StatSensor-i Creatinine Meter Instructions for Use Manual

Nova Biomedical Symbol DirectorY

In vitro diagnostic medical device

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

Caution, consult accompanying documents

90

30

Discard 90 days after opening

Operator (By)

Do not use 30 days after opening

Date Opened (Test Strip Vial)

Date Opened (Control and Linearity Solution Vial)

CONT Contents

Consult instructions for use

Manufactured by

Discard Date

Biological risk

Control

Polarity

Irritant

SOLN

Solution

On/Off

Catalog number

LEVEL

Level

Indoor, Dry Location Only

Batch code

This Side Up

Double Insulated

Serial Number

Fragile, Handle With Care

Ethernet Network

Temperature limitation

Keep Dry

AC (alternating current)

Upper Limit of Temperature

Authorized Representative EC REP Nova Biomedical UKin the

DC (direct current)

Xi

SN

European Community

Use by (last day of the month) YYYY - MM

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

1

Electronic Waste

StatSensor-i Creatinine Meter StatSensor-i Creatinine Meter Instructions for Use Manual - International Ordering Information The StatSensor-i Creatinine Hospital Meter Instructions for Use Manual can be ordered from Nova Biomedical Order Services. Write or call: Nova Biomedical 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

EU Authorized Representative Nova Biomedical Telephone: C3-5, Evans Business Centre Fax: Deeside Industrial Park, Deeside Flintshire, CH5 2JZ

+44 1244 287087 +44 1244 287080

Trademark and Patents The Nova Statsensor-i Creatinine 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 2009, Nova Biomedical, Waltham, MA 02454-9141

i

Instructions-i for Use Manual

Preface

Technical Assistance For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. 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 C3-5 Evans Business Centre Deeside Industrial Park, Deeside Flintshire, CH5 2JZ UK Tel: + 44 1244 287087 Nova Biomedical GmbH Messenhauser Str. 42 Roedermark Urberach 63322 Germany Tel: + 49 6074 8448 0

ii

Nova Biomedical GesmbH Laxenburgerstrasse 33/6 A-1100 Vienna Austria Tel: + 43 1 603 09700 Nova Biomedical KK B-3F Omori Bellport 26 Minami Oi 6-chome Shinagawa-ku Tokyo 140-0013 Japan Tel: + (813) 5471-5461

StatSensor-i Creatinine 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

Quality Control... 2-1 2.1 2.2 2.3

3

About This Manual...1-1 Safety and Warnings...1-1 Intended Use, Tests Performed, and Clinical Utility...1-3 The Sample...1-4 Interfering Substances and Limitations...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/Wakeup...1-10 1.6.5 Result Alerts...1-11 1.6.6 Multi-screen Menus...1-11 Installing the StatSensor-i Creatinine 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

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

Operation... 3-1 3.1 3.2

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

45304B 2009-10

TOC-1

Instructions for Use Manual

Table of Contents

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

A.8

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

Creatinine Meter Specifications...A-1 Controls/Linearity Solutions...A-2 Barcode Scanner...A-3 Reference Values...A-4 Ordering Information...A-4 Theory...A-5 A.6.1 Creatinine...A-5 Calculations for Estimated Glomerular Filtration Rate( eGFR) as an Indicator of Creatinine Clearance(CrCl)for Adults...A-6 A.7.1 Estimated Glomerular Filtration Rate (eGFR) Using the MDRD Equation for Adults...A-6 A.7.2 Estimated Glomerular Filtration Rate(eGFR) Using Cockcroft-Gault Equation for Adults...A-7 Warranty...A-8

Instructions for Use Manual Introduction

This manual provides all necessary instructions for the routine operation and maintenance of the StatSensor-i Creatinine Meter. Please read this manual carefully. It has been prepared to help you attain optimum performance from your Meter. 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. This section introduces the Meter and covers requirements, tests performed, procedural limitations, clinical utility, and sample handling. The StatSensor-i Creatinine Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring creatinine, 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 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 StatSensor-i Creatinine 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 and Warnings 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. 1-1

1. Intro.

1

1 Introduction

StatSensor-i Creatinine Meter 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. 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: yellow 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. 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: 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, Tests Performed, and Clinical Utility Intended Use The StatSensor-i Creatinine Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. StatSensor-i Creatinine Test Strips are intended for use only with the StatSensor-i Creatinine Meter for quantitative tests. The Creatinine Meter is intended to quantitatively measure creatinine in whole blood. The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods. StatSensor-i Creatinine Test Strips are for testing outside the body (in vitro diagnostic use only). StatSensor Creatinine Control Solutions are intended for use with the StatSensor-i Creatinine Meter and StatSensor-i Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine test results. There are three levels of controls, (Level 1, Level 2, and Level 3). StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the StatSensor-i Creatinine Meter System. There are 5 levels of Linearity Solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5). Clinical Utility The measurement of Creatinine is used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

1-3

StatSensor-i Creatinine Meter 1.4

The Sample • • • •

1.5

Whole blood Plasma calibrated patient test results Sample size 1.2 µL Anticoagulants: sodium, lithium, and ammonium heparin

Interfering Substances and Limitations The StatSensor-i Creatinine Meter exhibits no interference from the following substances up to the following concentration levels: Tested Interfering Substances Acetaminophen Ascorbic Acid Bilirubin Cholesterol Creatine Dopamine Glucose Hematocrit (RBC) Heparin L-Dopa D(+) Maltose Monohydrate Oxygen Triglycerides Uric Acid

Tested Concentration Level 10.0 mg/dL 3.5 mg/dL 15.0 mg/dL 1000.0 mg/dL 4.0 mg/dL 10.0 mg/dL 500 mg/dL 30% - 60% 120 units/dL 300.0 mg/dL 100.0 mg/dL All Concentrations 1000.0 mg/dL 20.0 mg/dL

Disclaimer Standard algorithms are available to convert the creatinine value into an estimated glomerular filtration rate (eGFR). When using an eGFR derived value, you should not assume that the patient does not have chronic kidney disease (CKD) until a physician confirms it.

1-4

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

Touch Screen Screen Title

Enter Patient ID

Op: 8636 13:42

Meter Name: ED

_________________________ 194546646

1

2

3

4

5

6

7

8

9

Scan

0

ABC...

Clear

Accept

OK

List

Back Button

Scan/Home Buttons (one on each side)

Onscreen Keypad

OK/Enter Button default action Forward Button

Sleep Mode Button CREA

Laser Barcode Scanner

Figure 1.1 StatSensor-i Creatinine Meter

The Meter provides audible feedback (if activated) 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

StatSensor-i Creatinine 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. The operator can recall and review test data stored in the Meter.

•

Meter operation involves entering operator, patient, QC, and strip lot data, as needed. Insert a test strip into the Meter. Touch the end of the test strip to the blood drop until the well of the test strip is full and the meter beeps. 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.

•

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 is 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 StatSensor-i Creatinine 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 or return to the Welcome screen

1-7

1. Intro.

1.6.1 Using the Display Keypad

StatSensor-i Creatinine Meter 1.6.2 Hard Buttons The following are the StatSensor-i Creatinine 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 wakeup within 5 seconds.

•

If the Meter is currently measuring (analyzing) a 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 returns you to the Welcome 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 each numeral, "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

StatSensor-i Creatinine Meter 1.6.4 Meter Sleep/Wakeup The LCD display is turned off to conserve battery power (sleep mode) after 90 seconds 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 a 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. Wakeup 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)

1-10

Instructions for Use Manual

1 Introduction

The result is displayed differently depending on whether it is in or out of the normal range for creatinine 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 (↑↑) is displayed for a result if the value is higher than the upper end of the critical range. 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 (↓↓) is displayed for a result if the value is lower than the lower end of the critical range. QC Result Patient Result

HI Displayed Result >12 When HI and LO display, eGFR is not calculated.

Op: 8636 13:42

Name: ED

Patient ID: 0213806081 Darryl Smith Strip Lot: 0206806099

CREAT Creat

HI mg/dL

Exceeds Measure

Double Up Arrow

>12

Range 0.5-1.2

OK

Accept

Comment

Figure 1.3 Patient Result: Not in Measured Range 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

StatSensor-i Creatinine Meter 1.7

Installing the StatSensor-i Creatinine 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 120/220 Volt AC outlet. The Meter needs to be charged until the green light on the lower right of 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 charging 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.

1-12

Instructions for Use Manual

Operator ID displays here Welcome 13:42

Name: ED

Press to assign/reassign a location

Beeper on/off

ED Facility: location:

Your Facility ED

Current Facility: Name Current Location: Name

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

Press OK to begin testing

Batt: Review

Mem: Login OK

Memory Icon View Setup

View Setup

Figure 1.4 Welcome Screen

Messages or Alerts on the Welcome 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

StatSensor-i Creatinine 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 press 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 1.5 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