Users Manual ACEZIN GLUGlod Blood Glucose Monitoring System A Model No. AM100 plus 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 Users 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. Any concerns? Or need any assistance about maintenance? Please call our Ace Medical Technology Co., Ltd. office or authorized distributor during business hours. 1 Caution To make sure that you operate AM100 plus Blood Glucose Monitoring System safely and accurately, please follow the users 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. Do not take AM100 plus Blood Glucose Meter apart, or modify anything. Such action may void your warranty. Do not place anything on top of AM100 plus Blood Glucose Meter. Keep the whole AM100 plus Blood Glucose Monitoring System away from children. They may choke on battery, or tiny component parts by accident. Keep AM100 plus Blood Glucose Meter free from dust, hair, etc. Store the meter in its container after use. If you feel you are suffering from severe dehydration, stop using and consult healthcare professionals right away. If your symptoms are not consistent with blood glucose test results and you have followed all instructions this manual, seek your healthcare professional for help. Dispose of medical waste per local regulations. Warning for potential biohazard: Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral disease. So the healthcare professionals should wear disposable gloves and have an inoculation regularly to prevent infections. 2 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 (1.5 V) Alkaline Batteries Biological Risks Discard the used product to the recycling collection point according to local regulations 3 Table of Contents About AM100 plus Blood Glucose Monitoring System..... 05 Intended Use Measuring Principle System Kit Component Description Eject Strip Design Meal Comment Function Battery Installation Presetting Date and Time Key Features..... 12 Get Ready for Testing...... 14 Quality Control of the System..... 16 Using Glucose Control Solution Perform the Blood Glucose Test..... 18 Perform the Blood Glucose Test LO and HI Readings Memory Recall Limitations Product Specifications Maintain Your Meter........... 29 System Specifications....... 30 Display Messages and Troubleshooting..... 33 Device Information....... 35 4 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). Severe dehydration resulting from excessive water loss may cause false results. If you feel you are suffering from severe dehydration, consult the healthcare professionals immediately. Test results below 70 mg/dl (3.9 mmol/l) mean low blood glucose Test results greater than 240 mg/dl (13.3 mmol/l) mean high blood
(hypoglycemia). glucose (hyperglycemia). If you get results below 70 mg/dl (3.9 mmol/l) or above 240 mg/dl
(13.3 mmol/l), and do not have symptoms, repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dl
(3.9 mmol/l) or above 240 mg/dl (13.3 mmol/l), follow the treatment advice of your healthcare professional. Record the opening date of test strips on its vial. Discard all unused strips 90 days after opening date. The strips are for single use only. If your symptoms are not consistent with blood glucose test results and you have followed all instructions this manual, seek your healthcare professional for help. Warning of potential biohazard: Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral disease. 5 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 (-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. It is indicated to be used by diabetics at home or in a clinical setting by professional healthcare personnel to measure the glucose concentration for aiding diabetes management. The owner can only use AM100 plus Blood Glucose Meter with AMG011 Blood Glucose Test Strips. Measuring Principle We design AM100 plus Blood Glucose Monitoring System by using the latest biosensor technology. It measures the glucose levels of the blood specimen by using a disposable dry reagent strip which can produce an electrical current. And the current will transfer to the meter for measurement. The amount of the current is proportional to the amount of glucose present in the blood sample. Test results are plasma equivalent. The system consists of three main products: AM100 plus Blood Glucose Meter, AMG011 Blood Glucose Test Strips, and ACEZIN GLUGold Control Solution. These products have been designed, tested, and proven to work together and perform accurate results. Note The accuracy of AM100 plus Blood Glucose Monitoring System was compared with YSI 2300 Analyzer. 6 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. Users 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. If contents of your package do not meet the system kit list local the whole package return to above, please distributor. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. 7 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 M Button Press to enter different mode. S Button Press to adjust settings and digits 8 1
2 5 6 About AM100 plus SMBG System Component Description Meter Display Hour & Minute 7 Wireless transmission 12 3 Month or Year 4 Day or Year Apply Blood Symbol Your meter is ready to measure. Decimal Point Appears when LCD displays blood glucose result in mmol/l unit. MEM Appear while LCD displays past results. mg/dl This device can display results in unit mg/dl. AVG Appear while LCD displays average of past 7 /14/ 30/ 60 days result. mmol/l This device can display results in mmol/l unit. 8 9 10 11 Low Battery Symbol Appears when battery is low Temperature Symbol Appears when ambient temperature exceeds operating temperature. Control Solution Test Symbol Appears while performing Control Solution Mode. Pre-meal or Post-meal Symbol Indicates whether the test result is taken before or after meal. 13 14 15 9 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. Note Only u se AMG011 Blood Glucose Test Strips with AM100 plus Blood Glucose Meter only. Do not touch the strip when your hands are wet. Record the first opening date on the vial, and use them within 90 days after first opening. If not, discard them in case inaccurate results may occur. Blood Glucose Test Strips are for single use only. Never reuse. Keep Blood Glucose Test Strips in vial always. Bending, cutting, or twisting strips are prohibited. Read Users Manual for AMG011 Blood Glucose Test Strips for more information. 10 About AM100 plus SMBG System Component Description Lancing Device Release Button Cocking Handle Depth Settings & Indicator Lancets Protective Cap Needle Handle 11 Key Features Meal Comment Function Meal Comment Function enables our user to add pre-meal or post-meal symbols on each represents pre-meal results, while PC symbol represents post-meal results. result. AC symbol test 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. 2 Our default setting is off (Upper Right). Press S button to switch the function on (Lower Right), or off. When done, press M button and return to Standby Mode. 12 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 . When measurement ends, users can press and hold the S button for 1 second, then waiting to hear a beep sound while LCD displaying the or Symbol, depending on their physical status. Eject Strip Design AM100 plus meter features its eject strip function, which provides user can take out the used strip by pushing and slide the strip eject button after taking measurement. 13 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. Install 2 new AAA alkaline batteries in accordance with correct polarities. Put the battery cap back. Note Flashing Symbol means the battery power is too low to work. Past results in storage are intact after battery replacement. After battery replacement, please reset year, date and time. Do not mix new and old batteries. To save the power, please take batteries out if you do not use the meter for a long period (approx. 2 months or more). 14 1 2 3 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. When YEAR digits flash, press S button to select current year. When done, press M button to confirm. To complete date and time settings, repeat above steps by setting MONTH, DATE, HOUR and MINUTE in sequence. the setting select After preferable unit by pressing S button. When done, press M button to confirm. correct year, 15 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. How does it work?
A known amount of glucose in the control solution reacts with AMG011 Blood Glucose Test Strip. Who or when to perform a control solution test?
Handling your meter at the first time. After opening a new vial of test strips. Strong impact on the meter. When your symptoms do not agree with the way you feel, or when the result Whenever users wish to check whether Blood Glucose Test Strip and Blood is higher or lower than expectation. Glucose Meter are working properly. Note For accurate results on both blood glucose measurements and quality control tests, use ACEZIN GLUGold Control Solution only. Results of quality control tests will not be stored in the memory. 1 Insert test strip into test strip slot. When symbol flashes, press S button to activate Quality Control Mode. With symbol on, your meter is ready to perform quality control test. 16 NOTE To avoid contamination, do not apply the control solution to the test strip directly from the bottle. 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. 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. 4 When results match with acceptable range printed on the Test Strip vial, your System is working properly. Note Check the Test Strip vial for acceptable ranges for High and Medium Levels. Refer to Glucose Control Solution instruction before use. Understanding Your Test Results When results match with acceptable range printed on the Test Strip vial, your System is working properly, and your test results are reliable. If your results do not match with the acceptable range, please check the following:
Are the control solutions or test strips within the expiration date?
Has the control solution been contaminated?
Did you follow the test procedures correctly?
Please repeat the test. If results still do not match, contact your local Ace Medical office or the authorized distributor. 17 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). Leave your meter in a room around 10 C ~ 40 C (50 F ~ 104 F) for 15 minutes, then repeat the test. Do not artificially heat or cool the meter. The strip is for single use only. Dispose of Test Strip that has blood or control solution on it. 1 Twist the cap of the lancing device to remove it. 2 Insert the lancet firmly into the circular lancet holder of lancing device until it is fully seated. 3 Twist off the protective cap of the lancet and save it for later use. 18 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. Note The meter does not response to any other ways of inserting 19 10 With use. 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 to the fingertip obtain the second drop of blood for testing. 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. 20 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 doesnt 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. 21 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 second and waiting to hear a beep sound, depending on their physical status. Pre-meal: Test result appears with Symbol . Post-meal: Our default setting. Test result appears with Symbol . Symbol by pressing and holding S button for 1 or 16 User can either take out the used strip by pushing and slide the Strip Eject button or remove the test strip directly to shut the meter off. Without any operation for 2 minutes, the meter automatically shuts off too. 22 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. The result will be stored in the memory but does not count in the average of last 7/ 14/ 30/ 60 days. Important information!
LO reading with symptoms!
If you have LO test results and also symptoms such as weakness, sweating, nervousness, headache or confusion, follow your doctors recommendation to treat hypoglycemia. LO reading without symptoms!
If you have LO test results but no symptoms of low blood glucose, please consult your doctor or call your local distributor for help. 2. If your test result is higher than 600 mg/dl (33.3 mmol/l), HI appears on LCD screen. The result will be stored in the memory but does not count in the average of last 7/ 14/ 30/ 60 days. Important information!
urination, HI reading with symptoms!
If you have HI test results and also symptoms such as fatigue, thirst, excess doctors recommendation to treat hyperglycemia. HI reading without symptoms!
If you have HI test results but no symptoms of high blood glucose, please consult your doctor or call your local distributor for help. vision, follow blurry your or 23 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 before use. 60 days. 1. To ensure accurate average values, please re-set date and time 2. Average result of last 7/ 14/ 30/ 60 days is calculated from test results performed during the last 7/ 14/ 30/ 60 days. 3. LO and HI results do not count in the average of last 7/ 14/ 30/
4. With Meal Comment Function on, Pre-meal or Post-meal Symbol will also appear under Memory Mode. Follow steps below to recall memory sets:
1 Under Standby Mode, press M button to enter Memory Mode. Note To quit Memory Mode, press S button and return to Standby Mode. 2 Average result of last 7 days appears first. Understanding Average Results Take average of last 7 days for example. While displaying average results, 07d on the upper left represents the result displaying now are from last 7 days. 021 on the upper right represents how many results are performed during last 7 days. The indications apply to the following figures of 7/14/30/60 days average. 24 Perform the Blood Glucose Test 3 Press M button again to view the average record 4 Press M button again to view the average record 5 Press M button again to view the average record for last 14 days. for last 30 days. 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. 9 Note To fast scroll forward, press and hold M button. To leave the Memory Mode, press S button for 2 seconds and the meter switches to Standby Mode. 25 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. if you want the delete Or function, press M button to return to Standby Mode. to check out Note Once deleted, your data can NOT be restored. 26 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. 3 AM100 plus can only pair up with one Wireless Transmission device at a time. To transmit measuring results to other Wireless Transmission device, please redo steps 1~2. 4 Note: Please do not turn on more than one Wireless transmission function of glucose meters. AM100 plus is subject to and complies with electromagnetic compatibility (EMC) standard of IEC 60601-1-2, EN 301 489-1, EN 301 489-17, EN 300 328 and U.S. federal guidelines, Part 15 of the FCC (Federal Communications Commission) rules for devices with RF capability. These guidelines help ensure that your device will not affect the operation of other nearby devices. Additionally, other devices should not affect the use of your device. Make sure AM100 plus and paired Wireless transmission device are within acceptable distance (no more than 10 meters) with each other. If not, put them closer. 27 Perform the Blood Glucose Test 1 2 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. 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. However, there is no guarantee that interference will not occur in a particular installation. If his equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help. CAUTION:
To assure continued FCC compliance:
1. Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. 2. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation. 28 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. Do not dip your meter in water, or any other liquid. Cleaning the Meter Keep the meter free of dust. If you need to clean or disinfect it, follow these guidelines carefully to help you get the best performance possible. 1 Make sure the meter is turned off. 2 Gently wipe the meters surface with a soft cloth slightly dampened (wiring out any excess liquid) with one of these cleaning solutions:
10 % household bleach solution (1 part bleach plus 9 parts water) made the 70 % isopropyl alcohol same day Warning Do not allow liquid to enter any openings in the meter. Do not spray a cleaning solution directly onto the meter. Do not immerse the meter in liquid. 29 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 wont work. 4 Extreme humidity may affect the results. A relative humidity greater than 80% may cause incorrect results. 5 Hematocrit:
Hematocrit ranging from 0 % ~ 70 % has no significant impact on test results. Other ranges:
Hematocrit > 70 %: may lead to incorrect low test results. To know exact hematocrit level of yours, consult healthcare professional for help. 30 System Specifications Product Specifications Product Name:
Model No.:
Range Response time Memory sets Operating Condition Storage Condition AceZin GLUGold blood glucose meter AM100 plus 20 ~ 600 mg/dl (1.1 ~ 33.3 mmol/l) 5 seconds 1000 Memory Sets Temperature 10 C ~ 40 C (50 F ~ 104 F) Humidity R.H. 80 %
Meter Strip Meter
-40 C ~ 55 C (-40 F ~ 131 F) R.H. 90 %
4 C ~ 30 C (39.2 F ~ 86 F) R.H. 90 %
-40 C ~ 55 C (-40 F ~ 131 F) R.H. 90 %
4 C ~ 30 C (39.2 F ~ 86 F) R.H. 90 %
Transportation Condition Package with Strips Blood Volume 1.0 l Sample Type Hematocrit (Hct) Power Supply Battery Life LCD Dimension Capillary whole blood from fingertip and venous whole blood 0% ~ 70%
AAA (1.5 V) Alkaline Battery x 2 1000 measurements 40 x 29 mm Device Dimension 100 mm (L) x 60 mm (W) x 23 mm (H) Weight Principles 63 3 g (Without Batteries) Electrochemical Biosensor Technology 31 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 effective data rate and integrity in noisy environments. AES-128 and application layer user defined Class 2 (Maximum: 10 meter)) 2402 - 2480 MHz
(allowing for guard bands) Unlimited 0.47 mW up to 40 bands (2 MHz spacing;
centered from 2402 to 2480 MHz) GATT Client and Server Support for 802.11 Coexistence Integrity Security Operating Distance RF Frequency / Need for Spectrum Management Maximum Limitation Maximum Permitted Power Proximity of Other In-band Transmitters Used in Vicinity Wireless Communication Profile Wireless Coexistence 32 Display Messages and Troubleshooting Display messages What it means Troubleshooting
"Er 1 appears when the strip is wet. 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.
"Er 2" appears when the meter fails to access memory. If "Er 2" appears constantly, please call Ace Medical Technology Co., Ltd. or authorized distributor in business hours.
"Er 3" appears when your Test Strip does not have enough blood sample on it. Repeat the test with a new Test Strip. See "Perform the Glucose Blood Test section. Repeat the test with a new Test Strip. See "Perform the Glucose Blood Test section.
"HI" and "LO" appear when your results fall out of measuring range. The result will be stored in the memory but does not count in the average of last 7/14/30/60 days. 33 Display Messages and Troubleshooting Display messages What it means Troubleshooting When HI t or LO t appears, ambient temperature falls out of acceptable range (10 C
~ 40 C /
50 F ~ 104 F). The meter is unable to measure. Do not artificially heat or cool the meter. Leave your meter in a room around 10 C ~ 40 C (50 F
~ 104 F) for 15 minutes, then repeat the test. See "Perform the Glucose Blood Test section. When appears, your batteries are about to run out. Repeat the test after battery replacement. See "Get Ready for Testing"
section. When appears, the batteries are too weak to work. 34 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.bio MedNet EC-REP GmbH Borkstrae 10, 48163 Mnster, Germany 35 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 36 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. The warranty of the repaired or replacement meter will expire on the date of the original warranty expiration or ninety days after shipment of a replacement meter, whichever period is longer. Note This warranty applies only to the original purchaser of the meter. 37 P/N: M709-000000-XXX VER: 001