Related Manuals for Icare HOME
Summary of Contents for Icare HOME
- Page 1 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com INSTRUCTION MANUAL FOR HEALTH CARE PROFESSIONALS ENGLISH...
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Page 2: Table Of Contents
18.1 Clinical performance data ................22 19. Symbols ......................29 20. Electromagnetic declaration ................30 Appendix 1. Icare home tonometer training procedures for certification of health care providers (HCP) ............34 Appendix 2. Icare home tonometer training procedures for certification of the patient for self-use .............. -
Page 3: Safety Instructions
To prevent contamination, do not touch the bare probe, do not use a probe if it touches a non-sterile surface like a table or a floor. WARNING! The Icare HOME Tonometer is indicated for use only under supervision of a health care professional. WARNING! Patients must be certified and trained for the procedures described in this manual prior to the device being prescribed for home use. - Page 4 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English WARNING! Federal (US) law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
- Page 5 • Bench testing of the Icare HOME tonometer on model eyes showed that there was no impact on probe function and performance with 30 repeated uses within a single testing session. The impact on probe function and performance when the probe is repeatedly used over 30 times is unknown.
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Page 6: Indications For Use
Icare HOME tonometer Instruction manual for health care professionals English 2. INDICATIONS FOR USE The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients. 3. CONTRAINDICATIONS... -
Page 7: Introduction
(right or left) and measurement quality. The Icare HOME tonometer can record over one thousand measurement results. You can copy the recorded measurement information to a PC through a USB cable. -
Page 8: Before You Start
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English BEFORE YOU START Find the main parts, buttons and indicator lights of the tonometer in the below figures. FRONT PARTS... -
Page 9: Setting Up The Tonometer
Icare HOME tonometer Instruction manual for health care professionals English SETTING UP THE TONOMETER Setting up your Icare HOME tonometer is easy, with few steps. The following subchapters describe how you get started. INSTALLING OR CHANGING THE BATTERY PRECAUTION! Make sure you use batteries with built-in PTC protection, for example Energizer Lithium Photo 123 3V CR123A. -
Page 10: Loading The Probe
The Icare HOME tonometer uses single-use probes that are packed in a plastic tube (container) and wrapped in blister packs as shown in the figures below. - Page 11 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English To load the probe: 1. Unwrap the probe. 2. Remove the lid of the 3. Drop the probe into...
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Page 12: Using The Tonometer
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English USING THE TONOMETER 10.1 CHOOSING THE MEASUREMENT MODE The tonometer can operate in two modes: Series mode The series mode is especially useful in self-tonometry. -
Page 13: Adjusting The Measurement Position
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English 10.2 ADJUSTING THE MEASUREMENT POSITION WARNING! Do not push the tonometer into the eye (the tip of the probe should be 4-8mm, or 5/32-5/16”, from the eye). -
Page 14: Automatic Eye Recognition
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English 10.3 AUTOMATIC EYE RECOGNITION PRECAUTION! Do not cover the eye recognition transmitters or sensor during the measurement, for example with fingers. -
Page 15: Taking The Measurements
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English 10.4 TAKING THE MEASUREMENTS WARNING! Do not push the tonometer into the eye (the tip of the probe should be 4-8mm, or 5/32-5/16”, from the eye). - Page 16 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English Correct measurement position. Incorrect measurement position. Incorrect measurement position. Correct alignment of the Incorrect alignment of the Incorrect alignment of the tonometer.
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Page 17: Reading The Measurement Data
Icare LINK software or when upgrading the HOME TA022 software using the Icare LINK software. Also the tonometer does not allow you to take any measurements when the USB is connected. All other traditional cybersecurity controls (anti- virus software, malware software, separate network for the device, etc.) do not apply since the... -
Page 18: Troubleshooting
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English TROUBLESHOOTING The tonometer automatically monitors and controls the measurement position and speed of the probe during the measurements, and indicates errors with sounds and lights. - Page 19 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English LOAD LOAD LOAD LOAD LOAD LOAD MEASURE MEASURE MEASURE MEASURE MEASURE MEASURE REPEAT REPEAT REPEAT REPEAT REPEAT REPEAT DONE...
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Page 20: Cleaning The Probe Base
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English 13. REPLACING THE PROBE BASE Replace the probe base every twelve months. Replace or clean the probe base if the Service light flashes. -
Page 21: Accessories
Measurement range: 5-50 mmHg. Accuracy and precision (bench study): Icare performed testing to evaluate the accuracy and precision of the Home tonometer in its intended measuring range in accordance with ANSI Z80.10 “Ophthalmic Instruments – Tonometers”. The testing was performed by measuring a manometrically controlled test eye. The pressure in the test eye was adjusted by a hydrostatic head and controlled manometrically by an attached calibrated pressure sensor as reference. -
Page 22: Clinical Performance Data
‘glaucoma suspect.’ Participants were trained by study staff as part of the certification procedure on how to use the Icare HOME tonometer. After a 10- minute break, the participants were asked to make three self-measurements without any direct supervision or interaction. - Page 23 Home reading and the GAT measurement differed by > 5mmHg (6.3%), subject requested to stop, (0.7%), and subject unable to use the device (3.0%). As a result, the Icare HOME labeling includes the same training and certification procedures described in the protocol for the patient to be eligible for home-use of the tonometer.
- Page 24 • Central corneal thickness greater than 0.60 mm or less than 0.50 mm in the study eye • Inability to demonstrate proficiency with Icare Home tonometer after training and failure to complete certification procedures described in the attachment to this protocol •...
- Page 25 23 mmHg % = Count N 100. 9 eyes had IOP ≥ 30 mmHg. Table 2 provides descriptive statistics for the IOP measurements from the Icare Home, GAT, and TA01i. Table 2. Descriptive Statistics of IOP Measurements (Effectiveness Analysis Cohort)
- Page 26 Cohort. N is the number of eyes with measurements from both devices. Difference = HOME - Reference. 95% confidence interval (CI) for mean difference is based on t-distribution. 95% limits of agreement (LOA) = mean difference ± 2 difference SD.
- Page 27 (CI) for mean difference is based on t-distribution. 95% limits of agreement (LOA) = mean difference ± 2 difference SD. % = n N 100. The first HOME IOP measurement of each study eye was used in the analysis. The Mean/Median of GAT was used in the analysis: the median was used if the eye had three measurements.
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Page 28: Icare Home Tonometer Instruction Manual For Health Care Professionals English Www.icare-Usa.com
“worst case scenario” as during the study visit subjects underwent more HOME measurements in a short period of time compared to what would be experienced by patients in real world use of the device. Nonetheless, under these study conditions, only 5% of eyes experienced an increase in staining after certification compared to baseline and only one eye (0.3%) experienced an increase of two... -
Page 29: Symbols
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English SYMBOLS Keep dry Caution Manufacturing date See operating instructions for more information Lot number BF-type device STERILE R Sterilized using irradiation... -
Page 30: Electromagnetic Declaration
Guidance and manufacturer’s declaration IEC 60601-1-2: Edition 4.0; 2014-02 - Electromagnetic emissions Icare HOME (TA022) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The user of the Icare HOME (TA022) should assure that it is used in such an environment. - Page 31 Guidance and manufacturer’s declaration IEC 60601-1-2: Edition 4.0; 2014-02 - Electromagnetic immunity Icare HOME (TA022) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The customers or users of Icare HOME (TA022) should assurre that it is used in such enviroment...
- Page 32 Icare HOME (TA022) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The customer or the user of the Icare HOME (TA022) should assure that it is used in such an environment. IEC 60601 test Compliance...
- Page 33 Guidance and manufacturer’s declaration IEC 60601-1-2: Edition 4.0; 2014-02 – Electromagnetic immunity Icare HOME (TA022) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The customer or the user of the Icare HOME (TA022) should assure that it is used in such an environment.
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Page 34: Appendix 1. Icare Home Tonometer Training Procedures For Certification Of Health Care Providers (Hcp)
2. Install batteries to the tonometer as instructed in the Icare HOME user documentation. 3. Install Icare LINK software to your PC as instructed in the Icare LINK user documentation. STEP 2 – Instruct the HCP 1. Show and explain the tonometer’s user interface, including icons and status indicators: •... - Page 35 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English 2. Turning the tonometer on: • Press the power button. All indicator lights on the back panel will flash once and you will hear a short beep.
- Page 36 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English 7. Show and explain how to collect, display and store the results (for HCPs only): • • Connect the tonometer to the PC using the USB cable. The Load and •...
- Page 37 2. Observe if the positioning is correct. Do not supervise or interact. STEP 6 – Certification Connect device to computer and view the readings in the Icare LINK software. The HCP passes the training and is certified for performing tonometry on...
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Page 38: Appendix 2. Icare Home Tonometer Training Procedures For Certification Of The Patient For Self-Use
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English APPENDIX 2. ICARE HOME TONOMETER TRAINING PROCEDURES FOR CERTIFICATION OF THE PATIENT FOR SELF-USE measurements. reasons for certification failure. - Page 39 Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME tonometer Instruction manual for health care professionals English The HCP turns on the tonometer: • Press the power button. All indicator lights on the back panel will flash once and you will hear a short beep.
- Page 40 Icare HOME tonometer Instruction manual for health care professionals English STEP 3 – Supervised patient use of the icare home 1. Load a new probe and carefully, without touching the patient’s eye, choose the eye and set the distance between the tip of the probe and the center of the cornea for support positioning as needed.
- Page 41 Icare HOME tonometer Instruction manual for health care professionals English Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare HOME www.icaretonometer.com...
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Page 42: Icare Finland Oy
Icare HOME tonometer Instruction manual for health care professionals ENGLISH www.icare-usa.com Icare Finland is the original developer and global leader in handheld tonometry. Our patented technology (over 20 patents/patent applications) combined with ISO 13485 certified quality system has made us a respected player in our field of expertise.