User’s Manual ACEZIN GLUGlod Blood Glucose Monitoring System A Model No.
Message to Our Dear User This booklet has important information you must know about ACEZIN GLUGold AM100 plus Blood Glucose Monitoring System with detailed directions and illustrations. To ensure that you use properly and obtain the best test results possible, please read the entire User’s Manual before testing. This package contains 2 new AAA alkaline batteries. Insert them into AM100 plus Blood Glucose Monitoring System by following steps in this manual to ensure normal function.
Caution To make sure that you operate AM100 plus Blood Glucose Monitoring System safely and accurately, please follow the user’s manual. Please keep AM100 plus Blood Glucose Monitoring System away from any liquid or sprays, keep them dry. Do not use AM100 plus Blood Glucose Monitoring System on purposes outside “Intended Use”. Only use accessories supplied or recommended by the manufacturer. Avoid severe impact on the meter. It may cause malfunction.
Appendices Explanation of Symbols Caution! Authorized representative in the European Community This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices Consult instructions for use In vitro diagnostic medical device Use-by date Manufacturer Date of manufacture Temperature limit Humidity limitation Keep away from sunlight Do not re-use Batch code Catalogue number 2 AAA (1.
Table of Contents About AM100 plus Blood Glucose Monitoring System…...……..…… 05 Intended Use Measuring Principle System Kit Component Description Key Features……………………………………………….……….…... 12 Eject Strip Design Meal Comment Function Get Ready for Testing…………………………………………..…...…. 14 Battery Installation Presetting Date and Time Quality Control of the System……………………………….…..…….. 16 Using Glucose Control Solution Perform the Blood Glucose Test……………………..…………...
About AM100 plus SMBG System Thank you for choosing AM100 plus Blood Glucose Monitoring System. Designed for ease of use, the device can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes. Important Information! Expected Results for Non-Diabetic, Non-Pregnant Adults: The normal fasting glucose range is 70 ~ 100 mg/dl (3.9 ~ 5.6 mmol/l). Two hours after meals, normal glucose values should be less than 140 mg/dl (7.8 mmol/l).
About AM100 plus SMBG System Intended Use ACEZIN GLUGold AM100 plus Blood Glucose Monitoring System is selftest medical device and intended for home testing to monitor the blood glucose (β-D-glucose) levels in fresh capillary whole blood from fingertip and venous whole blood. ACEZIN GLUGold AM100 plus Blood Glucose Monitoring System is for In-vitro use only.
About AM100 plus SMBG System System Kit • AM100 plus Blood Glucose Meter • AMG011 Blood Glucose Test Strips (Sold separately) • ACEZIN GLUGold Control Solution (Sold separately) • Lancing Device • 50 Lancets • AAA (1.5 V) Alkaline Battery x 2 • Pouch • Complete instructions: 1. User’s Manual for AM100 plus Blood Glucose Monitoring System 2. Quick Reference Guide 3. Logbook Note Please consult your provider/local distributor for extra Blood Glucose Test Strips and Glucose Control Solution pack.
About AM100 plus SMBG System Component Description AM100 plus Blood Glucose Meter Test Strip Slot Insert test strip here. LCD Screen Displays blood glucose results, messages, and glucose results stored in memory. Strip Eject Button Press to eject the used strip S Button Press to adjust settings and digits M Button Press to enter different mode.
About AM100 plus SMBG System Component Description Meter Display 1 & 2 Hour & Minute 7 Wireless transmission 12 3 Month or Year 8 Apply Blood Symbol Your meter is ready to measure. 13 4 Day or Year 9 Decimal Point Appears when LCD displays blood glucose result in mmol/l unit. 14 5 MEM Appear while LCD displays past results. 10 mg/dl This device can display results in unit mg/dl. 15 6 AVG Appear while LCD displays average of past 7 /14/ 30/ 60 days result.
About AM100 plus SMBG System Component Description Blood Glucose Test Strips (Sold Separately) Contact Electrode Insert into the test strip slot. Insert the test strip as far as it will go. Top Edge (Collection Zone) Move blood sample or glucose control solution close to the top edge of the test strip. WARNING Keep the strip vial away from children; in case any choking hazard happens. The desiccate reagent in the vial may cause skin or eye irritation by contact.
About AM100 plus SMBG System Component Description Lancing Device Release Button Depth Settings & Indicator Lancets Protective Cap Needle Handle 11 Cocking Handle
Key Features Meal Comment Function Meal Comment Function enables our user to add pre-meal or post-meal symbols on each test result. AC symbol represents pre-meal results, while PC symbol represents post-meal results. It benefits user to better manage the glucose control plan, also your healthcare professional by providing data when diagnosing and prescribing. Follow below steps to activate Meal Comment Function: 1 Under Standby Mode (Right Figure), press S button to enter Meal Comment Setting Mode.
Key Features Note For those who do not wish to change meal comment to test results, simply remove test strip from test strip port after measurement ends. Meter will automatically store your test result in its memory with previous set symbol. With Meal Comment Function on: Pre-meal: Test result appears with Symbol . Post-meal: Our default setting. Test result appears with Symbol .
Get Ready for Testing To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipment, do not use the device near a mobile phone or microwave oven. Battery Installation The meter uses 2 pieces of AAA alkaline battery as power source. For new users, please insert 2 new batteries before use, and please replace old batteries with new ones when Low Battery Symbol shows up. Slide battery cover from back of meter.
Get Ready for Testing Presetting Date/ Time/ Unit Please pre-set your meter whenever you insert or replace the batteries. See following steps for details. 1 Under Standby Mode, press and hold M button for 3 seconds to enter Setting Mode. Note: After battery replacement, meter automatically activates Setting Mode. 2 When YEAR digits flash, press S button to select current year. When done, press M button to confirm.
Quality Control of the System Using Glucose Control Solution (Sold Separately) The purpose of ACEZIN GLUGold Control Solution is to perform a quality control test to verify whether your meter and test strips are working together properly. There are two levels of Glucose Control Solutions for different acceptable ranges: High Level and Medium Level. We recommend testing with both levels of Glucose Control Solution.
Quality Control of the System 3 Shake the vial of Glucose Control Solution well before use. Squeeze the vial but discard the first droplet. Squeeze the second droplet to your clean fingertip or on a clean object such as a transparency. NOTE Move the collection zone of test strip close to Glucose Control Solution droplet. Collection zone automatically drink the droplet in. When full, your meter beeps and counts down for 5 seconds.
Perform the Blood Glucose Test Perform the Blood Glucose Test CAUTION To avoid infection, do not share the lancing device and lancets with other people. The lancet is for single use only. Never reuse them. Be sure to save the protective cap of the lancet for later use. Remember to put it back on to the lancet before disposal. When or appears, ambient temperature falls out of acceptable range (10 °C ~ 40 °C / 50 °F ~ 104 °F).
Perform the Blood Glucose Test 4 Replace and screw the cap snugly. Choose the depth of lancing. Select 1~2 for soft or thin skin, 3~4 for average skin, 5~6 for thick or calloused skin. 5 Pull the cocking handle out until it clicks. 6 Wash hands first, or use an alcohol swab to wipe your finger clean. Wait until your hands are totally dry. 7 Insert the test strip into the test strip slot as the figure on the right.
Perform the Blood Glucose Test 8 Hold the lancing device firmly against the side of your finger tip. Let go of the Release Button to take a sample. 9 To avoid body fluid contamination, wipe off the first drop of blood with a clean gauze or cotton. Gently squeeze the fingertip to obtain the second drop of blood for testing. 10 With use. symbol on, your meter is ready for 11 Move the collection zone close to your finger tip. Do not drip your blood sample on the top of the test strip.
Perform the Blood Glucose Test NOTICE Make sure to apply enough blood on the collection zone of the Test Strip. An unfilled collection zone may lead to false or inaccurate result. Your Test Strip doesn’t have enough blood sample on it. An unfilled collection zone may lead to false or inaccurate result. A totally filled collection zone. Do not drip your blood sample on the top of the test strip. Instead, move the test strip close to blood sample, and let collection zone automatically drink the droplet in.
Perform the Blood Glucose Test 12 Meter beeps when blood is detected, and user can then move your finger away. 13 Glucose test result displays in 5 seconds. 14 The result is shown on the display. 15 With Meal Comment Function on, test result appears with flashing or symbol, depending on the setting. Note User can replace or Symbol by pressing and holding S button for 1 second and waiting to hear a “beep” sound, depending on their physical status. Pre-meal: Test result appears with Symbol .
Perform the Blood Glucose Test 17 After testing, push the lancet ejector forward to remove the lancet. Be sure to put protective cap of the lancet back before disposal. 18 Dispose of medical waste per local regulations. LO and HI Readings AM100 plus Blood Glucose Monitoring System can display results from 20 to 600 mg/dl (1.1 to 33.3 mmol/l). 1. If your test result is lower than 20 mg/dl (1.1 mmol/l), “LO” appears on LCD screen.
Perform the Blood Glucose Test Memory Recall AM100 plus Blood Glucose Meter can store up to 1000 test results with date and time automatically in its memory. When full, the meter will replace the oldest with the latest result automatically. User can also view their average results of last 7/ 14/ 30/ 60 days with ease. Note 1. To ensure accurate average values, please re-set date and time before use. 2.
Perform the Blood Glucose Test 3 Press M button again to view the average record for last 14 days. 4 Press M button again to view the average record for last 30 days. 5 Press M button again to view the average record for last 60 days. 6 To view the records in the memory: press M button again, the meter start displaying each test result with memory sequence number, and then corresponding date and time. 7 8 Keep pressing M button, user can scroll thorough all memory sets from the latest to the oldest.
Perform the Blood Glucose Test To delete all records 1 Press S and M buttons for 3 seconds, the screen will show "dA" for confirmation. 2 Press S button again for 3 seconds to delete all records. Or if you want to check out the delete function, press M button to return to Standby Mode. Note Once deleted, your data can NOT be restored.
Perform the Blood Glucose Test Wireless Transmission 1 To activate Wireless Transmission function, please make sure your Wireless Transmission device have downloaded APP, and follow pairing instruction. 2 Once the meter is on, the Wireless Transmission will broadcast with “ ” symbol shows up. When connect and data transmit to Wireless Transmission device, the screen flashes “ ” symbol. Please make sure the meter and Wireless Transmission device are in 5 meters.
Perform the Blood Glucose Test 1 This equipment has been tested and found to comply with the limits for a 2 Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Maintain Your Meter 1 Display Check When the meter is off, press any key to switch it on. The display should look exactly like the figure in the right. If not, call Customer Service of Ace Medical Technology Co., Ltd. 2 Storage and Handling Keep your meter free from dust, and extreme weather. Always handle your meter with care. Run a quality control test after strong impact of the meter. Important Information Watch out for ingress of water while wiping Test Strip Slot.
System Specifications Limitations 1 Do NOT use neonate blood sample. 2 Blood Glucose Test Strips are for single use only. Never reuse a test strip that had either blood or control solution applied to it. 3 Use AM100 plus Blood Glucose Monitoring System at room temperature between 10 °C ~ 40 °C (50 °F ~ 104 °F). Out of this range, the device just won’t work. 4 Extreme humidity may affect the results. A relative humidity greater than 80% may cause incorrect results.
System Specifications Product Specifications Product Name: Model No.: Range Response time Memory sets AceZin GLUGold blood glucose meter AM100 plus 20 ~ 600 mg/dl (1.1 ~ 33.3 mmol/l) 5 seconds 1000 Memory Sets Operating Condition Temperature 10 °C ~ 40 °C (50 °F ~ 104 °F) Humidity R.H. ≤ 80 % Meter -40 °C ~ 55 °C (-40 °F ~ 131 °F) R.H. ≤ 90 % Strip 4 °C ~ 30 °C (39.2 °F ~ 86 °F) R.H. ≤ 90 % Meter -40 °C ~ 55 °C (-40 °F ~ 131 °F) R.H. ≤ 90 % Package with Strips 4 °C ~ 30 °C (39.2 °F ~ 86 °F) R.
System Specifications Wireless Transmission Specifications RF Type RF Modulation Effective Radiated Power Data Throughput Expected Delay (Latency Range) in Wireless (RF) Communication 5.0 BLE GFSK 3.99 dBm 1Mbps The latency time is less than 0.3ms second from sender to receiver. Channel Quality-Driven Data Rate (CQDDR) technology increases the Integrity effective data rate and integrity in noisy environments.
Display Messages and Troubleshooting Display messages What it means "Er 1” appears when the strip is wet. "Er 2" appears when the meter fails to access memory. Troubleshooting Perform the test in a room around 10 °C ~ 40 °C, and R.H. ≤ 80 %. Repeat the test with a new Test Strip. See "Perform the Glucose Blood Test” section. If "Er 2" appears constantly, please call Ace Medical Technology Co., Ltd. or authorized distributor in business hours.
Display Messages and Troubleshooting Display messages What it means Troubleshooting When “HI t” or “LO t” Do not artificially heat or cool the meter. appears, ambient temperature falls out of Leave your meter in a room around 10 °C ~ 40 °C (50 °F acceptable range (10 °C ~ 104 °F) for 15 minutes, ~ 40 °C / then repeat the test. 50 °F ~ 104 °F). See "Perform the Glucose The meter is unable to Blood Test” section. measure. When appears, your batteries are about to run out.
Device Information AM100 plus Blood Glucose Monitoring System AM100 plus Blood Glucose Meter AMG011 Blood Glucose Test Strips ACEZIN GLUGold Glucose Control Solution ACEZIN Lancing Device ACEZIN Lancets Ace Medical Co., Ltd. No. 52, Dinghu Road, Guishan District 33378, Tauyuan City, Taiwan (R.O.C.) Tel: + 886-3-327-8180 Fax: + 886-3-327-8176 E-mail:amt@acemed.com.tw http://www.acemed.
Device Information Lancing Device Meets the requirement of MDD 93/42/EEC Medifun Corporation No. 8 Shuyi Rd., South Dist., Taichung City, Taiwan Tel: +886-4-22601991 http://www.medifuncorp.com Lancets Meets the requirement of MDD 93/42/EEC Tianjin Huahong Technology Co., Ltd A 01, Plant B, No.278 Hangkong Road, Tianjin Pilot Free Trade Zone (Air Poet Industrial Park), Tianjin 300308, China Tel: +86-022-58775333 http://en.huahong-technology.
Device Information Warranty Ace Medical Technology Co., Ltd. warrants that your ACEZIN GLUGold AM100 plus Blood Glucose Meter will be free from defects in materials and workmanship for one year from the date of purchase. If during this one-year period, the meter does not work properly because of a defect in materials or workmanship, Ace Medical Technology Co., Ltd. SERVICE will repair the meter or replace it with a new ACEZIN GLUGold AM100 plus Blood Glucose Meter or equivalent product free of charge.
P/N: M709-000000-XXX VER: 001
