Pico Flow User Manual Rev H Dec 2005

User Manual

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File Name: Menfis bioMedica - Pico Flow User Manual Rev H Dec 2005 - 2005-12.pdf

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Pico Flow User Manual

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Menfis bioMedica s.r.l. Via della Beverara, 46/D 40131 - Bologna (BO) - ITALY Tel. +39-0516351074 - Fax. +39-0516351081 Web site: www.menfis.it - E-mail: [email protected]

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Pico Flow User Manual CONTENTS SAFETY WARNINGS...3 DISPOSAL OF WASTE ...4 CONDITIONS OF WARRANTY...5 FEATURES ...8 GENERAL OPERATING PRINCIPLES...9 CENTRAL PROCESSING UNIT ...10 KEYBOARD ...11 Sensor for measuring urinary flow ...11 CARRYING OUT FLOW METERING ...12 Automatic mode...12 Manual mode ...13 Changing operating mode...13 Flow Metering report...14 Calibration procedure for Flow Sensor...15 Transfer of examination data to PC with FlowSoft package ...15 Installation of Pico Flow...16 Accessories and Spare Parts ...17 Specifications...18 PICO FLOW SERVICE SOFTWARE...19 Memory Reset of PicoFlow ...20 EC DECLARATION OF CONFORMITY ...21

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Pico Flow User Manual SAFETY WARNINGS This manual contains all information necessary for a correct use of the equipment. In order to safeguard patients, operators and the equipment itself, this manual should be carefully read before attempting to utilise the equipment. Every warning in this manual regarding the safety of patients, operators or the equipment itself is marked by the symbol:

Warning: ensure that all personnel involved in the installation, running and maintenance of this equipment have read and fully understood the following instructions before preparing to install, run or carry out maintenance operations upon same. In the case of any query regarding the safe and correct running of the equipment, please contact Menfis bioMedica before proceeding. No modification or alteration should be made to this product without the express prior written consent of Menfis bioMedica. •

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Utilization condition of the device: o Environment temperature: from 10 to 40 °C o Relative Humidity of the air: from 30 to 75 % o Atmospheric pressure: from 700 to 1060 hPa Transport and storage condition of the device: o Environment temperature: from -40 to 70 °C o Relative Humidity of the air: from 10 to 95 % o Atmospheric pressure: from 500 to 1060 hPa

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Pico Flow User Manual DISPOSAL OF WASTE

The Medical Device, as become waste, must be disposed according to the disposition of Single State Laws. Respect to European Community : The Device can be disposed according to European Community Council Directive 2002/96, as assimilated on Single State Laws system. The Device conforms to European Community Council Directive 2002/95, as assimilated on Single State Laws system. WARNING : For a correct disposal, please take care the relevant state laws and clinic procedures, related to contaminated products handling and discarding. The packaging has to be discarded according to the rules in force.

Symbol stating separate collection for electric and electronic devices, as per DLgs n°151/2005, Italian receipt of council directives 2002/95/EC and 2002/96/EC

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Pico Flow User Manual

CONDITIONS OF WARRANTY This Menfis bioMedica product is guaranteed against manufacturing and material defects for a period of one year from date of purchase subject to the conditions specified below: the installation, fitting of parts, calibration and any modifications and repairs to the equipment shall be carried out by personnel duly approved by Menfis bioMedica; the electrical system in the room housing the equipment shall conform to IEC standards; the equipment shall be used in accordance with the instructions and directions for use contained in this manual. The following are not covered by the assistance provided under the terms of this warranty: Parts liable to wear; Defects resulting from normal wear and tear; Defects caused by use of the product that does not fall within the parameters laid down in the User Manual; Incorrect running due to damage (even if accidental), maintenance operations or modifications carried out by personnel not specifically approved by Menfis bioMedica.. Should the equipment shows signs of performance loss during use, the user should immediately notify the Menfis bioMedica Technical Support Service, suspending all use of the product until such time as the fault has been identified and repaired and the equipment has thus been restored to perfect working order. Neither Menfis bioMedica, nor its service centres, will accept liability for any damage or loss of data or programmes. For this reason, Menfis bioMedica recommends that backup copies of all data and programmes be made. Menfis bioMedica advises all users requiring extended maintenance cover for their entire system to take out a comprehensive service contract with Menfis bioMedica.

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Pico Flow User Manual TECHNICAL SUPPORT Should the equipment shows signs of performance loss during use, the user should immediately notify the Menfis bioMedica Technical Support Service, suspending all use of the product until such time as the fault has been identified and repaired and the equipment has thus been restored to perfect working order. Should a problem occur that you are unable to resolve yourselves, please contact your local authorised dealer or ourselves direct: Menfis bioMedica srl - Technical Service Via della Beverara, 46/D 40131 - Bologna (BO) - ITALY Tel. +39-0516351074 - Fax. +39-0516351081 Web site: www.menfis.it - E-mail: [email protected] Should it be necessary to send us the equipment or a part of same for an operation that cannot be carried out satisfactorily on your premises (e.g. complete overhaul of the equipment), you are kindly requested to utilise the original packing and containers in which the equipment was delivered to you. Before sending us the equipment, please contact our Technical Support Service in order to advise of the fault and obtain the necessary authorisation to forward the entire apparatus or part of same. It is advisable to enclose the following along with the equipment: Full details of the problems and symptoms that lead to believe there may be a fault in the apparatus. Order number in the case of repairs outside of the warranty period. Return details for the repaired or overhauled equipment (name, address, means of transport, details of carrier) Company/personal data and VAT number for the issue of Packing List and Invoice..

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Pico Flow User Manual MANUFACTURER’S LIABILITY Menfis bioMedica S.r.l., manufacturer of the equipment, will only consider itself liable for the safety, reliability and performance of the same if: the installation, fitting of parts, calibration and any modifications and repairs to the equipment are carried out by personnel duly approved by Menfis bioMedica; the electrical system in the room housing the equipment conforms to IEC standards; the equipment is used EXCLUSIVELY by suitably TRAINED and QUALIFIED personnel. The equipment may only be operated by specialist users (specialist doctors or nurses with experience of clinical practice in this sector) that have specific knowledge as to the use of the equipment after undergoing an adequate period of training. the equipment is used in accordance with the instructions and directions for use contained in this manual. Since the equipment effects measurements of quantities, in order that the diagnostic data supplied may continue to be reliable with the passing of time, it is recommended that skilled personnel, specifically authorised by Menfis bioMedica, carry out a check on the calibration at least once a year.

ADDRESS OF MANUFACTURER

Menfis bioMedica s.r.l. Via della Beverara, 46/D 40131 - Bologna (BO) - ITALY Tel. +39-0516351074 - Fax. +39-0516351081 Web site: www.menfis.it - E-mail: [email protected]

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Pico Flow User Manual FEATURES Safety class The appliance has been constructed in compliance with standards IEC 60601-1 and protection class: I, type B. Power supply and consumption The maximum consumption of the PicoFlow system is 50 Watt. Earthing In order to be able to operate in conditions of safety, the protection offered by grounding the earth connector fitted to the power cable is essential. Before connecting the system to the mains and powering up, ensure that the room’s electrical system, and in particular the earthing system, conforms to IEC standards. If the earth connector of the power supply cable is not grounded, or the earthing system does not respect the required standards, contact with the instrument’s wires and cables could provoke shocks. The use of extension leads and transformer/adapter plugs for connecting the system to the mains is strictly forbidden. Operating limits The system is not designed to operate in gaseous atmospheres; therefore, no protection is offered in this respect. The system is not designed to operate whilst coming into direct contact with liquids; it therefore offers no protection against dripping water, splashes or immersion. Precautions Do not remove covers or panels that require the use of tools (screwdrivers, pliers, etc.) since in doing so one is likely to access internal parts that: may be live. are designed to be of a delicate nature in order to guarantee the correct and reliable functioning of the system. have been specially protected in order to avoid accidental contact. All checks and technical operations should be carried out by specialised personnel. In such cases please contact your local dealer or the manufacturer of the equipment.. Cleaning, sterilization and disinfections All Cleaning, sterilization and disinfections operations should be carried out with the system off. As regards the rules to be followed when cleaning the apparatus and its accessories, the following precautions should be taken. * All external parts, both plastic and metal, that comprise the external shell of a unit or accessory device may be cleaned using a damp cloth. Under no circumstances should water be used. * It is strictly forbidden to spray alcohol directly onto surfaces, since in proximity to slots or other openings it could penetrate the inside of the instrument. * Do not rub hard, especially in the vicinity of the various notices and signs. Although composed using indelible materials, over a period of time they may be subject to usual wear and tear. Cod. 01064

Pico Flow User Manual * The connections cables should be cleaned with a cloth soaked in alcohol. Please be careful to avoid tugging them, especially when not attached to their connector.

GENERAL OPERATING PRINCIPLES Pico Flow is a uroflowmeter controlled by a fully-automatic microprocessor. The unit combines various special features making it both reliable and user friendly. It allows one to: record a urinary-bladder emptying test. automatically print: patient’s medical record requiring completion graph of urinated flow as a function of time table of processed numeric data reprint the latest examination carried out. The optional FlowSoft software package is available on request. When installed in an IBMcompatible Personal Computer, it allows: transfer of examination data from Pico Flow to PC creation of patient files and records of examinations carried out using Pico Flow that can be stored on the PC. review, analysis and printing of all examination records stored on PC. The Pico Flow system consists of the following units: Central processing unit Flow transducer Suitcase (optional) Flowsoft: high-level software package for Uroflowmetry (optional) Micturition chair (optional)

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Pico Flow User Manual CENTRAL PROCESSING UNIT The central processing unit of the Pico Flow system (Fig. 1) allows the acquisition of flowmeter data and control of the operations regarding the carrying out of the examination, printing and data transfer to Personal Computer. It consists of the following components: - microprocessor card - keyboard - thermal matrix printer.

Fig. 1

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Pico Flow User Manual KEYBOARD The keyboard has three keys (Fig. 2): Start/Stop: controls the beginning and end of the test Paper Feed: feeds the printer paper Print: prints the last examination carried out. The keyboard is fitted with two Leds, a green one on the Start/Stop key and an orange one on the Print key. Their significance is shown in “Carrying out flow metering” section.

Fig. 2 Sensor for measuring urinary flow The Sensor for measuring urinary flow (fig. 3) amplifies, filters and checks the electric signals produced by the load cell connected to it that measures the quantity of urine passed. The method of measuring urinary flow, starting from the measurement of the quantity of urine passed, allows extremely accurate results to be obtained. The volume signal is sent to the processor that calculates with precision the urinary flow curve, second by second, using a sophisticated procedure of digital filtering and subsequent derivation. The only precaution that must be taken when measuring flow regards the fact that the urine imparts a certain degree of kinetic energy to the transducer and thus exerts a certain force, or rather weight, upon reaching it. This distorts the reading. In order to avoid this problem, the speed of the jet of urine must be slowed down. For this reason, the bottom of the funnel that conveys the urine to the transducer is fitted with a jet breaker. The channel is fitted with a low-pass filter that eliminates very fast variations in the signal. The flow-metering channel operates using one of three measuring ranges that can be set via software: 25-50-100 ml/sec that refer to the possible end scale values on the printed graph.

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Pico Flow User Manual CARRYING OUT FLOW METERING Flow metering is carried out in two different manners: an automatic one and a manual one. Automatic mode This mode lets the user perform examinations in a continuous way without interacting with the machine apart from switching it on. It works as follows: 1. Turn on the device using the switch positioned at the rear. 2. Await the end of the internal control phase (during such phase both LEDs are lit). A short beep, the going out of the LEDs and the flashing of the Green LED indicate that the flow meter has successfully completed a first phase of internal check. 3. Now wait for six more seconds during which the Green LED will be flashing. After this period a second and longer beep will advice that the PICO FLOW is ready for flow metering: the Orange LED now is flashing and the ON time is twice as much as the OFF time. This phase that precedes the recognition of urine flow is known as “Micturition Waiting Phase” and in Automatic Mode it can last with no limits. 4. Right after the recognition of the first drop of urine the flow metering starts: the Green LED flashing and remains ON, the Orange LED stops flashing and stays OFF. In Automatic Mode the examination finishes when the urine-flow stage is followed by the absence of flow for a period of 20 seconds. This time can be changed by FLOWSOFT. The examination will, in any event, come to an end 4 minutes and 40 seconds after the recognition of the flow of urine has taken place. 5. At the end of the examination the result of the test is automatically printed. In the print-out of the examination the waiting time is not mentioned because in Automatic mode it wouldn’t make sense. During printing the LED fitted to the Print key is lit. After the printing for 8 seconds PICO FLOW doesn’t make data acquisition and the orange LED stays OFF. After the 8 seconds a beep and the orange LED flashing indicates that you can start a new test. 6. If you press the Paper Feed key to move the paper, you must wait 6 seconds before start a new test. During this 6 seconds the orange LED stays OFF. After this 6 seconds a beep and the orange LED flashing indicates that you can start a new test. 7. Press the Print key if wishing to reprint the results of the last test. 8. In Automatic Mode the PICO FLOW detects the picking up of the Beaker and prints the message “No Beaker”: the Green LED starts flashing and the machine is NOT ready for flow metering. In this phase the printing of the last examination can be performed but it’s advisable putting the Beaker on the flow cell again after the printing has come to an end. After putting the Beaker again on the flow cell the PICO FLOW needs six seconds to be ready for flow metering. A long beep, the Orange LED flashing again and the Green LED staying ON permanently advice that the PICO FLOW is ready for examination again. In order to clear the internal examination archive, turn on the appliance while keeping ‘Paper Feed’ key pressed.

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Pico Flow User Manual Manual mode This mode, thanks to its manual-stop, is particularly useful for prostatic patients. It works as follows: 1. Turn on the device using the switch positioned at the rear. 2. Await the end of the internal control phase (during such phase both LEDs are lit). A beep, the going out of the LEDs and the flashing of the Green LED indicate that the flow meter has successfully completed the first phase of internal check. 3. Now wait for six more seconds during which the Green LED will be flashing. After this period a second and longer beep will advice that the PICO FLOW is ready for starting flow metering: Green LED now is flashing and the Orange LED is OFF . 4. To start flow metering, press Start/Stop key after which the LED fitted to it will light up. The phase that follows the start of the examination and precedes the recognition of the flow of urine is known as “Micturition Waiting Phase” and may last up to 1 hour and 40 minutes; after this time the examination comes automatically to an end without storing any data. During such phase the Orange LED flashes with the OFF period which lasts twice as much as the ON period. As soon as the PICO FLOW recognises the first drop the “ Micturition Waiting Phase” comes to an end, the Orange LED stops flashing and data start to be stored. 5. In order to end flow metering, press the Start/Stop key again. If automatic printing has been set by FLOWSOFT, the printing of the report will be performed. Otherwise the PICO FLOW will have the green LED flashing and will be waiting for the next examination start as explained at the previous paragraph. In any event examination comes to an end 4 minutes and 40 seconds after the recognition of the flow of urine has taken place. 6. At the end of the examination the result of the test is automatically printed. During printing the LED fitted to the Print key is lit. 7. Press the Print key if wishing to reprint the results of the last test. In order to clear the internal examination archive, turn on the appliance while keeping ‘Paper Feed’ key pressed. Changing operating mode There are two ways for changing the operating mode. Turn the PICO FLOW ON keeping Start/Stop key and the Print Key pressed till the first short beep. This lets the user switch from one mode to the other. The success of this change is detected after the second and longer beep after which the Orange LED flashes in Automatic Mode or stays OFF in Manual Mode. Using FLOWSOFT it’s possible to change the operating mode at any time. Please refer to FLOWSOFT manual about this.

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Pico Flow User Manual Flow Metering report The flow metering report consists of the urinary flow curve and voided volume as a function of time and a table showing the main urodynamic parameters of clinical interest. An explanation follows as to the significance of the urodynamic parameters that are automatically calculated by Pico Flow at the end of the test. The Waiting time is the time elapsed between the moment in which the operator enables data acquisition and that in which the urine begins to flow into the beaker fitted to the transducer. It’s non printed in Automatic Mode. The Maximum flow (Qmax) is the maximum value reached by the flow curve throughout the entire test. The Average flow rate is the flow value that if kept constant throughout the entire emptying time, would have resulted in the same volume of urine being passed. The Time to Maximum flow is the time interval between the start of micturition and the moment in which the flow reaches its maximum value. The Time between 5% and 95% is the time interval between the moment in which the volume of urine passed reaches 5% of the total volume and the moment in which the volume of urine passed reaches 95% of the total volume. The Flow time is the total time in which the urinary flow reading has been other than zero. The Descent time is the time interval between the moment in which the flow reaches its maximum value and the moment in which the volume of urine passed reaches 95% of the total volume. The Voiding time on the other hand, is the time elapsed between the start of the flow and the moment in which micturition is finally over. The flow time is therefore always less than or equal to the emptying time. The Volume to maximum flow on the other hand, is the quantity of urine passed up until the moment in which the urinary flow reaches its maximum value. The Voided volume is the quantity of urine passed during micturition. The Corrected maximum flow is the ratio between the maximum flow and the square root of the volume of urine passed. The Flow acceleration shows the increase of the voiding flow in time. It’s an index of the bladder neck opening speed, which increases when there are detrusor instabilities (values greater than 5 ml/s2). It’s calculated by the ratio between the maximum flow and time to maximum flow. The Siroky diagram give a classification of the patients according to their maximum or average flow versus voided volume. These diagrams were built studying a normal male population therefore they are valid only for male patients. The grey zones indicates flow rates that can be found in less than 2.5% of the normal population and which are beyond 2 Standard Deviation from the Mean value.

NOTE on the VERSION 3.8 and successive of PICOFLOW This version corrects the errors that appeared on the previous version in automatic modality. This new version requires the following caution whenever the Pico Flow is kept without working for one or two months. In this event just do a simulated test in manual modality, starting with Start/stop button, pouring water and ending the test pressing Start/Stop again. Then get a printout. This procedure ensures a correct re-initialising of the internal memory.

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Pico Flow User Manual Calibration procedure for Flow Sensor The calibration procedure is necessary only occasionally when for instance the flowmeter has been hit. It is recommended to check the function of the flowmeter twice a month by pouring a known volume of water into it and verifying the correspondence between the volume poured and the volume shown on the printout. Proceed as follows in order to calibrate the flow sensor: 1. Press the ‘Start/Stop’ key and while keeping it pressed turn on the Pico Flow. A beep is heard. 2. The system will enter the calibration phase of the first point that is signalled by the flashing of the Orange LED. Place a known weight on the dish of the sensor (the empty beaker), wait 5 seconds and press ‘Start/Stop’ key. 3. The system will enter the calibration phase of the second point that is signalled by the flashing of both LEDs. Place on the dish of the sensor a weight of 0.5 Kg (fill the beaker with 500 ml of water or a calibrated weight of 0.5 Kg.), wait 5 seconds and press ‘Start/Stop’ key. At this point the system has been calibrated and is ready to carry out a new examination. Such state is signalled by the flashing of the green LED .

Transfer of examination data to PC with FlowSoft package By means of FlowSoft package (optional) it is possible: To import from Pico Flow the data of one or more tests To set the internal parameters of Pico Flow To manage the imported tests by creating Patients List and Test File To analyse again the tests To write a report To print graphs, data report and notes To transfer the tests and to set the parameters of Pico Flow it is necessary to connect the computer and Pico Flow by a standard serial cable with connectors DB9 respectively male and female with 3 wires without crossing (pins: 2, 3, 5). For installation and other instruction about FlowSoft program you can see the FlowSoft software manual.

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Pico Flow User Manual Installation of Pico Flow Connection of system components In order to complete the installation of the Pico Flow system, the following connections should be made: 1. Power supply cable of the Central processing unit Connect the power supply cable to the central processing unit. 2. Flow transducer data cable Connect one end of the data cable (fig. 5) to the flow transducer and the other end to the socket fitted to the central processing unit.

fig. 5

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Pico Flow User Manual Accessories and Spare Parts Code SUITCASE FLOWSOFT MIC-CHAIR 70005 70015 13006 89001 89042 89043 40119 40120 40113 40266 01064 01066 01032 11002 11003 40021 40020 MA011

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Description SUITCASE (37 x 55x17 cm). It contains Pico Flow, demountable cell stand, power supply and cables. Flowsoft: high-level software package for Uroflowmetry. Micturition chair Pico Flow card (acquisition board) External cable for load cell 9 pin male/female 1 to 1 serial cable Flow transducer (Load cell) Funnel holder Flow cell stand – demountable type Flat dish to support the beaker Plastic beaker 1000 ml Funnel Jet breaker User manual for Pico Flow Service manual for Pico Flow Software manual of FLOWSOFT Thermal printer 4” Parallel card for the thermal printer Paper shaft Paper shaft rest (a pair) 110 mm paper roll ( 5 rolls x box)

Pico Flow User Manual Specifications Flow channel Measuring range of flow of urine passed: 0÷20, 0÷50, 0÷100 ml/sec Measuring volume of urine passed: Range: from 0 to 1000 ml, Accuracy: 1 ml Sampling frequency: 10 samples/sec Resolution of A/D converter: 12 bit Incorporated thermal matrix printer Paper width: 112 mm Resolution: 200 dpi Central processing unit Serial port (RS-232C) for communication with PC Size: 290 x 200 x 70 mm Weight: 3.94 kg Supply voltage: 110/220 VAC Max. absorbed power: 50 Watt Fuses: 2 x 800 mA-T – 220-240VAC 2 x 1.6 A-T – 110-130VAC Safety standards IEC-60601-1 Class 1 type B

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Pico Flow User Manual PICO FLOW SERVICE SOFTWARE Pico Flow Service is a software package designed to set the parameters of Pico Flow. Once installed in any PC in Windows environment you have to connect the Pico Flow unit to the serial port of the PC by means of the supplied cable When you run the program you must set the communication port used by Pico Flow; the choices are two: COM1 or COM2. Then click on EXECUTE Button.

Then the program displays a form in which you can set Pico Flow Parameters. ¾ Time and Date are taken from System Clock; so if you click on Set Timer button time and date became the same as your PC’s. ¾ You can change the language of Pico Flow. To do so just choose the language from the available list. ¾ You can choose the mode, either Automatic or Manual. In Automatic Mode you can set the time without uroflow before the test is ended. Usually we set a time of 20 seconds ¾ You can enable or not the report printing after tests and the font type. At last, to Accept the changes, click on Ok Button.

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Pico Flow User Manual Memory Reset of PicoFlow To make the memory reset of PicoFlow: 1. Power off the PicoFlow 2. Keeping pressed the Paper Feed key, power on the PicoFlow.

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Pico Flow User Manual Rev H Dec 2005