StatStrip Ref 54253 User Manual Rev 1.86

NOVA BIOMEDICAL SYMBOL DIRECTORY In vitro diagnostic medical device

Batch code

Product fulfills the requirements of Directive 98/79 EC (IVDD) and 1999/5/EC on radio and telecommunications terminal equipment (R&TTE) Caution, consult accompanying documents Consult instructions for use

SN

Serial Number Temperature limitation Upper Limit of Temperature

Biological risk Number of Tests Catalog number Use by

Manufacturer 2497

Date of Manufacture Electronic Waste Control LEVEL

Level

2

Do not reuse

Authorized Representative in the European Community

EC REP Nova Biomedical UK

This device complies with Part 15 of the FCC Rules and with RSS-210 of industry Canada

Glucose

The system fulfills the Canadian and US safety requirements (UL LISTED, in accordance with UL 61010A-1:02 and CAN/CSAC22.2 No. 61010-1-04).

Power supply connection Humidity limitation

Caution: Federal Law restricts this

Only device to sale by or on the order of a licensed practitioner.

1

StatStrip Glucose and ß-Ketone Hospital Meter

Ordering Information ®

The StatStrip Glucose and ß-Ketone Hospital Meter Instructions for Use Manual can be ordered from Nova Biomedical Order Services. Write or call: Nova Biomedical Corporation Telephone:1-800-458-5813 200 Prospect Street FAX: 1-781-893-6998 Waltham, MA 02453 (in the U.S.A.) U.S.A. FAX: 1-781-899-0417 (outside the U.S.A.) Web: www.novabiomedical.com

EC REP Authorized Representative Nova Biomedical UK Telephone:+ 44 1928 704040 Innovation House Fax:+ 44 1928 796792 Aston Lane South, Runcorn Cheshire, WA7 3FY, UK

Trademark

StatStrip is a registered trademark of Nova Biomedical Corporation.

Copyright

Printed in the U.S.A. Copyright 2018, Nova Biomedical Corporation, Waltham, MA 02453

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Technical Assistance For technical assistance inside the United States, call Nova Biomedical Technical Services at: U.S.A.: 1-800-545-NOVA 1-781-894-0800 FAX: 1-781-894-0585

or

For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical Canada Ltd. 17 - 2900 Argentia Road Mississauga, Ontario L5N 7X9 Canada Tel: 1-800-263-5999 1 905 567 7700

Nova Biomedical Deutschland GmbH Hessenring 13, Geb. G 64546 Mörfelden-Walldorf Germany Tel: + 49 6105 45050

Nova Biomedical France Parc Technopolis - Bât. Sigma 3 avenue du Canada 1er étage Les Ulis courtaboeuf 91940 France Tel: + 33 1 64 86 11 74

Nova Biomedical KK Mita43MT Bldg-7F 13-16 Mita 3-chome Minato-ku Tokyo 108-0073 JAPAN Tel: +81 3-5418-4141 Fax: +81 3-5418-4676

Nova Biomedical UK Innovation House Aston Lane South, Runcorn Cheshire, WA7 3FY UK Tel: + 44 1928 704040

Nova Biomedical Italia Srl Via Como 19 20020 Lainate Milano Italia Tel: +39 02 87070041

Nova Biomedical Iberia Av. Corts Catalanes 9-11 08173 Sant Cugat Barcelona, Spain

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Nova Biomedical Brasil Rua Massena, 107 Bairro: Jardim Canadá Nova Lima – MG – Brasil CEP: 34007-746 Tel: +55 31 3360-2500

Table of Contents

Contents 1

Introduction

1-1

1.1 About This Manual...1-2 1.2 Safety Instructions...1-2 1.3 Intended Use and Tests Performed...1-5 1.4 Limitations...1-8 1.5 General Precautions...1-8 1.6 The Sample...1-9 1.7 Interfering Substances...1-9 1.8 Operation Overview...1-11 1.8.1 Using the Display Keypad... 1-13 1.8.2 Soft Buttons... 1-14 1.8.3 Meter Sleep/Wake Up... 1-15 1.8.4 Result Alerts... 1-16 1.8.5 Multi-screen Menus... 1-17 1.9 Installing the StatStrip Glucose and ß-Ketone Hospital Meter...1-17 1.9.1 Power Up Procedure... 1-18 1.10 Operator Login...1-20 1.11 Administration (Admin) Screen...1-21 1.11.1 Setting the Time/Date... 1-22 1.11.2 Naming the Meter... 1-23 1.11.3 Sound On/Off... 1-23 1.11.4 View Setup... 1-23 1.11.5 Unarchive... 1-23 1.11.6 Resetting the Facility... 1-24 1.12 Assign Location...1-24 1.13 Meter Transport Case...1-25

2

Quality Control 2.1 2.2 2.3 2.4

3

2-1

When to Perform a QC Test...2-1 StatStrip Glucose and ß-Ketone Control Solution...2-1 Quality Control Test...2-2 Add Comment to a Result (Patient, QC, Linearity)...2-6

Patient Samples

3-1

3.1 Important Safety Instructions...3-1 3.2 Running a Patient Sample...3-2 3.3 Review Results...3-8 54253B 2018-11

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Instructions for Use Manual

Table of Contents

4

Docking/Charging Station

4-1

5

Linearity Test

5-1

5.1 Running a Linearity Test...5-1

6

Maintenance

6-1

6.1 Charging the Meter...6-1 6.2 Changing the Battery...6-2 6.3 Cleaning and Disinfecting the Meter...6-4

7

Troubleshooting

7-1

7.1 Meter Screen Alerts...7-1

A

Appendix

A-1

A.1 StatStrip Glucose and ß-Ketone Hospital Meter Specifications...A-1 A.2 Controls/Linearity Solutions... A-3 A.2.1 Traceability...A-3 A.3 Barcode Scanner... A-3 A.4 Reference Values... A-4 A.5 Ordering Information... A-5 A.6 Theory... A-6 A.6.1 Glucose...A-6 A.6.2 ß-Ketone...A-6 A.7 Wireless Meter Use... A-7 A.7.1 Wired & Wireless Network Unauthorized Access Protection... A-7 A.7.2 Wireless Network Connections (802.11a/b/g WiFi) A-7 A.7.3 Radio Frequency and Radiation Exposure...A-8 A.7.4 WiFi Radio Option Operation...A-10 A.7.5 Enabling/Disabling the WiFi Radio ...A-12 A.7.6 WiFi Usage Considerations...A-13 A.7.7 WiFi Technical Considerations...A-15 A.7.8 WiFi Function and Performance...A-16 A.7.9 Meter Wi-Fi Settings, Range, Options...A-18 A.8 Warranty... A-21

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Instructions for Use Manual

1 Introduction

This manual provides all necessary instructions for the routine operation and maintenance of the StatStrip Glucose and ß-Ketone Hospital Meter. Please read this manual carefully. It has been prepared to help you attain optimum performance from your Meter. WARNING: Healthcare professionals and others using this system on multiple patients should be aware that all products or objects that come into contact with human blood should be handled as if capable of transmitting viral diseases, even after cleaning. WARNING: Blood samples and blood products are potential sources of infectious agents. Handle all blood products and strips with care. Gloves and protective clothing are recommended. When performing maintenance and troubleshooting procedures, also use protective eyewear. CAUTION: Capillary blood glucose testing may not be appropriate for persons with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. This section introduces the meter and covers requirements, tests performed, procedural limitations, clinical utility, and sample handling. The StatStrip Glucose and ß-Ketone Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose or ß-ketone electrochemical test strips to measure glucose or ß-ketone in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring glucose and ketone, the meter stores patient test data, QC test data, and other information relating to patient, patient sample, operator, reagents, and the meter. 1-1

1. Intro.

1 Introduction

StatStrip Glucose and ß-Ketone Hospital Meter A user interface provides for a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter. Always ensure the proper units of measure are selected to ensure the proper therapy is provided to the patient. In Canada, the Nova StatStrip Glucose Hospital Meter is hard-coded to display glucose results in mmol/L units of measure only.

1.1 About This Manual This manual is for the Nova Biomedical StatStrip Glucose and ß-Ketone Hospital Meter. Throughout this manual, NOTE: indicates especially important information, CAUTION: indicates information that is critical to avoid instrument damage or incorrect results, and WARNING: indicates possible hazard to the operator.

1.2 Safety Instructions Personnel operating this meter must be proficient in the operating and maintenance procedures of the meter. The following safety procedures must be followed. Blood-Borne Pathogens Safety 1. Healthcare professionals and others using this system should adhere to Standard Precautions when handling or using the StatStrip Glucose and ß-Ketone Hospital Meter. 2. Healthcare professionals should be aware that all parts of the StatStrip Glucose and ß-Ketone Hospital Meter are considered potentially infectious and can potentially transmit blood-borne pathogens between patients and healthcare professionals. 3. The StatStrip Glucose and ß-Ketone Hospital Meter may only be used for testing on multiple patients when standard precautions are followed and when the system is cleaned and disinfected after use on each patient following the procedure in Section 6.3. Healthcare professionals should wear a new pair of protective gloves before testing each new patient. 1-2

Instructions for Use Manual

1 Introduction

Personnel operating this meter must be proficient in the operating and maintenance procedures of the meter. The following safety procedures must be followed. General Safety 1. Read the safety and operating instructions before operating the meter. 2. Retain the safety and operating instructions for future reference. 3. Observe all warnings on the meter and in the operating instructions. 4. Follow all operating and use instructions. 5. Place the meter away from heat sources. 6. Connect the meter to the Charging Station, as described in the operating instructions. 7. The meter should be cleaned only as recommended by the manufacturer. 1-3

1. Intro.

4. Only auto-disabling, single-use lancing devices may be used with this system. 5. For more information, refer to the following references: "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007," http://www.cdc.gov/hicpac/2007ip/2007isolatio nprecautons.html. Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at http://www.cdc.gov/biosafety/publications/bmbl5/. "Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline-Third Edition," Clinical and Laboratory Standards Institute (CLSI) M29A3. "FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Tranmitting Bloodborne Pathogens: Initial Communication." (2010) http://www.fda.gov/Medicaldevices/Safety/ AlertsandNotices/ucm224025.html. "CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens." (2010) http://www.cdc.gov/ injectionsafety/Fingerstick-DevicesBGM.html.

StatStrip Glucose and ß-Ketone Hospital Meter 8. The meter should be serviced by qualified service personnel. Electrical Safety 1. Battery powered: 3.7 V Li Ion battery (rechargeable/ replaceable) 2. Desk-mount Charging Station 3. An LED indicator light to show the battery is charging: yellow indicates charging and green indicates fully charged. 4. Extra battery slot recharges and stores spare battery. An LED indicates the spare battery is charging or charged: amber indicates charging and green indicates fully charged. WARNING: All rechargeable Lithium batteries have a finite useful life that will vary depending upon use and handling conditions. A Lithium battery exhibiting any of the following conditions should be immediately removed from use and properly disposed of in accordance with local regulations. • Has exceeded its expiration date • Swelling, cracking, or damage to the battery case • Leakage • Failure to hold a proper charge The Lithium battery may present a fire or chemical burn hazard, if mistreated. Do not disassemble, heat above 100°C (212°F), or incinerate. Disposal of Used Batteries •

This symbol on the battery label indicates that the battery provided with the meter should not be treated as household waste. To ensure the used battery is treated properly, remove the used battery from the meter and hand over the used battery to the applicable collection point for the recycling of electrical and electronic equipment. Disposal of Used Meters • The meter may become infectious during the course of use. Discard in accordance with local regulations for biohazardous waste. Chemical and Biological Safety 1. Observe all precautionary information printed on the original solution containers. 1-4

Instructions for Use Manual

1 Introduction

1.3 Intended Use and Tests Performed Intended Use The Nova StatStrip Glucose and ß-Ketone Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in fresh capillary, venous, arterial, and neonate whole blood and ß-Ketone in fresh capillary and venous whole blood samples. The Nova StatStrip Glucose and ß-Ketone Meter System is specifically indicated for use in a clinical or ambulatory care setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. It is not for diagnosis of or screening for diabetes. Nova StatStrip Glucose Test Strips are intended for use only with the Nova StatStrip Glucose Hospital Meter and/or the Nova StatStrip Glucose and ß-Ketone Hospital Meter. The Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). It is not for diagnosis of or screening for diabetes. The Nova StatStrip Ketone Test Strips are intended for use 1-5

1. Intro.

2. Do not use test strips, control solutions, or linearity solutions after the expiration date. 3. Test strips are single use only. 4. Operate the Meter in the appropriate environment. 5. Dispose of all waste solutions according to standard procedures. Environmental • The operating temperature range for Meter operation: 34˚F to 104˚F (1˚C to 40˚C) • The relative humidity range for Meter operation: up to 90% non-condensing • The maximum altitude for Meter operation: Up to 15,000 feet (4572 meters) Dimensions: Height: 147 mm (5.8 in) Width: 79 mm (3.1 in) Depth: 30 mm (1.18 in) Weight: 220 g (0.49 lb)

StatStrip Glucose and ß-Ketone Hospital Meter only on the Nova StatStrip Glucose and ß-Ketone Meter. Nova StatStrip Glucose and ß-Ketone Hospital Control Solutions are intended for use with the Nova StatStrip Glucose and ß-Ketone Hospital Meter as well as the Nova StatStrip Glucose Test Strips and the Nova StatStrip ß-Ketone Test Strips. The control solutions act as a quality control check to verify the accuracy of blood glucose and ß-ketone test results. There are 3 levels of controls (Levels 1, 2, and 3). Nova StatStrip Glucose and ß-Ketone Linearity Solutions are intended for use with the Nova StatStrip Glucose and ß-Ketone Hospital Meter to check the linearity of the Meters. There are 5 levels of linearity solutions. Clinical Utility The measurement of glucose1 is used in the monitoring of carbohydrate metabolism disturbances including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Ketone measurement is important in diagnosing ketosis which is a state of elevated levels of ketone bodies in the body.[1] It is almost always generalized throughout the body, with hyperketonemia, that is, an elevated level of ketone bodies in the blood. Ketone bodies are formed by ketogenesis when liver glycogen stores are depleted. The ketone bodies acetoacetate and β-hydroxybutyrate are used for energy.[2] ß-hydroxybutyrate measured in whole blood represents 80% of the ketone bodies in ketosis. Ketone bodies are acidic, but acid-base homeostasis in the blood is normally maintained through bicarbonate buffering, respiratory compensation to vary the amount of CO2 in the bloodstream, hydrogen ion absorption by tissue proteins and bone, and renal compensation through increased excretion of dihydrogen phosphate and ammonium ions.[4] Prolonged excess of ketone bodies can overwhelm normal compensatory mechanisms, leading to acidosis if blood pH falls below 7.35. There are 2 major causes of ketoacidosis: • Most commonly, ketoacidosis is diabetic ketoacidosis (DKA), resulting from increased fat metabolism due to a shortage of insulin. It is associated primarily with type I diabetes, and may result in a diabetic 1-6

Instructions for Use Manual

1 Introduction

1-7

1. Intro.

coma if left untreated.[5] Alcoholic ketoacidosis (AKA) presents infrequently, but can occur with acute alcohol intoxication, most often following a binge in alcoholics with acute or chronic liver or pancreatic disorders. Alcoholic ketoacidosis occurs more frequently following methanol or ethylene glycol intoxication than following intoxication with uncontaminated ethanol.[6] A mild acidosis may result from prolonged fasting or when following a ketogenic diet or a very low calorie diet.[7][8] Ref. 1. Burtis, Carl A. and Ashwood, Edward R., ed. 1999. Tietz Textbook of Clinical Chemistry. Philadelphia, PA: W. B. Saunders Co. 2. thefreedictionary.com/ketosis citing: The American Heritage® Medical Dictionary Copyright © 2007 Mosby's Medical Dictionary, 8th edition. © 2009 Dorland's Medical Dictionary for Health Consumers. © 2007 3. Harvey & Champe, biochemistry 4. Marshall, William J.; Bangert, Stephen K. (2008). Clinical biochemistry: metabolic and clinical aspects. Elsevier Health Sciences. pp. 67–80. ISBN 978-0443-10186-1. 5. Kitabchi AE, Umpierrez GE, Murphy MB, Kreisberg RA (December 2006). "Hyperglycemic crises in adult patients with diabetes: a consensus statement from the American Diabetes Association". Diabetes Care 29 (12): 2739–48. doi:10.2337/dc06-9916. 6. Kraut JA, Kurtz I (January 2008). "Toxic alcohol ingestions: clinical features, diagnosis, and management". Clinical Journal of the American Society of Nephrology : CJASN 3 (1): 208–25. doi:10.2215/ CJN.03220807. 7. Hartman AL, Vining EP (January 2007). "Clinical aspects of the ketogenic diet". Epilepsia 48 (1): 31–42. doi:10.1111/j.1528-1167.2007.00914.x. 8. Delbridge E, Proietto J (2006). "State of the science: VLED (Very Low Energy Diet) for obesity". Asia Pac J Clin Nutr 15: 49–54. •

StatStrip Glucose and ß-Ketone Hospital Meter 1.4Limitations • • • • • • •

For Glucose, capillary,venous, arterial and neonate whole blood specimens. For ß-Ketone, capillary and venous whole blood specimens. Blood source - Use only whole blood. Do not use serum or plasma. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4572 meters) above sea level have not been evaluated. Anticoagulants: sodium, lithium, and ammonium heparin Fluoride and EDTA blood collection devices should not be used for venous specimens.

1.5 General Precautions • • • • • • •

1-8

Prior to use, read the Instructions for Use Manual. DO NOT reuse test strips. Test strips should be disposed after a single use. Discard used test strips according to local regulations. Remove the test strip from the vial only when ready to test. Do not use the test strip if the expiration date has passed, for this may cause inaccurate results. Do not tamper with the test strip. If test result is higher or lower than expected, run a control solution test to confirm test strip performance. 1. If control solution result is out of range, remove test strip vial from point of use and repeat control solution test with new test strip vial. 2. If control solution test is within expected range, repeat patient test. 3. If patient test result is higher or lower than expected, perform the test using an alternate method and consult a healthcare professional.

Instructions for Use Manual

1 Introduction

Glucose • Capillary, venous, arterial, and neonate whole blood • Plasma calibrated patient test results • Sample size 1.2µL • Anticoagulants: sodium, lithium, and ammonium heparin ß-Ketone • Capillary and venous whole blood • Plasma calibrated patient test results • Sample size 0.8 µL • Anticoagulants: sodium, lithium, and ammonium heparin

1.7 Interfering Substances

Glucose Interferences: The StatStrip Glucose and ß-Ketone Hospital Meter exhibits no interference for Glucose from the following substances up to the following concentration levels: Tested Substances Acetaminophen Ascorbic Acid Bilirubin Cholesterol Creatinine Dopamine Ephedrine D(+) Galactose Hematocrit (RBC) Ibuprofen L-Dopa D(+) Maltose Monohydrate D(+) Maltotetraose D(+) Maltotetriose Methyl-Dopa Oxygen Salicylate Tetracycline Tolazamide Tolbutamide Triglycerides Uric Acid

Concentration Level 10.0 mg/dL 0.66 mmol/L 10.0 mg/dL 0.57 mmol/L 15.0 mg/dL 0.26 mmol/L 500.0 mg/dL 12.9 mmol/L 6.0 mg/dL 0.53 mmol/L 10.0 mg/dL 0.53 mmol/L 0.9 mg/dL 0.055 mmol/L 350.0 mg/dL 19.4 mmol/L 20% - 65% 48.0 mg/dL 2.33 mmol/L 100.0 mg/dL 5.07 mmol/L 240.0 mg/dL 6.66 mmol/L 240.0 mg/dL 3.6 mmol/L 240.0 mg/dL 4.76 mmol/L 1.0 mg/dL 0.042 mmol/L All Concentrations 30.0 mg/dL 1.87 mmol/L 30.0 mg/dL 0.62 mmol/L 15.0 mg/dL 0.48 mmol/L 45.0 mg/dL 1.67 mmol/L 750.0 mg/dL 8.78 mmol/L 20.0 mg/dL 1.05 mmol/L 1-9

1. Intro.

1.6 The Sample

StatStrip Glucose and ß-Ketone Hospital Meter Ketone Interferences: The StatStrip Glucose and ß-Ketone Hospital Meter exhibits no interference for ß-Ketone from the following substances up to the following concentration levels: Tested Substances Acetaminophen Acetone Acetoacetate Ascorbic Acid Bilirubin Captopril Cholesterol Creatinine Dopamine Ephedrine Glucose Ibuprofen L-Dopa Methyl-Dopa N-Acetyl-L-Cysteine Tetracycline Tolazamide Tolbutamide Triglycerides Salicylate Uric Acid

1-10

Concentration Level 20mg/dL 1.32 mmol/L 10mg/dL 1.72 mmol/L 10mg/dL 0.93 mmol/L 20mg/dL 1.14 mmol/L 10mg/dL 0.18 mmol/L 10mg/dL 0.46 mmol/L 500mg/dL 12.9 mmol/L 6mg/dL 0.53 mmol/L 10mg/dL 0.53 mmol/L 0.9mg/dL 0.035 mmol/L 900mg/dL 50.0 mmol/L 48mg/dL 2.33 mmol/L 100mg/dL 0.51 mmol/L 1mg/dL 0.042 mmol/L 10mg/dL 0.61 mmol/L 30mg/dL 0.62 mmol/L 15mg/dL 0.48 mmol/L 45mg/dL 1.67 mmol/L 750mg/dL 8.47 mmol/L 30mg/dL 1.87 mmol/L 20mg/dL 1.05 mmol/L

Instructions for Use Manual

1 Introduction

NOTE: The operation overview provided in this section is for hospital settings. The meter configuration and screens may vary depending on your healthcare setting (e.g. Ambulatory Care Settings). The meter uses a touch screen for menu navigation and data entry. An on-screen keypad allows manual data entry of alphanumeric characters. Barcode ON/OFF Button Scanner

Screen Title

Touch Screen On-screen Keypad

Back or Left Soft Key

Forward or Right Soft Key

OK, Scan, Accept,etc. Soft Key Strip Port with GLU Strip Strip Ejector Button: Bottom-Middle-Back Figure 1.1 StatStrip Glucose and ß-Ketone Hospital Meter 1-11

1. Intro.

1.8 Operation Overview

StatStrip Glucose and ß-Ketone Hospital Meter The meter provides audible feedback of user inputs such as key presses and barcode scans and audible and/or visual feedback for prompts and user alerts. A built-in barcode scanner provides automated data entry. NOTE: The Meter is designed such that the Operator uses his or her finger when dealing with the touch screen. A PDA-style pen may be used as a replacement for finger input. Any other type of implement with a sharp or abrasive end may damage or disable the Meter. • •

•

•

•

1-12

The meter stores patient test data, quality control test data, linearity test data, and other information relating to the patient, patient sample, and operator. Meter operation involves entering operator, patient, QC, and strip lot data, as needed. Insert a test strip into the meter. Present a blood sample onto the test strip. View the test result; and, if required, annotate the result by adding "comments" relating to the patient sample. QC and Linearity results can also be commented, if needed. The barcode scanner allows for scanning operator ID, patient ID, QC, Strip Lot Numbers, and Linearity Lot Numbers. These fields can be manually entered as well. The meter stores patient samples, quality control test data, and linearity test data on-board. The operator can recall and review test data stored in the meter. A rechargeable battery provides power to operate the meter. A low-battery warning on the meter display alerts the operator to recharge the battery. An auto sleep feature conserves power when the meter is not in use. Test data information are stored in a non-volatile memory to prevent data loss.

Instructions for Use Manual Using the Display Keypad

The Display Keypad has 2 formats: numeric and alphanumeric. To display the alphanumeric keypad from the numeric display, press the 'ABC...' key. To display the numerical display from the alphanumeric display, press the '0..9' key. Title Bar

Enter Operator ID 13:42

Name: NICU-1

_________________________

1

2

3

4

5

6

7

8

9

Scan

0

ABC...

Back

Scan OK

Data Entry: cursor in active entry field Body

Soft Buttons

Enter Operator ID 13:42

Name: NICU-1

_________________________ /+-.!, 1

ABC 2

DEF 3

GHI 4

JKL 5

MNO 6

PQRS 7

TUV 8

WXYZ 9

Scan

space 0

0..9

Back

Scan OK

Figure 1.2 The Numerical and the Alphanumerical Keypad Screens

To use the alphanumeric keys, press the key with the letter of choice until it is displayed in the text display above the keypad. The screen is composed of 3 sections: 1. A Title Bar (top) – Colored (Blue for Glucose, Green for Ketone, Gray for test not selected), the title of the screen, Time of day, logged-in operator ID, Sound status, Meter name 2. The Body – data entries, selections, and screens 3. The Soft Key Bar – confirmation of data entry and screen navigation The StatStrip Glucose and ß-Ketone Hospital Meter has the following operator input mechanisms: • Soft buttons for menu navigation and menu prompt acknowledgement • Soft keyboard for data input

1-13

1. Intro.

1.8.1

1 Introduction

StatStrip Glucose and ß-Ketone Hospital Meter 1.8.2

Soft Buttons

On-screen buttons, called "Soft Buttons," are used for menu navigation and screen menu choice. Soft Keyboard The soft keyboard functions in the following manner: • An “ABC” soft key turns Alpha Mode ON (letters A-Z, space, +-.!,) to allow alphabetical character input to be inserted. A Punctuation soft key allows a plus (+), dash (-), period (.), exclamation (!) or comma (,). • A "0..9" soft key turns Alpha Mode OFF to allow numeric character input only. A soft key is provided for numerals "0" through "9." In Alpha Mode, most soft keys have multiple characters associated with them. For these soft keys, a particular character is selected by pressing the soft key multiple times, so as to scroll through the list of characters. Each character is displayed in the data entry field when it has been pressed. In addition, barcode scan input can be enabled for those menu fields that support it to make data input easier and quicker. Cursor The cursor blinks in the active data entry field of a screen. Data entry fields have a 16-character fixed length. When an attempt is made to input more data than is allowed for a particular data field: • The cursor remains at the right most position in the field. • The pressed keys are not inputted. • An audible tone is emitted. Data entry fields are completed once the cursor moves to another field or once the OK Button is pressed.

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