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ABOUT THIS PRODUCT
Thank you for choosing ForaCare POCT S10 Blood Glucose
Monitoring System. Please use with ForaCare POCT S10 Blood
Glucose Test Strips only.
This easy-to-use POCT system provides fast, accurate results,
including automatic upload of test results to hospital and laboratory
information systems which enables powerful data management.
This POCT system also reduces risks of operator errors and allows
one hand operation by hospital professionals through simple steps.
Integrated barcode scanning helps reduce the risk of manual data
entry errors as well. There is no subjective calibration procedure
required.
This manual contains important information about the system.
Please read it thoroughly and carefully, and keep it for future
reference. If you have further questions about this system, please
contact the Customer Service for assistance.
Version 1.0 10/2011
311-4258200-002
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Table of Contents
Related Manuals for ForaCare POCT S10a
Summary of Contents for ForaCare POCT S10a
- Page 1 ABOUT THIS PRODUCT Thank you for choosing ForaCare POCT S10 Blood Glucose Monitoring System. Please use with ForaCare POCT S10 Blood Glucose Test Strips only. This easy-to-use POCT system provides fast, accurate results, including automatic upload of test results to hospital and laboratory information systems which enables powerful data management.
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Page 2: Important Safety Instructions
IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USE The following basic safety precautions should always be taken. 1. Only the healthcare providers who have trained for this system should operate. 2. Use the device only for the intended use described in this manual. - Page 3 11. The meter should be disinfected after use on each patient. This Blood Glucose Monitoring System may only be used for testing multiple patients when Standard Precautions and the manufacturer’s disinfection procedures are followed. Please refer to section Taking Care of the Meter & Strips for cleaning and disinfection procedures.
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Page 4: Table Of Contents
TABLE OF CONTENTS IMPORTANT SAFETY INSTRUCTIONS INTRODUCTION Intended Use Important Information Contents of System THE SYSTEM Appearance of the Meter Meter Function Test Strip BEFORE USE Battery Setup & Recharge Setup Mode Barcode Scanning Procedure Calibration TRAINING CONTROL TEST Guidelines for Control Solution Testing Control Test Procedure PATIENT TEST Collecting Blood Samples... - Page 5 TAKING CARE OF THE METER & STRIP Disinfecting Procedures Storage ERROR MESSAGES SPECIFICATIONS Performance Characteristics...
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Page 6: Introduction
Important Information Before you start, there are a few important things to remember. Before performing patient tests, please read this Operator’s Manual carefully. The ForaCare POCT S10 Blood Glucose Monitoring System must be properly set up (configured) before performing patient or quality control tests. Configurations can be set up on the meter or through POCT Management System according to each facility’s requirements. -
Page 7: Contents Of System
Contents of System The ForaCare POCT S10 Blood Glucose Monitoring System includes the following items: Meter Control solutions Docking station mini USB cable Battery Operator’s manual POCT Management System Operator’s Manual Note 1. Please make sure that all components listed above are included in the kit before using this system. -
Page 8: The System
THE SYSTEM Appearance of the Meter USB port (for mini USB cable) Strip Ejection Button Recharge Indicator LCM Panel Reset Key Battery Compartment Up Button On/Off Button Scan Button Down Button Number Key Return Button Barcode Scanner... -
Page 9: Meter Function
Meter Function When the meter is turned on by pressing On/Off button, there are four modes on the main menu: Measure Mode, QC Mode, Memory Mode, Urgent Mode and Setup Mode. User can select each mode simply by pressing Up button or Down button and enter the desired mode by pressing S button. -
Page 10: Test Strip
Test Strip Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction cell where the reaction takes place. The test strip consists of the following parts: Absorbent Hole Apply a drop of blood here and the blood will be sucked up automatically. -
Page 11: Before Use
BEFORE USE Battery Setup & Recharge This meter uses one Li-ion rechargeable battery. Please follow the instructions below to setup the meter. 1) Press and push the battery cover on the back of the meter outward, and then remove the cover. 2) Read the instructions on the battery first. Then put in the battery and push it to the right side of the compartment and insert the battery appropriately. -
Page 12: Setup Mode
Setup Mode Please follow the step-by-step instructions below to setup your ForaCare POCT S10 Meter. 1.) Setting the year, month, and date 2008/06/20 12:59 AM Training Press On/Off button to turn on the Setting Date meter. After press Up/Down button to Setting Uni t select”... -
Page 13: Barcode Scanning Procedure
Press Up/Down button to select the Setting time desired “hour” and “minute”. Press S button to the next step. : 32 AM 3.) Setting the unit of blood glucose The screen returns to “Setup Mode” menu. Press Up/Down button to Measurement unit Measurement uni t select “Measurement Unit”... -
Page 14: Training
Training Each operator has to pass a training test through Training Mode before performing measurements for patients (Measure Mode). This ForaCare POCT S10 system will evaluate the examinee’s training by simple testing and only successful trainees will be- come proficient operator to access Measure Mode. Training Test Procedure Please follow the steps below to access Training Mode. - Page 15 PC via a USB cable. Note If the examinee passes the evaluation, he/she will become a “Proficient Operator” and only “Proficient Operator” can ac- cess the Measure Mode. For detailed information about the POCT Management System, please refer to ForaCare POCT Management System Operator’s Manual.
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Page 16: Control Test
ForaCare POCT S10 Blood Glucose Monitoring System. Only use the control solutions for ForaCare POCT S10 test strips. When using a new bottle of control solution, write the opening date on the bottle label. Each bottle of control solution is stable for use within 3 months after first opened (replace cap tightly af- ter use each time). Discard all remaining solutions after opened... -
Page 17: Control Test Procedure
Note Users should follow local, state and federal regulations for quality control testing since the test system is considered CLIA moderately complex. Control Test Procedure Use the following procedure to perform control tests. 12:59 AM 2008/06/20 1.) Press On/Off button to turn on meter. Measure Mode QC Mode Memory Mode 2.) Press Up/Down button to select QC Mode. - Page 18 7.) Apply a drop of control solution to Apply sample to strip the absorbent hole of the test strip until the confirmation window is fully covered with blood. 8.) Wait for the meter to finish analyz- ing the sample and display the test result. Note The meter will produce a beep sound and then begin to count down. The results will display on the screen and automatically saved in the meter.
- Page 19 10.) Push up the Strip Ejection button and the strip will be ejected, and the meter will shut down automatically. 11.) If the test result fails, the operator may select one of the following : 0. Cancel 1. Repeat test 2. Finish test If the test result passes, the operator may select one of the following: Pass 0.
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Page 20: Patient Test
Change gloves between patients. Wear protective glasses and/or other protective clothing if necessary. Use control solutions approved for ForaCare POCT S10 Blood Glucose test strips use only to ensure the performance of Fora- Care POCT S10 Blood Glucose test strips and meter. -
Page 21: Collecting Blood Samples
Collecting Blood Samples WARNING To reduce the chance of infection: Never share a lancet or the lancing device. Only auto-disabling, single use lancing devices may be used with this device. Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device. -
Page 22: Patient Test Procedure
Patient Test Procedure 1.) Press On/Off button to turn on the the meter. 2.) Press Up/Down button to select 2008/06/20 12:59 AM Measure Mode. Setup Mode Measure Mode QC Mode 3.) Press S button to scan the Opera- Operator ID tor ID barcode, or manually enter the Operator ID via the keypad. Operator: Patient ID : Test Strip Lot: Test strip Lot : Patient ID: 4.) Press S button to scan the Test... - Page 23 5.) Press S button to scan the Patient Test strip ID Patient ID ID barcode, or manually enter the Patient ID via the keypad. Op. :A100000029 Pt. :04731221 Lot: Test strip Lot : Patient ID: 6.) Press Up/Down button to select Sample Type Capillary/Venous, press S button to the next step. Capillary Venous Note Select VENOUS only for venous samples.
- Page 24 10.) Wait for the meter to finish ana- Analyzing sampl e lyzing the sample and display the wait fo r test result. seconds Note The meter will produce a beep sound and then begin to count down. The results will be display on the screen and automati- cally saved in the meter.
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Page 25: Results Indicators
Results Indicators Message What it means 12:59 AM 2008/06/20 The result is below measurement limit, Less than mg/dL 20 mg/dL. (1.1 mmol/L). Please remove strip 12:59 AM 2008/06/20 This indicates low blood glucose level. The "low" blood glucose level is between mg/dL 20 mg/dL and 69 mg/dL (1.1 mmol/L and Please remove strip 3.8 mmol/L). -
Page 26: Memory Mode
Memory Mode Reviewing Test Results ForaCare POCT S10 Meter stores 2000 sets of test results that can be retrieved by the following categories: All Record: This option displays all data. Patient Record: This will display the test results for a particular patient. - Page 27 Please follow the steps below to access the Memory Mode menu: 1.) Press the On/Off button to turn on the meter. 2.) Press Up/Down button to select 12:59 AM 2008/06/20 Memory Mode, then press S QC Mode Urgent Memory Mode button. Setup Mode 3.) Press Up/Down button to select 2008/06/20 12:59 AM Test Results. Proficiency Dat a Test Results QC Dat a Note...
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Page 28: Reviewing Test Results By All Records
Reviewing Test Results by “All Records”: 1.) Press Up/Down button to select 12:59 AM 2008/06/20 Memory Mode, then press S Urgent QC Mode button. Memory Mode Setup Mode 2.) Press Up/Down button to select 2008/06/20 12:59 AM Test Results, then press S button. Proficiency Dat a Test Results QC Dat a 3.) Press Up/Down button to select 2008/06/20 12:59 AM... -
Page 29: Reviewing Test Results By Patient Record
Reviewing Test Results by “Patient Record”: 1.) Press Up/Down button to select 2008/06/20 12:59 AM Test Results, then press S button. Proficiency Dat a Test Results QC Dat a 2.) Press Up/Down button to select 2008/06/20 12:59 AM Patient Record, then press S All Record Patient Record button. Operator Record 3.) Scan or manually enter the Patient Search by Patient ID via the keypad, then press Enter. -
Page 30: Reviewing Test Results By Operator Record
Reviewing Test Results by “Operator Record” 1.) Press Up/Down button to select 2008/06/20 12:59 AM Test Results, then press S button. Proficiency Dat a Test Results QC Dat a 2.) Press Up/Down button to select 12:59 AM 2008/06/20 Operator Record, then press S Patient Record Operator Record button. Search by Value 3.) Scan or manually enter the Opera- Search by operator tor ID via the keypad, then press... -
Page 31: Reviewing Test Results By Search By Value
Reviewing Test Results by “Search by Value” 1.) Press Up/Down button to select 2008/06/20 12:59 AM Test Results, then press S button. Proficiency Data Test Results QC Data 2.) Press Up/Down button to select 12:59 AM 2008/06/20 Search by Value, then press S Operator Record Search by Value button. All Record 3.) Press Up/Down button to select Search by value value range, then press S button. -
Page 32: Reviewing Qc Data
Reviewing QC Data ForaCare POCT S10 Meter stores 500 sets of QC data (each set includes test results of the three levels of control solution) that can be retrieved by the following categories: All QC Record: This option displays all QC records. Search by Level: This will display test results of a particular control solution level range. -
Page 33: Reviewing Qc Data By All Qc Records
Reviewing QC Data by “All QC Record” Please refer to “Memory Mode” section for step-by-step instruc- tions to access to the Memory Mode menu. 1.) Press Up/Down button to select QC 2008/06/20 12:59 AM Data, then press S button. Test Results QC Data Proficiency Data 2.) Press Up/Down button to select All 12:59 AM 2008/06/20 QC Record, then press S button. -
Page 34: Reviewing Qc Data By Search By Level
Reviewing QC Data by “Search by Level” Please refer to “Memory Mode” section for step-by-step instructions to access to the Memory Mode menu. 1.) Press Up/Down button to select 2008/06/20 12:59 AM QC Data, then press S button. Test Results QC Data Proficiency Data 2.) Press Up/Down button to select 12:59 AM 2008/06/20 Search by Level, then press S... -
Page 35: Reviewing Qc Data By Search By Strip
Reviewing QC Data by “Search by Strip” Please refer to “Memory Mode” section for step-by-step instructions to access to the Memory Mode menu. 1.) Press Up/Down button to select 2008/06/20 12:59 AM QC Data, then press S button. Test Results QC Data Proficiency Data 2.) Press Up/Down button to select 2008/06/20 12:59 AM Search by Strip, then press S... -
Page 36: Reviewing Proficiency Data
Reviewing Proficiency Data Please refer to “Memory Mode” section for step-by-step instructions to access Memory Mode menu. 2008/06/20 12:59 AM QC Data 1.) Press Up/Down button to select Pro. Data Pro. Data then press S button. Test Results Proficient Operator A100000001 A100000002 2.) Press Up/Down button to select A100000003 the proficient operator. A100000004 A100000005 : Next Page... -
Page 37: Taking Care Of The Meter & Strip
To obtain disinfecting wipes and other information, please contact Medline at 1-800-MEDLINE (1-800-633-5463) or visit www.medline.com. The Micro-Kill Plus disinfectant product has been shown to be safe for use with ForaCare POCT S10 meter, but any disinfectant product with the EPA registration number of (EPA Reg. No.59894-10-37549) may be used on this device. -
Page 38: Disinfecting Procedures
Disinfecting Procedures: 1.) Put on non-sterile gloves. 2.) Take out one disinfecting wipe from the package and squeeze out any excess liquid in order to prevent damage to the meter. 3.) Wipe all meter’s exterior surface display and buttons. Hold the meter with the test strip slot pointing down and wipe the area around the test slot but be careful not to allow excess liquid to get inside. - Page 39 The meter should be replaced after the validated number of cleaning and disinfection cycles or the warranty period, which ever comes first. Stop using the meter if you see any signs of deterioration, such as Meter can not be turned on LCD display cracks or becomes cloudy buttons no longer function outer casing cracks Data can not be transmitted to PC...
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Page 40: Storage
For more information regarding the risk of transmission of blood- borne pathogens, please refer to: “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm224025.htm “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”... - Page 41 2 . Strips Storage Storage conditions: 35.6°F to 89.6°F (2°C to 32°C), below 85% relative humidity. Do not freeze. Store your test strips in their original vial only. Do not transfer to another container. Store test strip packages in a cool, dry place. Keep away from direct sunlight and heat. After removing a test strip from the vial, imme- diately replace the vial cap and close it tightly.
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Page 42: Error Messages
ERROR MESSAGES MESSAGE PROBABLE CAUSE SOLUTION QC has to be done every 12 or 24 hours. If QC Error - 000 is overdue, “Error” will Please proceed with QC Mode. appear. After 3 seconds, device will enter QC Mode. Error - 002 Battery voltage too low Please recharge the battery. -
Page 43: Specifications
SPECIFICATIONS Model POCT S10 Dimension & 122mm x 64mm x 24mm, 130g (without battery) Weight Power Source One 3.7 V rechargeable Li-ion battery Memory 2000 test results and an additional of 500 sets of control solution testing data. Auto shutdown After idle for 3 minutes Data Mini USB cable Transmission Operating 50°F to 104°F (10°C to 40°C), below 85% R.H. -
Page 44: Performance Characteristics
PERFORMANCE CHARACTERISTICS Please refer to the test strip labeling for detailed information on test limitations and analytical performance. Accuracy Within ±15 mg/dL (0.83 mmol/L) at glucose concentration < 75 mg/dL (4.2 mmol/L) and within ±20% at glucose concentration ≥ 75 mg/dL (4.2 mmol/L). Precision The coefficient of variation (CV%) of intermediate precision and repeatability are less than 5%. This product has been tested to meet the requirements of ISO 15197. - Page 45 MEMO...
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