Multi User Model. Product Overview

Transcription

1 Multi User Model Product Overview

2 Features and Benefits NO CODING EASY TO USE o o o Large LCD display. Large buttons with simple functions Easy Setup. Pre-Setup before shipping. Easy strip insertion. SMALL SAMPLE SIZE o Tiny 0.6 ul blood sample size. ACCURATE o Clinically proven. o Exceeds new ISO 15197:2013 accuracy standards. RUGGED o Used in Northern Climates and Clinics o Highly resistant to impact, moisture and temperature o Strongest Vials of all less interference from moisture and/or damage. more protection for test strips. o Carrying case clear meter holder for testing without removing meter from case. POPULAR IN CLINICS o Meter of choice - NIHB Northern Manitoba, Nursing Stations,, North East CCAC o Meter of Choice - MCI The Drs Office. o Meter of Choice - HealthPRO. o Meter of Choice - Corrections Canada. QUICK RESULTS o Results in six seconds or less. o Stores 960 test results. LONG BATTERY LIFE o Lasts one Year. o Free Battery Replacement LIFETIME UNLIMITED WARRANTY 1

3 Clinically Proven Accuracy The ISO Accuracy Standard (15197:2013) for Blood Glucose Meters specifies that 95% of glucose results, compared to laboratory results, must fall: o Within ± 0.83 mmol/l at concentrations < 5.6 mmol/l o Within 15% of laboratory results at concentrations 5.6 mmol/l For Type 1 Diabetes : 99% of individual glucose measured values must fall within zones A and B of a Consensus Error Grid (CEG) MediSure Exceeds the new ISO Accuracy Standards 2

4 Multi User Meter Kit Contents MediSure Blood Glucose Meter 3-Volt Lithium Battery (CR2032) User Guide Getting Started Guide Carrying Case Warranty Card Log Book Content and Specifications Meter Specifications Storage Conditions Memory Capacity Measurement Unit Display Reaction Time Meter Dimensions Meter Weight Measuring Range Power Supply Battery Lifetime Temperature: -20 ~+50 C Humidity RH 80% 960 test results with respective dates and times mmol/l LCD display 6 Seconds or less Millimeters 53 Grams (with battery) 1.1~41.7 mmol/l One 3 Volt lithium battery (Model CR2032) Over 1,000 tests Test Strip Specifications Strip Size Millimeters Storage Conditions Temperature: 2 ~30 C Humidity: RH 80% Blood Volume 0.6 µl Expiration of Test Strips See printed expiry on the side of test strip box or vial Chemical Assay Glucose Oxidase System Operating Conditions Test Strips Operating Conditions Sample Type Hematocrit of Tested Blood Altitude Limit Use only Medi+Sure Blood Glucose Test Strips Temperature: 10 ~40 C Humidity: RH 80% Capillary whole blood in finger 25%~60% To be used no higher than feet above sea level The meter is calibrated to capillary whole blood equivalent results 3

5 Product Comparison MediSure to Roche Accu-Chek Performa # Item MediSure Inc. Roche Diagnostics 1 Blood Glucose Meter MediSure Accu-Chek Performa 1.1 Requires Code Chip NO YES 1.2 Large LCD Screen YES YES 1.3 Results in 6 seconds 5 seconds 1.4 Sample Size 0.6µL 0.6µL 1.5 Weight 53g with battery 62g with battery 1.6 Meter Dimensions 54 x 93 x 16 mm 94 x 52 x 21 mm 1.7 Testing Reminder Alarms Meets ISO 15197:2013 Accuracy Standard YES YES 1.9 Battery One 3V type CR2032 One 3V type CR Free Battery Replacement YES UNKNOWN 1.11 Battery Life Approx 1 year Approx 2,000 tests 1.12 Auto Power On with test Strip insert YES YES 1.13 Auto Power off time 3 minutes 2 minutes 1.14 UnderDosing Detection YES YES 1.15 Memory Capacity 960 tests 500 tests 1.16 Measuring Temperature 10 C to 40 C 10 C to 40 C 1.17 Measuring Relative Humidity <= 80% 10 to 90 % 1.18 HCT Range 25% to 60% 10% to 65% 1.19 Sample Type Fresh whole blood Fresh whole blood 1.20 Meter storage conditions Temperature: -20ºC to 70ºC Temperature: -25ºC to 70ºC 1.21 Testing Range (mmol/l) 1.1 to 4.17 mmol/l 0.6 to 33.3 mmol/l 1.22 Continues Testing above 33.3 mmol/l YES NO 1.23 Strip Eject button NO NO 1.24 Blood type Capillary whole blood Capillary whole blood 1.25 Alternate Site Testing (AST) YES - Option YES - Option 1.26 Upload Data To Computer Yes - Via Cable & Software Yes - Infrared (IR) window & PDA 1.27 Average Display 7/14/21/28 day average 7/14/30 day average 1.28 Temperature Display YES NO 1.29 Lo and Hi Alerts YES YES 1.30 Date and Time Preset YES NO 1.31 Memory retained when changing battery YES YES 1.32 Multi Patient Use YES YES 1.33 In Between Cleaning CaviWipes VIHA Percept wipes 4

6 # Item MediSure Inc. Roche Diagnostics 1.34 Control Solutions Lo and Hi Lo and Hi 2 Test Strips 2.1 Covered by the Ontario Formulary Yes No 2.2 Chemical Assay (GOD) Glucose Oxidase (GDH-PQQ) -Quinoprotein glucose dehydrogenase, Pyrroloquinoline quinon 2.3 Interferance from Non Glucose Sugars - See: dicalprocedures/invitrodiagnostics/ucm htm NO Only if Green Symbol is on Vial - See Note (1) 2.4 Interferences for patients on Dialysis NONE UNKNOWN 2.5 Sip In Indicator YES YES 2.6 Insert Inidcators Arrow Arrow 2.7 Coding Chip required for insertion into Meter NO YES 2.8 Meter Calibration Required for new vial NO YES 2.9 Tamper Proof Vial YES NO 2.10 Tamper Proof Seal on Vial YES NO 2.11 Test Strip Expiry 18 months 18 months 2.12 Test Strip Expiry after opening 3 months until expiry 2.13 Reinforced Vial for Clinical and Institutional Protection YES - See Note (2) 2.14 Interfering Compounds (See Test Strip Inserts) High levels of acetaminophen, uric acid, ascorbic acid in blood may result in inaccurate glucose reading. Blood glucose readings from these cases should be interpreted with caution. Therapeutic levels of L-dopa or dopamine may result in inaccurate glucose readings with the system. Notes. (1). Accu-Chek Performa test strips are labeled with a green symbol to distinguish them from earlier test strips that were subject to a clinically relevant maltose interference. The green symbol can be found on the test strip box and on the label of the test strip container NO galactose (>0.83 mmol/l) will cause overestimation of blood glucose results. 2. Lipemic samples (triglycerides) (>20.3 mmol/l) may produce elevated blood glucose results. 3. Intravenous administration of ascorbic acid which results in blood concentrations of ascorbic acid (>0.17 mmol/l) will cause overestimation of blood glucose results. (2) MediSure is the Meter of choice for Corrections Canada. The Reinforced vial is the strongest in the industry. This prevents tampering while providing extra protection for test strips in a clinical and institutional Environment 5

7 Part Numbers MediSure Items: # Item Part Number 1 MediSure Multi Use Meter Kit. (Meter, Battery, Carrying Case, Log book). DG001MM 2 MediSure Test Strips - Box of 100 DG001S 3 MediSure Control Solution (1 bottle of Hi, 1 bottle of Lo) - DG001C 4 MediSure 3V replacement battery (free) DG001B 5 MediSure Log Book (free) DG001LB 6 MediSure Cable and Data Software (free) DG001D For Use by Individual Patients (not multi-use) 7 MediSure Single Patient Meter kit (for use by individual patients) - Meter, Battery, Lancing Device. Carrying Case, Log book, Qty G Lancets. (free with first purchase of test strips) DG001M 8 MediSure Lancing Device DG001L 9 MediSure 30G Twist Lancets DG030N 10 MediSure 33G Twist Lancets DG033N 6

8 TESTING AND CLEANING Fingertip Blood Sampling 1. Wash hands in warm, soapy water. Rinse well and dry thoroughly. 2. Press a single use lancing device firmly onto the chosen site and draw a sufficient blood sample. 3. Dispose of lancet device in a suitable sharps container. NOTES Only an auto-disabling, single use lancing device should be used. A new pair of clean gloves should be worn by the user before testing each patient. See section of How to Clean Your Device for more detailed information on Cleaning and Disinfection. Wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips. For more detailed information on cleaning and disinfection refer to How to Clean and Disinfect Your Device. in the user guide Viewing Test Results 1. Press the M button to turn on the meter. Press the M button again. 2. Last test results are displayed. Press < and > button to toggle results. 3. Press M button a third time to see 7, 14, 21, and 28 day averages. 4. Press S button to turn off Meter Cleaning and Disinfecting The MediSure Meter STEP 1: Clean Before Disinfecting 1. Dispense CaviWipes towelette. 2. Clean surface of your device with towelette to remove debris and bio burden. 3. Discard used towelette. STEP 2: Disinfect After Cleaning 1. Dispense CaviWipes towelette. 2. Disinfect pre-cleaned surface with towelette for 2 minutes. 3. Discard used towelette. 7

9 MediSure Canada Inc. Founded in 2010 in Ajax, Ontario, Canada. Mission to Provide Simplicity and Value to those who live with Diabetes. A Canadian Company Our jobs and taxes stay in Canada. Success with in retail, acute care, alternative markets in Canada. Health Canada Licensed with product in over 4,000 Pharmacies. MediSure is on all Provincial formularies and Insurance Plans. Sales Forces across Canada in every province and key cities. Flexible and Targeted Marketing and Educational Strategies. Excellent Quality - Manufactured to ISO standards with world class quality controls. A Highly Accurate system sold in 38 countries worldwide. Our high quality, technically advanced glucometers are free along with the purchase of our high quality affordable glucose test strips. We deliver the highest possible value, through our commitment to quality, customer service, and the most affordable prices. For more Information, please contact us at: info@medisure.ca