CLIA WAIVED OSMOLARITY SYSTEM - USER MANUAL
Contents
1. Reader LCD displays E55 Reader LCD displays E56 Reader LCD displays E57 Reader LCD displays E58 TROUBLESHOOTING Test result was below 275 mOsms L Not sure if correct Test Card code was entered onto Reader during test Osmolarity test result may be inaccurate Pen or Reader electrical contact failure Pen Reader communication error Pen not responding to Reader Communication protocol failure between Pen and Reader Reader and Pen software do not Match size error Reader and Pen firmware incompatible Vers ON enor Pen failed premeasurement relay check Pen battery will not hold a charge Measurement attempted with uncalibrated Pen Verify function with quality control procedures Retest patient as values outside the measurement range may be indicative of an error Once value is confirmed record patient result as Below 275 mOsms L Using either Pen test with an Electronic Check Card in the same docking port as the test in question The Test Card code that is displayed on the Reader LCD will be the same code as that of the last test performed Verify that this Test Card code matches the code for the test in question If it does not match disregard the osmolarity test result Dock Pen charge batteries and retest with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Dock Pen cha2. TearLab MeMOLARITY SYSTEM CLIA WAI i ath pE OSMOLARITY SYSTEM CONTENTS CLIA CONSIDERATIONS The TearLab Osmolarity System is a CLIA waived test system for human tears Each laboratory or testing site using the TearLab Osmolarity System must have a CLIA Certificate of Waiver before starting testing To obtain a Certificate of Waiver call your state department of health or TearLab Customer Support at 1 858 455 6006 for an application Form CMS 116 TearLab can provide the phone number of your state department of health and assist you in filling out the application The TearLab Osmolarity System is a waived test so long as it is used according to the instructions in the Package Insert Any modification by the laboratory to the test system or the test system instructions will result in this test no longer meeting the requirements for waived categorization A modified test is considered to be high complexity and is subject to all applicable CLIA requirements INCLUDED CONTENTS SOLD SEPARATELY TEARLAB READER PEN ELECTRONIC OSMOLARITY OSMOLARITY CHECK CARDS TEST CARDS CONTROL SOLUTIONS TearLab Reader Set of 2 Electronic Check Cards 2 TearLab individually boxed with Instructions for Use Pens with magnetic cardboard TearLab User Manual sleeves Instructions for Use and a TearLab Quick Reference Guides set of adhesive identification labels Power Supply Power Cord s OSMOLARITY SYSTEM TABLE OF CONTENT
3. 1 S NOM A A 4 Operational Precautions o i 11 Electronic Check Card 0c e a n ence ene enees 4 Testing the Electronic Check Card 00 0 cece cece ees 4 MAIN TENA NC Ez assanesiein nasaia eniinn 11 Control Solutions o oo coco z Technical Service 0 00 ccc ccc ccc cece nen een e ee en cence 11 COM INC HIOING dos eee heen yee 5 Replacement Parts 00 cee ceteris 11 OSMOLARITY TEST ee ee O E 5 TROUBLESHOOTING BO abe ew Fel eS He We OO eR E od OR SN See Hs Ge 12 How to Perform an Osmolarity Test 00 cece ees z WARRANTY LL 14 Before Each Test 2 0 0 0 cece ccc cece eee cence nese rra EMC AND SAFETY oonan aeaea 14 Tear Collection Procedure 0 ccc cece nee 6 Get the Results ee oo LLL LL LLL 6 PEER ENC E airan enn E eA A AAA ENR 16 PRODUCT OVERVIEW The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of Dry Eye Disease in patients suspected of having Dry Eye Disease in conjunction with other methods of clinical evaluation Tears fulfill an essential role in maintaining ocular surface integrity protecting against microbial challenge and preserving visual acuity These functions in turn are critically dependent upon the composition and stability of the tear film structure Osmolarity is a basic and essential aspect of physiologic homeostasis in body fluids Small deviations in homeostasis such as variations in pH temperature
4. 12 VDC Transport and storage relative humidity 10 85 noncondensing Output current 2 5A Transport and storage altitude 0 2 000 meters Class ll Operating temperature 15 30 C 59 86 F Continuous service Operating altitude 0 2 000 meters Operating relative humidity 10 85 noncondensing SYSTEM CLASSIFICATION Class Il powered by Class Il power supply Type B applied part Continuous service HAZARDS The TearLab Osmolarity System is designed for stability reliability and safety and it has been developed manufactured and marketed under a quality management system certified to ISO 13485 2003 The TearLab Osmolarity System complies with the following materials WEEE Directive 2002 96 EC Waste Electrical and Electronic Equipment RoHS Directive 2002 95 EC Restriction of Hazardous Substances IEC 60601 1 Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance The TearLab Osmolarity Test Cards do not contain reagents or chemicals Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide The American Academy of Ophthalmology AAO states Human tears are not considered to contain significant amounts of bloodborne pathogens and thus do not require OSHA s Occupational Safety and Health Administration s bloodborne pathogens precautions but exposure to human tears does require good office hygiene practices s
5. the Card is attached properly The green light will remain on until tears are collected or the Pen times out after two minutes Remove the protective cover by holding the wings of the Test Card firmly and pulling the sheath up and off of the Test Card WARNING A Test Card without a protective cover should be considered used DO NOT use for patient testing TEAR COLLECTION PROCEDURE NOTE For Osmolarity Controls refer to the Testing Osmolarity Controls section on page 7 Seat the patient with chin tilted upward and eyes directed toward the ceiling Place one hand on the face for stabilization Do not pull the eyelid down or away from the eye Position the tip of the Pen just above the lower eyelid Gently lower the Pen until the bottom of the tip touches the thin line of moisture between the eyelid and the eye It is not necessary to press inward toward the eye The Pen will beep and the green light will turn off after a successful tear collection NOTE Sometimes when there is very little tear the act of withdrawing the Pen breaks the surface tension of the tear meniscus and allows tears to enter the microfluidic channel In this case the Pen will beep upon withdrawal indicating a successful tear collection NOTE Tear collection should be performed at the lateral temporal extent of the eyelid where the risk of inadvertent injury to the cornea can be minimized rather than adjacent to the cornea where inj
6. 8 1993 A1 2000 Power Frequency Magnetic Field Immunity IEC 61000 4 11 2004 Voltage Dips and Short Interruptions Air Discharge up to 8kV Contact Discharge up to 6 kV Radiation Field Strength of 3V m 80 6000 MHz 80 AM 1 kHz Power line pulses of 2 kV direct I O line pulses of 1 kV Power line surge of 2 kV common 1 kV differential mode 150 kHz 80 MHz at 3 ee kHz 80 amplitude modulated Helmholtz coil at 50 Hz and 60 Hz to 3 Amps RMS per meter Voltage dips of gt 95 30 and 60 interruptions of gt 95 Air Discharge up to 8kV Contact Discharge up to 6 kV Radiation Field Strength of 3V m 80 6000 MHz 80 AM 1 kHz Power line pulses of 2 kV direct I O line pulses of 1 kV Power line surge of 2 kV common 1 kV differential mode 150 kKHz 80 MHz at 3 V 1 KHz RMS 80 amplitude modulated Helmholtz coil at 50 Hz and 60 Hz to 3 Amps RMS per meter Voltage dips of gt 95 30 and 60 interruptions of gt 95 The TearLab Osmolarity System is intended for use in an electromagnetic environment with controlled HF disturbances The user of the TearLab Osmolarity System can help to avoid electromagnetic disturbances by keeping the minimum distance between portable and mobile telecommu nication devices transmitters and the TearLab device depending on the output power of the telecommunication devices as described below Rated maximum output power of transm
7. AB MAKES NO OTHER WARRANTIES RELATING TO THE PRODUCT EXPRESS OR IMPLIED AND EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION WARRANTIES OF NONINFRINGEMENT FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY In the event that you experience any difficulty with the TearLab Osmolarity System contact your local sales representative or TearLab Customer Support OSMOLARITY SYSTEM EMC AND SAFETY SPECIFICATION FREQUENCY RANGE EN 55011 2007 Group 1 Class A 0 15 MHz 30 00 MHz Conducted Emissions EN 55014 1 2006 0 15 MHz 30 00 MHz Disturbance Click EN 55011 2007 Group 1 Class A 30 00 MHz 1000 MHz Radiated Emissions EN 61000 3 2 2000 A2 2005 Up to the 40th Harmonic Power Line Harmonics EN 61000 3 3 1995 A1 2001 A2 2005 Less than or equal to 4 Maximum Relative Voltage Charge Value Power Line Flicker of D T less than or equal to 3 for more than 200 ms NOTE 1 No discontinuous disturbance clicks identified at this frequency range SPECIFICATION MINIMUM TEST LEVEL REQUIRED PER EN 60601 1 2 FOR NON LIFE SUPPORT EQUIPMENT TEST LEVEL COMPLETED IEC 61000 4 2 1995 A1 1998 A2 2000 Electrostatic Discharge Immunity IEC 61000 4 3 2006 RF Radiated Fields Immunity IEC 61000 4 4 2004 Corrigendum 1 2006 Electrical Fast Transient Immunity IEC 61000 4 5 2005 Lightning Surge Immunity IEC 61000 4 6 2004 A2 2006 RF Common Mode Immunity IEC 61000 4
8. Mode following tear collection the data will be erased and the Test Card will not be able to be reused WARNING Pen should always be docked immediately after tear collection to avoid loss of data OSMOLARITY SYSTEM QUALITY CONTROL CALIBRATION The manufacturer calibrates the TearLab Osmolarity System against a reference standard solution prepared from dried high purity sodium chloride traceable to the National Institute of Standards and Technology NIST Calibration by the user is not required ELECTRONIC CHECK CARD The blue Electronic Check Card should be tested on each Pen before each day of patient testing or if the Pen has been dropped or mishandled to verify that the system is performing within manufactured calibration specifications Values obtained with the Electronic Check Card should not deviate by more than 3 0 mOsms L units of osmolarity from the expected value The TearLab Osmolarity System comes with two identical blue reusable Electronic Check Cards The Electronic Check Cards can be used simultaneously one on each Pen for quality control testing WARNING Fluid samples cannot be collected with the Electronic Check Card DO NOT try to collect tears or Control Solutions with the blue Electronic Check Card TESTING THE ELECTRONIC CHECK CARD 1 Attach an Electronic Check Card onto a Pen The green light on top of the Pen will illuminate and the Pen will beep Wait approximately five seconds for the Pen to
9. N the Reader LCD will display Ready indicating that testing may be performed The LCD is split into left and right sides corresponding to the left and right docking cradles OSMOLARITY SYSTEM PENS TEARLAB PENS Each Pen contains a permanent rechargeable battery Pens should be docked in the Reader and allowed to charge for 20 minutes before initial use The Pen battery automatically recharges when the Pen is docked in the Reader and the power is switched ON It is recommended that the Reader power remain ON for continu ous Pen battery charging Battery icons are located in the left and right corners of the LCD A flashing battery icon indicates that the battery is charging If the icon is not flashing the battery is fully charged Pen batteries will not overcharge WARNING Only collect tears ifthe green light is on NEVER collect tears when the green light is off Ifa Test Card is attached and there is no beep and no green light from the Pen DO NOT collect tears LOW BATTERY WARNING When a Pen with low battery power is removed from the Reader the Reader will emit two informational beeps and the BAT LOW message will appear on the LCD Do not perform testing Dock the Pen into the Reader to charge the battery When BAT LOW changes to Ready the Pen is ready to perform a test LONG TERM PEN STORAGE Please retain Pen box and magnetic cardboard sleeve for long term storage The Pen is packaged with a magnetic c
10. NCE ON PATIENTS WITH OBJECTIVE SIGNS OF DRY EYE 140 subjects were enrolled in a multicenter study n 45 Normal n 95 Dry Eye To qualify as a Dry Eye patient subjects were required to have a positive score on the Ocular Surface Disease Index OSDI and 2 or more positive indications of Tear Film Breakup Time TBUT Schirmer Test Corneal Staining Conjunctival Staining or Meibomian Gland Dysfunction Performance of the TearLab Osmolarity System using these selection criteria is shown in the table below TearLab Osmolarity Diagnostic Performance for Dry Eye Disease Normal Dry Eye Total 3 6 By 34 66 48 NPV gt 316 is 61 74 82 PPV Total 45 95 140 Specificity 71 Sensitivity 64 Figures 1 amp 2 Distribution of Osmolarities in Normal and Dry Eye Disease subjects Figure 1 Figure 2 400 0 05 T 2 i 0 04 Normal 309 9 11 0 S 360 gt E 0 03 D 340 2 6 ee Dry Eye z 320 324 3 20 1 0 01 g 316 280 250 300 350 400 Normal Dry Eye Disease Osmolarity mOsms L Dry Eye distribution is not normal It is skewed toward 400 mOsms L SPECIFICATIONS POWER REQUIREMENTS PEN POWER SOURCE Use only Power Supply Model PDM30US12 XP Power Input 4 5 5 5 VDC 0 6A Internally powered by rechargeable battery POWER SUPPLY Continuous service Input voltage 100 240 VAC Input current 0 6A MAX ENVIRONMENTAL CONDITIONS Frequency 47 63 Hz Transport and storage temperature 2 35 C 36 95 F Output voltage
11. Report a serious adverse event product quality problem product use error or therapeutic inequivalence failure that you suspect is associated with the use of the TearLab Osmolarity System to TearLab Customer Support Tel 858 455 6006 and or to FDA MedWatch Tel 800 FDA 1088 Fax 800 FDA 0178 or www fda gov medwatch PRECAUTIONS OPERATIONAL PRECAUTIONS For professional in vitro diagnostic use only CLIA Waived Use only at ambient temperature of 15 30 C 59 86 F Pen timer In order to conserve battery life the Pen is programmed to enter Sleep Mode automatically two minutes after it powers up When a Pen is not being used for 30 days or more store it in the magnetic cardboard sleeve to conserve battery life Osmolarity Test Cards are stable until the expiration date marked on the label Leave Test Card in its sealed pouch until use Do not remove the protective Test Card cover until the Test Card is attached onto a Pen Remove the protective cover immediately prior to tear collection Any Test Card that does not contain a protective cover should not be used for patient testing A Test Card that has been contaminated or dropped without a protective cover should not be used for patient testing A measurement should not be performed if a Pen that contains a Test Card with a patient sample has been dropped Discard Test Card and perform test with an Electronic Check Card to verify that the Pen is performi
12. S PRODUCT OVERVIEW 0 ccc eee ees 1 Testing Osmolarity Cantois pu 06 lt ons ataddonche howne gs 7 EHS ee INS CS Nees Rice ene eens PERFORMANCE 0eccecececeeeeeeeeeeeeeeeeeees 7 Oo PEIMVCOMIPONIE TT Soar counter a Gases eh aoe ake ens 1 Result Interpretation 00 ccc cece cece cee e ence e eens 7 Osmolarity System Reader 0 cece eee 1 Expected Results 0 cece ccc ce cee ence cence eens ences 7 QOsmolarity System Peesi erreser dee neks REENER 1 Accuracy Method Comparison 0 ce cence cence 8 ee TE a CLINICAL STUDIES oaaao 9 EISCHONIC CHECK CONG i vpenvinve vevnhurbeneta rset 2 CAMPAIGN DAT eain i ea A AER 9 INSIALLAMON sisrerreirre rires pikirin AE EE E k 2 Performance on Patients with Objective Signs of Dry Eye 9 HTM PTA NGL TINS STU ash epee SPECIFICATIONS lt anan 10 Recall Keys and Test Memory sssssssssrrrrrrnns 3 POSE eI STS IS ceed nacht keen uti eaten eR 10 PEN osanna ena doks EEES a aahe ws nna epackcad e boars 3 POWT SUDO u risar aaa ia a EA 10 TEAMS PENE 5 6409 bau ETIE E EE ERIE ied 3 DE E yas ievyncnxuemsn dena easineeyensneesutn 10 Low Battery Warning 0 ccc cece eens 3 Pern OWED SOUE ace dracdoe dedcteendsaccreduecteeedacedacndaneedundaceed as 10 Long Term Pen Storage s aiiccrnevacivaneawanvnown Owes 3 Envionmental CONCINIONG sse ideea ch indaadrrnnn 10 A CI 0 thc car gaenietacergtc incre eet i HAZARDS ooa 10 SP He en eA UN te es e nanena j PRECAUTIONS oaao
13. ader LCD displays Used Whee Reader LCD displays Pen i Ox Reader LCD displays Above Range A Test Card is not properly attached B Test Card is used C Pen battery is low D Pen electrical contacts are worn Pen will time out in 10 seconds A Two minutes have passed since attachment of Test Card and Pen has entered Sleep Mode B Pen battery is too low for tear collection The TearLab Osmolarity System does not meet manufacturer specifications Either Test Card or TearLab Osmolarity System does not meet manufacturer specifications Pen battery is low and testing cannot proceed Test Card has already been used Test Cards are for single use Pen will not accept a Test Card that has been used previously to collect tear fluid samples Pen was not docked into Reader within 40 seconds of tear collection Data is lost Test result was above 400 mOsms L TROUBLESHOOTING 1 Remove Test Card and reattach if protective cover is still on NEVER use a Test Card that does not have a Protective Gover 2 Dock Pen into Reader to assess battery charge level 3 Use the Electronic Check Card to confirm Pen function 4 Try anew Test Card 5 Contact TearLab Customer Support Immediately dock the Pen into the Reader Pen must always be docked within 40 seconds of tear collection 1 Remove unused Test Card and reattach onto Pen Proceed with tear collection 2 Dock the Pen to allow bat
14. ardboard sleeve that automatically turns the Pen OFF when the Pen is properly inserted When the magnetic cardboard sleeve is removed the Pen automatically turns ON The Pen will remain ON indefinitely in either Wake Mode or Sleep Mode If the Pen is not used for 30 days or more it is recommended to store the Pen in the magnetic cardboard sleeve and in its original box to turn the Pen OFF and to conserve the life of the battery Failure to store the Pen properly may result in a battery that is discharged beyond its ability to recharge Pen batteries are permanent and cannot be exchanged or replaced Battery failure requires replacement of the Pen The Pen battery will not overcharge fthe Pen has been dropped or mishandled test with an Electronic Check Card to verify that it is functioning properly before testing patients or Control Solutions WAKE AND SLEEP MODES The Pen will enter Sleep Mode when not in use and will automatically awaken when a new Test Card is attached as indicated by the green light and the beep The Pen will remain in Wake Mode for two minutes If two minutes pass without tear collection the Pen will return to Sleep Mode and the green light will turn off To wake the Pen remove the Test Card and reattach it onto the Pen The green light will illuminate and the Pen will beep Following tear collection a user has 40 seconds to return the Pen to the Reader before the Pen enters Sleep Mode If the Pen enters Sleep
15. beep again or for the green light to turn off 2 After the green light turns off dock the Pen into the Reader The LCD will display a code number It is not necessary to enter a specific code for Electronic Check Cards Press OK to accept any code 3 The LCD will display a test result that should fall within the expected value range indicated in the Instructions for Use provided with the Electronic Check Cards Remove the Pen and press the RECALL Key to confirm that the test result was properly stored in memory Repeat the procedure with the other Pen Record the date and the Electronic Check Card test results in a quality log CONTROL SOLUTIONS Good laboratory practice suggests the use of Normal and High Osmolarity Control Solutions to ensure that the TearLab Osmolarity System is functioning properly Test both levels of control solution with each new shipment of test cards even if the lot number is the same with each new lot number and monthly to check storage To ensure proper performance with the TearLab Osmolarity System only TearLab Osmolarity Control Solutions should be used Osmolarity Control Solutions are not included with the TearLab Osmolarity System or the TearLab Osmolarity Test Cards If correct electronic or control solution test results are not obtained do not test patient samples instead contact your local sales representative or TearLab Customer Support in your area Please refer to the Testing Osmolar
16. es for Normal and Dry Eye osmolarity levels NOTE Osmolarity may differ from left eye to right eye and each eye should be tested and assessed to determine which eye represents higher osmolarity Normal Mean 309 9 mOsms L 11 0 288 331 mOsms L 90 Cl 288 331 Dry Eye Disease Mean 324 3 mOsms L 20 1 291 382 mOsms L 90 Cl 284 392 The results of the TearLab Osmometer should be evaluated with all clinical and laboratory data available If the results do not agree with the clinical evaluation additional tests should be performed Osmolarities above or below the measurement range are very rare and should generally be confirmed with subsequent testing as values outside the measurement range may indicate an error e g user error during the test Test only on human tears or TearLab Osmolarity Control Solutions ACCURACY METHOD COMPARISON The correlation study was performed internally by the manufacturer using contrived tear samples of various osmolarity levels within the clinical reference range on both the TearLab Osmolarity System and the Wescor Model 5520 vapor pressure osmometer calibrated to NIST traceable standards Sn a 80 y 0 9146x 23 061 0 9443 TearLab Osmolarity y 0 9146x 23 061 r 0 9443 260 280 300 320 340 360 380 400 Wescor Osmolarity At each of three physician office sites 40 contrived tear specimens across seven levels of the clinically significant range were prepared and mea
17. glucose and oxygen concentrations and osmotic pressure activate physiological mechanisms to return that variable to its set point The body is able to regulate osmolarity of body fluids within very narrow limits through various mechanisms of osmoregulation such as the compensation and correction of fluid volume and salt concentration Hyperosmolarity of any body fluid including tear fluid indicates a disorder in the body s ability to regulate homeostasis and is a basic indication of a physiological disorder The higher the osmolarity the more concentrated the tear films Hyperosmolarity has been described in the literature as a primary marker of tear film integrity When either the quantity or the quality of secreted tears is compromised known as aqueous deficient or evaporative Dry Eye Disease an increased evaporation rate leads to a concentrated tear film increased osmolarity that places stress on the corneal epithelium and conjunctiva The TearLab Osmolarity Test Card in conjunction with the TearLab Osmolarity System provides a quick and simple method for determining tear osmolarity using nanoliter nL volumes of tear fluid collected directly from the eyelid margin To perform a test attach a new Test Card onto the Pen and touch the tip of the Pen to the tear fluid meniscus located above the lower eyelid After a successful collection dock the Pen into the Reader which will display a quantitative tear osmolarity test result on the liquid cr
18. itter W 0 01 0 12 0 1 Choy 1 1 17 10 SJ 100 Rey 150 kHz to 80 MHz d 3 5 V1 P 80 MHz to 800 Mhz E Ee 0 04 0 11 035 e 350 SAFETY DISTANCE DEPENDING ON THE FREQUENCY IN m 800 MHz to 2 5 GHz OEE 0 08 Oe 0 70 22 7 00 For transmitters with a maximum nominal power not mentioned above To detect the recommended safety distance use the equation in the corresponding column P is the maximum nominal power of the transmitter in watts W according to the specifications of the transmitter manufacturer NOTE These guidelines may not be applicable for all cases The propagation of electromagnetic values is influenced by absorptions and reflections of buildings objects and people 15 OSMOLARITY SYSTEM REFERENCES 1 Sullivan DA Dartt DA et al Lachrymal Gland Tear Film and Dry Eye Syndromes 2 Basic Science and Clinical Relevance Advances in Experimental Medicine and Biology 1998 438 2 Sullivan BD Whitmer D Nichols KK et al An Objective Approach to Dry Eye Disease Severity Invest Ophthalmol Vis Sci 2010 51 6125 30 3 Definition and Classification of Dry Eye Report of the Diagnosis and Classification Subcommittee of the Dry Eye Workshop DEWS The Ocular Surface 2007 5 2 75 92 4 Pedersen Bjergaard K Smidt BC Electrolytic Conductivity Osmotic Pressure and Hydrogen lon Concentration of Human Lachrymal Fluid Acta Derm Venereol Suppl Stockh 1952 32 29 261 7 5 Erstad BL Osmolal
19. ity Controls section on page 7 of this manual for the Osmolarity Control Solutions testing procedure CONTRAINDICATIONS Human tear fluid samples may be used Collect tear fluid samples directly from the eye Do not collect tear fluid from a patient within two hours of medicinal eye drop use or use of topical medications Do not collect or store tear fluid samples for transport or testing at a later time Do not collect tear fluid after ocular surface staining Do not collect tear fluid within 15 minutes of use of anesthetic or mydriatic dilating eye drops or after other invasive ocular diagnostic testing a Do not collect tear fluid within 15 minutes after a slit lamp examination a Do not collect tear fluid within 15 minutes from a patient who has been crying WARNING feither the Electronic Check Card or the Control Solution test results do not match the expected value range DO NOT test patients Contact your local sales representative or TearLab Customer Support for assistance OSMOLARITY SYSTEM OSMOLARITY TEST HOW TO PERFORM AN OSMOLARITY TEST NOTE Use appropriate clinically hygienic methods when collecting tears BEFORE EACH TEST Remove either Pen from the Reader The LCD will display Ready NOTE DO NOT collect tear samples if the Reader does not display Ready Remove a Test Card from its package and attach it onto the Pen The Pen will beep and the green light will illuminate when
20. ity and Osmolarity Narrowing the Terminology Gap Pharmacotherapy 2003 23 9 1085 6 6 Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms American Academy of Ophthalmology Information Statement Available at http one aao org CE PracticeGuidelines ClinicalStatements aspx p 3 accessed March 1 2003 GLOSSARY OF SYMBOLS Use by date Date of manufacture aoe Manufacturer Bu Serial number In vitro diagnostic device Catalog number Authorized representative for the European Union Consult Instructions for Use Control Type B applied part IEC 60601 1 B op gt Ja gx m U eaei CE TearLab Corporation Cavendish Scott Ltd San Diego CA U S A PO Box 107 EXCELLENCE Tel 1 858 455 6006 SG5 1FW England AWARDS 2009 WINNER Website www tearlab com One or more of the following patents may apply U S Patents 7 017 394 7 051 569 7 111 502 7 129 717 7 204 122 8 020 433 7 987 702 7 905 134 7 810 380 7 574 902 A TearLab 930066 Rev C OS Instructions for Use English 2012 TearLab Corporation
21. ng correctly Avoid touching the tip of the Test Card Test Cards are for single use only Never reuse or try to clean a Test Card Dock the Pen into the Reader within 40 seconds of collecting a sample or the Pen will time out T O The Pen will emit a series of reminder beeps approximately 30 seconds after tear collection to prompt immediate docking A Pen docked into the Reader after 40 seconds will display a Pen T O error message all data will be lost and the test will be invalid Test Card should not be removed after tear collection or prior to docking or data will be lost Tear collection should not be attempted if the green light on the Pen is not illuminated The green light will not illuminate if battery power is low or the Test Card is used Donotremove a Test Card from the Pen after tear collection until a measurement has been displayed Removing a Test Card from the Pen prior to docking will clear the Pen s memory and data will be lost The Pen will not recognize a fluid filled Test Card if it is removed and reattached onto the Pen Refer to the Contraindications and the How to Perform an Osmolarity Test sections on page 5 of this manual for tear fluid sample collection guidelines Prior to use inspect the Reader Pen and Test Card for physical damage If anything is damaged do not perform testing until the System s performance has been verified with both the Electronic Check Cards and the O
22. not spill out Touch the tip of the Pen to the control solution Return the Pen to the Reader enter the code Check control result to the expected value If within the expected range patient testing may proceed f not within the expected range you should not perform patient testing Contact TearLab Customer Support in your area or call TearLab at 858 455 6006 MO L A R I j Y amp Y S i jj IE M P E R F O R M A N C E RESULT INTERPRETATION TearLab test results are displayed on the LCD in mOsms L No calculations are required Osmotic concentration determinations are often expressed as either osmolarity milliosmoles liter i e mOsms L or as centiosmoles liter i e COsms L or osmolality milliosmoles kilogram i e mOsms kg or as centiosmoles kg i e COsms kg In tear fluid the difference between osmolarity and osmolality is insignificant and it is common in the clinical literature to use the terms interchangeably TearLab measurement range is linear from 275 400 mOsms L Test results outside this range will be reported as either Below Range indicating a measurement below 275 mOsms L or Above Range indicating a measurement above 400 mOsms L Osmolarities outside the stated range are very rare and should generally be confirmed with a subsequent test as values outside the measurement range may be indicative of an error e g user error during the test EXPECTED RESULTS Reference tear osmolarity valu
23. of the Reader Locate the switch on the back of the Reader and set to the ON position WARNING Modification of this equipment is not recommended This may cause a safety hazard and will nullify the manufacturer s warranty Do not locate the TearLab System directly in front of the power outlet The power cord and plug must be accessible for removal from the power outlet INITIAL SETUP AND MENU NAVIGATION Upon first use press the MENU Key once to enter the Menu Mode and setup screen Press the RECALL Key below the UP and DOWN arrows to scroll Press the OK Key to choose a menu item Press the MENU Key S to return to the main screen When in Test Mode press the RECALL Key to display the previous test result RECALL KEYS AND TEST MEMORY ones There are two RECALL Keys corresponding to the left and right cradles RECALL Keys are used to view the Ready previous test result 11 22 56 AM To recall the previous test result press and hold the RECALL Key The previous test result will be displayed on a dark background to distinguish it from the current test result Release the RECALL Key and the LCD will revert to the active screen displaying the current test result or operation screen Only the last test result will be held in memory and it will remain in memory until the Reader is turned OFF The RECALL Keys also function as UP and DOWN arrows when you are entering the code or navigating the menu When turned O
24. rge batteries and retest with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Dock Pen charge batteries and retest with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Dock Pen charge batteries and retest with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Test with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Test with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Test with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Test with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support Test with Electronic Check Card If error repeats or result does not fall within the expected value range contact TearLab Customer Support 14 OSMOLARITY SYSTEM WARRANTY The TearLab Reader and Pens Product are warranted against defects in material and workmanship for 12 months from the date of delivery The foregoing warranty is subject to the following condition
25. s and exceptions Warranty excludes repair of failures resulting from mishandling or abuse Warranty excludes consumable items such as Test Cards Warranty does not apply to damage sustained in transit Warranty service may be performed only by TearLab Corporation TearLab or its authorized representative Warranty is void if the Product has been modified or repaired by anyone other than TearLab or its authorized representative Warranty is nontransferable Warranty is void if the serial number tag is removed or altered If the Product fails to conform to the foregoing warranty you may return the nonconforming Product during the 12 month warranty period accompanied by a a copy of the sales receipt of the Product for the purposes of evidencing the applicable warranty period and b a Return Material Authorization RMA number for the defective Product obtained from TearLab prior to initiating the shipment of the defective Product to TearLab Products returned without a sales receipt and valid RMA number shall be returned to you with no further obligation by TearLab regarding the Product If you return a Product in compliance with the foregoing requirements TearLab shall repair or replace the Product as soon as is practicable THE REPLACEMENT OF THE NONCONFORMING PRODUCTS BY TEARLAB AS PROVIDED ABOVE SHALL BE YOUR SOLE AND EXCLUSIVE REMEDY FOR BREACH OF THE FOREGOING WARRANTY OTHER THAN AS WARRANTED ABOVE THE PRODUCT IS PROVIDED AS IS TEARL
26. smolarity Control Solutions MAINTENANCE The TearLab Osmolarity System is designed to work without direct service or preventive maintenance If quality checks fail contact TearLab Customer Support The TearLab Reader and Pens can be cleaned with a damp cloth or alcohol wipe as required When cleaning it is important to keep the electronic contacts of the Pen and Reader dry The electronic contacts and docking port should also be kept free of dust and dirt Pen batteries cannot be replaced If the Pen battery fails to recharge contact your sales representative or TearLab Customer Support to purchase a replacement Pen Cleaning fluids should never be used on the Test Cards TECHNICAL SERVICE For technical service contact your sales representative or TearLab Customer Support See back cover for contact information REPLACEMENT PARTS To order replacement parts contact your local sales representative or TearLab Customer Support in your area for assistance Test Card is attached green light does not illuminate and Pen does not beep Pen begins beeping approximately 30 seconds after tear collection Pen s green light turns off with an unused Test Card attached prior to tear collection Electronic Check Card does not fall within the expected value range Osmolarity Control Solution results do not fall within the expected value range When Pen is removed from Reader Pen beeps twice and LCD displays BAT LOW Re
27. sured on the TearLab Osmolarity System The physician office laboratories did not have access to the Wescor 5520 Vapro vapor pressure osmometer Wescor values were determined by an average of two to three measurements on each level of osmolarity immediately prior to the beginning of the study he Regression Line rP 120 y 0 9402x 12 512 0955 TearLab Osmolarity 400 380 360 y 0 9402x 12 512 r 0 9515 340 320 300 280 260 260 280 300 320 340 360 380 400 Wescor Osmolarity OSMOLARITY SYSTEM CLINICAL STUDIES CALIBRATION DATA To determine clinical performance for tear film hyperosmolarity in the diagnosis of Dry Eye Disease a meta analysis was performed on historical published data for tear osmolarity in samples of Normal and Dry Eye subjects An osmolarity referent value of 316 mOsms L was found to yield sensitivity of 69 specificity of 92 and an overall predictive accuracy of 82 for the diagnosis of Dry Eye Disease Studies in the meta analysis used earlier osmolarity devices not TearLab Performance of Osmolarity in Meta analysis Normal Dry Eye Total SING 750 192 942 80 NPV e 65 429 494 87 PPV Total 815 621 1 436 Specificity 92 Sensitivity 69 Tomlinson A Khanal S Ramaesh K Diaper C McFadyen A Tear Film Osmolarity Determination of a Referent for Dry Eye Diagnosis Investigative Ophthalmology amp Visual Science October 2006 4 10 4309 4315 PERFORMA
28. tery to recharge Reader LCD will indicate battery charging status Retest using the second Electronic Check Card If result does not fall within the expected value range contact TearLab Customer Support 1 Check the expiration dates of the Test Card and Osmolarity Control Solutions 2 Test with the Electronic Check Card A If results are out of range contact TearLab CUStOMmer UPPOO B If results are in range retest Osmolarity Controls If results are still out of range contact TearLab Customer Support 3 Do not perform patient testing until Osmolarity Control results fall within the expected value range Dock Pen into Reader to recharge battery Remove the Test Card Attach a new Test Card and proceed with testing If necessary the last test can be recalled by pressing and holding the RECALL key Retest patient with a new Test Card Dock Pen into Reader within 40 seconds of tear collection Verify function with quality control procedures Retest patient as values Outside the measurement range may be indicative of an error Once value is confirmed record patient result as Above 400 mOsms L Reader LCD displays Below Range Need to confirm which Test Card code was entered onto Reader after an osmolarity test was performed Reader fails to detect a docked Pen Reader LCD displays E51 Reader LCD displays E52 Reader LCD displays E53 Reader LCD displays E54
29. tion of the TearLab if it is mishandled or the Pens are dropped Tear fluid samples cannot be collected with the Electronic Check Cards OSMOLARITY SYSTEM INSTALLATION A Reader two Pens a power supply power cord s and Electronic Check Cards are delivered together with Osmolarity System User Manual s and Quick Reference Guide s Open the carton on a stable surface remove the components and set them on a flat surface with at least two inches of space around the Reader The Reader and Pens should not be used in direct sunlight and should be at ambient temperature 15 30 C 59 86 F before use After the Reader is switched ON a 25 minute warm up before use is required The Reader will indicate when it is ready for use 1 Each Pen comes with a set of identification labels that can be affixed to the back of the Pen to distinguish one Pen from the other Affix labels to the back of each Pen if desired Each Pen is also supplied with a reusable magnetic cardboard sleeve for long term storage DO NOT DISCARD See Long Term Pen Storage section on page 3 of this manual 2 Insert each Pen into a cradle The Reader has two cradles to allow simultaneous docking of both Pens Either Pen will function in either cradle 3 Select the power cord that corresponds to your local electrical outlet configuration Connect the power cord to the power supply plug the power cord into an electrical outlet and connect the power supply to the back
30. uch as hand washing However contact with tears contaminated with blood such as in minor surgery requires the use of bloodborne pathogen precautions Proper handling and disposal methods of used Test Cards should be established according to relevant state and federal regulations TearLab is designed to collect samples of tear fluid from the eye a nonsterile environment The AAO has issued guidance to minimize the transmission of ocular surface infectious agents Prevention of transmission of these pathogens requires good hygienic techniques such as washing hands and instruments that touch the eye Refer to the Maintenance section on page 11 of this manual for information about proper cleaning of the TearLab Reader and Pen TearLab Osmolarity Test Cards are for single use are clinically hygienic and individually packaged and contain a protective cover Never reuse or attempt to clean a Test Card Do not touch the Test Card tip after removal of the protective cover Although the device is manufactured to a level of disinfection deemed appropriate by the CDC Division of Healthcare Quality Promotion Disinfection and Sterilization of Patient Care Equipment 1985 last modified June 22 2005 it is not sterile and there is a minimal risk of infection ocular abrasion or vision loss as there is with any foreign object that is brought in direct contact with the eye and appropriate hygiene and care should be adhered to FDA MEDWATCH
31. udes two Pens to allow sequential tear fluid sample collection from multiple patients or from the left and right eyes of a single patient TEARLAB OSMOLARITY TEST CARD Each Test Card is a single use individually packaged nonsterile polycarbonate microchip containing a microfluidic channel to collect 50 nanoliters nL of tear fluid by passive capillary action and b gold electrodes embedded in the polycarbonate microfluidic channel to enable on board measurement of tear osmolarity Test Cards are clinically hygienic and have a protective cover that should be removed only after the Test Card has been successfully attached onto the Pen and immediately prior to tear collection Each Test Card is imprinted with a code that must be entered into the Reader at the time of testing Designed to work in conjunction with the TearLab Pen the Test Card does not contain chemicals or reagents and collects tear fluid in less than one second Please note that TearLab Osmolarity Test Cards are not included with the TearLab Osmolarity System and must be purchased separately TEARLAB ELECTRONIC CHECK CARDS Two identical blue reusable Electronic Check Cards are provided as a procedural quality control to confirm the function and calibration of the TearLab Osmolarity System within manufacturer specifications The Electronic Check Cards can be used simultaneously for quality control testing one with each Pen The Electronic Check Cards can be used to verify the func
32. ury is more likely TO GET THE RESULT Locate the code on top of the Test Card see example in picture Dock the Pen into the Reader within 40 seconds of collecting the sample Immediately press the RECALL Key gt below the UP and DOWN arrows to select the Test Card code IMPORTANT fa code is not selected within eight seconds the Reader will automatically use the default code displayed on the LCD Itis important to select the correct code to obtain an accurate osmolarity test result Press the OK Key or wait eight seconds to accept the code The test result will display in a few seconds Record the date and test result in the patient chart NOTE After recording test result remove the used Test Card from the Pen by pressing forward on top of the Test Card with your thumb Do not pull from the wings Dispose in an appropriate manner reference page 10 HAZARDS TESTING OSMOLARITY CONTROLS Test both levels of control solution with each new shipment of test cards even if the lot number is the same with each new lot number and monthly to check storage Read the control solution instruction sheet for expected values Attach a Test Card to the Pen refer to the How to Perform an Osmolarity Test section on page 5 of this manual Do NOT collect tears Instead of collecting tears use a control solution Use the blue sleeve to snap off the top of an ampule Turn the ampule upside down the fluid will
33. ystal display LCD The TearLab Osmolarity System simplifies the tear collection process by eliminating the need to transfer tear fluid samples and reducing the risk of evaporation PRINCIPLES OF THE PROCEDURE The TearLab Osmolarity Test utilizes a temperature corrected impedance measurement to provide an indirect assessment of osmolarity After application of a calibration curve to the steady state electrical impedance of the tear fluid osmolarity is calculated and displayed as a quantitative numerical value SYSTEM COMPONENTS TEARLAB OSMOLARITY SYSTEM READER The Reader is a portable countertop unit that calculates and displays the osmolarity test result The Reader has an LCD screen a keypad and an external AC power supply Left and right cradles allow two Pens to dock into the Reader When Pens are docked the Reader automatically converts the tear fluid sample data into an osmolarity measurement and displays the reading on the LCD TEARLAB OSMOLARITY SYSTEM PEN The Pen is designed to hold the Test Card and facilitate safe simple tear fluid collection The Pen electronics confirm the proper attachment of the Test Card onto the Pen detect the presence of tear fluid in the Test Card and signal when a tear fluid sample has been successfully collected Powered by a permanent rechargeable battery the Pen provides a mechanical electrical interface to convey data to the Reader automatically when docked Each TearLab Osmolarity System incl
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