1. Manuals
  2. Brands
  3. Nipro Manuals
  4. Blood Glucose Meter
  5. TrueResult Twist 2
  6. User manual

Nipro TrueResult Twist 2 User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

INTRODUCTION:
Welcome to the TRUEresult twist 2 Blood

Glucose Monitoring System

Our Commitment to You
TRUEresult twist 2 is a simple, accurate way to
test whole blood glucose (sugar) level, anytime,
anywhere. Our goal is to provide quality healthcare
products and dedicated customer service. For
questions about TRUEresult products, please see
cover for phone number.
This booklet contains all the information needed to
get the most from the TRUEresult twist 2 System.
To start testing quickly, please see the Quick
Reference Guide found inside the front cover of
this Owner's Booklet.
Please read complete Owner's Booklet and
all product Instructions for Use before
using the System.
SYMBOLS:
Biological
Risk
For
Assistance
Call
For in vitro
Diagnostic
Lot
Testing Only
Number
Control
Serial
Number
Sterile
Attention! Read
Instructions
for Use.
Authorised
Representative
1
Caution
Control
Level
Use By
Date
Storage
Temperature
Do Not
Range
Resterilise
Date of
Manufacture
Keep
Dry
Single
Use
Only
Manufactured
By

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the TrueResult Twist 2 and is the answer not in the manual?

Questions and answers

Related Manuals for Nipro TrueResult Twist 2

Summary of Contents for Nipro TrueResult Twist 2

  • Page 1: Introduction And Important Information

    Welcome to the TRUEresult twist 2 Blood Glucose Monitoring System Our Commitment to You TRUEresult twist 2 is a simple, accurate way to test whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about TRUEresult products, please see cover for phone number.
  • Page 2 Owner’s Booklet is not recommended and may affect your ability to determine true blood glucose levels. The TRUEresult twist 2 System is an in vitro (outside body) quantitative system that is used for self-testing and point-of-care testing of only human whole blood.
  • Page 3 • Read all product instructions for use before testing. • Use only TRUEresult Test Strips and TRUEresult Control Solution with TRUEresult twist 2 Meter. • To help prevent false high results, wash hands before using the System to test blood, especially after handling fruit or other foods containing sugar.
  • Page 4 System is for one person use ONLY. DO NOT share your Meter or your Lancing Device with anyone, including family members. DO NOT use on more than one person. ALL parts of the TRUEresult twist 2 Blood Glucose Monitoring System could carry blood-borne pathogens after use, even after cleaning and disinfection.
  • Page 5 ~ severe dehydration ~ hyperglycaemia with hyperosmolarity, with or without ketosis. • Do not use the TRUEresult twist 2 for the diagnosis of diabetes or for testing blood glucose in neonates (newborns). • Do not use TRUEresult twist 2 System during a xylose absorption test.

  • Page 6: Table Of Contents

    Introduction and Important Information ...1 Know the System ...........8 Meter ................8 Test Strip ..............10 Control Solution .............12 Attach/Remove TRUEresult twist 2 Meter to TRUEresult Test Strip Vial ........13 Getting Started ............14 Quality Control Testing .........15 Automatic Self-Test ..........15 Control Test .............16 How to Test Control Solution ......17...
  • Page 7 Time/Date Set Up ..........26 Memory..............27 View Averages (7-, 14-, 30-day) ......27 View Results ............28 Care, Cleaning .............29 Meter Care ...............29 Control Solution Care ..........30 Test Strip Care ............30 Changing Battery ............31 Troubleshooting ..........32 Messages ..............33 Technical Information ........35 Performance Characteristics .........35 System Specifications ..........39 Operating Range .............39 Chemical Composition ..........39...

  • Page 8: Know The System

    KNOW THE SYSTEM Meter Back of Meter Front of Meter Display - Shows test results, messages, user prompts, other information. Test Port - Insert TRUEresult Test Strip here. Set Button - Turn Meter on for Memory, view/ scroll results in Memory, mark result as Alternate Site, set up date/time.
  • Page 9 Display Screen Meter Full Display Screen Time, Date, Control Symbol (-C-), Alternate Site Symbol (-A-), Average Symbol (7-, 14-, or 30-day) Test Result Memory Result Battery Symbol Units of Measure - Factory set, cannot be changed by user. Drop Symbol...

  • Page 10: Test Strip

    Test Strip Top of Test Strip Contact End - Insert into Test Port with blocks (contacts) facing up. Sample Tip - Touch to top of sample (fresh, capillary or venous blood or Control Solution) after inserting Contact End into Meter. Sample Placement Correct Incorrect...
  • Page 11 Test Strip Vial Label May 30, 2014 May 30, 2014 Lot Number ( ) - Used for identification when calling for assistance. Use By Dates ( ) - Write date first opened on vial label. Discard vial and unused Test Strips if either 4 months after opening or date printed next to on vial label has passed, whichever...

  • Page 12: Control Solution

    Control Solution Control Solution Bottle Label Lot Number ( ) - Used for identification when calling for assistance. Use By Dates ( ) - Write date first opened on bottle label. Discard bottle if either 3 months after opening or date printed next to on bottle label has passed, whichever comes first.

  • Page 13: Attach/Remove Trueresult Twist 2 Meter To Trueresult Test Strip Vial

    Attach / Remove TRUEresult twist 2 Meter to TRUEresult Test Strip Vial The TRUEresult twist 2 Meter is made to attach to the top of the TRUEresult Test Strip vial cap. Test Port To attach: Vial Lip 1. Set Test Strip vial on flat surface with vial lip facing front.

  • Page 14: Getting Started

    GETTING STARTED The Meter turns on when a Test Strip is inserted into the Test Port or when Set Button is pressed and released (see Memory). Meter turns off when the Test Strip is released from the Meter, Set Button is pressed and held for 20 seconds, or after 2 minutes of non-use.

  • Page 15: Quality Control Testing

    Quality Control Testing To assure you are getting accurate and reliable results, TRUEresult twist 2 offers two kinds of quality control tests. These tests let you know that your TRUEresult twist 2 System is working properly and your testing technique is good.

  • Page 16: Control Test

    Control Test The Control Test checks that the System is working correctly and testing technique is good. Use ONLY TRUEresult Control Solution to perform Control Tests. Perform Control Tests: • For practice before using the System for the first time, •...

  • Page 17: How To Test Control Solution

    How to Test Control Solution Use ONLY TRUEresult Control Solution with the TRUEresult twist 2 Meter. 1. Check supplies. See Getting Started. 2. Allow Control Solution, vial of Test Strips and Meter to adjust to room temperature (20°C-25°C). May 30, 2014...
  • Page 18 7. With cap removed, turn Control Solution bottle upside down. Gently squeeze one drop of Control Solution onto a clean tissue. Wipe off bottle tip with the tissue. Drop Symbol Note: If Test Strip is removed before testing is finished, an error message appears. Discard old Test Strip.
  • Page 19 11. Compare result to Control Test Range printed on Test Control Solution Bottle Label Strip vial label for Control Solution Level you are using. If result is in range, Test Strip Vial Label System can be used for testing blood. If result does not fall within range, repeat test using a new Test Strip.

  • Page 20: Testing Blood

    TESTING BLOOD Obtaining a Blood Sample Refer to lancing device’s Instructions for Use for detailed instructions. The lancing device is for single patient use ONLY. For cleaning your lancing device see Lancing Device Care in the lancing device’s Instructions for Use. Wash your hands thoroughly with soap and warm water after handling the Meter, lancing device, or Test Strips.
  • Page 21 From Forearm Note: Some lancing devices include a special end cap for alternate site testing. Check lancing device’s Instructions for Use. 1. Select area to be lanced. Wash with soap and warm water, rinse and dry thoroughly. 2. Rub area vigorously or apply a warm dry compress to increase blood flow.

  • Page 22: How To Test Blood Glucose

    How to Test Blood Glucose Press Down 1. Check supplies. See Getting Started. To Close 2. Wash hands (and forearm for alternate site testing). Rinse well and dry thoroughly. 3. Remove one Test Strip from vial. Close vial immediately. Use Test Strips quickly after removal from vial.
  • Page 23 6. With Test Strip still in Meter, touch Sample Tip to top of blood drop and allow blood to be drawn into Test Strip. Remove from blood drop immediately after the dashes appear across Meter Display. Note: If Meter does not begin testing soon after touching blood drop to Sample Tip, discard Test Strip.

  • Page 24: Unusual Blood Glucose Test Results

    Unusual Blood Glucose Test Results If you have symptoms of low or high glucose, check your blood glucose immediately. If your result does not match the way you feel, repeat test. If your results still do not match the way you feel, call your Doctor or Healthcare Professional.

  • Page 25: Trueresult Twist 2 System And Laboratory Testing

    (100 mg/dL), and within 15% of a laboratory method when the glucose concentration is 5.55 mmol/L (100 mg/dL) or higher. If the patient has recently eaten, fingerstick results from the TRUEresult twist 2 System can be up to 3.9 mmol/L (70 mg/dL) higher than venous laboratory results.

  • Page 26: Time/Date Set Up

    Time/Date Set Up Note: If Meter turns off at any time during Set Up, go back to Step #1 and begin again. 1. Start with the Meter off. Press and hold the Set Button until the full Display appears and begins to blink. Release Set Button. 2.

  • Page 27: Memory

    MEMORY View Averages (7-, 14-, and 30-day) Averages allows you to view the average of all blood glucose results within a 7-, 14-, or 30 day period. 1. With Meter off, press and release Set Button. 2. Display scrolls through the 7-, 14-, and 30-day Averages.

  • Page 28: View Results

    View Results Memory holds 500 total blood and Control Test results, which are displayed from most recent to oldest. When Memory is full, the oldest result is replaced with the newest result. 1. Press and release Set Button. Meter turns on to view results in Memory with the date and then the time in the lower left..

  • Page 29: Care, Cleaning

    CARE, CLEANING Caring for TRUEresult twist 2 • Store System (Meter, Control Solution, Test Strips) in Carrying Case to protect from liquids, dust and dirt. Do not keep meter in an area where it may be crushed (i.e. back pocket, drawer, bottom of bag, etc.).

  • Page 30: Control Solution Care

    Control Solution Care • Write date opened on Control Solution label. Discard if either 3 months after opening or after date printed next to on bottle label has passed, whichever comes first. 30°C • Store at 2°C-30°C (room temperature). DO NOT REFRIGERATE 2°C OR FREEZE.

  • Page 31: Changing Battery

    Changing Battery 1. Remove Meter from top of test strip vial by holding the vial and twisting the Meter ¼ turn counterclockwise. Lift Meter from vial top. 2. Turn Meter over until the Meter label is facing up. Pull Battery Tray out until battery is exposed.

  • Page 32: Troubleshooting

    TROUBLESHOOTING 1) After inserting Test Strip, Meter does not turn on. Reason Action Test Strip inserted upside Remove Test Strip. down or backwards Re-insert correctly. Test Strip not fully Remove Test Strip. Re-insert inserted Test Strip fully into Meter. Test Strip Error Repeat with new Test Strip.

  • Page 33: Messages

    Messages Display Reason Action Meter Call for Error assistance. Temperature Move Meter and Test Strips Error to area between 10°C-40ºC; • wait 10 minutes for System Too Cold/ to reach room temperature Too Hot before testing. Sample Not Retest with new Detected or Test Strip and Using Wrong...
  • Page 34 Messages (continued) Display Reason Action Test Strip Remove micro USB cable. Removed During Retest with new Test Strip. Test or Micro USB Make sure result is displayed Cable Attached before removing Test Strip. Meter Call for assistance. Error Result was not recorded in Memory Memory.

  • Page 35: Technical Information

    Performance Characteristics Precision: Precision describes the variation between results. There are two types of precision results measured, repeatability (using blood) and intermediate precision (using control solution). Repeatability: N=100 Mean (mmol/L) 2.6 11.4 18.4 Mean (mg/dL) SD (mmol/L) 0.09 0.12 0.19 0.33 0.61 SD (mg/dL)
  • Page 36 Zone A of the Parkes Error Grid (PEG). 99% of TRUEresult twist 2 forearm values performed by healthcare professionals (HCP) fell within 0.83 mmol/L (15 mg/dL) of the YSI results at glucose levels < 5.55 mmol/L (100 mg/dL) and within 15% at glucose levels >...
  • Page 37 Zone A and 1% fell within Zone B of the Parkes Error Grid (PEG). For Consumers 100% of TRUEresult twist 2 fingertip values performed by users fell within 0.83 mmol/L (15 mg/dL) of the YSI results at glucose levels < 5.55 mmol/L (100 mg/dL) and within 15% at glucose levels >...
  • Page 38 99% of TRUEresult twist 2 forearm values performed by users fell within 0.83 mmol/L (15 mg/dL) of the YSI results at glucose levels < 5.55 mmol/L (100 mg/dL) and within 15% at glucose levels > 5.55 mmol/L (100 mg/dL). Forearm Samples (User vs. YSI) for glucose concentrations < 5.55 mmol/L (100 mg/dL)

  • Page 39: System Specifications

    SYSTEM SPECIFICATIONS Result Range: 1.1 - 33.3 mmol/L (20-600 mg/dL) Sample Size: Minimum 0.5 microlitre (0.5 μL) Sample: Fresh capillary whole blood, venous blood drawn in sodium or lithium heparin blood collection tubes, or Control Solution. Test Time: Results in as little as 4 seconds Result Value: Plasma equivalent values Assay Method: Electrochemical Power Supply: One 3V Lithium Battery...

  • Page 40: Emc Safety Information

    EMC Safety Information This meter meets the electromagnetic immunity requirements as per ISO 15197:2013 Annex A. It meets the electromagnetic emissions requirements as per EN 61326 series. Interference from the meter to other electronically driven equipment is not anticipated. The electromagnetic environment should be evaluated prior to operation of the device.

  • Page 41: References

    REFERENCES 1. Joslin Diabetes Center. Goals for Blood Glucose Control [Electronic Version]. Retrieved February 16, 2012 from http://www.joslin.org/info/Goals-for-Blood-Glucose-Control.html. 2. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication Update 11/29/2010 [Electronic Version]. Retrieved February 22, 2012 from http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm224025.htm.

  • Page 42: Notes

    Notes:...
  • Page 43 Notes:...
  • Page 44 Notes: Q4INP03FD Rev. 1...

Table of Contents