Summary of Contents for SIGHT SCIENCES TearCare
- Page 1 Document Number 07418 Rev C January 2022 © 2022 Sight Sciences. All rights reserved.
- Page 2 Instructions For Use...
- Page 3 TEARCARE.COM...
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Page 4: Table Of Contents
2.8.1 TearCare SmartHub ..........12 8.4.1 Electromagnetic Emissions ......... 29 2.8.2 TearCare SmartLids ..........14 8.4.2 Essential Performance .......... 30 PERFORMING A TEARCARE PROCEDURE ..15 8.4.3 EMC Susceptibility ..........30 Unpacking and Checking the TearCare System Products ........15 Preparing the Patient .......... -
Page 5: Introduction
• Ocular surface ulcers. should be directed to: • Hordeolum, stye, or chalazion. Sight Sciences, Inc. • Do not use TearCare in patients under the age of 22 years. 4040 Campbell Ave. • Pacemakers or implantable cardiac defibrillators (ICD). Suite 100 Use of the TearCare System may affect the performance... -
Page 6: Precautions
Section 2.7 “Clinical and/or reduced benefit. Study Summary.” • Use caution when using the TearCare System in patients with ocular surface abnormalities (e.g. pterygium, pingueculum, 2.5 POTENTIAL ADVERSE EFFECTS OF THE DEVICE corneal dystrophies, etc.) as the heat delivered by TearCare ON HEALTH... -
Page 7: For Prescription Use Only
There were 93 subjects There is a potential risk of thermal injury to eye or eyelid based in Cohort 1, comprised of 47 LipiFlow and 46 TearCare subjects on the device design. treated with the prior SmartLid design. There were 142 subjects in Cohort 2, comprised of 73 LipiFlow and 69 TearCare subjects 2.6 FOR PRESCRIPTION USE ONLY... - Page 8 (such as lifitegrast, cyclosporine, antihistamines), Table 1. Baseline Demographics (Cohort 1 + Cohort 2) or systemic medications (such as diuretics, anti-hypertensives) known to cause ocular dryness within specific timeframes prior TearCare Lipiflow Combined to enrollment, prior dry eye treatments (such as laser, thermal...
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Page 9: Baseline
Cohort 2. Subjects in both treatment groups min, max [2.81, 32.50] [2.94, 23.83] demonstrated a statistically significant improvement in both endpoints and the TearCare arm of the study established 95% CI [6.84, 8.43] [6.54, 7.62] non-inferiority relative to the LipiFlow arm for both TBUT TBUT change-from- and MGSS. -
Page 10: Total Meibomian Gland
Table 3. Change in MGSS at 1 month compared to baseline (Cohort 2) Results of the secondary endpoints for both treatment groups in Cohort 2 are presented in the following tables: Visit Parameter Statistics TearCare LipiFlow Table 4. OSDI – Mean change from baseline at 1-Month (Cohort 2) Baseline... -
Page 11: Median
No subject in either group experienced any serious adverse events Baseline or serious device related adverse events that required further management. There were 4 device related AEs in the TearCare N (eyes) group reported in 3 subjects (Chalazion-1, Superficial Punctate Total Conjunctival... - Page 12 2.1% (n=2 AEs/92 eyes) and 2.1% (n=3 AEs/138 eyes) (n=3 subjects/73) of subjects in Cohort 2 of the LipiFlow group. respectively in Cohort 1 and Cohort 2 of the TearCare group and The observed rate of ocular AEs of any type was 4.3% (4 eyes/ 1.0% (n=1 AEs/94 eyes) and 2.1% (n=3 AEs/146 eyes) respectively...
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Page 13: Lipiflow
LipiFlow subjects during and immediately following the procedure. However, by Day 1 the reported pain and discomfort was reduced and TearCare results were less than LipiFlow. Subjects were asked to indicate their level of pain and discomfort using a Visual Analog Scale with “0”... - Page 14 2 (2.9%) 4 (5.8%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (1.4%) Table 9. Proportion of subjects reporting discomfort, stratified by treatment arm and cohort TearCare (n=115) LipiFlow (n=120) Discomfort During During After 1 day after During After...
- Page 15 One subject The investigator did not consider this AE as device or procedure treated in the Cohort 1 of TearCare group had a history of visual related. No other subjects reported any significant visual acuity fluctuation in the right eye.
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Page 16: Device Description
TearCare SmartLids A control button on the center of the SmartHub (1) is used to turn the system on and off, and to initiate or discontinue the TearCare session. Two buttons, “+” and “-”, on the SmartHub (2 and 5) allow The single use SmartLid pair comprises four flexible, sensor- the user to adjust the preferred temperature level. - Page 17 Active therapy indicator Warmth setting decrease button SmartLid Port - left SmartLid Port - right Charging Port SmartLid error indicator - left Figure 1. TearCare SmartHub Feature key SmartLid error indicator - right Remaining Procedures (battery indicator) Timer complete indicator Timer indicators...
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Page 18: Tearcare Smartlids
A clip is included with each SmartLid. This clip may be used to secure the cables behind the patient’s head. Figure 2. TearCare SmartLid SmartLids are digitally marked as “used” during a session and cannot be re-used. The SmartHub will not allow initiation of a... -
Page 19: Performing A Tearcare Procedure
3. PERFORMING A TEARCARE PROCEDURE 3.1 UNPACKING AND CHECKING THE TEARCARE SYSTEM PRODUCTS Warning: Do not use any TearCare component if the component or its packaging appears damaged. Inspect all components for damage before each use. Caution: Do not use SmartLids if they are expired (past the expiration date on the label). -
Page 20: Applying The Smartlid
If the patient is wearing contact lenses, have them remove their SmartLids by forming a bend at the distal tip, and another in lenses prior to the TearCare procedure. the middle portion. iii. Have the patient tilt their head slightly up, and look down- ward with eyes closed. -
Page 21: Plugging The Smartlids Into The Smarthub
Figure 5 shows the SmartLids applied to all four eyelids. just lateral to the punctum Figure 4. SmartLid positioning on patient eyelids Figure 5. TearCare SmartLid attached to a patient’s eyelid 3.4 PLUGGING THE SMARTLIDS INTO THE SMARTHUB a) Position the cables behind the patient’s head to minimize pulling/twisting of the temple housing. -
Page 22: Starting A Tearcare Procedure
Caution: An eye care provider must be present during the entire heat treatment to ensure safe use of the device. d) The TearCare session will last for 15 minutes. The eye care provider should verbally instruct each patient • The Timer Indicator lights on the right-hand side of the... -
Page 23: Adjusting Temperature
• Inadvertently removing the SmartLid cables from the SmartHub NOTE: The TearCare therapeutic temperature operates to set will pause the procedure and delay the procedure. points ranging 41-45°C (106-113°F), which correspond to the •... -
Page 24: Terminating A Procedure Early
TearCare blinking of the level 5 warmth indicator. In addition, delivery of heat Clearance Assistant device (provided separately). -
Page 25: Charging The Smarthub
SmartHub from use and Caution: contact the Sight Sciences Customer Service Department (see • Use only the charger supplied with the TearCare System. Use of other AC adapters may result in Appendix B) or the Sight Sciences representative in your area. -
Page 26: User Maintenance
Caution: should not require technical maintenance. However, routine • Do not clean the TearCare SmartHub while the system is on cleaning for these re-usable components is recommended. or while the SmartHub and SmartLids are The section below discusses the prescribed cleaning method. -
Page 27: Troubleshooting
(None) seconds shutdown Power button light flashing Beeping, SmartHub power error Return SmartHub to Sight Sciences. All 4 Remaining Procedures (battery level) 10 seconds indicators flashing, followed by auto shutoff. Status Indicator light(s) flashes before SmartLid below indicator is Remove/replace used SmartLid. - Page 28 Remaining timer counter increments flashing procedure Step 3.5b. Power button light flashing If errors persist, replace SmartLid to continue. Return faulty SmartLid to Sight Sciences. Status Indicator on (steady) Steady tone, An error has occurred Check that connector is fully inserted 15 seconds communicating with the into the SmartHub port.
- Page 29 Step 3.5b. SmartHub turns off during procedure None Connector shorted Check ports for debris. Replace SmartLids to continue. Return faulty SmartLid to Sight Sciences. Excessive electrostatic discharge Determine and remove source of static charge. SmartHub Resets during procedure None...
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Page 30: Smartlid Troubleshooting
SmartLid (s) with new device. Therapy may be resumed by following Step 3.5b. SmartHub Power error Return SmartHub to Sight Sciences. SmartLid(s) do not stick Skin is not clean of dirt/oil/ Gently clean the patient’s eyelids and temples before adhering the makeup prior to application SmartLid(s). -
Page 31: Specifications
• Keep the SmartHub away from high electromagnetic fields. SmartLid Dimensions 4’3” L x .25” H x .75” W • TearCare may not perform to specification if stored (left or right) (1295 mm L x 6 mm H x or operated outside the specified enviornmental conditions above. -
Page 32: Standards Compliance
Compliance with EMC Standards All components of TearCare listed in the System Description If TearCare causes interference with other devices, or if other section (Section 2.6), including the accessories, have been tested equipment is causing interference with this equipment, which may... -
Page 33: Electromagnetic Emissions
8.4.1 ELECTROMAGNETIC EMISSIONS The TearCare System has been tested to the standards in the table below. To maintain proper function of the TearCare System as it pertains to EMC, all the instructions in this manual should be followed throughout the useful life of the product. -
Page 34: Essential Performance
8.4.2 ESSENTIAL PERFORMANCE The Essential Performance of the TearCare System is to provide controlled heat to a patient’s eyelids. If the Essential Performance is lost or degraded due to electromagnetic disturbances, the operator can expect the following: • Loss of temperature control resulting in a measured heater temperature exceeding 47°C that does not result in an “over temperature error.”... -
Page 35: Appendix A: Symbols
APPENDIX A SYMBOLS The following symbols are used on the TearCare System and component packaging. The symbols below comply with the international standard - ISO 15223-1:2021: ISO 7000 SYMBOL TITLE OF SYMBOL REG. NO. DEFINITION Warning 0434A Indicates the need for the user to consult the instructions for use for important warnings. - Page 36 ISO 7000 SYMBOL TITLE OF SYMBOL REG. NO. DEFINITION Manufacturer 3082 Indicates the device manufacturer. For prescription use only. Temperature limit 0632 Indicates the temperature limits to which the device can be safely exposed. Consult instructions 1641 Indicates the need for the user to consult the instructions for use. for use Keep dry 0626...
- Page 37 APPENDIX A The symbols below comply with the international standards listed below, as applicable. SYMBOL TITLE OF SYMBOL STANDARD DEFINITION Type BF applied part IEC 60601-1 Indicates the device has conductive contact with the patient. Separate Collection (disposal) EU WEEE Indicates this device is designed for separate collection at an appropriate Directive collection point.
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Page 38: Product Returns
2. The equipment is used in accordance with the instructions for use. ADVERSE EVENT REPORTING Adverse events and/or potential patient injury complications that are reasonably associated with the use of the TearCare System should be reported to Sight Sciences, Inc. at the Manufacturer address below. MANUFACTURER Sight Sciences, Inc.
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