt
Page 4 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
1.1. Technical data of UROMIC Jive
Supply
110-230 VAC, 50/60 Hz
Power inputs
max. 300 VA
Class
I
Dimensions
60×65×(115 – 140) cm, keyboard height 75 – 100 cm
Weight
37 kg (max. 40 kg with accessories)
Operational temperature
+15 to +35 C
Storage temperature
–25 to +45 C
Transportation temperature
–25 to +60 C
Humidity
75% non-condensing
Storage and operational pressure
no special requirements (700 to 1060 kPa)
The device has one applied part of the BF type, with multiple functions – catheter puller, cystometric pump and
EMG probes.
Cystometric pump
Delivery
0 – 100 ml/min  
Predefined ranges
1, 2, 5, 10, 20, 50, 75, 100 ml/min
Catheter puller
Speed
0 – 10 mm/s  2 %
Predefined ranges
1, 2, 5 mm/s
Length of travel
200 mm (standard), max. 5940mm
Pressure measurement
Inputs
equal channels CH1 to CH3
Sensors
bridge circuit type, direct sensing or water-column/air pressure transmission
Range
–5 to +25 kPa  
max. allowed overpressure
+40 kPa
max. allowed underpressure
–20 kPa
Measurement of volume and flow
Input
MU5003 weight sensor connected to the CH5 input
MU5013 wireless weight sensor
Volume range
1000 ml  (max. 3000 ml    according to receptacle used)
Flow rate range
0 – 500 ml/s  
EMG
Inputs
EMG sensor stickers, connection to the CH4 input (or CH1 – CH3)
Sensitivity
50µV
Wireless sensors
Operational frequency
ISM range 865.0 MHz – 868.0 MHz (according to setting)
Output power at Tx
10 dBm (10 mW)
Modulation type
wide-range FSK
Communication speed
172.5 kbps
Bandwidth
480 kHz typical
Max. length of the data packet
3.5 ms
Typical keying ratio
<1 % per hour in continual measurement mode, with typical usage (up to
4 measurements each 5 minutes per hour) <0,1 % per hour
45009019 - User manual UROMIC Jive 08-2018.odt
Page 5 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
1.2. Device Label and Explanation of Symbols
The device label is positioned at the back side of the device's height-adjustable stand and
includes the name and type of the product, the basic technical data for the device power
supply, the manufacturer identification, year of manufacture and the following symbols listed
in the table:
Manufacturer
Mark of conformity with European standards and number of Notified body.
The product should be disposed of in separated waste at corresponding site.
Do not dispose into municipal waste.
The device includes an applied part of the BF type.
Electrical safety class II.
Consult instructions for use
For single use.
The device is a RF transmitter and receiver.
Caution
Do not push.
This side up.
Fragile, handle with care
Keep dry
Temperature limit
Humidity limit.
Year of manufacture.
Serial number.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 6 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
1.3. Connecting Other Devices
When connecting the instrument to other devices please proceed according to the instructions
in the IEC 60601-1 standard (General requirements for basic safety and essential
performance).
UROMIC Jive is equipped with safety insulating transformer.
The connectors of the control PC are galvanically isolated from the patient.
!
!
!
Caution!
Only those devices may be connected to the instrument, which are approved according
to IEC 60601-1 or that are powered through a safety insulating transformer or by
batteries or accumulators; the devices must be also approved by UROMIC Jive
manufacturer.
Caution!
The operator must not touch at the same time the patient and the connected devices
mentioned in this chapter.
Caution!
Any equipment connected to the USB connectors of the control PC must comply with
the USB interface specification, version 2.0/1.1 (http://www.usb.org/) and with the
IEC 60950-1 standard (Information technology equipment – Safety – General
requirements).
1.4. Connecting to Electrical Installation
UROMIC Jive is designed for operation in patient´s field, it is a BF type system, and may be
operated only at urology workplaces corresponding to safety precautions defined by valid
regulations. The location of socket must allow power supplying of measure unit without using
any extension cables or adapters, supply network type TN-S, TT or IT must be used.
After switching off, the instrument can be disconnected from the electric mains by removing
the power cable from the electric outlet.
!
Caution!
To avoid risk of electric shock, this device must be connected to electric installation
with protective earth!
45009019 - User manual UROMIC Jive 08-2018.odt
Page 7 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
1.5. Replacement of Fuses
The instrument has one pair of user-replaceable line fuses.
The fuse box is located on the input line on the rear side of the instrument stand and it is
grouped together with the mains connector. The mains fuses are placed in a draw-out holder.
The fuses are of the T2AL 250V type.
line connector
fuse box
!
Caution!
During the fuses exchange, the instrument must be switched off and the power cable
must be disconnected.
The fuses used for the replacement must be of the same type and rating.
1.6. Input Power Cable Exchange
If damaged, the input power cable may be replaced. After replacement, the electrical safety of
the device must be verified according to IEC 60601-1.
The cable should be replaced by an equivalent or better rated type, which means at least:
250 VAC, 10 A, 50 Hz, protection class I, inseparable device terminal of the
IEC C13 / 70 °C type.
As a standard, the manufacturer delivers Schurter cable, type 6003.0215.
!
Caution!
Using an unsuitable cable for the replacement may reduce the electrical safety of the
device and increase electric shock risk both for the operator and for the patient!
45009019 - User manual UROMIC Jive 08-2018.odt
Page 8 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2. Device Description
LCD monitor
water-proof keyboard
with touchpad
transducers holder
cystometric pump
(not visible)
control PC
measuring unit
input connectors
main power switch
isolation
transformer
The main power switch is located on the left side of the device stand base. It is equipped with
a visual indication of switching on.
main power switch
45009019 - User manual UROMIC Jive 08-2018.odt
Page 9 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
At the left side of the device there are connectors for connection of sensors and peripherals.
The connectors are marked as CH1–CH5, PULLER.
The inputs marked CH1–CH4 serve for connection of bridge circuit type transducers.
Also one or more transducers for EMG measurements may be connected to one of these
inputs (mostly CH4).
Connector marked CH5 is intended for connection of weight uroflowmeter.
The connector marked PULLER is for connection of external extractor of catheters.
universal input
connectors (4x)
input dedicated
for EMG
uroflowmeter
connector
catheter puller
connector
cystometric pump
45009019 - User manual UROMIC Jive 08-2018.odt
Page 10 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2.1. Accessories
!
Caution!
Using of accessories or cables other than those delivered by the manufacturer and
specified as spare parts, or unauthorised changes and modifications of this device may
impair the device parameters including violation of concordance with the standards for
wireless communication and EMC.
Sensors for measurement of the biometric data are connected to the patient unit by means of
cables.
Though some of the cables are universal, they are prepared by the manufacturer for userselected sensors (this may be subsequently changed with help of a service engineer).
2.1.1. Bridge Circuit Type Pressure Transducers
They serve for measuring pressure in body cavities.
They can work on principle of water column pressure transfer, on principle of pressure
transfer through an air-balloon catheter or using direct pressure sensing in the
measurement site.
The maximal length of the shielded connecting cable is 2.5 meters.
The pressure sensors with hydraulic pressure transfer may be offered in two variants – for
single use and reusable.
Reusable sensors with hydraulic pressure transfer – the pressure sensor is not sterile, the
pressure is transferred by membrane contact on the sensor and a disposable sterile chamber.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 11 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2.1.2. Cystometric Pump (MU5004)
The peristaltic pump is used for volumetric filling of the bladder with a sterile fluid (typically
saline) using a defined filling speed (0.5 to 100 ml/min). The fluid has the room temperature,
only for special applications (chill test), the temperature is lower.
Cystometric pump is operated from operating PC and its activity is semi-autonomous.
It is equipped with a safety automatic stop while its cover is open.
The pump is mounted to the side wall of the device and is accessible from the right side. On
demand, a model with an adversely oriented pump and input connectors can be delivered.
Before inserting the tube set, open the pump door, take out the sterile set from the original
package and insert it with the flexible part of the tube inside the pump. When inserting, be
careful to follow the correct direction. The fluid must flow from the bag to the patient.
The correct orientation is indicated by arrows on the pump head and in the centre of the
carrier.
!
!
Caution!
The controlling circuitry of the cystometric pump continually tracks its working
conditions and in case of a deviation from the expected value it stops the pump
operation immediately.
Electrostatic discharge, or interference in electrical mains may cause activation of this
protection.
Caution!
The pump lid should be closed with caution and the lid motion should be gently braked
by hand, so that the lid would not bump against the pump body. The bump may cause
displacement of the holding magnet on the lid, or the lid itself may crack.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 12 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2.1.3. Wireless Uroflowmeter (MU5013)
The wireless uroflowmeter consists of a plastic die-casting (uroflowmeter body) and a
stainless-steel funnel holder for guiding the urine stream.
The plastic body of the transducer holds a hollow on its upper side, into which the container
for capturing the urine is placed.
The container and the funnel are replaceable, made of plastic, and they are for single use only.
The uroflowmeter can be fastened to a stand with a continually adjustable height, or placed
under a seat for uroflowmetric examination of women and children.
Inside the plastic body of the uroflowmeter is a strain-gauge weight sensor (load cell), a
controlling and measuring electronics with an integrated antenna and a power source battery.
The ON/OFF switch is located at the bottom side of the uroflowmeter.
The uroflowmeter has no external indicators.
Each operating mode is indicated by an audio signal (buzzer).
!
Caution!
The uroflowmeter must not be exposed to mechanical stress caused by pulling the
measuring surface; otherwise a permanent damage of the transducer may occur!
This type of damage is not covered by the warranty!
MU5013
(wireless uroflowmeter)
product label
ON/OFF
switch
radio
identification
address
The main ON/OFF switch of wireless transducer is located on its bottom side.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 13 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2.1.4. Uroflowmeter (MU5003)
The uroflowmeter consists of plastic moulding (uroflowmeter body) containing a weight
sensor. The urine collection vessel is placed on the measuring surface. A stainless-steel funnel
holder is affixed to the body.
The vessel and the funnel are made of plastic and are for single use only.
The uroflowmeter can be attached to a stand with continuously adjustable stand.
The uroflowmeter connects to the device through UFM input. The maximal length of
the shielded connecting cable is 2.5 meters.
!
Caution!
The uroflowmeter must not be exposed to mechanical stress caused by pulling the
measuring surface; otherwise a permanent damage of the transducer may occur!
This type of damage is not covered by the warranty!
plastic funnel
for urine stream
direction
urine collection
container
funnel holder
measuring plate
with a recession
for urine container
2.1.5. Examining Chair for Uroflowmetry in Paediatric and Female
Patients (MU9009)
For examinations of children and females, a special examining chair
with weight capacity up to 150 kg can be delivered
Below the chair, the uroflowmeter can be pushed on the stand of the
economical type or on the tube-type stand.
The chair can be disinfected using a disinfecting solution.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 14 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2.1.6. Catheter Puller (MU5005)
It is used for pulling the measuring catheter from the urethra using a defined speed (0.5 to
5 mm/s). The slider is magnetically engaged in carrier rollers and the catheter is attached to
the slider using a collet. The slider can be easily removed from the puller for disinfection.
Also, the mechanism of the puller is waterproof and can be disinfected by liquid disinfectants.
The puller is secured in an articulated joint on a separate stand. It is connected to the
controlling unit by means of a cable, through the connector indicated as PULLER. The
maximal length of the shielded connecting cable is 2.5 meters.
2.1.7. Infusion Sensor (MU7102)
The infusion sensor is an optional accessory that is used only in special applications and
serves for feedback and verification of the exact amount of the fluid dosed by the peristaltic
pump. The highly exact peristaltic pump itself does not require this feedback, but, for
economical reasons, it may be replaced by an infusion sensor and a pressure bag.
The infusion sensor is delivered as a stand-mountable model and it connects to one of the
universal input connectors (CH1 to CH4).
The maximal length of the shielded connecting cable is 2.5 meters.
The infusion bag with the fluid can be hung on the infusion sensor hook.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 15 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
2.1.8. EMG Pre-amplifier (PEMG)
EMG pre-amplifier serves for amplification of the muscle voltage (0 – 500 µV) to the level
suitable for the CH1 to CH4 universal inputs (amplification approx. 1000×).
The maximal length of the shielded connecting cable is 2.5 meters.
The two side contacts on the amplifier are designed for connecting the active electrodes and
the central contact is for the grounding electrode. For a good transfer of the relatively low
muscular voltage, the electrodes must be fresh, with highly conductive gel.
The wires between the adhesive electrodes and the input terminals of the pre-amplifier must
be as short as possible, must be free and they must not be held by another person.
The pre-amplifier can be fastened to the patient's body using Velcro straps.
The pre-amplifier body can be disinfected by wiping with a cloth soaked with liquid
disinfectants. Take care not to let the liquid get into the terminals for connecting the
electrodes.
EMG is designed for informational assessment of the sphincter function through evaluation of
the electric potential changes. It is also possible to use exercises by means of the Biofeedback.
A direct measurement of sphincter is difficult and, virtually, it is practically possible to be
performed only as an invasive examination by means of needle sensors, which defies the
effort to simulate the physiological conditions during the urodynamic examination. For that
reason, the sphincter activity is measured indirectly by electromyography of the rectal
sphincter, which acts synergistically with the urethral sphincter.
!
!
Caution!
During the EMG measurement, the patient must not have any conductive connection
with the protective earth!
Prevent the patient contact with the metal parts of the examining table, in case it is
connected to the protective earth!
Caution!
EMG measurement in examination rooms with earthed metal floor is not
recommended!
Eventual interference induced in the earthed floor (transient effects originating in
electric mains) can overlay the useful signal generated by the patient and destroy the
measurement or make it impossible!
45009019 - User manual UROMIC Jive 08-2018.odt
Page 16 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
3. Preparation and Commissioning of the Device
3.1. Preparation of the Device before Switching on
Before the first switching-on the device, or when the device is moved to another site, the
following steps must be performed:
If the device was transferred from a place with significantly lower temperature, let the
switched-off device stay in room temperature for adequately long time (20 minutes at least),
to balance the temperature and evaporate potential condensate from the inner and outer parts
of the device.
Check if the main switch of UROMIC Jive is switched off.
Connect the puller cable to the device, to the PULLER connector.
Connect the uroflowmeter to the dedicated connector CH5.
Connect the pressure sensors to the CH1 to CH3 connectors.
Connect the EMG probe to the CH4 dedicated connector (or to other ones, according to the
configuration).
3.2. Switching the Device ON
Switch on the main power switch on the left side of the device stand. The switched-on state of
the device is indicated by a green backlight of the main switch button.
The built-in computer is automatically restarted, the measuring unit is initialized and the
entire process is completed by an automatic start of the Uromic measurement software.
Wait 10 minutes for stabilization of the device temperature and parameters. After this time,
the system is prepared for operation.
3.3. Switching the Device OFF
During switching the device off, first exit the Uromic measurement software, then correctly
switch off the operational system of the built-in computer and finally switch off the main
power switch of the device.
!
Caution!
Switching the device off without exiting the operational system of the built-in
computer (in "live state") may cause damage of the file system and render the device
non-functional.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 17 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
4. Setup and Calibration of the Device
The instrument is factory-set from the manufacturer's testing laboratory. A regular check of
the setting should be done once a year within the regular annual service check. Only in case of
repetitive evident mismatch of data or of the module or sensor exchange, a new setting
(calibration) can be carried out according to the following description.
Before starting the calibration (setting), connect the computer and all inputs to be set. Switch
on the device and start the Uromic program. The calibration program can be accessed under
the menu combination System – Configuration – Calibration.
4.1. Uroflowmetry Calibration
Select UFM1 from the menu.
•
•
•
•
•
•
•
Prompt "Set zero" – leave the uroflowmeter measuring surface empty and confirm
OK.
Prompt "Pour 100 ml to the container" – from the graduated cylinder, pour
pre-measured 100 ml of water. Confirm OK.
Question "How many ml did you add?" – enter actually poured volume (100 ml).
Confirm OK.
Prompt "Pour 200 ml to the container" – from the graduated cylinder, pour
pre-measured 200 ml of water. Confirm OK.
Question "How many ml did you add?" – enter actually poured volume (200 ml).
Confirm OK.
The calculated constant value will be displayed. Confirm OK.
Question, whether the new constant should be written into the .INI file. Confirm YES.
Check the setting by means of testing measurement using a graduated cylinder.
4.2. Calibration of Pressure Channels CH1 to CH3 (CH4)
Select the required channel and launch the setting program for individual pressure sensor.
•
•
•
•
•
•
•
Prompt "Set zero" – on the pressure gauge, using a syringe set the pressure of
0 cmH2O. Confirm OK.
Prompt "Set the pressure of 50 cmH2O" – on the pressure gauge, set the pressure of
50 cmH2O.
Question "What pressure was set?" – enter the pressure on the pressure gauge and
confirm OK.
Prompt "Set the pressure of 200 cmH2O" – on the pressure gauge, set the pressure of
200 cmH2O.
Question "What pressure was set?" – enter the pressure on the pressure gauge and
confirm OK.
The calculated constant value will be displayed. Confirm OK.
Question, whether the new constant should be written into the .INI file. Confirm YES.
Check the setting by means of testing measurement using a pressure gauge.
Using the same steps, calibrate all pressure channels.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 18 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
4.3. EMG Calibration
Connect a NF generator to the input.
Select EMG1 and launch the setting program for each input.
•
•
•
•
•
•
•
Prompt "Short EMG inputs". Short-circuit the inputs and confirm OK.
Prompt "Set 100 µV" – set the generator for the signal level of 100 µV. Confirm OK.
Question "What signal level was actually set?" – enter actual setting of the signal
strength (100) and confirm OK.
Prompt "Set 500 µV" – set the generator for the signal level of 500 µV. Confirm OK.
Question "What signal level was actually set?" – enter actual setting of the signal
strength (500) and confirm OK.
The calculated constant value will be displayed. Confirm OK.
Question, whether the new constants should be written into the .INI file. Confirm
YES.
Finally, check the setting using a testing measurement.
4.4. Cystometric Pump Calibration
Insert the infusion set with the infusion bottle and connected catheter to the pump. Prime the
path completely by opening the door or starting the pump motor.
Select PUMP and start the testing program. The settings are done separately for each
requested speed.
•
•
•
•
Selection "Put speed" – choose one of the pump speeds 1, 2, 5, 10, 20, 50, 75 or
100 ml/min. Confirm OK.
Prompt "Enter the requested volume to pump" – enter the volume you want to pump
and confirm OK.
Question "Enter the actual volume" – enter the volume actually pumped to the
graduated cylinder. Confirm OK.
Question, whether the new constant should be written into the .INI file. Confirm YES.
After completing the settings, compare the actually pumped amount against the data on the
screen. In case of mismatch, repeat the setting procedure for the given speed.
Using the same steps, calibrate all pump speeds.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 19 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
4.5. Calibration of the Puller
Select PULLER and start the testing program. The settings are done separately for each
requested speed.
•
•
•
•
Option "Initial speed" – choose one of the speeds 1, 2, 5 mm/s. Confirm OK.
Question "Enter the requested travel length" – enter the travel length in millimetres
(typically 100) and confirm OK.
Question "Enter the actual distance moved" – enter the measured travel length in
millimetres and confirm OK.
Question, whether the new constant should be written into the .INI file. Confirm YES.
After the settings are completed, compare the actual pulled-out length measured by a slide
gauge with the data on the screen. In case of mismatch, repeat the setting.
Using the same steps, calibrate all the pulling speeds one by one.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 20 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
5. Uromic Measurement Software
UROMIC Jive is delivered with the measurement software Uromic, version 2.8 or higher.
The Uromic software is described in a separate document that is delivered in form of
appendix to this User manual, or eventually on demand.
Please ask your seller for the required documentation (chap. 13).
45009019 - User manual UROMIC Jive 08-2018.odt
Page 21 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
6. Basic Troubleshooting
Error
Possible Cause
Resolution
Indication on the
main power
switch does not
light after
switching on.
The device is disconnected
from the electrical mains.
Connect the device to the mains.
Blown mains fuses.
Replace the mains fuses.
The control PC
does not start (its
power button does
not light).
Internal power supply for the
PC is faulty.
Contact the service centre.
The control PC is faulty.
Contact the service centre.
The monitor does
not work.
The monitor's mains cable is
disconnected.
Connect the mains cable into
monitor.
The monitor is turned off.
Turn on the monitor by its power
button.
The monitor is faulty.
Verify monitor's condition by using
of another monitor.
Contact the service centre.
The program
signals a
communication
error.
Wrong selection of the
computer communication port
in the program.
Check and repair the data in the
Uromic.cfg file.
Defective measuring unit.
Contact the service centre.
Neither
cystometric
pump, nor the
catheter puller are
working.
Defective measuring unit
(power circuitry of the patient
section).
Contact the service centre.
Cystometric
pump does not
work.
Wrong contact of the lid.
Open and close the lid of the pump
several times and restart the
controlling program. If the fault
persists, contact the service centre.
Defective electronics of the
pump.
Contact the service centre.
Defective motor of the pump.
The puller does
not work.
The puller cable is not well
connected to the measuring
unit.
Switch the device off and disconnect
and then reconnect the connector of
the puller cable.
If the fault persists, contact the
service centre.
Defective puller.
Contact the service centre.
Defective measuring unit
(puller control circuitry).
45009019 - User manual UROMIC Jive 08-2018.odt
Page 22 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Error
Possible Cause
Resolution
Uroflowmeter
does not measure
Wrong connection of the
uroflowmeter to the measuring
unit (incorrect input or poor
contact)
Check if the uroflowmeter is
connected to the correct input.
Disconnect and reconnect the
uroflowmeter cable connector.
If the fault persists, contact the
service centre.
Defective sensor
Contact the service centre.
Defective measuring unit
(analogue input circuitry)
Pressure sensors
do not measure
EMG does not
measure
Wrong connection of the
Check if the sensor is connected to
sensors to the measuring unit
the correct input.
(incorrect input or poor contact) Disconnect and reconnect the sensor
cable connector.
Use a new sensor.
If the fault persists, contact the
service centre.
Defective sensor
Use a new sensor.
Defective measuring unit
Contact the service centre.
Wrong connection of the EMG
pre-amplifier to the measuring
unit (incorrect input or poor
contact)
Check if the EMG pre-amplifier is
connected to the correct input.
Disconnect and reconnect the preamplifier cable connector.
If the fault persists, contact the
service centre.
Defective electrodes
Use new electrodes.
Defective pre-amplifier of the
probe
Contact the service centre.
Defective measuring unit
(analogue input circuitry)
Measurement
results are not
satisfactory.
Wrong resetting of the
measured channels
Perform resetting according to the
steps described in this manual at the
respective method.
Mistake in methodology of the
measurement procedure
Proceed according to the Uromic
Software Guide.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 23 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
7. Repairs and Warranty
The UROMIC Jive system is covered by a warranty according to the letter of guarantee,
lasting 12 months since the date of installation.
Repairs and calibration should be carried out by the service centre whose address is provided
to the customer at the installation. Removing of covers and any repairs and manipulation
inside the device are forbidden. The device may be serviced only by the service centre
approved by the manufacturer and supplier.
!
!
Caution!
Tampering the warranty seal will cause ceasing of the warranty!
Caution!
The device implements lead-free technologies according to the DIRECTIVE
2011/65/EU – Restriction of the use of Hazardous Substances (RoHS).
For that reason, the used materials are much more sensitive to surrounding conditions,
and even with proper usage, a defect may occur caused by frailty of the lead-free
solder.
Protect the device against mechanical shocks (particularly during its operation), against
increased humidity and high temperatures.
8. Optional Accessories of the Measure Apparatus
The delivery of UROMIC Jive includes: uroflowmeter stand, uroflowmeter with several
collection vessels, one plastic funnel.
Optional parts: examining chair for examination of children and females, extractor of
catheters with a stand, EMG pre-amplifier.
The delivery also includes this operations manual, the guide for clinicians (Uromic Software
Guide) including installation USB with operation program and medical guide. Service manual
can be delivered upon request.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 24 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
9. Preventive Checks and Periodical Maintenance
The manufacturer of UROMIC Jive recommends carrying out a preventive check of the
device annually.
!
Caution!
The preventive check may be completed solely by the device manufacturer or a person
authorised and trained by the manufacturer.
The preventive check involves the following activities:
•
electrical safety verification according to IEC 60601-1
•
check of calibration and eventual re-calibration of the inputs
•
overall cleaning of the device
•
attaching of the label indicating the date of next preventive check
The preventive check outcome is the Protocol on the device preventive check performance
and related Protocol on the electrical safety test performance according to IEC 60601-1.
The manufacturer recommends regular checks of the device calibrations, and if needed, recalibration according to the procedure described in this manual, chapter 4.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 25 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
10. Disinfection and Maintenance
10.1. Single-use Items
The device contains parts (accessories) the following part that are for single use only:
•
uroflowmeter funnel
•
urine collection vessel made of plastic
•
catheters of all types
•
urodynamic sets
•
EMG electrodes
•
pressure transducers
10.2. Disinfection of Components Possibly Contacting the Patient
After each usage, the seat of the chair for female examination should be disinfected by wiping
with a cloth dampened in a disinfectant agent.
Disinfect the slider of the catheter puller after each usage. Any disinfectant may be used and
the part may be immersed and autoclaved.
The uroflowmeter body should be disinfected by wiping with a cloth dampened in a
disinfectant agent.
Disinfect the catheter puller body by wiping with a cloth dampened in a disinfectant agent.
10.3. Maintenance of the Device
The system itself does not come into contact with patient, nevertheless, it must be kept
meticulously clean.
!
Caution!
The maintenance must be carried out always on a switched-off system!
The varnished components and covers of the system are resistant to ordinary chemicals,
and thus we recommend wiping them regularly, after each examination, with a cloth slightly
dampened in a disinfectant agent. Please be sure to have the cloth dampened only and to
prevent the liquid ingress into the device through gaps or ventilation openings.
Only in case of contamination of the device case by biologic material, especially by blood, we
recommend to disinfect the device by wiping with an agent with virucidal effect. Decision
about the type of these agents depends on local practice and to the provisions of the regulatory
hygienic authorities.
As the disinfectant, a solution based on 2% glutaraldehyde may be used (the solution
has no cleaning effects!). Glutaraldehyde is delivered by various producers under more
trademarks, for instance "Cidex" (Johnson & Johnson).
Use only products approved by the national regulations.
Repetitive cleaning of the device and its parts by disinfecting agents may cause discolouration
of the disinfected surfaces. Avoid using of cleaning agents containing abrasives, especially for
cleaning of the monitor displaying screen as they may cause a permanent damage to the
functional components or to the device surface.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 26 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
11. Consumables
This manual contains appendix – a list of recommended consumables necessary for
completing all examinations performed by UROMIC Jive. This appendix is relevant from
the date of signing the contract; an updated list can be found on the supplier's website
(chap. 13). In case of using consumables other than recommended, the manufacturer does not
guarantee the technical and safety parameters of the device.
11.1. Consumables Usage Guide
The UROMIC urodynamic systems can be connected to a variety of sensors and measuring
catheters. During their usage, it is necessary to follow the instructions of the consumable
manufacturer. Nevertheless, some rules are valid generally.
The UROMIC urodynamic systems are delivered with measuring catheters, connecting tubes,
tube sets for cystometric pumps, and pressure sensors, all produced by high-quality
manufacturers.
Some of these items are delivered in sterile packages. Before use always check that the
package is not damaged. Also check the expiration date. Sterile items with damaged sterile
barrier or expired products
must not be used because of risk of contamination and infection of the patient.
Majority of the items are disposable and they cannot be resterilised.
The reasons are the following:
◦ A difficult preparation for sterilization leading to an imperfect sterilization endangering
the patient with infection.
◦ Possible degradation of plastic especially during autoclaving and non-functional or
distorted measurement.
◦ Sterilization is not capable to remove prions that carry a risk of Creutzfeldt-Jakob
disease infection (mad cow disease)
Pressure sensing using the hydraulic method requires an absolutely precise preparation of the
measuring system, namely removal of all bubbles from the tube system as these can
distort or prevent the pressure changes transmission, and thus also the measurement itself.
Priming of tubes is done always in sterile conditions, using sterile water for injections or
sterile saline./The tubes are always prepared in sterile conditions using sterile water for
injections or sterile saline.
The electromyography electrodes must be fresh (date of expiration is indicated at each
delivery) because drying of gel on the active part of the electrode affects the measurement.
The tube sets for the cystometric pump must be checked for integrity of package and date of
guaranteed sterilization. The expired sets should not be used because there is not only risk of
infection, but also risk of tube breakage caused by degradation of the plastic material. During
insertion of a tube set to the cystometric pump for priming, it is necessary to inspect visually
each new tube set for water-tightness.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 27 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
11.2. Risks Caused by Reusing the Disposable Items
Disposable material
Possible risk
Logical set – sterile disposable
chamber for MEDEX sensors
Infection transmission across patients
Air charged catheter
Infection transmission across patients
Affecting validity of the examination (material
deterioration)
Profilocystometric catheter
Cystometric catheter
Rectal catheter
Infection transmission across patients
Affecting validity of the examination (material
deterioration)
EMG electrodes – pre-gelled
Infection transmission across patients
Affecting validity of the examination (drying of gel,
poor contact)
Plastic funnel for the uroflowmeter Transmission of infection to the operator
Plastic container for
the uroflowmeter
Urodynamic set
Perfusion set
Infection transmission across patients
Affecting validity of the examination (improper dosing)
Affecting function of the device (possible ingress of
fluids in the device)
Three-way stopcock
Y connector for uroflowmetry
Connection tube
Adapter with damping tube
Infection transmission across patients
Affecting function of the device (fluid leak)
45009019 - User manual UROMIC Jive 08-2018.odt
Page 28 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
11.3. Risks Involved in Manipulation with Infectious Materials
Uroflowmetric examination is based on measuring the flow rate and volume of urine of the
patient; the urine falls into the funnel that directs it into the vessel. Although the urine of most
of patients is sterile and the principles of the examination exclude patients suffering from
urinary tract infections from examination (it is biased by irritation of the bladder), urine of
some examined patients may be contaminated by bacteria.
!
Caution!
To avoid risk of infection, the personnel should treat the urine in the vessel and also the
components soiled by urine as infectious material!
According to the type of infection (in vast majority it is gramnegative escherichia coli)
an ascendant infection of urinary tract or purulent affections in case of skin damage can
develop. In exceptional situations, an infection by tuberculosis or A hepatitis may occur.
Recommended procedures:
• Use personal protective aids for manipulation with urine (rubber gloves, surgical
mask).
• Adhere to personal hygiene rules (washing hands, no eating or drinking in examination
room).
• The urine should be poured out of the vessel only when using gloves.
• It is recommended to vaccinate the personnel against hepatitis A and B.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 29 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
12. Instructions for Waste Disposal
Instructions for disposal of waste that evolves in the lifetime of the medical device. 1)
Type of waste
Code1)
Category2) Method of disposal
Paper and cardboard
packages
O
Other waste – recyclable waste – hand over to a
body authorised for waste treatment, through
sorted waste in municipalities
Wooden package
O
Plastic packaging – PE
foil
O
Other waste – must be gathered and handed over
for for disposal in waste incineration plant
Discarded electric and
electronic device
D
Dangerous waste – contains batteries and
accumulators.
The worn-away device must be delivered,
complete, at the dedicated scrap yard (free of
charge) or returned to the manufacturer. It must
not be discarded to municipal waste.3)
Waste from electric and
electronic devices –
discarded devices
O
Other waste – recyclable waste – after sorting must
be handed over to an authorised body ensuring
processing of waste or secondary raw material.
Other discarded devices
– metal pieces (without
oil residuals)
O
Other discarded devices
– non-metal pieces
O
Other waste – must be gathered and handed over
to a waste disposal site.3)
Other discarded devices
– rubber pieces
O
Other waste – must be gathered and handed over
for disposal in waste incineration plant
Small plastic pieces3)
O
Other batteries and
accumulators – lithium
batteries
D
Dangerous waste – must be gathered and handed
over for disposal to an authorised body.
Consumables coming
into direct contact with
patient – potentially
infectious material
D
The used consumables should be discarded to a
container for infectious material and disposed of
according to local regulations.
1)
please follow the national regulations for waste disposal
2)
O – means Other waste, D – means Dangerous waste
3)
CAUTION – Poly-tetrafluoroethylene (PTFE, Teflon), due to burnt gases toxicity, must
not be incinerated in facilities other than waste incineration plants.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 30 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
13. Contact Addresses
Manufacturer:
MEDKONSULT medical technology s. r. o.
Pasteurova 67/15, Klášterní Hradisko
779 00 Olomouc
Czech Republic
phone:
e-mail:
web:
+420 581 113 030
info@mmtsystems.com, support@mmtsystems.com
http://www.mmtsystems.com/
Commercial representation and service centre:
web:
http://www.mmtsystems.com/contacts
Notified body:
3EC International a.s.
Hraničná 18
Bratislava 82105
Slovak Republic
phone:
fax:
e-mail:
web:
+421 258 318 343
+421 258 318 345
katarina.srdosova@3ec.sk
http://www.3ec.sk/
45009019 - User manual UROMIC Jive 08-2018.odt
Page 31 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Appendix A – EMC information
!
!
!
!
Caution!
When used with compatible accessories delivered together with the device and
shielded cables connecting the system components, the device was proven to conform
to EMC standards.
Using of accessories other than those delivered by the manufacturer and specified as
spare parts, or unauthorised changes or modifications of this device may violate the
concordance with EMC and with the standards for wireless communication.
Caution!
Measuring methods involving EMG (uroflowmetry with EMG, Biofeedback, etc.), due
to their basic character, may be adversely affected by interference in electric network
(transient effects).
During measurement including EMG, the patient must not be conductively connected
with protective earth, e.g. through a contact with metal parts of the examination couch.
It is not recommended to measure EMG in examination rooms with earthed metal floor
that may, through its significant stray capacity, induce interference directly into the
patient's body.
Caution!
The controlling circuitry of the cystometric pump continually monitors its working
conditions and in case of a deviation from the expected value, stops the pump
operation immediately.
Electrostatic discharge, or interference in electrical mains, may cause activation of this
protection.
Caution!
The UROMIC Jive is a radio transmitter and receiver working in the ISM frequency
bands of 865.0 – 868.0 MHz and 2.4 GHz.
It may interfere with, or be interfered by, a radio signal from nearby electronic devices
operating in the same frequency range.
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions IEC 60601-1-2
The UROMIC Jive is suitable for use in the specified electromagnetic environment. The customer and/or
the user of the UROMIC Jive should assure that it is used in an electromagnetic environment as described
below:
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF emissions
CISPR 11
Group 1
UROMIC Jive uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
The UROMIC Jive is 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.
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
45009019 - User manual UROMIC Jive 08-2018.odt
Page 32 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
IEC 60601-1-2
The UROMIC Jive is suitable for use in the specified electromagnetic environment. The customer and/or
the user of the UROMIC Jive should assure that it is used in an electromagnetic environment as described
below:
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601-1-2
Test Level
Compliance
Level
±6 kV contact
±2, 4 and 6 kV
contact
±8 kV air
±2, 4 and 8 kV
air
±2 kV for power
supply lines
±2 kV for power
supply lines
±1 kV for
input/output lines
±1 kV for
input/output lines
±1 kV differential mode
±0.5 and 1 kV
differential mode
±2 kV common mode
±0.5, 1 and 2 kV
common mode
<5% UT
(>95% dip in UT)
for 0.5 cycle
< 11.5 VAC
for 0.5 cycle
40 % UT
(60% dip in UT)
for 5 cycles
92 VAC
for 5 cycles
70 % UT
(30% dip in UT)
for 25 cycles
161 VAC
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
< 11.5 VAC
for 5 sec
3 A/m
3 A/m
Electromagnetic Environment
Guidance
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Mains power quality should be
that of a typical commercial
and/or hospital environment. If
the user of the UROMIC Jive
requires continued operation
during power mains interruptions,
it is recommended that
the UROMIC Jive be powered
from an un-interruptible power
supply or a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial and/or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 33 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
IEC 60601-1-2
The UROMIC Jive is suitable for use in the specified electromagnetic environment. The customer and/or
the user of the UROMIC Jive should assure that it is used in an electromagnetic environment as described
below:
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the UROMIC Jive, including
cables, than the recommended separation
distance calculated from the equation
appropriate for the frequency of the transmitter.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
3 Vrms
3 Vrms
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
3 V/m
80 MHz to 2.5 GHz
d =1.2 √ P
d =1.2 √ P 80 MHz to 800 MHz
d =2.3 √ P 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a ,
should be less than the compliance level in each
frequency range b .
Interference may occur in the vicinity of equipment
marked with the following symbol:
Note 1
Note 2
a
b
For 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the UROMIC Jive is used exceeds the applicable RF compliance level above,
the UROMIC Jive should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the UROMIC
Jive.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 34 of 35
MEDKONSULT
medical technology s. r. o.
UROMIC Jive
User Manual
Valid from: 13. 6. 2018
Revision: 08/2018
Recommended Separation Distances
between Portable and Mobile RF Communications Equipment
and the UROMIC Jive
IEC 60601-1-2
The UROMIC Jive Set is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the UROMIC Jive Set can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the UROMIC Jive Set as recommended below, according to
the maximum output power of the communications equipment.
Rated Maximum Output
Power of Transmitter
0
150 kHz to 80 MHz
800 MHz to 2.5 GHz
W
d =1.2 √ P
80 MHz to 800 MHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
d =1.2 √ P
d =2.3 √ P
For transmitters rated at a maximum output power not listed above, the separation distance can be estimated
using the equation in the corresponding column, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
Note 1
For 80 MHz and 800 MHz, the higher frequency range applies.
Note 2
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
45009019 - User manual UROMIC Jive 08-2018.odt
Page 35 of 35