Summary of Contents for Ace Medical ACEZIN GLUGlod
- Page 1 User’s Manual ACEZIN GLUGlod Blood Glucose Monitoring System Model No. AM100 plus...
- Page 3 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.
- Page 4 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”.
- Page 5 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...
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Page 6: Table Of Contents
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……………………..…………...……... - Page 7 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).
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Page 8: Intended Use
About AM100 plus SMBG System Intended Use ACEZIN GLUGold AM100 plus Blood Glucose Monitoring System is self- test 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. -
Page 9: System Kit
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 • Lancets • AAA (1.5 V) Alkaline Battery x 2 •... -
Page 10: Component Description
About AM100 plus SMBG System Component Description AM100 plus Blood Glucose Meter Test Strip Slot Insert test strip here. LCD Screen Strip Eject Button Displays blood Press to eject the used glucose results, strip messages, and glucose results stored in memory. S Button M Button Press to adjust... - Page 11 About AM100 plus SMBG System Component Description Meter Display Low Battery Symbol & Hour & Minute Wireless transmission Appears when battery is low Temperature Symbol Apply Blood Symbol Appears when ambient Your meter is ready to Month or Year temperature exceeds measure.
- Page 12 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.
- Page 13 About AM100 plus SMBG System Component Description Lancing Device Release Button Cocking Handle Depth Settings & Indicator Lancets Protective Cap Needle Handle...
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Page 14: Key Features
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. -
Page 15: Eject Strip Design
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. -
Page 16: Get Ready For Testing
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. - Page 17 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. Under Standby Mode, press and hold M button for 3 seconds to enter Setting Mode. Note: After battery replacement, meter automatically activates Setting Mode.
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Page 18: Quality Control Of The System
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. - Page 19 Quality Control of the System 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 To avoid contamination, Move the collection zone of test strip close to Glucose...
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Page 20: Perform The Blood Glucose Test
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. - Page 21 Perform the Blood Glucose Test 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. Pull the cocking handle out until it clicks. Wash hands first, or use an alcohol swab to wipe your finger clean.
- Page 22 Perform the Blood Glucose Test Hold the lancing device firmly against the side of your finger tip. Let go of the Release Button to take a sample. To avoid body fluid contamination, wipe off the first drop of blood with a clean gauze or cotton.
- Page 23 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.
- Page 24 Perform the Blood Glucose Test Meter beeps when blood is detected, and user can then move your finger away. Glucose test result displays in 5 seconds. The result is shown on the display. With Meal Comment Function on, test result appears with flashing symbol, depending on the setting.
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Page 25: Lo And Hi Readings
Perform the Blood Glucose Test After testing, push the lancet ejector forward to remove the lancet. Be sure to put protective cap of the lancet back before disposal. 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). -
Page 26: Memory Recall
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. - Page 27 Perform the Blood Glucose Test Press M button again to view the average record for last 14 days. Press M button again to view the average record for last 30 days. Press M button again to view the average record for last 60 days.
- Page 28 Perform the Blood Glucose Test To delete all records Press S and M buttons for 3 seconds, the screen will show "dA" for confirmation. Press S button again for 3 seconds to delete all records. Or if want to check out the delete function, press M button to return to Standby Mode.
- Page 29 Perform the Blood Glucose Test Wireless Transmission To activate Wireless Transmission function, please make sure your Wireless Transmission device have downloaded APP, and follow pairing instruction. 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 “...
- Page 30 Perform the Blood Glucose Test This equipment has been tested and found to comply with the limits for a 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.
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Page 31: Maintain Your Meter
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. Storage and Handling Keep your meter free from dust, and extreme weather. Always handle your meter with care. -
Page 32: System Specifications
System Specifications Limitations Do NOT use neonate blood sample. Blood Glucose Test Strips are for single use only. Never reuse a test strip that had either blood or control solution applied to it. Use AM100 plus Blood Glucose Monitoring System at room temperature between 10 °C ~ 40 °C (50 °F ~ 104 °F). -
Page 33: Product Specifications
System Specifications Product Specifications Product Name: AceZin GLUGold blood glucose meter Model No.: AM100 plus Range 20 ~ 600 mg/dl (1.1 ~ 33.3 mmol/l) Response time 5 seconds Memory sets 1000 Memory Sets Operating Temperature 10 °C ~ 40 °C (50 °F ~ 104 °F) Condition R.H. - Page 34 System Specifications Wireless Transmission Specifications RF Type 5.0 BLE RF Modulation GFSK Effective Radiated Power 3.99 dBm Data Throughput 1Mbps Expected Delay (Latency The latency time is less than 0.3ms Range) in Wireless (RF) second from sender to receiver. Communication Channel Quality-Driven Data Rate (CQDDR) technology increases the Integrity...
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Page 35: Display Messages And Troubleshooting
Test Strip. See "Perform the Glucose Blood Test” section. "Er 2" appears when the If "Er 2" appears constantly, please call Ace Medical meter fails to access Technology Co., memory. Ltd. or authorized distributor in business hours. Repeat the test with a new "Er 3"... - Page 36 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 Leave your meter in a room temperature falls out of around 10 °C ~ 40 °C (50 °F acceptable range (10 °C ~ 104 °F) for 15 minutes, ~ 40 °C /...
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Page 37: Device Information
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.bio... - Page 38 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.com...
- Page 39 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.
- Page 40 P/N: M709-000000-XXX VER: 001...