GEM 5000 PREMIER Operators Manual Rev 02 Jan 2017

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 5000 system 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.

Warranty information The following language applies to all warranties listed in this manual. Excluded from all warranties are any defects caused by misuse, accidental damage, or unauthorized repair of the product. Those parts which deteriorate or which are in any case considered consumables or those parts or “items” which by their nature are normally required to be replaced periodically consistent with normal maintenance are not covered by the analyzer warranty. The warranty is limited to the replacement, at no cost to the purchaser, of any component or accessory found to be defective during the period in which the warranty is in effect, except for cartridges, for which a pro rata credit for the unused portion of the cartridge may be provided. Product functionality must be determined per the manufacturer’s instructions prior to reporting patient results. The warranty is expressly in lieu of all other warranties, expressed or implied, including any implied warranty of merchantability or fitness for a particular purpose. It is the responsibility of the purchaser to determine the suitability of this product for any particular application, and to take any necessary actions to determine the fitness of the product at time of use. The purchaser agrees that any liability against IL for a breach of a warranty shall be limited to the replacement of any defective part, or for cartridges, credit on a pro rata basis as determined by IL. No other remedy including, but not limited to, incidental or consequential damages or lost profits, lost sales, injury to person or property, or any other incidental or consequential loss shall be available to the purchaser. No agent or employee of IL is authorized to extend any other warranty or to assume for IL any liability except as above set forth.

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Limited Warranty

GEM Premier 5000 Manual • P/N 00024019203

GEM Premier 5000 Manual • P/N 00024019203

GEM Premier 5000 PAK Warranty GEM Premier 5000 system GEM PAKs are warrantied against defects in materials and workmanship up to the expiration date stamped on the product. Damages caused by or connected to transport are excluded. A defect is defined as follows: visible leakage or mechanical defect as noted at the time the protective wrapper is removed; a sensor failure as indicated by an error code and message displayed or printed by the analyzer at the time of initial cartridge insertion and start-up, or a disabled sensor during cartridge use life that is a result of an internal defect. A sensor disabled as a result of introducing samples that contain clots or interfering substances is not considered a defect. The purchaser must notify IL within 30 days of the occurrence of any defect. The cartridge information must be returned to IL or its authorized distributor on CD, DVD or via email for warranty adjustment. Cartridges may be requested to be returned to IL. A return authorization number or incident number must be obtained from IL prior to returning the cartridge information or cartridge. IL may issue credit for the partially used cartridges on a pro rata basis at IL’s discretion. Please note the “Copy IL Data” feature on the analyzer removes all patient demographic information.

GEM Premier 5000 Analyzer Warranty IL declares to the original purchaser that each GEM Premier 5000 system manufactured and sold by IL or sold by an authorized IL distributor shall be free from defects in material and workmanship and, under normal and proper use conditions, warrants it for a period of one year from installation and no more than 13 months from the shipping date, except as otherwise provided in writing. IL’s obligation is limited to repairing, replacing, or modifying (at IL’s undisputed judgment) at IL’s factory, or elsewhere as designated by IL, the material whose defects have been verified, on condition that the purchaser has informed IL of any defects found within 10 days from receipt, or 10 days of discovery in case of defects which may not be identified in the normal inspection. Damages caused by or connected to transport are excluded. Transport to an IL facility or authorized IL distributor will be at purchaser’s charge and risk. Replacements, repairs, or alterations will in no case determine extension to the warranty period. The warranty does not cover those parts which deteriorate or which are in any case considered consumables or those parts or “items” which by their nature are normally required to be replaced periodically consistent with normal maintenance. It is also understood that following the purchase and delivery of the instrument, the purchaser shall be deemed liable for any losses, damages, or complaints concerning persons or things incurred by the use or misuse of the instrument on behalf of the purchaser, its employees, co-operators, or others.

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Exceptions to any of the warranties listed in this manual must be generated by an Instrumentation Laboratory corporate office or authorized distributor corporate office.

GEM Premier 5000 Manual • P/N 00024019203

Warranty will not apply to those defective instruments or materials showing defects or damage arising from the following causes:

1. Insufficient or negligent care by the purchaser. 2. Insufficient or negligent maintenance by the purchaser in relation to the instructions contained in the manuals prepared by IL for this purpose; tampering or alterations of the instruments or in any case interventions or repairs made by any person not duly authorized by IL.

3. Misuse due to carelessness, negligence, or inexperience. 4. Employment of materials under heavier conditions than those for which they have been designed and manufactured and use of the same in combination with incompatible or dangerous products.

5. Non-observance of the regulations relevant to installation, power supply, and operation of the instruments.

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IL does not assume any obligation or warranty engagement concerning precision and/ or accuracy of the measurements as well as for any damage to the instrument directly or indirectly resulting from the use of reagents and/or consumables different from those produced by IL specifically for its own instruments and for the same properly tested.

Understanding labels and symbols This manual contains the procedures necessary to operate and maintain the IL GEM Premier 5000 system. 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.

Important Warning Symbols Throughout this manual you should pay particular attention to paragraphs marked WARNING, CAUTION, NOTE and BIOHAZARD. Paragraphs containing these symbols contain important information. WARNING: General warning, caution, risk of danger. 

CAUTION: Caution, risk of electrical shock. 

BIOHAZARD: alerts the user of potential biological risks associated with the medical device.  NOTE: Documentation must be consulted in all cases where this symbol is marked. Warning, hot surface. 

Example: Safety sign combined with additional symbol to indicate the type of hazard.

ii

INFORMATION: statements contain helpful user information.

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1 - USING THIS MANUAL

GEM Premier 5000 Manual • P/N 00024019203

GEM Premier 5000 Manual • P/N 00024019203

Instrumentation Laboratory uses some symbols in consumable product and instrument labeling: The CE label is on the back of the instrument indicates that the GEM Premier  5000 system conforms to the European Directives as stated in IL’s Declaration of Conformity. Accompanying documents must be consulted Consult instructions for use Caution, consult accompanying documents. Attention, see instructions for use. Fragile, handle with care Temperature limitation Use by date Date of manufacture Batch code or lot number Catalog or part number SN Serial number  In vitro diagnostic device Manufacturer Authorized representative in the European Community 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 This way up Prescription Use Only

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Marking Labels Description

GEM Premier 5000 Manual • P/N 00024019203

Product Intended Use The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized 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 , sO2*) parameters. 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. *sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin. • pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances. • Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes: • Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. • Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. • Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. • Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as, cystic fibrosis and diabetic acidosis. • Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). • Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. • Lactate (Lac) measurement is used: • to evaluate the acid-base status of patients suspected of having lactic acidosis; • to monitor tissue hypoxia and strenuous physical exertion; • in diagnosis of hyperlactatemia.

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2 - The GEM Premier 5000 Analyzer

GEM Premier 5000 Manual • P/N 00024019203

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species. • Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. • COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. • MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia. • HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status. • O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status. • sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

Device Description The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2). Intelligent Quality Management 2 (iQM2®) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement 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 (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, 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 spectrophotometer to evaluate the sample at a variety of wavelengths.

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• Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

GEM Premier 5000 Manual • P/N 00024019203

The GEM Premier 5000 system consists of non-interchangeable components. Use only components supplied by Instrumentation Laboratory.

Abbreviations Measured Analytes The measured analytes are represented on the analyzer and throughout the manual by the following symbols or abbreviations. Analyte Name Hydrogen ion Carbon dioxide partial pressure Oxygen partial pressure Sodium ion Potassium ion Chloride Ionized calcium Glucose Lactate Hematocrit Total hemoglobin Oxyhemoglobin Carboxyhemoglobin Methemoglobin Deoxyhemoglobin or reduced hemoglobin Oxygen Saturation Total bilirubin

Abbreviation pH or cH pCO2 pO2 Na+ K+ ClCa++ Glu Lac Hct tHb O2Hb COHb MetHb HHb sO2 tBili

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Refer to the “Measurement Methodology” chapter for additional information on analyte methodologies.

GEM Premier 5000 Manual • P/N 00024019203

Derived calculations are represented on the analyzer and throughout the manual by the following symbols or abbreviations. Derived Parameter Total Carbon Dioxide Base Excess of Extracellular Fluid (In vivo) Base Excess of Blood (In vitro) Calculated Total Hemoglobin* Ionized Calcium normalize to a pH of 7.4 Anion Gap Arterial partial pressure/inspired oxygen ratio – (estimate of gas exchange ratio) Alveolar oxygen partial pressure Arterial oxygen content Mixed venous oxygen content Partial pressure of oxygen in a hemoglobin solution having an oxygen saturation of 50% Arterial sample oxygen capacity Calculated Oxygen Saturation Standard bicarbonate Actual bicarbonate Alveolar-arterial oxygen gradient Arterial-alveolar oxygen ratio Respiratory index End pulmonary capillary oxygen content Arterial-mixed venous oxygen gradient Estimated shunt Physiological shunt Calculated Hematocrit ** Oxygen Content

Abbreviation TCO2 BEecf BE(B) tHb(c) Ca++ (7.4) AG P/F Ratio

pAO2 CaO2 CvO2 p 50 O2cap sO2(c) HCO3- std HCO3- actual A-aDO2paO2/pAO2 RI CcO2 a-vDO2 Qsp/Qt (est) Qsp/Qt Hct(c) O2ct

* Utilizes Hct measurement to calculate when CO-Oxinmetry (tHb measured) is unavailable. ** Utilizes tHb measurement to calculate when Hct sensor is unavailable.

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Derived Parameters

GEM Premier 5000 Manual • P/N 00024019203

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, pCO2 and pO2 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 5000 system 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 other 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 A/C A/C PC APRV BiPAP HFOV MMV PCIRV PCVAPS SIMV SIMV/PC SIMV/PS VCIRV VDR CPAP

O2 Device Names Aerosol Mask Aerosol Tee Ambu Cannula Heli OX (20-80) Heli OX (30-70) High flow Cannula Non Rebreather Oxy Hood Oxymizer Partial Rebreather Simple Mask Tracheal Collar Venti Mask Face Mask

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User-Entered Parameters

GEM Premier 5000 Manual • P/N 00024019203 Abbreviation Not Applicable Not Applicable Not Applicable Not Applicable O2 FIO2 Mech VT Spont VT Set Minute Vol Total Minute Vol Mech Rate(bpm) Mech Rate(Hz) Spont Rate(bpm) Spont Rate(Hz) PIP MAP Itime(sec) Itime(%) PEEP CPAP BIPAP(I) BIPAP(E) PS PC Pulse Ox Not Applicable Not Applicable Not Applicable High PEEP Low PEEP IPAP EPAP ASV PAV Not Applicable

TABLE OF CONTENTS

O2 or Vent Parameter Mode #1 Mode #2 O2 Device #1 O2 Device #2 Oxygen flow Percent inspired oxygen Mechanical Tidal Volume Spontaneous Tidal Volume Set Minute Volume Total Minute Volume Mechanical Rate in bpm Mechanical Rate in Hz Spontaneous Rate in bpm Spontaneous Rate in Hz Peak Inspiratory Pressure Mean Airway Pressure Inspiratory time Inspiratory time Positive End Expiratory Pressure Continuous Positive Airway Pressure Bi-level Positive Airway Pressure (Inspiratory) Bi-level Positive Airway Pressure (Expiratory) Pressure Support Pressure Control Pulse Oximeter Flow Amplitude Delta P High Positive End Expiratory Pressure Low Positive End Expiratory Pressure Inspiratory Positive Airway Pressure Expiratory Positive Airway Pressure Adaptive Support Ventilation Proportional Assist Ventilation Nitric Oxide

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GEM Premier 5000 Manual • P/N 00024019203

Analytes pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2, tBili or any combination of Electrochemical* analytes and CO-Oximetry** and/or tBili tHb, O2Hb, COHb, MetHb, HHb, sO2, tBili pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, (Capillary Device Only)

Sample Volume (µL) 150

100 65 (Capillary Only)

* Electrochemical analytes = pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, ** CO-Oximetry = tHb, O2Hb, COHb, MetHb, HHb, sO2

Sample Type: Time To Results: Sample Capacity: Throughput

Whole blood with addition of an appropriate concentration of lithium heparin anticoagulant. 45 seconds from sample aspiration 75 tests to 600 tests 29 samples/hour

Measurement Methodology Amperometric: pO2, Glucose, Lactate Potentiometric: pH, pCO2, Na+, K+, Ca++, ClConductivity: Hct Optical Measurement CO-Oximetry, tBili following chemical lysing and mixing of the whole blood sample:

ii Refer to Section 6., “Measurement Methodology” for further information on methodologies. ii Internal Temperature Control: Electrode chamber maintained at 37°C (98.6°F) nominal.

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Sample Type/Volume Requirements ii Use only Lithium (Li+) Heparin anticoagulant. Refer to the “Sample Device and Collection Procedures” in Section 4 of this manual for important information on anticoagulants.

GEM Premier 5000 Manual • P/N 00024019203

Measured Analyte Units Measurable Range* Reportable Range** pH pH scale 6.80 to 7.92 7.00 to 7.92 cH nmol/L 158.5 to 12.0 100.0 to 12.0 cH nEq/L 158.5 to 12.0 100.0 to 12.0 pCO2 mmHg 6 to 150 6 to 125 pCO2 kPa 0.8 to 20.0 0.8 to 16.7 pO2 mmHg 6 to 756 6 to 690 pO2 kPa 0.8 10 100.5 0.8 to 92.0 + Na mmol/L 100 to 200 100 to 180 + Na mEq/L 100 10 200 100 to 180 K+ mmol/L 1.0 to 20.0 1.0 to 19.0 + K mEq/L 1.0 to 20.0 1.0 to 19.0 ++ Ca mmol/L 0.11 to 5.00 0.11 to 4.25 Ca++ mEq/L 0.22 to 10.00 0.22 to 8.50 ++ Ca mg/dL 0.44 to 20.00 0.44 to 17.00 Cl mmol/L 40 to 170 40 to 158 ClmEq/L 40 to 170 40 to 158 Glu mg/dL 4 to 750 4 to 685 Glu mmol/L 0.2 to 41.6 0.2 to 38.0 Lac mmol/L 0.3 to 20.0 0.3 to 17.0 Lac mg/dL 3 to 180 3 to 153 Hct % 15 to 75 15 to 72 tHb g/dL 3.0 to 23.0 3.0 to 23.0 tHb g/L 30 to 230 30 to 230 tHb mmol/L 1.8 to 14.3 1.8 to 14.3 O2Hb % 0.0 to 100.0 0.0 to 100.0 COHb % 0.0 to 75.0 0.0 to 75.0 MetHb % 0.0 to 30.0 0.0 to 30.0 HHb % 0.0 to 100.0 0.0 to 100.0 sO2 % 0.0 to 100.0 0.0 to 100.0 tBili mg/dL 2.0 to 40.0 2.0 to 40.0 tBili μmol/L 34 to 684 34 to 684

Resolution 0.01 0.1 0.1 1 0.1 1 0.1 1 1 0.1 0.1 0.01 0.01 0.01 1 1 1 0.1 0.1 1 1 0.1 1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 1

* The Measuring Range for a parameter is the range where analyte performance claims are verified and validated. ** The Reportable Range for a parameter is the range where software default limits have been configured. Notes: Analytes with measured values outside the Reportable Range are reported with a > or < symbol. Incalculable will be displayed for results that are outside the measuring capability of the analyzer.

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Measured Analytes

GEM Premier 5000 Manual • P/N 00024019203 Derived Parameter TCO2 BEecf (In vivo) BE(B) (In vitro) tHb(c) tHb(c) tHb(c) Ca++ (7.4) Ca++ (7.4) Ca++ (7.4) Anion Gap Anion Gap P/F Ratio P/F Ratio pAO2 pAO2 CaO2 CvO2 P50 P50 O2cap O2cap O2cap O2cap sO2(c) HCO3- std HCO3- (c) A-aDO2 A-aDO2 paO2/pAO2 RI CcO2 CcO2 CcO2 CcO2 a-vDO2 a-vDO2 a-vDO2 a-vDO2 Qsp/Qt (est) Qsp/Qt Hct(c)

Unit of Measure mmol/L mmol/L mmol/L g/dL g/L mmol/L mmol/L mEq/L mg/dL mmol/L mEq/L mmHg kPa mmHg kPa mL/dL mL/dL mmHg kPa mL/dL mL/L mmol/L Vol% % mmol/L mmol/L mmHg pKa Not Applicable Not Applicable mL/dL mL/L mmol/L Vol% mL/dL mL/L mmol/L Vol% % % %

TABLE OF CONTENTS

Derived (Calculated) Analytes Resoution 0.1 0.1 0.1 0.1 1 0.1 0.01 0.01 0.01 1 1 1 0.1 1 0.1 0.1 0.1 1 0.1 0.1 1 0.1 0.1 0.1 0.1 0.1 1 0.1 0.01 0.1 0.1 1 0.1 0.1 0.1 1 0.1 0.1 0.1 0.1 1

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GEM Premier 5000 Manual • P/N 00024019203

Analyte

Default Unit

pH

pH Units

pCO2 pO2 Na+ K+ Cl-

mmHg mmHg mmol/L mmol/L mmol/L

Ca++

mmol/L

Glucose Lactate

mg/dL mmol/L

tHb

g/dL

tBili

mg/dL

SI or Alternate Units Conversion Equation cH (nmol/L) = 10(-pH) * 109 cH (nEq/L) = 10(-pH) * 109 pCO2 (kPa) = pCO2 (mmHg) ÷ 7.5 pO2 (kPa) = pO2 (mmHg) ÷ 7.5 Na+(mEq/L) = Na+ (mmol/L) Cl-(mEq/L) = Cl- (mmol/L) K+ (mEq/L) = K+ (mmol/L) Ca++ (mEq/L) = 2.0 * Ca++ (mmol/L) Ca++ (mg/dL) = 4.0 * Ca++ (mmol/L) Glu (mmol/L) = Glu (mg/dL) ÷ 18.0 Lac (mg/dL) = 9.0 * Lac (mmol/L) tHb (g/L) = 10 * tHb (g/dL) tHb (mmol/L) = 0.6206 * tHb (g/dL) tBili (µmol/L)= 17.1 * tBili (mg/dL)

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Analyte Conversion Chart

GEM Premier 5000 Manual • P/N 00024019203

The following general reference ranges for arterial adult blood (unless noted) have been obtained from the sources listed at the end of the tables. Reference ranges are guidelines for the clinician, but they should not be considered as the sole indicator of health and disease. Reference ranges can be dependent on a number of factors, such as age, gender, and the patient’s normal physiological condition. Each facility may define gender and age specific reference ranges that are applicable to their patient populations. Parameter pH 2 cH cH pH pCO2 2 pO2 2 Na+ 2 K+ 2 Cl- 2

Ca++ 2 Hct 7 Gluc 2 Lac 2

tHb 7 O2Hb 8 COHb 4, 5, 6 MetHb 3 HHb 9 sO2 7 TCO2 1 BE1 HCO3- 1 Anion Gap1

Reference Range 1, 2, 3, 4, 5, 6, 7, 8, 9 7.35 to 7.45 35.5 to 44.7 35.5 to 44.7 7.32 to 7.43 (venous) Arterial blood: 35 to 48 (male) and 32 to 35 (female) Arterial blood: 4.6 to 6.4 (male) and 4.3 to 6.0 (female) venous blood (right atrium) - 6-7 mmHg (0.80-0.93 kPa) higher than arterial pCO2 83 to 108 11.0 to 14.4 136 to 145 136 to 145 3.5 to 5.1 3.5 to 5.1 98 to 107 98 to 107 1.15 to 1.33 2.30 to 2.66 4.60 to 5.32 1.16 to 1.32 (venous) 4.64 to 5.28 (venous) 40-50 (male) and 37-47 (female) 65 to 95 3.6 to 5.3 0.36 to 0.75 (at rest) 2.24 to 6.76 (at rest) 0.56 to 1.39 (venous at rest) 5.0 to 12.5 (venous at rest) 12.6 - 17.4 (male) and 11.7 - 16.1 (female) 126 - 174 (male) and 117 - 161 (female) 7.8 - 10.8 (male) and 7.3 - 10.0 (female) 90.0 to 95.0 <3.0 (nonsmoker) <10.0 (smokers) 0.0 to 1.5 1.0 to 5.0 94.0 to 98.0 19.0 to 24.0 22.0 to 26.0 (Venous) -2.0 to 3.0 21 to 28 21 to 28 22 to 29 (venous) 22 to 29 (venous) 10 to 20 (Na+ + K+) - (Cl-+HCO3-) 10 to 20 (Na+ + K+) - (Cl-+HCO3-)

Unit pH nmol/L nEq/L pH mmHg kPa mmHg kPa mmol/L mEq/L mmol/L mEq/L mmol/L mEq/L mmol/L mEq/L mg/dL mmol/L mEq/L % mg/dL mmol/L mmol/L mg/dL mmol/L mg/dL g/dL g/L mmol/L % % % % % mmol/L mmol/L mmol/L mEq/L mmol/L mEq/L mEq/L mmol/L

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GEM Premier 5000 Analyzer Reference Ranges

GEM Premier 5000 Manual • P/N 00024019203 Parameter Notes: Reference Range References: General Normal Ranges: 2

Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Elsevier Saunders, 7th edition, 2015, pp 952-982

CO-Oximetry Normal Ranges: 3

Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 7th edition, 2015, pp 952-982

4

Hampson, NB, et al. Practice Recommendations in the Diagnosis, Management and Prevention of Carbon Monoxide Poisoning, Am J Respir Crit Care Med, 2012:186:1095-1101

5

Piantadosi, C.A, Carbon Monoxide Poisoning, New England Journal of Medicine (2002), 347 (14): 1054-1055

6

Radford, EP, Blood Carbon Monoxide Levels in Person 3-74 Years of Age: United States, 1976-1980. National Center for Health Statistics, 1982.

7

Wu, A., Tietz Clinical Guide to Laboratory Tests, W.B. Saunders Co., St. Louis MO, 4th Edition, 2006: 951-982

8

Haymond, S., Oxygen Saturation, A Guide to Laboratory Assessment, Clinical Laboratory News, February 2006, pages 10-12.

9

American Environmental Laboratory: The Laboratory Assessment of Oxygenation. Robert F. Morgan, 1993, 5(4), p. 147-153.

Parameter

Source

Reference Range

Unit

tBili

Premature Infant 0 – 1 day

<8.0

mg/dL

Premature Infant 0 – 1 day

<137

µmol/L

Premature Infant 1 – 2 days

<12.0

mg/dL

Premature Infant 1 – 2 days

<205

µmol/L

Premature Infant 3 – 5 days

<16.0

mg/dL

Premature Infant 3 – 5 days

<274

µmol/L

Full-term Infant 0 – 1 day

1.4 – 8.7

mg/dL

Full-term Infant 0 – 1 day

24 – 149

µmol/L

Full-term Infant 1 – 2 days

3.4 – 11.5

mg/dL

Full-term Infant 1 – 2 days

58 – 197

µmol/L

Full-term Infant 3 – 5 days

1.5 – 12.0

mg/dL

Full-term Infant 3 – 5 days

26 – 205

µmol/L

>5 days to < 60 years

0.3 – 1.2

mg/dL

>5 days to < 60 years

5 – 21

µmol/L

Reference: Wu, A., Tietz Clinical Guide to Laboratory Tests, W.B. Saunders Co., St. Louis MO, 4th Edition, 2006

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1 TCO , HCO -, Anion Gap, and BE (Base Excess) are derived parameters 2 3

GEM Premier 5000 Manual • P/N 00024019203

The following table of critical values has been obtained from the reference listed at the end of the table. Unless otherwise noted, the values are for arterial whole blood samples. These are only suggested critical limits. Each facility may define gender and age specific critical limits that are applicable for their institutions. Parameter pH cH cH pCO2 pO2 Na+ K+

Lower Limit 7.20 63.1 63.1 20 2.6 40 6 120 120 2.8 2.8

Upper Limit 7.60 25.1 25.1 70 9.3 160 160 7.8 7.8

Unit pH nmol/L nEq/L mmHg kPa mmHg kPa mmol/L mEq/L mmol/L mEq/L

Cl-

80

120

mmol/L

HCO3-

10.0 10.0 0.75 1.50 3.00 18

40.0 40.0 1.60 3.20 6.40 60

mmol/L mEq/L mmol/L mEq/L mg/dL %

Glu

40 2.2

450 25.0

mg/dL mmol/L

Lac * B + C tHb tBili (newborn)

7 -

3.4 20 15

mmol/L g/dL mg/dL

Ca++ Hct

* Hyperlactemia is an indicator commonly used to detect tissue hyperfusion, particularly in the case of sepsis, but also in trauma and surgical settings. References: A) Tietz, N.W., Fundamentals of Clinical Chemistry, W.B. Saunders Co., Philadelphia, 5th Edition, 2001. B) Dellinger R. P et al, “Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis Shock: 2012”, Critical Care Medical, 41 (2): 580-637, 2013. C) Levraut J, Ichai C, Petit I, Ciebiera JP, Persus O, Grimaud D. “Low Exogenous Lactate Clearance As An Early Predictor of Mortality in Normolactatemic Critically Ill Septic Patients”’ Critical Care Medicine 2003; 31 (3): 705-710.

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GEM Premier 5000 Analyzer Critical Ranges

GEM Premier 5000 Manual • P/N 00024019203

The following table of medical decision levels (MDLs) has been obtained from the references listed at the end of the table. Unless otherwise noted, the values are for arterial whole blood samples. These are only suggested medical decision levels. Each facility may define institute specific MDLs that are applicable for their patient population. Parameter pH pCO2 pO2 Na+ K+ ClCa++ Hct Glu Lac tHb tBili O2Hb HHb COHb MetHb sO2

MDL1 7.30 35 30 115 3.0 90 0.37 21 45 2.0 7.0 3.0 - 6.0 90.0 6.0 3 5 90

MDL2 7.35 50 45 135 5.8 112 0.82 33 120 5.0 10.5 14.0 10 10 -

MDL3 7.45 70 60 150 7.5 N/A 1.58 56 (male) 180 18 (male) 20.0 15 -

MDL4 53 (female) 350 17 (female) -

Unit pH mmHg mmHg mmol/L mmol/L mmol/L mmol/L % mg/dL mmol/L g/dL mg/dL % % % % %

References: 1

Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Elsevier Saunders, 7th edition, 2015, pp 952-982

2

Statland, Bernard E., Clinical Decision Levels for Lab Tests, 2nd edition. Medical Economics Company Inc. New Jersey. 1987.

3

Kost, G.J, Table of Critical Limits, Clinical Laboratory Reference, 2013-2014, pp 6-7.

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GEM Premier 5000 Medical Decision Levels (MDLs)