GEM PREMIER 4000 Operators Guide Sw V2.3.0 Rev 2 May 2013

TABLE OF CONTENTS LIMITED WARRANTY... 3 USING THIS MANUAL... 4 INTRODUCING THE GEM PREMIER 4000 ANALYZER... 10 GEM PREMIER 4000 ANALYZER OVERVIEW... 14 STARTING UP THE ANALYZER... 16 GENERAL OPERATION INFORMATION... 19 CVP (CALIBRATION VALUATION PRODUCT) SAMPLING... 21 START NEW SAMPLE TAB... 27 PATIENT SAMPLING... 29 SEARCH RESULTS... 47 REMOVING THE CARTRIDGE... 50 TRAINING VIDEOS... 52 SHUTTING DOWN THE ANALYZER... 55 DIAGNOSTICS... 56 ERROR CODES AND OPERATOR MESSAGES... 60 MAINTENANCE... 63 REFERENCE RANGES... 69 CRITICAL LIMITS... 71 iQM® REPORTS ... 72 ORDERING INFORMATION... 77 ANALYZING PROFICIENCY MATERIALS... 79

I.

LIMITED WARRANTY Manufacturer responsibility for safety and performance

Instrumentation Laboratory (IL) is responsible for the safety and electrical performance of this equipment if and only if: • Persons authorized by IL carry out assembly operations, extensions, adjustments, modifications, or repairs. • The GEM Premier 4000 analyzer is repaired by authorized IL personnel or persons authorized by IL. • The electrical installation of the room complies with the local, state, or national requirements (including power supply circuit with independent grounding). • The equipment is used in accordance with the instructions for use contained in this manual. • IL brand products are used; non-IL brands are not covered.

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USING THIS MANUAL Understanding labels and symbols

This manual contains the procedures necessary to operate and maintain the IL GEM Premier 4000 analyzer. Personnel responsible for operating and maintaining the analyzer should read and understand the included material prior to use. This manual should be kept near the instrument or in a suitable location for reference as required.

Symbols and Labeling Throughout this manual you should pay particular attention to paragraphs marked with the following symbols. Paragraphs containing these symbols contain important information.

WARNING: statements provide information about potential electrical hazards.

!

CAUTION: statements provide information about potential personal injury or product damage hazards.

BIOHAZARD: statements alert the user to potentially biohazard conditions.

NOTE: statements contain important user information.

Instrumentation Laboratory uses some symbols in consumable product and instrument labeling. These symbols are required by some regulatory agencies and provide a universal method to communicate important information. Confirms the product meets EU (European Union) guidelines applicable to the product and, in particular, that all safety requirements have been met. Consult instructions for use Caution, consult accompanying documents. Attention, see instructions for use. Fragile, handle with care Temperature limitation Use by Date of manufacture Batch code or lot number Catalogue or part number Serial number

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USING THIS MANUAL Understanding labels and symbols

In vitro diagnostic device Manufacturer Authorized representative Contains sufficient for <n> tests Standby Earth (ground) Fuse Alternating current Output Modem Ethernet USB Keypad Serial Printer Electrical and electronic equipment waste that requires specific disposable instructions from the manufacturer Caution, Risk of electric shock This way up Biological hazards Warning, hot surface

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USING THIS MANUAL Understanding labels and symbols

Measured Analytes The measured analytes are represented on the analyzer and throughout the manual by the following symbols or abbreviations.

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Analyte Name

Abbreviation

Hydrogen ion

pH or cH

Carbon dioxide partial pressure

pCO2

Oxygen partial pressure

pO2

Sodium ion

Na+

Potassium ion

K+

Chloride

Cl-

Ionized calcium

Ca++

Glucose

Glu

Lactate

Lac

Hematocrit

Hct

Total hemoglobin

tHb

Oxyhemoglobin

O2Hb

Carboxyhemoglobin

COHb

Methemoglobin

MetHb

Deoxyhemoglobin or reduced hemoglobin

HHb

Total bilirubin

tBili

GEM Premier 4000 Operator’s Guide

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USING THIS MANUAL Understanding labels and symbols

Derived Parameters Derived calculations are represented on the analyzer and throughout the manual by the following symbols or abbreviations. Derived Parameter

Abbreviation

Total Carbon Dioxide

TCO2

Base Excess of Extracellular Fluid (In vitro)

BEecf

Base Excess of Blood (In vitro)

BE(B)

Calculated Total Hemoglobin

tHb(c)

Ionized Calcium normalize to a pH of 7.4

Ca++ (7.4)

Anion Gap

AG

Arterial partial pressure/inspired oxygen ratio – (estimate of gas exchange ratio)

P/F Ratio

Alveolar oxygen partial pressure

pAO2

Arterial oxygen content

CaO2

Mixed venous oxygen content

CvO2

Partial pressure of oxygen in a hemoglobin solution having an oxygen saturation of 50%

p 50

Arterial sample oxygen capacity

O2cap

Oxygen Saturation – (calculated from measured CO-Oximetry analytes)

sO2

Calculated Oxygen Saturation

sO2 (c)

Standard bicarbonate

HCO3- std

Actual bicarbonate

HCO3- actual

Alveolar-arterial oxygen gradient

A-aDO2

Arterial-alveolar oxygen ratio

paO2/pAO2

Respiratory index

RI

End pulmonary capillary oxygen content

CcO2

Arterial-mixed venous oxygen gradient

a-vDO2

Estimated shunt

Qsp/Qt (est)

Physiological shunt

Qsp/Qt

Calculated Hematocrit

Hct(c)

Oxygen Content

O2ct

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USING THIS MANUAL Understanding labels and symbols User-Entered Parameters The analyzer provides space for entering the following parameters, which operators must measure, calculate, or obtain elsewhere: • Actual patient temperature (Temp) The default temperature is 37°C. This temperature will be used to calculate pH, p CO2 and p O2 unless a different entry is made by the operator. The measured and corrected temperature results, if applicable, are displayed on the View Results screen and on the printout. • Barometric Pressure (BP) The default Barometric Pressure is 760 mmHg. This BP will be used unless a different entry is made by the operator. The GEM Premier 4000 analyzer does not need daily entry of Barometric Pressure for sample analysis, as the solutions are sealed in gas impermeable bags with no headspace. However, Barometric Pressure is used in various calculated parameter equations, alveolar oxygen partial pressure (pAO2) for example. Therefore, if a BP othen than 760 mmHg is desired for use in the calculated parameter equations the operator must enter it when the Enter Information tab is presented. The entered value will be displayed on the screen and shown on the printed report. In addition, more user-entered parameters and O2/vent settings can be defined by the facility in Configuration. Ventilator Modes

O2 Device Names

A/C

Aerosol Mask

A/C PC

Aerosol Tee

APRV

Ambu

BiPAP

Cannula

CPAP

Face Mask

HFOV

Heli OX (20-80)

MMV

Heli OX (30-70)

PCIRV

High flow Cannula

PCVAPS

Non Rebreather

SIMV

Oxy Hood

SIMV/PC

Oxymizer

SIMV/PS

Partial Rebreather

VCIRV

Simple Mask

VDR

Tracheal Collar Venti Mask

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USING THIS MANUAL Understanding labels and symbols

O2 or Vent Parameter

Abbreviation

Mode #1

Not Applicable

Mode #2

Not Applicable

O2 Device #1

Not Applicable

O2 Device #2

Not Applicable

Oxygen flow

O2

Percent inspired oxygen

FIO2

Mechanical Tidal Volume

Mech VT

Spontaneous Tidal Volume

Spont VT

Set Minute Volume

Set Minute Vol

Total Minute Volume

Total Minute Vol

Mechanical Rate in bpm

Mech Rate(bpm)

Mechanical Rate in Hz

Mech Rate(Hz)

Spontaneous Rate in bpm

Spont Rate(bpm)

Spontaneous Rate in Hz

Spont Rate(Hz)

Peak Inspiratory Pressure

PIP

Mean Airway Pressure

MAP

Inspiratory time

Itime(sec)

Inspiratory time

Itime(%)

Positive End Expiratory Pressure

PEEP

Continuous Positive Airway Pressure

CPAP

Bi-level Positive Airway Pressure (Inspiratory)

BIPAP(I)

Bi-level Positive Airway Pressure (Expiratory)

BIPAP(E)

Pressure Support

PS

Pressure Control

PC

Pulse Oximeter

Pulse Ox

Flow

Not Applicable

Amplitude

Not Applicable

Delta P

Not Applicable

High Positive End Expiratory Pressure

High PEEP

Low Positive End Expiratory Pressure

Low PEEP

Inspiratory Positive Airway Pressure

IPAP

Expiratory Positive Airway Pressure

EPAP

Adaptive Support Ventilation

ASV

Proportional Assist Ventilation

PAV

Nitric Oxide

Not Applicable

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INTRODUCING THE GEM PREMIER 4000 ANALYZER Description of the Instrumentation Laboratory GEM Premier 4000 analyzer

Product Intended Use The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient’s acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.

Intelligent Quality Management (iQM®) Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin, CO-Oximetry and hematocrit) must meet IL’s specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.

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INTRODUCING THE GEM PREMIER 4000 ANALYZER Description of the Instrumentation Laboratory GEM Premier 4000 analyzer

Clinical Overview The GEM Premier 4000 analyzer provides fast, accurate, quantitative measurements of whole blood pH, p CO 2 , p O 2, Na+, K+, Cl–, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry. Heparinized Plasma may also be used to assay total bilirubin in the tBili/CO-Ox mode. • pH and p C O 2 , along with their derived parameters Base Excess, HCO3–, and TCO2, define acid-base status. • Arterial p O 2 indicates adequacy of oxygen exchange. • Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes: • Sodium is the major cation of extracellular fluid. It is critical for maintenance of water distribution and osmotic pressure in body tissues. • Potassium is the major intracellular cation. It is critical for maintaining proper neuromuscular irritability including respiratory and myocardial function. • Ionized calcium is critical for functions including hemostasis. • Chloride is the major negative ion in the fluid outside the body’s cells. Its main function is to maintain electrical neutrality, mostly as a counter-ion to sodium. Changes in the chloride level often accompany sodium losses and excesses. • Hematocrit indicates the red cell fraction of the blood, a vital component in determining its oxygen carrying capacity. • Glucose is the primary energy source, and its blood level is maintained within a fairly narrow range. The most common disorder affecting blood glucose levels is due to diabetes mellitus, which can cause hyperglycemia (high blood glucose) and hypoglycemia (low blood glucose). • Lactate is an intermediary product of carbohydrate metabolism and is derived mainly from muscle cells and erythrocytes. Severe oxygen deprivation of tissues due to shock, cardiac decompensation, hematologic disorders, and pulmonary insufficiency leads to “lactic acidosis” and is associated with a significant increase in blood lactate. Lactate clearance has been utilized as a prognostic marker of global tissue hypoxia in circulatory shock. Liver malfunction may also play an important role in the production of lactate. • Bilirubin is produced by the degradation of heme groups present in hemoglobin. High levels of bilirubin (hyperbilirubinemia) lead to jaundice. Severe jaundice (total bilirubin >20 mg/dL) may in turn lead to Kernicterus, a disease that may cause irreversible brain damage to the newborn. In adults, hyperbilirubinemia is caused by a variety of liver disorders such as hepatitis or by biliary obstruction leading to impaired bilirubin excretion. The GEM Premier 4000 measures total bilirubin. Total bilirubin is the sum of the concentrations of two typical bilirubin fractions, Unconjugated (Indirect) and Conjugated (Direct) bilirubins, as well as delta bilirubin. Different bilirubin fractions exhibit slightly different spectral properties and the GEM Premier 4000 measures and reports the total bilirubin concentration. • CO-Oximetry evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.

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INTRODUCING THE GEM PREMIER 4000 ANALYZER Description of the Instrumentation Laboratory GEM Premier 4000 analyzer The GEM Premier 4000 analyzer makes use of potentiometric sensors to measure p CO2, pH, Na+, K+, Cl–, and Ca++. It uses amperometric sensors to measure p O2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrometer to evaluate the sample at a variety of wavelengths. Heparinized plasma may also be utilized to assay total bilirubin when analyzed using the tBili/CO-Ox mode. Refer to the Reference Guide for additional information on analyte methodologies.

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The GEM Premier 4000 analyzer consists of non-interchangeable components. Use only components supplied by Instrumentation Laboratory.

System Components and Features The GEM Premier 4000 analyzer has two primary components: the analyzer and a disposable, multi-use cartridge. These components are described in the following paragraphs.

GEM Premier 4000 Analyzer The GEM Premier 4000 analyzer employs a unique color touch screen and a simple set of menus and buttons for user interaction. The instrument guides operators through the sampling process with simple, clear messages and prompts.

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INTRODUCING THE GEM PREMIER 4000 ANALYZER Description of the Instrumentation Laboratory GEM Premier 4000 analyzer

GEM Premier 4000 Cartridge (PAK) The primary component of the GEM Premier 4000 analyzer is the GEM Premier 4000 PAK cartridge. The disposable, multi-use PAK houses all components necessary to operate the instrument once the cartridge is validated. These components include the sensors, solutions, sampler, CO-Ox/tBili optical

cell, and waste bag. A variety of cartridge menus and test volumes are available. The values of all reference solutions are read from the cartridge EEPROM. The components and processes used to manufacture the solutions in the GEM Premier 4000 PAK are traceable to NIST standards whenever possible. For those analytes where NIST materials are not available, primary analytical standards are used. Material Safety Data Sheets (MSDS) for GEM Premier 4000 cartridges can be requested through Customer Support at Instrumentation Laboratory. Setup of the instrument consists of inserting the cartridge into the instrument. The instrument then performs a warm-up during which the sensors are hydrated and a variety of checks occur, all of which takes about 40 minutes. During warm-up, the instrument requires no user intervention. IL GEM CVP material is required to validate Intelligent Quality Management cartridges. From that point on, iQM manages the quality control process, replacing the use of external quality controls. The GEM Premier 4000 automatically notifies operators when it is time to remove the cartridge; when sample capacity has been reached, or when cartridge use life expires. The internal waste bag, which collects used blood and solutions throughout cartridge life, reduces biohazard exposure. The Instrumentation Laboratory GEM Premier 4000 analyzer may be used with a variety of GEM Premier 4000 analyzer cartridges. The screens that are pictured in this manual are appropriate for the full menu of test capabilities. If other cartridges are used, the options on the screens will be relative to the cartridge installed. Specifically, the Start New Sample and Patient Results screens will reflect only those tests that the installed cartridge is able to perform. Basic operation of the analyzer is the same for all cartridges, and the information in this manual applies to operation with all cartridges.

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IV.

GEM PREMIER 4000 ANALYZER OVERVIEW Designed for easy, reliable operation The Instrumentation Laboratory GEM Premier 4000 analyzer with Intelligent Quality Management (iQM) is an advanced, critical care system used by health care professionals to analyze whole blood samples in centralized or point-of-care clinical settings. It provides measured results for pH, pCO2, p O2, hematocrit, sodium, potassium, ionized calcium, chloride, glucose, lactate and total bilirubin. It also integrates CO-Oximetry capabilities, enabling you to perform critical types of testing from one sample.

Key Components of the GEM Premier 4000 Analyzer The two key components of the GEM Premier 4000 system are: • The analyzer, which has the internal logic and processing power necessary to perform analysis. • The cartridge, which contains the reagents, sensors, CO-Ox and total bilirubin optical cell, sampler, and waste bag, enable analysis of 75 to 600 samples. These illustrations highlight important parts and features of the analyzer and cartridge.

Analyzer front view

1. Color touch screen 2. DVD/CD RW drive 3. PCMCIA slot 4. Sampling area 5. Cartridge door 6. Bar code gun

Analyzer back view 1. Color touch screen tilt adjuster 2. Printer paper compartment 3. Handle

10. Instrument serial number

4. Network port (Ethernet) 5. Modem communication port 6. Serial communication ports (4) 7. Custom peripheral connectors (2) (one is used for the barcode gun connection)

8. Parallel port

11. Antennae Housing Unit* 12. External power connection 13. Power switch 14. USB ports (4)

9. Keyboard connector

*Not available on all analyzers

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GEM PREMIER 4000 ANALYZER OVERVIEW Designed for easy, reliable operation

Cartridge front view

1. Cartridge label 2. Sampling area 1. Cartridge label 2. Sampling area

Cartridge back view

1. CO-Oximetry and total bilirubin optical cell 2. EEPROM 3. Sensor card 1. and total bilirubin optical cell 4. CO-Oximetry Pump windings 2. EEPROM 3. Sensor card 4. Pump windings

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V.

STARTING UP THE ANALYZER Starting up the analyzer and installing the cartridge The GEM Premier 4000 analyzer requires a cartridge to perform analysis. Only cartridges designed for use with the GEM Premier 4000 analyzer and supplied by Instrumentation Laboratory can be used with the analyzer. Here you can learn how to start up the analyzer for use and how to install the cartridge correctly. Refer to the Configuration Guide for information on analyzer installation.

1

If the analyzer power is OFF, press the power switch to turn it ON. The system will automatically begin the power-up cycle. The analyzer has a momentary power switch (button). Press the button and immediately release it to turn the analyzer on. If the button is pressed and held for 5 seconds or longer, the power is turned off. The analyzer should remain powered on unless it is being transported to another source without an uninterruptible power source (UPS).

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Press Open Door on the touch screen. You will hear an audio prompt, and the door will release and open slightly. Then manually move the door all the way to the left.

GEM Premier 4000 Operator’s Guide

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STARTING UP THE ANALYZER Starting up the analyzer and installing the cartridge

3

Unpack the cartridge from its protective wrapper. Remove the clear plastic cover from the pump winding area. The cartridge must be at room temperature (15 to 25° C).

Only IL supplied cartridges may be used with this analyzer. The use of non-IL supplied cartridges will invalidate the analyzer warranty and will release IL from any responsibility for analyzer or cartridge performance.

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4

Position the cartridge with the gray sampling area facing forward. Push the cartridge in until you feel resistance. Please note that approximately one inch of the cartridge will extend beyond the front of the analyzer.

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V. 5

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STARTING UP THE ANALYZER Starting up the analyzer and installing the cartridge

Guide the analyzer door to the right to close it and move the cartridge into its final position.

In approximately 20 seconds, the analyzer will inform you that the cartridge is warming up. The clock will count down for the next 40 minutes as the cartridge warms up. During this time, the sensors will hydrate, and the analyzer will perform internal checks and processes.

GEM Premier 4000 Operator’s Guide

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GENERAL OPERATION INFORMATION An intuitive instrument keeps you informed

The GEM Premier 4000 analyzer is designed for intuitive use, and provides clear direction when you are operating the system:

Changes in color signal different conditions: green

Fully operational or normal

yellow

Conditional state, awaiting specific action

red

Stopped or non-functional

gray/shaded Functionality unavailable or not selected

Operator messages provide clear directions to you for next steps. These instructions are generally in white boxes with black text.

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VI.

GENERAL OPERATION INFORMATION An intuitive instrument keeps you informed

Password protection prevents unauthorized access to key activities. When prompted, enter your password, as provided by your supervisor or other managerial personnel.

Audio prompts also aid use by providing programmed beeps or tones to indicate that an action has occurred or is about to occur.

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