TECIL ISEsweatII User Manual Download Page 1

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ISEsweat II

Sweat Chloride Analyzer

User’s manual

V00EVP012014

Summary of Contents for ISEsweatII

Page 1: ...ISEsweat II Sweat Chloride Analyzer User s manual V00EVP012014 ...

Page 2: ......

Page 3: ...14 3 2 Power source connection 14 3 3 Battery 16 4 SWEAT ANALYSIS 19 4 1 Settings 20 4 2 Sweat induction and analysis 22 4 3 Interpreting of sweat test results 27 4 4 Calibration and control 27 4 5 Quality Control Mode QC ISEtrol N and ISEtrol A 28 5 DATA PORT USE 30 5 1 General summary 31 5 2 Data port connection 31 5 3 Print Data 31 5 4 Memory 33 6 MAINTENANCE 35 6 1 Technical service 36 6 2 Per...

Page 4: ...TIONS 40 ANNEX C POSSIBLE INTERFERENCE 43 ANNEX D RECOMMENDATIONS FOR THE RESULTS INTERPRETATION 45 ANNEX E SYMBOL DEFINITIONS 47 ANNEX F REGULATIONS 50 ANNEX G MANUFACTURER DECLARATION 53 ANNEX H WARRANTY 56 ANNEX I HISTORY SWEAT TEST 58 ANNEX J REFERENCE 60 ...

Page 5: ...1 INTRODUCTION ...

Page 6: ...s formation and accumulation of dense mucus that affects mainly lungs intestines pancreas and liver Cystic fibrosis is also characterized by the presence of a high chloride Cl concentration in sweat which is the basisi of this diagnosis commonly known as the sweat test This test QUANTIFIES the chloride levels excreted while sweating and is indicative for CF diagnosis The ISEsweat runs the sweat te...

Page 7: ...r to calculate the chloride ion concentration 1 3 How to use this manual This user manual has been produced by Tecil in order to guarantee the correct use of the ISEsweat equipment Before putting the equipment to work please read carefully all pages and if you have any doubts contact the relevant department Only authorized Tecil agents can translate this manual Information in this manual can be ch...

Page 8: ...2 Device description ...

Page 9: ...oride is displayed in mmol l The analyzer consists of 2 separate parts 1 Terminal or receiver base includes an LCD screen where results of the analysis are displayed 2 Remote module has just one push button on the front This remote module has the holder for the innovative disposable sensor card patented by Tecil which are involved with the stimulation sweat collection and reading the chloride conc...

Page 10: ...terphase on the software s base Their function could change depending on which screen appears on the base Remote module slot It s a connector to charge the remote battery once the base of the remote It s plugged in on this slot On Off switch Turns On or Off the base of the ISEsweat AC Power supply connector Side where plug the power supply connector to the base of ISEsweat Printer connector Port t...

Page 11: ...een Remote push button Pressing this button starts changes the phase and stop the remote Sensor card slot Slot where the sensor cards are connected to run the iontophoresis and the measurement phase On Off switch Turns On Off the Remote Charge contacts Contacts where the remote it s plugged to the remote module slot Remote LED indicator Charge LED indicator Remote push button Sensor card slot On O...

Page 12: ...ese two sides by the appearance thus making it difficult to make a mistake when choosing the approriate side IONTO SIDE this stimulates sweat on the patient through two square shaped hydrogel iontophoresis pads containing a solution of 0 5 pilocarpine nitrate MEASURE SIDE this measures the chloride concentration sample or control through the ISE technique It consists of 2 concentric circular elect...

Page 13: ...3 ISEsweat installation ...

Page 14: ... Power source connection WARNING When you connect the ISEsweat check that it works correctly before using it for clinical purposes The accessories connected to the ISEsweat data interface must comply with IEC EN 60950 regulations for data processing equipment certificate or IEC EN 60601 1 regulations for electrical medical equipment certificate Any person that connects other equipment to the input...

Page 15: ...ector to the power supply connector 3 2 Plug the power supply cord to a CA power network point with an earth connection Shuko type 3 Press the power On Off switch O 2 to the ON position symbol to start up When connecting the equipment to the power network please ensure that it cannot become easily disconnected After connecting and installing the ISEsweat press the power switch to the ON position t...

Page 16: ...eferring to the symbol on the upper left hand corner of the base screen The battery indicator appears once the analysis has begun Charged battery Battery at medium low level Discharged battery WARNING Starting an analysis with a low battery level can influence the results It is highly recommended that you recharge the battery level whenever it is low Please check that the remote has an adequate ba...

Page 17: ...is should be off 2 Remote disconnection Once the remote is not operating and before starting the charging please disconnect the remote completely by switching the side switch to OFF WARNING During a test session you can continue to charge the equipment without disconnecting the remote but in this case you will not be able to check that it is fully charged green LED because of the power the remote ...

Page 18: ...harging slot with the green LED showing charged battery and replace the remote back in the slot the LED will glow red for a few moments even though the battery is fully charged because the remote needs some time to check the battery state Battery change The advantages of the Lithium Ion batteries are among other things the lightness of their components their high power capacity and their capacity ...

Page 19: ...4 Sweat analysis ...

Page 20: ...de designed to run the analysis or sweat test Quality Control Mode ISEtrol N or ISEtrol A designed to check the equipment It is recommended to use TECIL controls or any other approved QC material for this Work Mode Selection Press SET at the Start Screen A menu will appear that allows you to choose between different programs or Work Modes QC ISEtrol N or ISEtrol A or Normal Sweat Test Use the scro...

Page 21: ...equence WARNING Keep in mind that it is very important to keep the central button of the remote pressed all the time until the linking is done otherwise the process will be interrupted and you will have to initiate the process again until linking is successfully completed When linking is completed the menu screen will change to the start screen menu thus showing that correct linking between the ba...

Page 22: ...in the image 5 Remove the protective plastic protector strip on the IONTO side CAUTION Please do not touch the hydrogels on the IONTO side it could affect their composition Pilocarpine found in the hydrogels can be toxic if inhaled or ingested Please clean carefully all contact zones after the analysis In some cases depending on the patients sensitivity the gels can cause an allergic reaction such...

Page 23: ...and into the slot with the cloth part on the inside b Without twisting insert the end of the armband into the other slot c Adjust the size of the armband to fit the forearm so that the hook side attaches to the cloth side CAUTION It is very important that the remote unit is fixed securely in place by the armband in order to maintain good contact with the skin and to prevent sample evaporation and ...

Page 24: ...sweat is stimulated from the patient s skin by means of the IONTO Phase 2 Sweat stimulation A flashing green light signal on the remote module shows that the sweat stimulation has started The screen shows that the sweat stimulation has start The sensor card stimulates sweat generation for 10 minutes through iontophoresis at the place it is lying on During this 10 minute period the remote unit will...

Page 25: ...he electrode on the measure side Be careful you don t damage it You can remove it with bare hands or with tweezers Do not use sensor cards in case that reference electrode is broken or in disrepair see image 9 Clean the card surface to avoid leaving bits of gel on the electrode Clean with plenty of distilled water and dry with a gauze or blotting paper The cleaning process is finished when the wat...

Page 26: ...with the sample so you won t get a good result Phase 3 Collecting sweat 14 The screen shows The remote makes a repeated visual signal of two green flashes This process lasts for 10 minutes During this phase the remote unit needs to receive a sufficiently amount of sample to be able to analyze it see Technical specifications chapter Phase 4 Measuring patient 15 Once 10 minutes of the Collecting swe...

Page 27: ...test results Reference Values Negative value 40 mmol l Intermediate value 40 X 60 mmol l Positive value 60 mmol l To newborn 30 mmol l Negative value 30 X 60 mmol l Intermediate value 4 4 Calibration and control The ISEsweat is factory calibrated and does not requiere any calibration by the user Together with the device the control solutions with two levels are delivered 20mmol l and 80 mmol l All...

Page 28: ...que or device Therefore before using a control you should consult with TECIL as to its compatibility with the ISEsweat Each hospital or laboratory should decide for itself the quality control steps to be taken but TECIL recommended to perform a quality control each day before the first test of your work list REMEMBER To avoid confusion please change back to Normal Mode once Quality Control has fin...

Page 29: ... Manufacturer should provide an acceptance range as well as the certificate analysis for the standardized control Take into account expiry dates Each laboratory will need to establish its own quality control procedures but it is highly recommended to run a control before the beginning of a series of analysis and each time a new batch of sensor cards is used WARNING Values that are out of range mig...

Page 30: ...5 Data port use ...

Page 31: ...disconnect any cables or wires while the device is working Any printer or PC connected to the ISEsweat data port must be certified under the EN 60950 regulation All equipment combinations must follow all the requirements of the EN 60601 1 1 regulations Any person that connects a printer or a PC to the data port is configuring a medical device and as such is responsible of guaranteeing that the sys...

Page 32: ... and working results of each analysis will be sent to the printer at the same time that they appear on screen The printing format is as shown in the following figure The printing shows the chloride results expressed in mmol l and an identifier ID corresponding to the number of samples recorded on the internal meter Once printing is done the user can write the laboratory identification number as we...

Page 33: ...sent via the USB port to a computer connected to the base To open the MEMORY menu press MEM at the buttons below the Start Screen Choose Print and press ENT in order to print the stored results The printing format for the memory results is shown in figure ISEsweat will print the last 50 results both QC results and Normal results ...

Page 34: ...ted to the base Choose Delete memory using scroll arrows and press ENT to delete all stored results Once you have erased the memory the identifier sequence number will be reset Press ESC to go back to the start screen Choose Last results using scroll arrows and press ENT the screnn shows the last 50 results Press ESC to go back to the start screen ...

Page 35: ...6 Maintenance ...

Page 36: ...lease check with TECIL Technical Support Service before sending the device 6 1 Technical service The ISEsweat does not need a routine technical service or calibration but the battery needs to be changed every 24 36 months Check the battery change process in the ISEsweat user manual Battery change chapter 6 2 Periodic security check It is recommended that you do the following every 24 months Check ...

Page 37: ...uthorized representative to gather information on the national and local regulations about product disposal and recycling in your area In some cases the provider may be legally obliged to take the product back and arrange for its correct disposal Alternatively the provider should be able to give specific instructions regarding correct product disposal Contact your local government department respo...

Page 38: ...ANNEX A Troubleshooting Table ...

Page 39: ...tructions given Alarm Problem Cause Solution Remote link lost please bring the remote closer to the base No communication between remot and base Interference Repeat the linking Insufficient sample There is no sample the pattient does not sweat Patient with sweating problems Sweating is related to skin state and other factors that cannot be completely controlled No signal Interferences or distance ...

Page 40: ...ANNEX B Product Specifications ...

Page 41: ... Doubt level 60 mmol l Positive level NOTE The sweat test requires human manipulation and the collection of very small samples of sweat This can give rise to measurement errors however if results are lower than 10mM or greater than 150mM they will not be of any diagnostic significance Electrical specifications Reading LCD screen with graphic capability Power 100V 240VAC 50 60Hz 0 8 A Base 12 V 2 5...

Page 42: ... between 18ºC and 35ºC Cards keep between 2ºC and 8ºC Environmental use conditions 18ºC 35ºC Humidity 50 80 Physical features Dimensions Base Width 150 mm Long 195 mm High 60 mm Remote module Width 556 mm Long 75 mm High 22 mm Receiver base weight 553 gr Remote module weight 65r ...

Page 43: ...ANNEX C Possible interference ...

Page 44: ... of 24h 2 The patient should not have been treated with any medicines that contain corticosteroids in a period less of 24h 3 It must take into account the patient s fluid imbalance because dehydration problems could give a high result The analgesic ointment AMETOP could give positive results in the test so is recommended not perform the sweat test in sites where Ametop has been applied within the ...

Page 45: ...ANNEX D Recommendations for the results interpretation ...

Page 46: ...is not taking mineralocorticoids Illnesses or disorders associated with a high electrolytes sweat concentration not related to Cystic Fibrosis Sweat test indicators Pulmonary and upper respiratory tract Gastrointestinal Metabolic and others Chronic cough Recurring or chronic pneumonia Wheezing Hyperinflation Tachypnea Retraction Atelectasis particulary at the right upper lobe Bronchiectasis Hemopt...

Page 47: ...ANNEX E Symbol Definitions ...

Page 48: ...Applied part Type BF Temperature limitation Contents for 10 analysis Catalogue number Manufacturer This product complies with European regulations certified by a Notified body Do not use if packaging is broken Avoid water contact USB Dock RS232 Irritant On Off Read carefully instructions of use 10 Keep away from sunlight Expiration date Ex 2010 06 Year Month Caution Warning Note ...

Page 49: ...SEsweat User s Manual 49 Symbols on the ISEsweat screen top right Battery Charged battery Battery at medium low level Flat battery Radio Coverage Correct coverage Coverage at medium low level No coverage ...

Page 50: ...ISEsweat User s Manual 50 ANNEX F Regulations ...

Page 51: ...l regulations or requirements Regulation Description EN 60601 General Requirements for electrical medical equipments in relation to Electromagnetical compatibility and Electrical security ISO 7000 Graphic symbols for equipment use ISO 1258 Guidelines for electrical medical equipment development and instructions use ISO 1000 Units EN 980 Symbols EN 20780 ISO 8601 Date representation ISO 639 1 Langu...

Page 52: ...tions However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the sepa...

Page 53: ...ANNEX G Manufacturer declaration ...

Page 54: ...vironment guideline RF Emissions CISPR 11 IEC 55011 and IEC 55022 Group 1 The ISEsweat only uses radiofrequency power for communication within a room Its RF emissions are very low and there is little probability of them causing interference with other nearby electronic equipment RF Emissions CISPR 11 IEC 55011 and IEC 55022 B Class The ISEsweat can be used in public places including diagnostic est...

Page 55: ...nt Voltage drops micro interruptions and inline voltage variations IEC 61000 4 11 95 U Var for 10 milliseconds Pass Power network supply must be the usual one in a hospital or commercial environment ISEsweat must run the program again after interruption 60 U Var for 100 milliseconds Pass 70 U VAr for 500 milliseconds Pass 95 U Var for 5000 milliseconds Pass 95 U Var for 20 milliseconds Pass Magnet...

Page 56: ...ISEsweat User s Manual 56 ANNEX H Warranty ...

Page 57: ...all labour needed to repair them All parts that have been replaced when repairing the unit will automatically become property of TECIL S A Damage caused by improper use or by non compliance with the operating instructions will result in the invalidation of the warranty Interventions from persons other than TECIL S A authorized specialists may lead to invalidity of warranty ...

Page 58: ...ISEsweat User s Manual 58 ANNEX I History Sweat Test ...

Page 59: ...sed on the results of quantitative pilocarpine iontophoresis sweat chloride described in the specific guidelines Those guidelines consider not acceptable for CF diagnostic the direct reading in situ test using Orion ISE or older electrical conductivity measurements or measurements or osmolality or sodium Conductivity instruments designed specifically for use with microbore tubing collector was app...

Page 60: ...ISEsweat User s Manual 60 ANNEX J Reference ...

Page 61: ...a ratio in patients with borderline Sweat test Pediatr Pulmonol 1995 20 369 71 6 Grupo de Trabajo Fibrosis Quística SENP Protocolo de diagnóstico y seguimiento de los enfermos con fibrosis quística An Esp Pediatr 1999 50 625 634 7 Javier Gonzalo Ruiz Roser Mas Carmen de Haro Enric Cabruja a Rafael Camero M Asuncion Alonso Lomillo F Javier Muñoz Early determination of cystic ﬁbrosis by electrochemi...

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