StatStrip Lactate Hospital Meter Instructions for Use Manual

Nova Biomedical Symbol DirectorY In vitro diagnostic medical device

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Product fulfills the requirements of Directive 98/79 EC (IVDD)

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SN

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Caution, consult accompanying documents

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Consult instructions for use

Authorized Representative EC REP Nova Biomedical UK in the

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Temperature limitation

Upper Limit of Temperature

European Community

LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT WAVELENGTH: 650 nm MAX. OUTPUT: 1.2 mW EN 60825-1: 2002

Laser Radiation - Do Not Stare Into Beam Class II Laser Product Wavelength: 650 nm Max. Output : 1.2 mW

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1

StatStrip Lactate Hospital Meter StatStrip® Lactate Meter Instructions for Use Manual for Export Only Ordering Information The StatStrip® Lactate 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 (in the U.S.A.) or Waltham, MA 02454-9141 U.S.A. +1-781-899-0417 (outside the U.S.A.) www.novabiomedical.com

EC REP

Authorized Representative

Nova Biomedical UK C3-5, Evans Business Centre Deeside Industrial Park, Deeside Flintshire, CH5 2JZ UK

Telephone: + 44 1244 287087 Fax: + 44 1244 287080 Accounts Fax: + 44 1244 287085

Trademark and Patents StatStrip is a registered trademark of Nova Biomedical Corporation. The Nova StatStrip Lactate Hospital Meter is patented by the following patents: US Patent Numbers. 6,258,229; 6,287,451; 6,837,976; 6,942,770; CA Patent Numbers: 2,375,089; 2,375,092; EP Patent Number: 1,212,609.

Copyright Printed in the U.S.A. Copyright 2011, Nova Biomedical Corporation, Waltham, MA 02454-9141

i

Instructions for Use Manual

Preface

Technical Assistance 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 GmbH Messenhauser Str. 42 Roedermark Urberach 63322 Germany Tel: + 49 6074 8448 0

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 GesmbH Laxenburgerstrasse 33/6 A-1100 Vienna Austria Tel: + 43 1 603 09700

Nova Biomedical UK C3-5 Evans Business Centre Deeside Industrial Park, Deeside Flintshire, CH5 2JZ UK Tel: + 44 1244 287087

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Nova Biomedical KK B-3F Omori Bellport 26 Minami Oi 6-chome Shinagawa-ku Tokyo 140-0013 Japan Tel: + (813) 5471-5461

StatStrip Lactate Hospital Meter

Contents 1

Introduction... 1-1 1.1 1.2 1.3 1.4 1.5 1.6

1.7 1.8 1.9

1.10 1.11

2

About This Manual...1-1 Safety...1-1 Intended Use and Tests Performed...1-3 The Sample...1-3 Interfering Substances...1-4 Operation Overview...1-5 1.6.1 Using the Display Keypad...1-7 1.6.2 Hard Buttons...1-8 1.6.3 Soft Buttons...1-9 1.6.4 Meter Sleep/Wake Up...1-10 1.6.5 Result Alerts...1-11 1.6.6 Multi-screen Menus...1-11 Installing the StatStrip Lactate Hospital Meter...1-12 1.7.1 Power Up Procedure...1-12 Operator Login...1-14 Administration (Admin) Screen...1-15 1.9.1 Naming the Meter...1-16 1.9.2 Setting the Time/Date...1-17 1.9.3 Sound On/Off...1-18 1.9.4 View Setup...1-18 1.9.5 Unarchive...1-18 1.9.6 Resetting the Facility...1-18 Assign Location...1-19 Meter Transport Case...1-19

Quality Control... 2-1 2.1 2.2 2.3 2.4

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

47632B 2011-03

TOC-1

Instructions for Use Manual 3

Table of Contents

Operation... 3-1 3.1 3.2

Running a Patient Sample...3-1 Review Results...3-7

4

Docking/Charging Station... 4-1

5

Linearity Test... 5-1 5.1

6

Maintenance... 6-1 6.1 6.2 6.3

7

Meter Screen Alerts...7-1

Appendix... A-1 A.1 A.2 A.3 A.4 A.5 A.6 A.7

TOC-2

Charging the Meter...6-1 Changing the Battery...6-2 Cleaning the Meter...6-4

Troubleshooting... 7-1 7.1

A

Running a Linearity Test...5-1

StatStrip Lactate Hospital Meter Specifications...A-1 Controls/Linearity Solutions...A-3 Barcode Scanner...A-3 Reference Values...A-4 Ordering Information...A-4 Theory...A-5 A.6.1 Lactate...A-5 Warranty...A-6

Instructions for Use Manual Introduction

Nova provides all necessary instructions for the routine operation and maintenance of the StatStrip Lactate 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. This section introduces the meter and covers requirements, tests performed, procedural limitations, clinical utility, and sample handling. The Nova StatStrip Lactate Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical lactate electrochemical test strips to measure lactate in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring lactate, the meter stores patient test data, QC test data, and other information relating to patient, patient sample, operator, reagents, and the meter. A user interface provides for a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter.

1.1

About This Manual This manual is for the Nova Biomedical StatStrip Lactate 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 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.

1-1

1. Intro.

1

1 Introduction

StatStrip Lactate Hospital Meter 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. 8. The meter should be serviced by qualified service personnel. Electrical Safety 1. Battery powered: 3.7 V Li Polymer 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: The battery used in this meter 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 for customers in Europe. •

on the battery label indicates that the battery provided with This symbol 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 for customers in Europe. • 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. 2. Operate the meter in the appropriate environment. 3. Dispose of all waste solutions according to standard hospital procedures. Environmental • The operating temperature range for Meter operation: 59˚F to 104˚F (15˚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 (4500 meters)

1-2

Instructions for Use Manual

Weight:

1.3

1. Intro.

Dimensions: Height: Width: Depth:

1 Introduction

153 mm (6.0 in) 82.5 mm (3.25 in) 46 mm (1.8 in)

360 g (0.8 lb)

Intended Use and Tests Performed Intended Use The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by health care professionals for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh whole blood venous and arterial blood samples. It is intended to provide plasma equivalent results to laboratory methods. The Nova StatStrip Lactate Hospital Meter System is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. Nova StatStrip Lactate Test Strips are intended for use only with the Nova StatStrip Family of Meters for quantitative determination of lactate in whole blood venous and arterial specimens. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only). The Nova StatStrip Family of Meters have StatStrip in their brand name. Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Family of Meters and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls, (Levels 1 and Level 2). The Nova StatStrip Family of Meters have StatStrip in their brand name. Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Family of Meters. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4. The Nova StatStrip Family of Meters have StatStrip in their brand name.

1.4

The Sample • • • •

Venous and arterial whole blood Plasma calibrated patient test results Sample size 0.6 µL Anticoagulants: sodium and lithium heparin

1-3

StatStrip Lactate Hospital Meter 1.5

Interfering Substances Lactate Interferences: The StatStrip Lactate Hospital Meter exhibits no interference from the following substances up to the following concentration levels: Tested Interfering Substances Acetaminophen Ascorbic Acid Bilirubin Cholesterol Creatinine Dopamine Ephedrine Glucose Ibuprofen L-Dopa Methyl-Dopa Salicylate Tetracycline Tolazamide Tolbutamide Triglycerides Uric Acid

1-4

Tested Concentration Level 20.0 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 900.0 mg/dL 49.7 mmol/L 48.0 mg/dL 2.33 mmol/L 5.0 mg/dL 0.25 mmol/L 1.0 mg/dL 0.042 mmol/L 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

Instructions for Use Manual Operation Overview

The meter uses a touch screen and 3-button keypad for menu navigation and data entry. An on-screen keypad allows manual data entry of alphanumeric characters. Pressing the Sleep button either places the meter into a power saving Sleep Mode or Wakes the meter for use. The Scan/Home buttons, one on each side of the meter, are used to scan in barcode data or return to the Welcome screen. Strip Port

Screen Title

Touch Screen Enter Patient ID

Op: 8636 13:42

Meter Name: NICU-1

_________________________ 194546646

1

2

3

4

5

6

7

8

9

Scan

0

ABC...

Clear

Accept

OK

List

Scan/Home Buttons (one on each side)

Onscreen Keypad

OK/Enter Button default action

Back Button

Forward Button

Sleep Mode Button LAC

Laser Barcode Scanner

Figure 1.1 StatStrip Lactate 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.

1-5

1. Intro.

1.6

1 Introduction

StatStrip Lactate Hospital Meter WARNING: Do not stare into the Laser light or point it towards anyone's eyes while scanning a barcode.

1-6

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.

•

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

1 Introduction

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: ED

_________________________

1

2

3

4

5

6

7

8

Scan

0

Back

Scan OK

Data Entry: cursor in active entry field

Enter Operator ID 13:42

Name: ED

_________________________ /+-.!, 1

ABC 2

DEF 3

GHI 4

JKL 5

MNO 6

9

PQRS 7

TUV 8

WXYZ 9

ABC...

Scan

space 0

0..9

Back

Scan OK

Body

Soft Buttons

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) – 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 Soft Key Bar duplicates and labels the functionality of the Left, OK, and Right hard buttons. The StatStrip Lactate Hospital Meter has the following operator input mechanisms: • Hard buttons for menu navigation and menu prompt acknowledgement • Soft buttons for menu navigation and menu prompt acknowledgement • Soft keyboard for data input • A power-on/sleep hard button • A pair of scan hard buttons to trigger a barcode label scan 1-7

1. Intro.

1.6.1 Using the Display Keypad

StatStrip Lactate Hospital Meter 1.6.2 Hard Buttons The following are the StatStrip Lactate Hospital Meter hard buttons: • Right Button – when enabled has the same functionality as the right arrow soft key on the screen. • Left Button – when enabled has the same functionality as the left arrow soft key on the screen. • OK Button – when enabled has the same functionality as the OK soft key on the screen. • Power Button – turns the Meter on or puts it into a sleep mode. • Scan Buttons – when enabled trigger a barcode scan. All the hard buttons are disabled when the Meter is in the Charging Station. Audible tones associated with the pressing of a hard button are not sounded when the Testing Sample screen is displayed. Sleep Button •

Pressing the Sleep Button when the Meter is active normally causes the Meter to immediately go into the sleep mode. Pressing the Sleep Button when the Meter is powered off causes the Meter to wake up within 5 seconds.

•

If the Meter is currently processing a sample (Testing Sample), the Power button is disabled.

Scan/Home Buttons The Scan/Home Buttons are only active and will only trigger a scan for screens that accept barcode label scanned data. When not barcode scanning, pressing these buttons brings you back to the Home screen.

1-8

Instructions for Use Manual

1 Introduction

On-screen buttons, called "Soft Buttons," are used for menu navigation and screen menu choice. Soft buttons have the same functionality as the corresponding hard buttons. 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 or OK soft button is pressed.

1-9

1. Intro.

1.6.3 Soft Buttons

StatStrip Lactate Hospital Meter 1.6.4 Meter Sleep/Wake Up The LCD display is turned off to conserve battery power (sleep mode) after an Operator defined time of no activity. Keep-awake activities include: • Pressing a hard button • Touching the screen • Placing the meter into the Charging Station • Inserting a test strip If the meter is placed into the docking station, the following conditions should be expected: • If Patient Result is the currently displayed screen when docking occurs, the results are auto-saved. • If the currently displayed screen is a Setup screen, any unconfirmed input data or menu selection is discarded upon docking. Wake Up When in the sleep mode, the following conditions activate the meter: the meter displays the last screen it displayed before it went to sleep. To wake the meter, one of the following can be done: • Pressing any hard button • Touching the screen • Inserting a strip (test/QC/Linearity)

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Instructions for Use Manual

1 Introduction

The result is displayed differently depending on whether it is in or out of the normal range for lactate measurement. • • •

Results within the normal range are displayed in Blue. Results outside the normal range are displayed in Red. If the value is outside the technical range of the meter, the low or high end of the technical range value displays as <XX or >YY (where XX-YY represents the technical range). A Single up arrow (↑) is displayed for a result if the value is higher than the upper end of the normal range but within the critical range. A double up arrow (↑↑ – HI) is displayed for a result if the value is higher than the upper end of the critical range (>20 mmol/L or > 192 mg/dL Lac). A Single down arrow (↓) is displayed for a result if the value is lower than the lower end of the normal range but within the critical range. A double down arrow (↓↓ – LO) is displayed for a result if the value is lower than the lower end of the critical range (<0.3 mmol/L <3.0 mg/dL Lac).

• • • •

Patient Result

Op: 8636 13:42

Name: ED

Pt ID: 194546646 Meltzer, Jessica

Strip Lot: 0206806099

LAC

HI mmol/L

Lac

Exceeds Measure

Double Up Arrows

Patient Result

13:42

Pt ID: 194546646 Meltzer, Jessica

Strip Lot: 0206806099

LAC

HI mg/dL

Lac >20

Op: 8636

Name: ED

Exceeds Measure

>192

HI Displayed Result >20 mmol/L or >192 mg/dL Reject

OK

Accept

Comment

Reject

OK

Accept

Comment

Figure 1.3 Patient Result: Exceeds Measure/HI screen

1.6.6 Multi-screen Menus When a menu or a list is too large to be fully displayed on the LCD screen, or a menu item is one of many in a list, a Page Up (lower left side) and a Page Down (lower right side) soft keys display to navigate forward and backward amongst the screens. The Hard Arrow buttons can also be used to scroll to the previous or next page. 1-11

1. Intro.

1.6.5 Result Alerts

StatStrip Lactate Hospital Meter 1.7

Installing the Nova StatStrip Lactate Hospital Meter First install one of the rechargeable Li batteries: both batteries come with a half charge thus the meter can be operated immediately. To fully charge the battery, place the meter onto the Charging Station. The Charging Station must be plugged into a 120 Volt AC outlet. The meter needs to be charged until the green light on the charging station lights up. At the same time, place the spare rechargeable battery into its place in the Charging Station. A spare battery is stored in a charging position in the Charging Station. The Charging Station recharges the battery of the meter when the meter is placed into the station. Indicator lights on the station provide feedback as to whether the meter battery is charging or fully charged. The station must remain plugged into a wall outlet for power. The station is designed to reside on a desk or counter top.

1.7.1 Power Up Procedure After initial power up or after battery replacement, the Boot screen appears and is displayed while the software loads. Once the software has loaded, the Welcome screen is displayed.

Figure 1.4 Boot Screen

1-12

Instructions for Use Manual

Operator ID displays here Welcome Name: ED

Facility: location:

13:42

Beeper on/off

ED

Current Facility: Name Current Location: Name

Your Facility ED

OK to test or Alert Message Here Battery Charge Icon Review Login or Continue

Press OK to begin testing

Batt: Review

Mem:

Login OK

View Setup

Memory Icon View Setup

Figure 1.5 Welcome Screen

Messages or Alerts on the Home screen • Press OK to begin testing • Memory Full Dock Meter Immediately • Battery Low Charge/Replace Battery • QC Due: xx:xx hrs. • Download Due: xx:xx hrs • LOCKED Perform QC before Patient Testing • QC Required • Linearity Required • Testing Not Allowed Assign Unit • Dock Required • Please return meter to dock for transfer • Memory Low Need to Dock Soon • LOCKED With a message

1-13

1. Intro.

Meter's name

1 Introduction

StatStrip Lactate Hospital Meter 1.8

Operator Login After initial power up, an operator can login to have access to all the assigned functions of the meter. To login, proceed as follows: 1. From the Home screen, press the Login soft key at the bottom middle of the screen. 2. The Enter Operator ID screen displays. a. To enter alphanumeric ID's, press the ABC soft key on the touchscreen keypad. An alphanumeric keypad will display. b. To return to numeric keypad, press the 0-9 soft key. c. To use the barcode scanner, press the Scan soft key on the Enter Operator ID screen or one of the side buttons to scan your badge with the bottom of the meter. NOTE:

When an invalid ID is entered, the screen displays the invalid ID number with a message "is not a valid ID Try again."

3. Press the Accept soft key at the bottom of the screen.. Enter Operator ID

Enter Operator ID 13:42

Name: ED

_________________________

Scan Soft Key

13:42

Name: ED

08636 ________________________

1

2

3

1

2

3

4

5

6

4

5

6

7

8

9

7

8

9

Scan

0

ABC...

Erase

0

ABC...

Back

Scan OK

Clear

Accept

OK

Accept Soft Key

Figure 1.6 Enter Operator ID Screens

4. After the Operator ID is accepted, the Patient Test screen displays. The meter is now ready to run Patient tests, QC tests, Linearity tests, review results, set the time, etc.

1-14