K Number

Device Name

AVL 9180 ELECTROLYTE ANALYZER

Manufacturer

AVL SCIENTIFIC CORP.

Date Cleared

1996-06-12

(58 days)

Product Code

JFP CEM CGZ JGS JIH

Regulation Number

862.1145

Intended Use

The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.

Device Description

The AVL 9180 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results. In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K861087, K862819, K870657

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard microprocessor-based ion-selective electrode technology and does not mention any AI or ML components. The performance studies are standard analytical and clinical validation tests, not indicative of AI/ML training or evaluation.

Therapeutic

No.
The device is an electrolyte analyzer, which diagnoses conditions by measuring analytes, rather than treating them.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the analytes measured by this device "are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders". This indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

The device description clearly states it is a "microprocessor-based instrument using ionselective electrodes" and describes the physical process of sample analysis, indicating it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the measurement of various analytes in biological samples (whole blood, serum, plasma, urine) and QC materials. These measurements are used in the "diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
Device Description: The device description details how the instrument analyzes these biological samples using ion-selective electrodes to obtain results.
Performance Studies: The document describes both nonclinical and clinical tests performed on various biological samples (serum, urine, whole blood) to demonstrate the device's performance and correlation with predicate and reference devices. This testing is typical for IVD devices to support their intended use in a clinical setting.
Intended User / Care Setting: The device is intended for use by "minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting," which is a common environment for IVD testing.

The core function of the AVL 9180 Electrolyte Analyzer is to perform tests on samples taken from the human body to provide information relevant to a patient's health status, which is the defining characteristic of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

75 JFP, 75 CGZ, 75 JIH, 75 CEM, 75 JGS

Device Description

In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The document describes nonclinical tests for precision and linearity, and clinical field tests for method correlation.

Nonclinical Tests:

Precision:
- Study Type: Within-Run (Sw), Between-Day (Sos), and Total (ST) Precision.
- Sample Size: 2 runs/day with 2 replicates per run for 20 days.
- Data Source: Two model AVL 9180 analyzers in each of its three main configurations (Na/K/Cl, Na/K/iCa, Na/K/Li) using samples of each suitable specimen type.
- Key Results: Typical precision values were determined; specific numerical values for Sw, Sos, and ST are not provided in detail, only that the study was conducted.
Linearity in Aqueous Standard Solutions:
- Study Type: Linearity evaluation using gravimetrically prepared standards.
- Sample Size: n=300 for Sodium and Potassium, n=100 for Chloride, Ionized Calcium, and Lithium.
- Data Source: Six AVL 9180 instruments (two of each configuration: Na/K/Cl, Na/K/iCa, Na/K/Li) and NIST-traceable salts.
- Key Results:
  - Sodium: Slope 0.99993, Intercept 0.0128, Correlation Coefficient 0.99995, Sy*x 0.666, Range 51-196.
  - Potassium: Slope 0.99838, Intercept 0.0119, Correlation Coefficient 0.99919, Sy*x 0.194, Range 2.0-12.6.
  - Chloride: Slope 0.97556, Intercept -0.1775, Correlation Coefficient 0.99994, Sy*x 0.674, Range 56-194.
  - Ionized Calcium: Slope 1.01552, Intercept -0.0078, Correlation Coefficient 0.99980, Sy*x 0.037, Range 0.4-3.3.
  - Lithium: Slope 0.99850, Intercept 0.0087, Correlation Coefficient 0.99985, Sy*x 0.038, Range 0.3-5.3.
Linearity in Serum:
- Study Type: Linearity evaluation against various comparison methods.
- Sample Size: n=50 for Sodium, Potassium, Chloride, Ionized Calcium; n=15 for Lithium.
- Data Source: Two AVL 9180 instruments in each configuration, commercially prepared serum linearity standards, random patient serum samples. Comparison instruments: IL 943 Flame Photometer, AVL 983, AVL 984, AVL 985 Electrolyte Analyzers, AVL 9130, AVL 9140 Electrolyte Analyzers.
- Key Results (vs. Flame Absorbance Emission Spectroscopy - IL 943 Flame Photometer):
  - Sodium: Slope 0.9617, Intercept 5.83, Correlation Coefficient 0.9908, Sy*x 2.04, Range 104-178.
  - Potassium: Slope 1.0249, Intercept 0.015, Correlation Coefficient 0.9991, Sy*x 0.075, Range 1.8-11.5.
  - Lithium: Slope 0.9803, Intercept 0.011, Correlation Coefficient 0.9822, Sy*x 0.028, Range 0.11-0.71.
- Key Results (vs. ISE Direct Potentiometry - AVL 983, AVL 984, AVL 985 Electrolyte Analyzers):
  - Sodium: Slope 0.9895, Intercept -6.35, Correlation Coefficient 0.9992, Sy*x 0.61, Range 110-186.
  - Potassium: Slope 1.0223, Intercept -0.25, Correlation Coefficient 0.9996, Sy*x 0.05, Range 2.0-11.6.
  - Chloride: Slope 0.9631, Intercept -1.01, Correlation Coefficient 0.9995, Sy*x 0.51, Range 70-152.
  - Ionized Calcium: Slope 0.8898, Intercept 0.107, Correlation Coefficient 0.9960, Sy*x 0.021, Range 0.67-1.66.
  - Lithium: Slope 0.9923, Intercept 0.008, Correlation Coefficient 0.9985, Sy*x 0.010, Range 0.11-0.71.
- Key Results (vs. ISE Direct Potentiometry with flame correlation - AVL 9130, AVL 9140 Electrolyte Analyzers):
  - Sodium: Slope 0.9856, Intercept -2.02, Correlation Coefficient 0.9856, Sy*x 1.21, Range 104-179.
  - Potassium: Slope 0.9992, Intercept 0.02, Correlation Coefficient 0.9994, Sy*x 0.05, Range 1.9-11.8.
  - Chloride: Slope 1.0026, Intercept -5.31, Correlation Coefficient 0.9989, Sy*x 0.73, Range 70-152.
  - Ionized Calcium: Slope 1.0023, Intercept 0.040, Correlation Coefficient 0.9954, Sy*x 0.022, Range 0.62-1.54.
Linearity in Urine:
- Study Type: Linearity evaluation against comparison methods.
- Sample Size: n=56 for Sodium, Potassium, Chloride.
- Data Source: Random patient urine specimens, two AVL 9810 Electrolyte Analyzers (Na/K/Cl config), two AVL 983 Na/K/Cl Electrolyte Analyzers, IL 943 Flame Photometer, Labconco Digital Chloridometer.
- Key Results (vs. direct ISE - AVL 983):
  - Sodium: Slope 1.0173, Intercept -7.4382, Correlation Coefficient 0.9973, Sy*x 5.55, Range 4-262.
  - Potassium: Slope 1.0312, Intercept -0.1539, Correlation Coefficient 0.9976, Sy*x 2.24, Range 6-147.
  - Chloride: Slope 0.9817, Intercept 2.4630, Correlation Coefficient 0.9972, Sy*x 5.64, Range 16-299.
- Key Results (vs. Flame Absorbance Emission Spectroscopy - IL 943 Flame Photometer):
  - Sodium: Slope 0.9173, Intercept 0.5627, Coefficient 0.9901, Sy'x 10.64, Range 7-285.
  - Potassium: Slope 1.0312, Intercept -0.1539, Coefficient 0.9976, Sy'x 2.24, Range 6-147.
- Key Results (vs. Chloridometry - Labconco Digital Chloridometer):
  - Chloride: Slope 0.9817, Intercept 2.4630, Correlation Coefficient 0.9972, Sy*x 5.64, Range 16-299.

Clinical Tests:

Study Type: Field tests to demonstrate correlation to legally marketed predicate devices, operated by trained personnel.
Sample Size: n=103 for serum study (Sodium, Potassium, Chloride); n=102 for other serum/whole blood studies (Sodium, Potassium, Chloride, ionized Calcium); n=104 for whole blood Lithium; n=15 for serum Lithium.
Data Source: Remnant patient specimens collected for routine analysis.
Key Results: In all evaluations, "there was no difference in mean values (P

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.

Summary

K961458

Image /page/0/Picture/1 description: The image shows the logo for AVL. The logo is composed of the letters AVL in a bold, sans-serif font. The letters are all connected to each other, and they are all the same height. The logo is black and white.

510(k) Summary JUN | 2 1998

(a) (1) Submitter's name, address AVL Scientific Corporation 33 Mansell Court Roswell, GA 30076

Contact Person

10 April 1996

Randy Byrd Ouality Assurance Manager (770) 587-4040 x 631

Date of preparation of this summary:

(2) Device trade or proprietary name:

AVL 9180 Electrolyte Analyzer

Device common or usual name or classification name

Ion-specific electrolyte analyzer for sodium, potassium and chloride or ionized calcium or lithium.

Product Nomenclature	Classification Number	Class	Panel
ELECTRODE, ION-SPECIFIC, CALCIUM	75 JFP	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, CHLORIDE	75 CGZ	II	CHEMISTRY
FLAME PHOTOMETER, LITHIUM	75 JIH	II	TOXICOLOGY
ELECTRODE, ION-SPECIFIC, POTASSIUM	75 CEM	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, SODIUM	75 JGS	II	CHEMISTRY

(3) Substantial Equivalence

The AVL 9180 is an improved design of our ISE electrolyte analyzer line to provide the user an ability to only exchange electrodes to change configuration between sodium, potassium and chloride to sodium, potassium and ionized calcium or sodium, potassium and lithium. The 9180, configured for sodium, potassium and chloride is equivalent to the AVL 983 Na/K/Cl Analyzer [K861087]; for sodium, potassium and ionized calcium, to the AVL 984 Na/K/iCa Analyzer [K862819] and; for sodium, potassium and lithium to the AVL 985 Na/K/Li Analyzer [K870657]. Additionally, for sodium, potassium and lithium the AVL 9180 is substantially equivalent to the I.L. Model 943 Flame Emission Photometer and for chloride, to the Labconco Digital Chloridometer.

(4) Description of the new device

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ

(2) Intended use of the device.

(6) Technological characteristics of the device.

Principles of Measurement

The principles of measurement used in the AVL 9180 Electrolyte Analyzer are identical to those principles existing in the electrolyte analyzers to which substantial equivalence is claimed in paragraph (a)(3) above.

Calibration

The AVL 9180 contains software which permits operation in one of six parameter configurations: Na+/K+/Ca++, Na+/K+/Cl-, Na+/K+/Li+, Na+/K+, Na+/Li+ or Li+. A 2-point calibration is performed automatically every 4 hours in READY mode, and a 1-point calibration is performed automatically with each measurement.

Technical Specifications

Measured Values

Parameter	Range	Display Resolution	units
whole blood, serum, plasma, dialysate and aqueous solutions
Sodium	40 - 205	0.1	mmol/L
Potassium	1.5 - 15	0.1 or 0.01	mmol/L
Chloride	50 - 200	0 or 0.1	mmol/L
ionized Calcium	0.2 - 5.0	0.01 or 0.001	mmol/L
Lithium	0.1 - 6.0	0.01 or 0.001	mmol/L
urine
Sodium	1-300	0	mmol/L
Potassium	4.5 - 120	0.1	mmol/L
(60 - 120 with additional dilution)
Chloride	1 - 300	0	mmol/L

Image /page/1/Picture/13 description: The image shows a drawing of an oval shape with the number 14 written inside. The number 14 is written in a simple, handwritten style. The oval shape appears to be hand-drawn as well, with slightly uneven lines.

المشاهدة

المقاطع
المقابل
المقابل المستوى
المقابل المستوى
المقابل المستوى
المقابل المستقل المستوى
المقابل المستقل المستوى
المقابل المستقل المستوى
المقابل
ا

Operating Conditions

• Minimum Sample Size:	95 µL
• Sample Type:	heparinized whole blood, serum, plasma, urine
aqueous standards and acetate or bicarbonate
dialysate solutions
• Sample Application:	syringe, capillary or AVL Microsampler,
collection tube or sample cup
• Sample Input	automatic aspiration
• Ambient Temperature:	+15 - +32 °C (59 - 90 °F)
• Relative Humidity:	5% to 95% (non-condensing)
• Type of Measurement:	direct potentiometry

Data Management

· Printout	................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

· Printout

................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................

------------

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Electrical Supply

· Voltage	100 - 240 VAC (50-60 Hz)
· Power Consumption	1.4 VA max., 375 max.

Dimensions and Weight

· Height x width x depth 13.2 x 12.4 x 12.0 inches (33.5 x 31.5 x 29.5 cm)
Weight

Classifications

• Safety category	I
• Device type	B (according to ÖVE-MG/EN 60601-1, IEC 601-1)
• Mode of operation	continuous operation
• Protection classification	IP 20
• Explosion protection	the device is not designed for operation in explosive environments
• Approvals	CSA, IEC 1010 (TÜV/GS), CE

(b) (1) Summary of nonclinical tests submitted with the premarket notification for the device. Precision

Typical Within-Run (Sw) Between-Day (Sos) and Total (ST) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two model AVL 9180 analyzers in each of its three main configurations using samples of each of the specimen types suitable for measurement on the 9180.

$$\langle \hat{\mathfrak{o}}_{\cdot} \rangle$$

المقامة

المستق

Linearity in Aqueous Standard Solutions

Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and measured on each of six AVL 9180 instruments, two of each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li.

| Parameter | Slope | Intercept | Correlation
Coefficient | Sy*x | Range | n |
|-----------------|---------|-----------|----------------------------|-------|------------|-----|
| Sodium | 0.99993 | 0.0128 | 0.99995 | 0.666 | 51 - 196 | 300 |
| Potassium | 0.99838 | 0.0119 | 0.99919 | 0.194 | 2.0 - 12.6 | 300 |
| Chloride | 0.97556 | -0.1775 | 0.99994 | 0.674 | 56 - 194 | 100 |
| ionized Calcium | 1.01552 | -0.0078 | 0.99980 | 0.037 | 0.4 - 3.3 | 100 |
| Lithium | 0.99850 | 0.0087 | 0.99985 | 0.038 | 0.3 - 5.3 | 100 |

Linearity in Serum

Linearity in serum was established with the analysis of two specimen sets in nonclinical tests: commercially prepared serum linearity standards for sodium, chloride and potassium with normal protein content, and a group of random patient serum samples. All samples were analyzed in pairs on each of two of AVL 9180 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and in pairs on each of several instrument types for comparison to various methods:

vs. Flame Absorbance Emission Spectroscopy (IL 943 Flame Photometer)

| Parameter | Slope | Intercept | Correlation
Coefficient | Sy*x | Range | n |
|----------------------|--------|-----------|----------------------------|-------|-------------|----|
| Sodium | 0.9617 | 5.83 | 0.9908 | 2.04 | 104 - 178 | 50 |
| normalized to Na=140 | | 0.47 | | | | |
| Potassium | 1.0249 | 0.015 | 0.9991 | 0.075 | 1.8 - 11.5 | 50 |
| normalized to K=4.0 | | 0.11 | | | | |
| Lithium | 0.9803 | 0.011 | 0.9822 | 0.028 | 0.11 - 0.71 | 15 |

vs. ISE Direct Potentiometry (AVL 983, AVL 984, AVL 985 Electrolyte Analyzers)

| Parameter | Slope | Intercept | Correlation
Coefficient | Sy*x | Range | n |
|-----------------|--------|-----------|----------------------------|-------|-------------|----|
| Sodium | 0.9895 | -6.35 | 0.9992 | 0.61 | 110 - 186 | 50 |
| Potassium | 1.0223 | -0.25 | 0.9996 | 0.05 | 2.0 - 11.6 | 50 |
| Chloride | 0.9631 | -1.01 | 0.9995 | 0.51 | 70 - 152 | 50 |
| ionized Calcium | 0.8898 | 0.107 | 0.9960 | 0.021 | 0.67 - 1.66 | 50 |
| Lithium | 0.9923 | 0.008 | 0.9985 | 0.010 | 0.11 - 0.71 | 15 |

vs. ISE Direct Potentiometry with flame correlation (AVL 9130, AVL 9140 Electrolyte Analyzers)

| Parameter | Slope | Intercept | Correlation
Coefficient | Sy*x | Range | n |
|-----------------|--------|-----------|----------------------------|-------|-------------|----|
| Sodium | 0.9856 | -2.02 | 0.9856 | 1.21 | 104 - 179 | 50 |
| Potassium | 0.9992 | 0.02 | 0.9994 | 0.05 | 1.9 - 11.8 | 50 |
| Chloride | 1.0026 | -5.31 | 0.9989 | 0.73 | 70 - 152 | 50 |
| ionized Calcium | 1.0023 | 0.040 | 0.9954 | 0.022 | 0.62 - 1.54 | 50 |

Image /page/3/Picture/14 description: The image contains a drawing of the number 2 inside of a circle. The number 2 is written in a simple, handwritten style. The circle is also drawn in a simple style, and it encloses the number 2. The drawing is in black and white.

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

Linearity in Urine

Linearity in urine was evaluated with the analysis of random patient urine specimens on two. AVL 9810 Electrolyte Analyzers in the Na/K/Cl configuration and, in duplicate on two AVL 983 Na/K/Cl Electrolyte Analyzers for sodium, potassium and chloride; on a IL 943 Flame Photometer for sodium and potassium; and on a Labconco Digital Chloridometer for chloride.

vs. direct ISE (AVL 983) in urine

| Parameter | Slope | Intercept | Correlation
Coefficient | Sy*x | Range | n |
|-----------|--------|-----------|----------------------------|------|----------|----|
| Sodium | 1.0173 | -7.4382 | 0.9973 | 5.55 | 4 - 262 | 56 |
| Potassium | 1.0312 | -0.1539 | 0.9976 | 2.24 | 6 - 147 | 56 |
| Chloride | 0.9817 | 2.4630 | 0.9972 | 5.64 | 16 - 299 | 56 |

vs. flame absorbance emission spectroscopy (IL 943 Flame Photometer) in urine

Parameter	Slope	Intercept	Coefficient	Sy'x	Range	n
Sodium	0.9173	0.5627	0.9901	10.64	7 - 285	56
Potassium	1.0312	-0.1539	0.9976	2.24	6 - 147	56

vs. chloridometry (Labconco Digital) Chloridometer in urine

(b) (2) Summary of clinical tests submitted with the premarket notification for the device. Three field tests were conducted to demonstrate the correlation of the AVL 9180 to legally marketed predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation.

In all evaluations, there was no difference in mean values ($P$