DANFLOW
DANFLOW 1100 User Manual April 2016
DANFLOW 1100 User Manual April 2016
43 Pages

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Page 1
User Manual
DANFLOW 1100
MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
Wireless Uroflowmetry Device
DANFLOW 1100
User Manual
MMT User guide DANFLOW1100.odt
Page 2 of 43
MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
Content 1. Features and Usage of DANFLOW 1100...4 1.1. DANFLOW 1100 Technical Data...5 1.2. Device Label and Explanation of Symbols...6 1.3. Connection to Electrical Installation...7 1.4. Replacement of Fuses...7 1.5. Replacing the Power Cable...8 1.6. Replacement of the Wireless Sensor Battery...8 2. Device Description...9 2.1. Control Panel of the Device...10 2.2. Wireless Transducer Controls...10 3. Accessories...11 3.1. Wireless Uroflowmeter MU5013...11 4. Device Operation...12 4.1. Preparation and Commissioning...12 4.2. Pre-measurement Preparation of the Device...12 4.3. Start of Uroflowmetry Measurement...13 4.4. End of the Test...14 4.5. Printing the Measured Data...14 4.5.1. Sample Measure Protocol...15 4.6. Re-printing of the Last Test...16 4.7. Paper Feed...16 4.8. Loading Paper into the Printer...17 4.9. Memory Card...19 4.9.1. Removing of the Memory Card from Device...19 4.9.2. Inserting the Memory Card to the Device...20 5. Calibration of the Device...21 5.1. Printing the Device Information Sheet...21 5.2. Calibration of the Device...22 5.3. Setting the Internal Clock / Updating the Time...24 5.3.1. Time Adjust Mode – Level 1...25 5.3.2. Time Adjust Mode – Level 2...25 5.3.3. Example of Time Adjustment...26 5.3.4. Modifying the Date...29 6. Troubleshooting...30 7. Signals and Error Messages...31 7.1. Status Indicators...31 7.2. Explanation of Audio Signals of the Wireless Transducer...32 7.3. Explanation of Printed Error Messages...33 8. Repairs and Warranty...35 9. Planned Preventative Maintenance (PPM) Inspection...35 10. Disinfection and Maintenance...36 10.1. Single-Use Items...36 10.2. Disinfection of Components Possibly Contacting the Patient...36 10.3. Maintenance of the Device...36 11. Consumables...37 11.1. Risks Involved in Manipulation with Infectious Materials...37 12. Delivered Components...37 13. Instructions for Waste Disposal...38 14. Contact Addresses...39 Annex A – EMC information...40 MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
1. Features and Usage of DANFLOW 1100 DANFLOW 1100 is a Medical Device for basic uroflowmetry examinations. It can be used to diagnose urinary tract conditions using standard ICS measurement methods. DANFLOW 1100 uses a weight cell sensor and built-in software to perform uroflowmetry measurements automatically. The weight cell has wireless connection to a compact device with thermal printing unit which also allows each test data to be stored on a built in SD data card (this allows optional further analysis on a PC if required). DANFLOW 1100 has a choice of stand options – advanced, economy model and wall mounted. The device can be used to investigate patients from the age of 5 years upwards. Caution should be used investigating patients with urinary tract infections – as results may be affected by the infection and associated bladder irritation. The device should only be operated by personnel thoroughly familiar with the instruction manual and have received training from somebody familiar with the system's operation. Training of operators will be done during installing of the equipment by supplier's employees or by the authorized representative of the manufacturer. DANFLOW 1100 does not have full protection against ingress of water/fluids. It is designed to operate in normal clinical environments with continuous operation and must be connected to a stable power supply. The device neither contains nor produces any harmful substances, which allows safe disposal after the end of the life cycle of the device. DANFLOW 1100 is classified as a Medical Electrical Device which requires special safety precautions regarding EMC (electromagnetic compatibility) and must be installed and put into service according to the EMC information specified in Annex A. The device works in a licence-free RF range of 865 – 870 MHz, in concordance with the general authorization VO-R/10/03.2007-4. The device has an internal, non-removable and non-replaceable antenna. Portable and mobile RF communication equipment and other RF sources may have negative impact on DANFLOW 1100 performance. DANFLOW 1100 should not be used adjacent or on top of other equipment. In case of adjacent or layered configuration in necessary, this device should be monitored for its normal performance in the arrangement in which it will be used.
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ATTENTION! Service should be performed only by a person trained by the manufacturer. Removing covers and any operation, repairs and modifications inside of the device are prohibited. When covers of the device are removed there is risk of an electric shock!
MMT User guide DANFLOW1100.odt
Page 4 of 43
MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
1.1. DANFLOW 1100 Technical Data Power supply
100 – 240 VAC, 50/60 Hz
Power consumption
Max. 40 VA
Class
II
Dimensions
21×14×6 cm
Weight
0.7 kg (max. 3 kg with accessories)
Operating temperature
+15 to +35 °C
Humidity
75% non-condensing
Storage temperature
–25 to +45 °C
Storage and operating pressure
No special requirements (700 – 1060 kPa)
The device has no Applied parts. Measurement of volume and flow rate Input
Wireless weight sensor MU5013
Range of volume
1000 ml ± 1% (max. 3000 ml ± 2% according to used container)
Range of flow
0 – 500 ml/s ± 2%
Wireless weight sensor MU5013 Voltage
3.0 – 3.6 V DC
Current consumption
Mode PowerDown (sleep): 100 µA typ., 16 mA max. (5 ms, 1:200) Mode Stand-By (waiting): 5 mA typ. Mode Active (measuring): 15 mA typ.
Power source
Lithium primary battery 3,6 V, 14 Ah, size D (for time of using 3 years)
Dimensions
20×23×32 cm (without stand and funnel)
Weight
2 kg (without stand)
Operational frequency
ISM range 865.0 MHz – 868.0 MHz (according to setting)
Output power (transmitting)
10 dBm (10 mW)
Type of modulation
broadband FSK
Communication speed
172.5 kbps
Wide of range
480 kHz typical
Max. length of data packets
3.5 ms
Typical Key rate
typical <1 % per hour in continual measurement mode, with typical usage (up to 10 measurements, 2 minutes each, per hour) <0,1 % per hour
Print medium Type
Thermal paper in roll
Width
57/58 mm
Length
30 m
Winding
Max. 50 mm
Diameter of bearing sleeve
Arbitrary (delivered standard 12 mm)
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
Memory Card Type
Secure Digital (SD), standard size. Types SDHC and SDXC are not supported.
Speed
Class 0 or higher
File system
FAT16
Capacity
2 GB
The device contains a backup lithium battery (primary cell). The wireless sensor contains high capacity lithium battery (primary cell).
1.2. Device Label and Explanation of Symbols The device label is located underneath the device and contains name and type of the device, basic technical data for power of the device, identification of manufacturer, year of production and other symbols, whose meaning is explained in the following table: Name and address of manufacturer.
0434
Mark of conformity with European standards and number of certification authority. The product should be disposed of in separated waste at corresponding site. Do not dispose to municipal waste. Electrical safety classification (2nd). For information, see instructions for use. Single use only. The device is a RF transmitter and receiver. This side up. Warning: Fragile! Do not expose to water. Storage temperature. Storage humidity of air.
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
1.3. Connection to Electrical Installation DANFLOW 1100 is designed for use in patient areas, and should be operated in areas that meet local regulations. The location of socket must allow the power supply of the device without the use of extension cords and Y-branches, requires the use of distribution system TN-S, TT or IT.
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Attention! To minimize electromagnetic interference to the power supply (EMI) this device must be connected to the mains with protective earth.
Attention! When the device is off, it could be disconnected from the mains supply manually by removing the plug from the wall socket. Do not place DANFLOW 1100 so that it is difficult to disconnect it from the mains.
1.4. Replacement of Fuses The device has a couple of user-replaceable mains fuses. The fuse box is located at the power inlet on the back of the device and is in one built in unit with the power cord socket and switch. The fuses are of the type T1AL 250V.
fuse box
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Warning! When replacing the fuses the device must be turned off and the power cord disconnected from the power socket. Fuses may only be exchanged for the same rating and type.
The wireless sensor MU5013 has no user-replaceable fuses.
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
1.5. Replacing the Power Cable If damaged, the power cord can be replaced, however, after replacement it will be necessary to verify the electrical safety of the device again according to IEC 60601-1 by technician with the appropriate qualifications. Cables must be replaced by the same or better performance-sized type, i. e. parameters with at least 250 VAC, 10A, 50Hz, protection class I, indivisible device type IEC C13/70 °C. The device is supplied with a standard power cord (Schurter 6003.0215).
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Warning! Replacing the power supply cable with the wrong type may lead to a reduction in the electrical safety of the device and increase the risk of electric shock to the operator and patient!
Warning! The third conductor in the power supply cable (green and yellow) is a ground connection, it is not protective grounding.
1.6. Replacement of the Wireless Sensor Battery The wireless weight sensor is powered by a non-rechargeable primary lithium-based cell ("battery"). The used type is SAFT LS33600, 3.6V, 14000mAh, size D (R20). This battery is delivered by the manufacturer as a spare part. The delivered power supply battery is sufficient for powering the device for 1 year at least, typically 3 and more years, depending on the device usage intensity. The manufacturer recommends replacing the power source battery within each annual check of the machine, completed by the service centre (chap. 9).
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Caution! The power source battery should be replaced solely by a person trained by the manufacturer.
MMT User guide DANFLOW1100.odt
Page 8 of 43
MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
2. Device Description DANFLOW 1100 consists of a control unit with accessories. The unit is fully automatic, and processes the signal from the sensor (uroflowmeter) and prints the measured data on the built-in thermal printer. It can be freely placed on a table or hung on the wall using the supplied bracket. Hanging kit is supplied on request.
thermal printer
cover of paper tray latch for removing the cover
control buttons (membrane keyboard) status lights (LED)
memory card
On top of the device there is a membrane keyboard, combined with light status indicators. The paper tray cover is removable by lifting up when you press the tabs on the right side of the cover. On the right side of the device is a memory card slot used to store the measured data.
fuse box main switch
power inlet
On the rear panel of DANFLOW 1100 is a one piece connector with a fuse box, power switch and socket for IEC power cable. At the base of the device is the manufacturer's label marking equipment type, power and serial number. MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
2.1. Control Panel of the Device The control panel has three buttons with combined functions and four LED indicators. button for start and end of test button to print copy of last test protocol button to shift paper
running of test indicator indicator of printing
power light indicator of error
For an overview of possible states of the LEDs and their meanings, see chapter 7.1.
2.2. Wireless Transducer Controls
ON/OFF switch
radio identification address
The main ON/OFF switch of wireless transducer is located on its bottom side.
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
3. Accessories
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Warning! Use of other accessories or cables other than those supplied by the manufacturer and specified as replacement parts or unauthorized changes or modifications of this device may affect the performance of device parameters, including failure to comply with wireless and EMC standards.
3.1. 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 settable height, or placed under the seat for uroflowmetric examination of women and children. Inside the plastic body of the uroflowmeter is a tensometric weight sensor (load cell), a controlling 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). Uroflowmeter design guarantees complete galvanic isolation of the patient from electrical parts of the instrument DANFLOW 1100.
Uroflowmeter on height adjustable stand
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Uroflowmeter with chair for examination of women and children
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!
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4. Device Operation DANFLOW 1100 should be operated only by personnel thoroughly familiar with the user manual and qualified for their role. Staff training will be carried out by the contractor during installation of the device, if required.
4.1. Preparation and Commissioning If the device was transported before use, leave it to stand at room temperature for 10 minutes before switching on to allow any condensation to dissipate. Switch the wireless transducer on using the switch on its bottom side. Switching on will be confirmed by an audio signal. Plug the power cord into an AC mains socket of the DANFLOW 1100 and then to a wall outlet. Click the main power switch to the “I” position to turn on the device. All LED indicators will briefly light after the device is switched on (for a function test), and then all of them go out except the POWER indicator which flashes. At this stage the device performs a self-test, during which it does not respond to any commands. After completion of self-test (approximately 10 seconds) POWER indicator LED will permanently light and the device is ready for operation. If the self-test detects a problem, the LED indicator ERROR starts flashing and the device will print a short report about the error found. If the problem is with the printer itself, the printer is not able to print an error message report, the LED indicator PRINT flashes too. With some minor errors you can still use the device, but with limitations of some functions. If this is the case, an error message is printed offering: “Press START+COPY to continue”
Simultaneously pressing START and COPY buttons together enables operation of the device with limited functionality. For a detailed explanation of error messages, see chapter 7.3. There is an overview of possible states of the LED indicators and their meanings in chapter 7.1. Without any other limitation, the instrument may be switched off by setting the switch to the “0” position. Please be sure to wait at least 15 seconds before switching back on to allow internal circuits to discharge, otherwise the initialization of the instrument may fail to proceed correctly. The wireless transducer may remain permanently on.
4.2. Pre-measurement Preparation of the Device Prepare the DANFLOW 1100 device according to chapter 4.1. Check, whether the device has a sufficient amount of thermal paper for printing the test result and, if necessary, replace the paper roll with a new one as described in chapter 4.8. MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
Verify that the device is ready to measure (the POWER LED is on, and all the others are off). Prepare an empty container for collection of urine. Prepare the patient for the test.
4.3. Start of Uroflowmetry Measurement When the POWER LED is on, it is possible to start the test by placing the empty container for urine collection on the measuring plate of the transducer.
The device first automatically balances (zeroes) the uroflowmetry sensor. During this time the LED light MEASURE flashes for about 5 seconds.
!
Warning! During balancing/zeroing of the sensor and during the test, do not touch any part of the sensor, as this could create unwanted artefacts of the measured data, or affect the calculation of the total volume of urine voided.
After the automatic balancing/zeroing of the sensor, the MEASURE LED will light continuously and DANFLOW 1100 is ready to record the urine flow.
Now the patient can urinate. If the patient does not start to urinate during the (adjustable) waiting period from the start of the test (standard is 3 minutes), the test is ended without further action, and the device returns to its default state. MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4.4. End of the Test The test is automatically ended after a period of no urine flow for a defined period of time (standard time is 15 seconds, but this can be changed by the manufacturer or distributor). The maximum total test time from the start of measurement is 15 minutes (depending on available internal storage space) and after this time the test will end automatically. During a test, the procedure can be ended manually at any time by pressing the START button.
When the uroflowmetry test is complete, the MEASURE LED goes off and the device processes and prints the measured data.
4.5. Printing the Measured Data Data processing and printout will be done automatically immediately after the test completes. During processing and printing the PRINT LED lights up.
At least 10 ml of urine must be passed to produce a valid printable result, the flow must also reach at least 2 ml/s and likewise, the test must have commenced within the automated period (3 min). If either of these parameters are not met, the printer will produce a brief message indicating why a result was not obtained (chap. 7.3). The unit then returns to standby mode. According to the ICS methodology, it is recommended to repeat the measurement in case that the voided volume is less than 50 ml.
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4.5.1. Sample Measure Protocol
device serial number and firmware version time axis with beginning at time of test start
serial number of protocol range of chart Qura curve Qura (bold)
curve Vura (thin)
automatic analysis of test
date and time of test start
space for individual remarks
Range of Qura is by default 0 – 50 ml/s, range of Vura 0 – 500 ml. On request it is possible to change these ranges by the manufacturer or distributor. If the Qura or Vura curve exceeded the scale, then the curve is displayed again from the left had axis overlaying the chart. This prevents loss of information. It is possible to independently enable/disable each of the Qura and Vura curves by the manufacturer or distributor. The chart is displayed from the moment flow is first detected. The time scale shown starts just at the beginning of voiding and chart therefore provide some indication if there was a delay in voiding starting from the patient. MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4.6. Re-printing of the Last Test If DANFLOW 1100 is in standby mode (only the POWER LED is on and all the others are off) if no further tests have been done/or power switched off, you can print a copy of the last test by pressing the button COPY.
The copied report is identical in every way to the original. If there is no recorded data in the memory (e.g. the device was turned off), you cannot re-print the last test and the printer prints a short message confirming this.
4.7. Paper Feed More paper can be fed through the printer at any time by pressing the FEED button. This can be used, for example, to obtain additional space for notes on the printed report.
The paper will feed for as long as the FEED button is pressed.
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4.8. Loading Paper into the Printer To insert a new roll of thermal paper into the printer, see the below: Open the paper tray cover by pressing the latch on the side of the cover and lifting the cover upwards.
locking lever of printer in closed position
print cylinder
slot for paper inserting
Move the green locking lever of printer to the open position.
locking lever in opened position
If the printer contains any remaining paper, it is now possible to remove it. Insert the (straight cut) end of the thermal paper into the slot under the printer roller.
MMT User guide DANFLOW1100.odt
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
Carefully insert paper into the slot, the roller mechanism will automatically turn until its end passes through the print mechanism and appears above the printer roller.
Align the thermal paper so that the edges on top and bottom of the print roller are flush and in the middle of the printing roller, and move the locking lever back into its closed position.
Make sure that the locking lever does not remain in the open position, or it will not be possible to completely close the paper tray cover.
Insert the roll into the paper tray and then close the cover.
MMT User guide DANFLOW1100.odt
Page 18 of 43
MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4.9. Memory Card The unit contains a Secure Digital (SD) memory card to store raw test data. These can then be transferred to a PC for archiving and further processing, if required. The capacity of the memory card (2 GB) is sufficient to last the lifespan of the device. The capacity can hold more than 65,000 tests, respectively – equivalent of approximately 17,000 hours of continuous measurement. If the card is ever full, a message will print on the printer and in that instance - please contact the service centre (because the error may have another cause), alternatively replace the memory card with a new one (2 GB max.). DANFLOW 1100 supports only SD memory cards up to capacity of 2 GB, with a FAT16 file system. Memory cards larger than 2 GB, e. g. SDHC with FAT32 can not be used in the device.
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Warning! Take care to never write/save any information (files) or delete of existing files on the card when inserted into a PC. This can potentially change or damage the file structure of the card, and can lead to irreversible damage of stored measured data.
4.9.1. Removing of the Memory Card from Device To remove the memory card from DANFLOW 1100, first press the card end with either a blunt object or the tip of your finger. The mechanism releases the card and ejects approximately 5 mm out from the slot. The card can then be pulled out with your fingers.
push
MMT User guide DANFLOW1100.odt
pull out
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MEDKONSULT medical technology s. r. o.
DANFLOW 1100 User Manual
Valid from: 17. 5. 2016 Revision: 04/2016
4.9.2. Inserting the Memory Card to the Device Insert the memory card into the slot so that the card gold contacts are orientated upward and toward the device. Push the card in and the mechanism will catch the card in the lock it in position.
push inside to stopper
MMT User guide DANFLOW1100.odt
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