Instructions for Use
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SmartFlow Instructions for use Version 1.3
SmartFlow Instructions for use
SUMMARY SUMMARY... 2 INTRODUCTION ... 2 PRESENTATION ... 3 PREPARATION ... 3 Power connection ... 3 Installation... 4 Modifications ... 4 Loading the paper ... 4 Calibrating the flowscale ... 4 FLOWSCALE FUNCTION ... 5 Presentation... 5 Measurements ... 5 RECORDER FUNCTION... 6 Presentation... 6 Set up... 6 Setting the date ... 7 Setting the time ... 7 Setting the language ... 7 Setting up the Mictiometry ... 7 Activating the radio frequency flowscale.. 8
INTRODUCTION We thank you for choosing the SmartFlow urine flowmeter. Use of the latest technology has allowed this flowmeter to combine high quality measurement with great simplicity in use: •
One or two simultaneous flowscales - one radio frequency and one fibre optic.
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Automatic detection of the collection jug.
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Digital signal analysis - to represent closely the dynamics of mictiometry.
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Real time display on an illuminated touchscreen LCD.
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Automatic detection, recording and saving of mictiometry studies. Intermittent studies are no longer lost!
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Automatic printing of the complete summary on wide thermal paper.
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Replaceable transparent plastic cover – protection and hygiene guaranteed.
Activating the fibre optic flowscale.. 9 Standby mode ... 9 The information area... 9 The flowscale area... 9 The memory area ... 10 Recording mode... 11 The information area... 11 The graphical area... 11 Printing a report ... 12 SPECIFICATIONS ... 13 Flowscale ... 13 Recorder ... 13 STANDARDS... 13 CLEANING... 13
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SmartFlow Instructions for use
PRESENTATION
PREPARATION
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To protect the flowscale during shipping, three load cell protectors are placed below the flowscale plate. Always remove these before use.
Power connection
In the box: •
Recording unit with tactile LCD screen.
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Medical grade power supply.
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2 thermal paper rolls, 1 of which is already installed in the recorder.
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HF 1 or FO 2 flowscale.
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Collection jug, 2-litre capacity.
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4 alkaline 1.5v batteries.
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Calibration weight (500g).
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Instructions for use / service manual.
Figure 1
Plug the AC power connection into the recorder (Figure 1, reference 1). Connect the AC adapter provided with the SmartFlow to mains power of 230V, 50Hz.
Options: •
1 2
Supplementary flowscale to form a group of 2 flowscales which may be used simultaneously, of which one is HF and the other FO.
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Ergonomic micturition chair (female & male patients).
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Micturition stand (male patients).
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Urodynamics procedure table.
Figure 2
The flowscale works using 4 alkaline 1.5V batteries, type C or LR14. Usage of rechargeable batteries is not recommended. Insert the batteries into the battery holder, observing the correct polarity, within the underside of the flowscale. This receptacle is protected by a cover, which must be replaced (Figure 2).
HF: transmission of data by radio frequency. FO: transmission of data by fibre optic.
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SmartFlow Instructions for use
Installation The recorder should be placed on a flat surface, on a desk for example. The connections at the rear of the device must be free from any constraints. If you are using the fibre optic type of flowscale, care should be taken not to bend the cable under its recommended minimum curvature - 40mm.
1cm Figure 4
Calibrating the flowscale If using the radio frequency type of flowscale, the aerial must be straightened away from the rear of the box, to ensure good reception (Figure 1, reference 3). The flowscale must be installed on a flat, stable and horizontal surface. Make sure that this surface is secure and does not vibrate.
The SmartFlow is a sensitive measurement device; it must be calibrated routinely (every 12 months) to ensure the correctness of the recorded values. The flowscale is factory calibrated and conserves its correction coefficient in permanent flash memory, even when not connected.
Modifications Before using a fibre optic flowscale, un-screw the cable input at the back of the recorder, introduce the fibre optic cable and re-tighten the screw (Figure 1, reference 2).
Loading the paper Figure 5
To calibrate: Place the flowscale on a flat, horizontal and stable surface. Remove the collection jug. Press the calibration button (Figure 5, reference 1), the light flashes red (Figure 1, reference 2). Wait until the light is a fixed (non flashing) red. Place the 500g calibration weight onto the flowscale, the light will again flash in red. Figure 3
Remove the paper cover and insert the new paper roll as indicated in Figure 3, pushing the paper into the guidance groove. As soon as the paper is detected, the printer will automatically activate and advance the paper through its mechanism. To facilitate the insertion, cut the paper as in Figure 4.
Remove the weight as soon as the light becomes a fixed green. The light will again flash in red, but now slowly, to indicate the return to the normal mode of working.
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SmartFlow Instructions for use
FLOWSCALE FUNCTION Presentation The flowscale is the measurement device of your SmartFlow. Albyn Medical has chosen a high quality weighing system to ensure a high precision calculation of flow, which will be made by an integrated microprocessor. Once calibrated, the flowscale operates entirely automatically. It is equipped with a dual coloured light to inform in which mode it is operating. The FO model sends its information to the recorder by means of a fibre optic cable. The HF model uses a radio frequency transmitter to allow a certain independence within the limit of the radio system’s range (10-30 metres on average, depending on the environment). The flowscale is designed to provide accurate measurement and robustness within a normal working environment. The measurement element is fragile and cannot withstand weight of over 3Kg.
Measurements In the absence of the collection jug, the flowscale light flashes slowly in red to indicate that the flowscale is in stand-by mode (low power consumption). Place the collection jug on the flowscale and wait until the light flashes slowly in green. When it does so, the flowscale is in mictiometry mode. When the patient voids into the collection jug; the flowscale automatically detects and transmits the details, in real time, to the recorder. During the mictiometry, the flowscale is in mictiometry mode, signalled by the light quickly flashing in green. The end of the mictiometry is automatically detected by the flowscale (zero flow for 15 consecutive seconds). Removing the collection jug when the study is finished will prolong the battery life, since the power consumption is lower.
Always use a replaceable transparent plastic cover to protect the flowscale from accidental spillage and ensure hygiene. The flowscale regularly transmits information about the status of the batteries and the presence of the collection jug. The recorder displays this information on the screen allowing the user to know the status of the equipment. Each flowscale contains a numerical signature or number to identify it to the recorder. This number corresponds to the serial number of module 256 (label on underside of flowscale). In the case of the FO flowscale, the number is always 0.
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To protect the flowscale during shipping, three load cell protectors are placed below the flowscale plate. Always remove these before use.
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SmartFlow Instructions for use
RECORDER FUNCTION
As soon as the power is connected, the recorder initialises and displays the start-up screen (Figure 7). Start-up lasts 10 seconds, and permits you to enter the setup functions (flowmeter parameters).
Presentation The SmartFlow recorder is equipped with an LCD touch screen (Figure 6, reference 1) that allows you to control the system just by touching with your finger. The LCD backlight is controlled by a system that automatically switches to stand-by mode after a period of 10 minutes without activity. Return to normal operation is automatic with the detection of a new mictiometry, or manually, with a simple touch of the screen.
Figure 7
Once the start-up phase has been completed, the recorder moves to stand-by mode. It is now ready to record and display the mictiometry studies from one or both flowscales.
Set up During the start-up phase, set up functions are accessible, by touching the set up button:
Figure 6
The recorder has four different examination memories, which are used in sequence. After each mictiometry, the thermal printer delivers a calculated report (Figure 6, reference 3). A space in the rear of the box contains the thermal paper (Figure 6, reference 2).
Note: You only have to remove and then reconnect power to the SmartFlow in order to initialise the start-up sequence again. The set up menu allows access to the essential recording parameters (Figure 8).
If you have chosen the double flowscale option, your recorder is capable of controlling both flowscales in real time: two mictiometry studies can therefore be recorded and displayed simultaneously (only one on the LCD screen). Your recorder includes an internal clock/calendar, which allows this information to be included on the report for each study. The calendar will automatically adjust for leap years, however summer and winter daylight saving changes are not automatically changed.
Figure 8
Press the
button to exit the set up menu.
The recorder then performs a new start up sequence to take into consideration the new parameters.
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SmartFlow Instructions for use
Setting the date
Press icon on the screen to adjust the date. The next screen shows (Figure 9).
Setting the language
Press the icon to select the language to be used for the graphic interface and recorder. The following screen is then displayed (Figure 11).
Figure 9
Press the or buttons to increase or decrease each date segment. Next, press the set up menu.
button to return to the main
Setting the time
Press icon on the screen to adjust the time. The next screen shows (Figure 10).
Figure 11
Press the box that corresponds to the desired language. Then press the set up menu.
button to return to the main
Note: The screen (Figure 11) may contain the extra languages of your particular recorder.
Setting up the Mictiometry
Press the icon to modify the mictiometry parameters. The following screen will be displayed (Figure 12).
Figure 10
Press the or buttons to increase or decrease each time segment. Then, press the main set up menu.
button to return to the
Figure 12
The recorder has 4 different examination memories. These memories are automatically 7
SmartFlow Instructions for use
cleared after a determined period: 5, 10 or 15 minutes. Choose by ticking the corresponding box.
Figure 14 will appear if the HF flowscale is already activated.
The filtering level of the mictiometry flow rate curve is adjustable to three possibilities:
Weak filtering: select this filtering level to display a high dynamic resolution. The flow curve will not be at all smooth.
Medium filtering: select this filtering level to maintain a good dynamic resolution whilst at the same time displaying a smooth curve. (Recommended).
Strong filtering: select this level to display a perfectly smooth curve. Note: In the case of a controlled study, it is important to maintain a common level of filtering for all the studies to ensure the homogeneity of the results. Press the up menu.
button to return to the main set
Figure 14
Press the selection box to activate or de-activate the flowscale. In de-activated position, the button is not available. Every HF flowscale has its own unique signature number which is factory programmed. This signature is transmitted by the flowscale to validate this information. When you activate the HF flowscale, press the button to find the HF flowscale you require to « connect » to your recorder. Its number will appear on the screen. If there is no flowscale within the recorder’s reception range the screen will display
Activating the radio frequency flowscale Then press the set up menu.
button to return to the main
Press the icon on the screen to activate the flowscales radio frequency. Figure 13 will appear if the HF flowscale is not already activated.
Figure 13
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SmartFlow Instructions for use
Activating the fibre optic flowscale
Press the icon on the screen to activate the fibre optic flowscale.
Standby mode After the start up sequence, the recorder goes to standby mode and displays the following screen (Figure 16).
Figure 16 Figure 15
Select the box to activate or de-activate the flowscale. Then press the set-up menu.
button to return to the main
The standby screen shows three different areas: The information area, the flowscale area and the memory area.
The information area This permanently displays the date and the time. When the printer is out of paper, the icon flashes. It disappears as soon as the printer has paper installed.
Figure 17
The flowscale area This area displays the state of the flowscale(s).
Figure 18
If you have chosen a double flowscale system, the central display shows two groups of icons (Figure 19). Note: The FO flowscale is always flowscale nº in a dual flowscale system.
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SmartFlow Instructions for use
i.e. Figure 21 indicates that the study from flowscale 1 has been recorded in the A memory and the study from flowscale 2 in the B memory. Figure 19
Each flowscale is indexed or . This index is used by the report generator in order to identify the origin of the recordings. The state of the flowscale is also displayed. icon indicates that the flowscale has The no collection jug present, and is currently in standby mode.
The icon indicates that the collection jug is placed on the flowscale. The flowscale is in waiting mictiometry mode. In both cases, if the recorder does not receive any more information from the flowscale, the icon flashes to indicate the loss of communication. The status of the batteries is displayed on the screen via icons. The icon format varies depending on the battery level: Maximum level, • •
Medium level,
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Low level,
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Critical level. The icon will flash to indicate the risk of losing data.
Figure 21
An icon indicates the status of each memory. Depending upon the status, different icons will be activated. Memory is empty. Icon is not activated
The memory has a recording present, performed by flowscale 1. The icon is active. Press the icon to print a copy of the report. The amount of time that the study will be kept in memory is fixed to 5, 10 or 15 minutes depending on the settings you have chosen in the recorder setup. The memory is in edition mode. A report from the mictiometry recorded is being printed. The icon is not active, waiting for the report to be printed.
The memory area The flowmeter has four different memory areas to record different exams (Figure 20). They are all used by the flowscales in a sequential mode. For each mictiometry study, the recorder uses the first available memory, or if all of them are used - the oldest one.
Figure 20
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SmartFlow Instructions for use
Recording mode When the flowscale detects the start of a mictiometry, it will inform the recorder, which will move from standby mode to recording mode (Figure 22). The recorder will display the mictiometry traces in real time. When the mictiometry ends, the recorder returns to standby mode and starts printing the report automatically. Such a report will be printed from the memory most recently used.
A , while flowscale 2 is in standby mode with no collection jug present.
Figure 24 Figure 25, shows a double system, which both flowscales are in recording mode. The icon indicates that the mictiometry from flowscale 1 is being displayed in the graphic area and it is being recorded within memory A . Flowscale 2 is also in recording mode, and the indicates that the information is being icon . However, traces of recorded within memory B this mictiometry study are not being displayed on the screen.
Figure 25
Figure 22
As in the standby mode, the top area of the display is an information area. The graphic area uses most of the screen to allow better display of the curves.
If you have a system with 2 flowscales, in which 2 simultaneous studies are being performed, the flowscale that detects the mictiometry first will display it on the screen, the other flowscale will record directly to the memory.
The graphical area The information area As in the standby mode, when the recorder runs out of paper, the icon flashes. It will remain flashing until the printer is reloaded.
The graphic area displays the curve in real time (Figure 26).
This area indicates also the status of the flowscales, and allows the user to identify from which flowscale the traces are being displayed on the screen. Also the memory being used for that particular flowscale recording is being shown. i.e. Figure 23 shows a system with only one flowscale. It also indicates that flowscale 1 is recording its study within memory A its traces are being displayed on the screen.
Figure 26
The vertical axis scale is in ml/s and has a default upper limit of 25 ml/s. If the detected flow is over 30 ml/s the scale will be adjusted automatically to 50 ml/s, and the flow curves will also be adjusted accordingly.
Figure 23 Figure 24 shows a system with two flowscales where flowscale 1 is now recording within memory
The horizontal axis is graduated in seconds. When the flow curve reaches the end of the screen, the screen then scrolls to the left and continues to show the new values. 11
SmartFlow Instructions for use
Printing a report At the end of each study, a report is printed automatically. The report contains a header area and a graphic area. The header area has some fields to be filled in by the clinician, such as name, surname, age, sex and also an area for any comments. The study date and hour are automatically displayed. The icons at the bottom left area, allow you to identify from which flowscale and from which memory the report has originated.
The time is indicated in the left side of the report with a precision of 0.1 seconds. A continuous line allows you to identify quickly the period of analysis. A broken line indicates intermittent flow. The maximum flow and the average flow are directly printed on the right hand side of the report. The vertical allocation will depend on the value represented in the vertical axis. The actual value on the trace is indicated with a dashed line . Total volume and volume at maximum flow are indicated at the bottom right of the report. Note: If the transmission has been disturbed during the mictiometry, the report will indicate the number of transmission errors.
Figure 27
The graphic area displays the flow traces. The horizontal axis is defined in seconds, and it has a fixed scale that corresponds to a paper speed of 12 cm/min. The vertical axis is graduated in ml/s and it may be in a scale of 25 ml/s or 50 ml/s depending on the max flow rate during the study.
Figure 28
The flow traces are automatically analysed by the signal processor (DSP) of the recorder, and all results are displayed on the report. To increase the quality and aid interpretation, the results are placed directly on the curve.
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SmartFlow Instructions for use
CLEANING SPECIFICATIONS Flowscale Maximum load: 3kg. Precision: 0.25g. Jug capacity: 2 litres. Measurement range: 0 – 60ml/s. Power: 4 alkaline batteries 1.5V type C or LR14. Battery life: 3 months at 5 flows/day, 5 days/week. Collection jug must be removed when not in use, to preserve battery life. Transmission: Plastic fibre-optic 5m or radio transmission ’FM 868MHz (medical range) depending on the model. HF range: 10m to 30m depending on the environment. Detection time: 3 seconds. End of Mictiometry: 15 seconds. Dimensions: ø 190mm x h 60mm. Weight: 0.7kg
Recorder Power: 24 V DC, 1.3A. Converter AC/DC 230V 50Hz. Screen: LCD tactile 320x240. Printer: Thermal printer 576 points, 75mm width. Calendar/Time: auto-powered. Processor: DSP 16 bits 150Mhz, 1 MB RAM Flowscale names: 1=HF and 2=FO (depending on model). Number of memories: 4 Maximum study length: 4 minutes per memory Duration of the memory: 5, 10 or 15 minutes, userselectable. Filter: numeric type FIR. 3 possible levels, user-selectable. Dimensions: L 250mm x w 140mm x h 110mm Weight: 1.3 kg
STANDARDS IEC 601-1-2 Class II Type BF Directive 93/42/EEC EN300-220 radio standard EN301-489 ECM standard EN60950 electrical security
Always check with your hospital infection control officer or local hygiene authority for the correct procedures regarding cleaning/disinfection. The flowscale unit may come into contact with urine and other bodily secretions. Disconnect mains power before cleaning the recorder unit. Use conventional cleaning products to wipe clean the flowscale, and the recorder unit, such as: GP Solutions (General Purpose Liquid Detergent) ie Youngs ‘Hospec’ – 5ml per 5 litres hot water. Aldehydes (Cidex PlusTM, Wavicide®-01, OmnicideTM ) DO NOT spray, pour or drip water or disinfectant solutions, inside the flowscale, or into the recorder unit paper area. DO NOT apply solvent or abrasive cleaners – these may damage the plastic enclosures. The transparent plastic flow-scale cover should be cleaned by immersing in hot soapy water. Inspect and replace the plastic cover frequently, replace immediately if the plastic is cracked or damaged. Replacement covers are available from the companies below, as well as further operation and service information.
DISPOSAL Batteries and other electrical components should be disposed of in accordance with your local environmental laws and guidelines. International
United Kingdom
Albyn Medical S.L. Polígono Industrial Cordovilla, Calle D Nº 1, 31191 Cordovilla Navarra – Spain. Tel. +34 948 29 33 24 Fax. +34 948 29 34 18 [email protected] www.albynmedical.com
Albyn Medical Ltd. Bridgend Road Industrial Estate Dingwall, Ross-shire IV15 9QF Scotland – U.K. Tel. +44 (0) 1349 862388 Fax. +44 (0) 1349 864146 [email protected] www.albynmedical.com
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