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AVL MEDICAL INSTRUMENTS AVL OPTI CCA

PRODUCT INFORMATION 1

PRODUCT INFORMATIONAVL OPTI Critical Care Analyzer

Analyzer Description

The AVL OPTI Critical Care Analyzer (CCA) is a fully automatic Point-of-Care analyzer that measures ph,PC02, P02, K+, Na+, iCa+, Cl-, Thb and 02 saturation. The analyzer utilizes single-use cassettes providingdifferent parameter configurations. The total weight is less than eleven pounds, which makes it easy totransport wherever it is needed. It can be operated either by its on-board rechargeable battery for up to eighthours or directly from A/C power. The AVL OPTI Critical Care Analyzer is a maintenance free device, usingsolid state single use optical fluorescence sensor cassettes. There are no external reagents required. Thesensor cassettes can be stored at room temperature. Each sensor pouch carries a barcode label containinginformation such as expiration date, lot number and calibration information. The AVL OPTI Critical CareAnalyzer is ideally suited for any near patient or POCT areas including the following:

♦ NICU

♦ Operating Room

♦ Emergency Department

♦ Stat Labs

♦ Main Laboratory

The OPTI Critical Care Analyzer is part of the broad family of products offered by AVL which includes theOMNI benchtop line, 9100 series stand alone electrolyte line, and data management systems.

AVL OPTI CCA

2

AVL OPTI CCA Cassette

Top View

The sensor cassette above is a real size example. The syringe adapter, shown at the right side of thecassette allows the automatic aspiration of a sample directly from a syringe. Removing the adapter allows fordirect sample aspiration from a capillary or AVL Microsampler. Once removed from the storage pouch thenthe cassette has to be used within one hour. The sensor calibration is verified automatically after insertion ofthe cassette. The OPTI CCA holds calibration verification for up to 10 minutes for performing a samplemeasurement. The cassette will be removed after sample analysis. No internal cleaning is required, and thewaste is contained in the anaerobically sealed valve compartment of the cassette.

Bottom View

PCO2 Sensor

pH Sensor

Fingergrips

Adapter (red) for syringesamples (removable forcapillary samples/AVL Microsampler)

Reservoir for buffer andwaste/ Valve

PO2 / tHb/ SO2 Sensor

Calibration gas port

Na+ Sensor

K+ Sensor

Ca++ or Cl- Sensor



Sensor Technology

The optical sensors in the OPTI cassette are designed in a way that the analytes bind with the fluorescentsensor molecule. The sensor molecule is selective for the specific analyte i.e. the pH sensor molecule reactsonly with "H+", the O2 sensor only with O2 molecules etc. The intensity of the emitted fluorescence light varieswith the concentration of the ions (H+, Na+ , K+) or the partial pressure of the gas molecules (O2 and CO2) inthe sample in a predictable fashion. The relationship is specific for each analyte. The according calibrationinformation is encrypted in the bar-code. Before the analyte can bind to the fluorescent molecule, it has totravel through an optical isolator (black coating). The isolator is just a precaution to prevent from interferenceby unspecific light with the light detection system.

The PO2-sensor in the OPTI Cassette has two functions. First, it works like the other sensors do, measuringoxygen. Second, it is used to analyze total hemoglobin (ctHb) and oxygen saturation (SO2). In difference tothe other sensors, the O2 sensor contains a pink overcoat, which acts as a reflector for the photometricmeasurement of O2Hb and HHb. The applied method uses three wavelengths in the red and near infraredrange to measure the two hemoglobin derivatives in non-hemolyzed blood. The advantage using non-hemolyzed blood has several advantages it avoids additional, space occupying hemolysis devices thatpotentially adds to the sample volume needed. Another advantage is that the same sample can be analysesfor three parameters in one sensor. This feature saves also precious blood.

The photometric measurement analyses the concentration of O2Hb and HHb. The sum of the two hemoglobinderivatives represents ctHb and the ratio in percent between O2Hb and tHb represents SO2.

Green Fluorescence Light

LED / LasersLight Detector

Pink Overcoat (Reflector)Fluorescent Sensor

Blue Excitation Light

Lens

BloodPlastic

PlasticO2 O2

O2

Blood

Plastic

Plastic

Optical IsolatorFluorescent Sensor

Lens

Blue Excitation Light

Green Fluorescence Light

H+ H+H+ H+

H+

AVL OPTI CCA

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Analyzer Specifications

Measured Parameters Range ResolutionpH 6.6 – 7.8 pH units 0.001 pH units

PCO2 10 – 200 mmHg (dialysate 5 – 200) 0.1 mmHg

PO2 10 – 700 mmHg 0.1 mmHg

Na+ 100 – 180 mmol/L 0.1 mmol/L

K+ 0.8 – 10 mmol/L (dialysate 0.2 – 7.0) 0.01 mmol/L

Ca++ 0.2 – 3.0 mmol/L 0.01 mmol/L

Cl- 50 – 160 mmol/L 0.1 mmol/L

ctHb 5 – 25 g/dl 0.1 g/dL

SO2 60% - 99.9% 0.1%

Barometric Pressure 300 – 800 mmHg

Calculated ParametersActual bicarbonate (HCO3

-) 1 to 200 mmol/L

Base excess (BE) -40 to +40 mmol/L

Base excess extra cellularfluid (BEecf)

-40 to +40 mmol/L

Base excess actual (BEact) -40 to +40 mmol/L

Buffer bases (BB) 0 to 100 mmol/L

Total CO2 (tCO2) 1 to 200 mmol/L

Standard bicarbonate(st.HCO3

-)1 to 100 mmol/L

Standard pH (st. pH) 6.5 to 8.0 pH units

Oxygen saturation (SO2) 0 to 100%

Oxygen content (O2ct) 0 to 56 ml/dL

Hematocrit (Hct) 15 to 75%

Hydrogen ion concentration(cH+)

1000 to 10 nmol/L

Alveolar-arterial oxygendifference (AaDO2)

0 to 800 mmHg

Anion Gap (AG) 3 to 30 mmol/L

Standardized ionized Calcium(pH = 7.4)(nCa++)

0.1 to 3.0 mmol/L

P50 15 to 35 mmHg



Analyzer Specifications (Cont.)

Operating ParametersMinimum Sample Size 125uL

Sample Type Whole blood, serum, Plasma, Dialysate and aqueous forQC

Samlpl Application Syringe, Capillary or AVL Microsampler

Sample Input Automatic aspiration

Analysis Time < 120 seconds

Ambient Temperature 2 °C – 32 °C (35 °F – 90 °F)

Relative Humidity 5% - 95% (non-condensing)

Measurement Principle Fluorescence, Reflectance

Input ValuesPatient Temperature 14 °C – 44 °C (58 °F – 111 °F)

Hemoglobin (ctHb) 1 – 16g/dL

Hemoglobin Type Adult / Fetal

P50 15 – 40 mmHg (2.0 – 5.3 kPa)

FIO2 0.21 – 1.0

RQ 0.7 – 2. 0

Patient and Operator identification numbers Blank to 99999999999

Patient sex ?/Male/Female

Mean corpuscular hemoglobin concentration(MCHC)

29.0 – 37.0%

Sample type Art/Ven/MixVen/Cap/Cord/CPB

User Defined Field Blank to 999999

AVL OPTI CCA

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Analyzer Specifications (Cont.)

Vent SettingsO2 Mode RmAir/Mask/T-P/NC/Vent/Bag/Hood/Other

Vent Mode No/SIMV/PSV/PCV/CMV-AC/CPAP/PCIVR/BIPAP

Pressure Support Value (PS) 0 – 99.9

Tidal Volume (VT) 0 – 4000 ml

Minute Volume (VE) 0 – 120 l

Peak Inspiratory Pressure (PIP) 0 – 140

Plateau Pressure (pPlat) 0 – 100

Positive End Expiratry Pressure (PEEP) 0 – 50

Continous Positive Airway Pressure (CPAP) 0 – 50

Rate (f) 0 – 155 bpm

Flow rate (Liter Flow) 0 – 300 lpm

Inspiratory / Expiratory Ratio (I/E Ratio) 1 : 9.9

Bi-Level Pressure 0 – 99.9 / 0 – 99.9

Data ManagementPrintout Built-in Thermal printer

Display 2 line, 24 characters backlit LCD (Liquid Crystal Display)

Interface RS-232C, Infrared interface, ASCII or ASTM format

Patient Data 100 recordsstored on-board

Quality Control Data 34 days at 3 levels stored on-board (Mean, SD, CV%)

Standard Reference Cassette Report 34 days stored on board (Mean, SD, CV%)

Electrical and Gas SupplyVoltage / Frequency 100 – 250 VAC / 16 VDC, 2.8 A / 50 – 60 Hz

Power Consumption (max) 110 VA

Battery operation Up to 8 hours (rechargeable battery pack)

Calibration Gas Disposable cylinder, 2 liters @ 9.7 bar (145 PSI), 14.0 ±0.02% O2, 6.0 ± 0.02% CO2

Dimensions / WeightHeight x Width x Depth 124 mm x 362 mm x 230 mm / 4.7 in x 14.2 in x 9.1 in

Weight 2 kg (9 lbs) w/o battery, 5 kg (11 lbs) with battery

MiscellaneousPlace of Manufacture AVL Scientific Corporation, USA; ISO 9001 Certified

Approvals CE, CSA; This is a class 1 laser product



Quick Highlights OPTI Critical Care AnalyzerUnique Features

♦ Room Temperature Storage of Cassettes at ALL times

♦ No refrigeration of cassettes required-No time consuming equilibration

♦ Automatic Aspiration of Sample

♦ Makes sampling easy and safe; Eliminates underfilling or overfilling of cartridges

♦ Barcode Calibration of Cassette

♦ No calibration codes for the operator to enter which eliminates potential for operator input errordue to incorrect patient id, calibration code and lot number information

♦ Calibration of Cassette before sampling occurs

♦ Eliminates wasting blood due to cassette calibration failure

♦ On Board Storage Capacity

♦ 100 patient, calibrations and 30 days of QC stored on the analyzer

♦ Flexible Connectivity Options

♦ Infrared (IR), RS-232, (both via ASCII, ASTM, or Mobil ASTM communication)

♦ Measured tHb and 02 Saturation (S02)

♦ measured tHb is a much more accurate than measured HCT through conductivity;

♦ I-Stat, Irma, GEM, and ABL 70 all measure HCT through conductivity that can render a falselydecreased result when used in conjunction with plasma expanders (cardioplegia) in O.R.settings.

♦ Can lead to unnecessary transfusions

♦ Automatic Gas Calibration

♦ Increases accuracy and stability; No gel issues

AVL OPTI CCA

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Features/Benefits

Ease of Use ♦ Ready for patient analysis in minutes

♦ Uniform sample aspiration makes sample introduction operator independent

♦ Sample aspiration reduces training requirements

♦ Direct sampling from standard syringes, capillaries and AVL Microsampler

♦ Convinient cassette storage at room temperature (6 months at 3-30 °C, 35-86 °F)

♦ Self contained, sealed waste reservoir built into cassette

♦ Different analyte configurations for various diagnostic requirements

♦ Calibration stable for up to 10 minutes after cassette insertion

♦ Maintenance free optical system

♦ Stable Standard Reference cassettes (SRC) available in three levels for cost effectivedaily electronic quality control

♦ Light weight and easy to transport with built-in handle

♦ Power supplied by either A/C or rechargeable battery

♦ Multi-lingual software and user interface

♦ Flexable set up functions to accommodate user preferences

♦ Password protected system configuration menus

♦ Wireless data download via infrared data port

♦ Results equal to reference benchtop analyzersAccuracy and

Precision ♦ All sensor cassettes have a six point factory calibration for al lanalytes

♦ Full 1-point gas calibration for PO2 and PCO2 after cassette insertion

♦ Calibration verification on all sensors prior to measurement is fully automatic

♦ Standard Reference Cassette (SRC) for instrument verification at low, high and normallevels

♦ Uniform sample aspiration assures consistent results, avoiding sampling techniquedependent errors

♦ On-board quality control program stores up to 30 days of QC results at three (3) levels

♦ User programmable reference ranges with auto alerts

♦ Self diagnostic program

♦ Storage for > 100 patient results

♦ Fully automatic, tracking baramoter for accurate blood gas results

♦ Clear, easy to read thermal printout from on-board printer



Features/Benefits (Cont.)

Economy ♦ Up to eight analytes per cassette (no reference electrode using up sensor space)

♦ Long term stable SRC’s in 3 levels for cost-effective daily QC

♦ Long shelf life of sensor cassette at room temperature (6 months)

♦ Cost savings due to improved turn-around-time and faster clinical decisions

♦ Accurate and precise analysis obtained by non-technical personnel

♦ Reduced training requirements due to high degree of automation

♦ Minimum maintenance requirements

♦ No consumption while analyzer not being used, the ultimate “Stand by Mode”

♦ Easy to use for syringe, capillary, or AVL MicrosamplerConvenience/

Flexibility ♦ Smal lsize allows location nearto the patient, no special accessories needed

♦ Room temperature storage of sensor cassettes for up to six months

♦ Calibration verified automatically for each and every sensor cassette

♦ Analyzer ststus reports on clear easy to read printout

♦ Calibration data scanned in utilizing the built-in barcode reader

♦ Easy to clean maintenance free optical measuring system

♦ No special collection devices required, standard procedure and material accepted

♦ Reports a full menu of calculated parameters

♦ Input for P50 and FIO2

♦ Correction for patient temperature

♦ Input values for patient ID, and sex can also be printed on the patient report

♦ Input field for various ventilator settings

♦ Input fields for Sample Type, Ventilator Mode and O2 Mode’s

♦ Automatic bubble and short sample detection

♦ Automatic detection and early warning for low gas and battery condition

Safety ♦ Biohazard waste is contained in each disposable sensor cassette

♦ Maintenance free measurement system

♦ Automatic bubble and short sample detection

♦ Fresh clean sample path for each patient measurement, no tedious clot removalprocedures

♦ Carryover impossible

♦ Cassette in place detection

AVL OPTI CCA

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Enhancements with OPTI 2.10 Software

♦ Additional Measured Parameters

♦ ionized Calcium and Chloride have been added to the OPTI CCA menu

♦ Faster Time to Result

Description Version 2.00 Version 2.10*

Hands-On time approx. 9 sec approx. 9 sec

Automatic Calibration time approx. 92 sec approx. 72 sec

Automatic Aspiration time approx. 20 sec approx. 16 sec

Measurement time approx. 59 sec approx. 52 sec

Total Time: 180 seconds/ Total Time: 149 seconds/

3 Minutes 2 minutes 29seconds

*This time does not include the time to print result; also does not factor in abnormally high or lowresult times

♦ Last Patient Recall

♦ No Need to enter in the patient id and demographic with every sample during repetitive sampleson same patient i.e. O.R. Suites-Very Important to perfusionists

♦ Enhanced Patient Demographics

♦ User can now enter the following:

Sample Type: Arterial, Venous, Mix Venous, Capillary, Cord, CPB

02 Mode: Room Air, Mask, T-P,NC, Vent, Bag, Hood, Other

Vent Mode: No, SIMV,PS,PCV, CMV,AC,CPAP,PCIVR,BIPAP

Pressure Support Value: PS

BiLevel Pressure

♦ 6 Digit User Defined Field-Similar to I-Stat

Important forRespiratoryTherapyDepartments



Enhancements with OPTI 2.10 Software (Cont.)

♦ Enhanced Secure Operator ID

• When Operator ID is activated under setup the user is required to enter a PIN to operate theanalyzer. This prevents any unauthorized or untrained users from running a sample.

• Offers true security

• Allows users to store up to 150 PIN’s with associated operator ID’s

• Strengthens hospital’s ability to maintain regulatory compliance with analyzer use

• Allows POC coordinator to control POC testing operations

♦ Improved Potassium Sensor (K+)

♦ Provides better stability and performance

Cassette Type Measured Parameters Part Number

E-Type (New) pH,PC02,P02,tHb,S02,Na+,K+ BP7587

♦ Not Ready Display

♦ Not ready will be displayed when battery voltage is low, temperature is out of range, or a cassettedetect error has occurred. The operator still has access to all other analyzer functions.

♦ Results Disabling/Blanking

♦ The user may remove or suppress measured parameters from printout and database whileperforming the measurement.

♦ Disable

♦ User may remove tHb/S02, Ca++ and/or Cl- from measurement; Disabled parameters are not QCcontrolled.

♦ Blanking

♦ Also under Setup allows parameter selection during sample measurement. Suppresses any of themeasured parameters available from printout and data export. They will still be displayed. Theseparameters are still QC controlled.

♦ Sample Pre-Attach

♦ Allows user to pre-attach sample, however, tHb/S02 must be disabled.

♦ Alarm Limits

♦ Allows user to select the “name” of the limit range as it appears on the printout. (Ex. Norm, Phys,Alarm, or Crit)

♦ Hb Cal Reminder

♦ Alerts user that tHb calibration is due

♦ Enhanced ASTM Protocol

♦ Enhances the interface with DataCare

♦ Calculated Password

♦ Allows technical support to provide the access to the unit if the password is unknown

AVL OPTI CCA

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Selling OPTI CCA in Critical Care Areas

Operating Rooms/O.R. Suites

Audience:� Perfusionists

� Cardiac Surgeons

� Anesthesiologists

� Decision Drivers:� Speed to result

� Ease of Use-Including QC

� Menu

� Data Connectivity

� OPTI CCA Features to Highlight:

� Ease of Sampling

� Barcode Readero Ability to enter patient data

� Fast Analysis Time with 10 minute stability after calibration of cassetteo Operator can calibrate cassette and wait to run sample

� Last Patient Recallo Eliminates the need for entering patient id and demographic information more than one time

during the case

� Wide Ambient Temperature Rangeo Easily accommodates all OR temperature needs

Typical Environment

Busy - Best time to see operators is beforecases start (very early a.m.) or after they arecompleted

Don’t want to spend a lot of time on chitchat - Get to the highlights quickly

Political - May be in a battle with lab or othertraditional areas of operation for ability to runtests; Sell all involved up and down the chain

Contracted Perfusion Group - Don’tassume if we don’t have a contract that theycan’t buy




Operating Rooms/O.R. Suites

� OPTI CCA Features to Highlight (Cont’d):

� THb and 02 Saturation Measuremento Directly measured tHb might reduce unnecessary transfusions as opposed to HCT measured

through conductivity (plasma expanders on HCT)

� Data Storage on OPTI CCAo Lab will be assured that all regulatory requirements are being met ; Perfusionists and other

O.R. staff aren’t concerned with CLIA however this will help appease what ever group holdsthe license.

� Transportability to Central Area for Data Download or QCo Convenient to take to a central repository area where they can be easily dropped off and

picked up ready to go the next day

AVL OPTI CCA

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ICU/CCU

Audience:� Nurse Manager

� Respiratory Care Practitioners

� ICU Physicians

� Medical Director

� Decision Drivers:� Ease of Use

� Logistics/Storage

� Data Transmission into HIS/LIS

� Quick TAT

OPTI CCA Features to Highlight:

� Ease of Samplingo Automatic aspiration of sample eliminates special tech

from injection; Minimizes training requirements

� Automatic Calibration and Barcode Capabilityo No need to manually enter cal data or patient data

� Room Temperature Storageo Eliminates having to manually record “new” out of refrig

cassettes to equilibrate, etc. (Won’t be a big issue unless

� Electronic QCo Eliminates liquid QC runs; adds to overall ease of use

� Data Storage and Flexible Connectivityo Insures regulatory compliance with easy transmission

Frequency will be big issues because they are used to ha

Busy - Ntaking onpatient ca

HierarchManagers

Don’t appshift -Usupm)

Equipmewith sale

Don’t knogroups -

Political nursing c

Referencl

Typical Environment

urses have been increasingly more responsibility along withre duties

y - Need to approach Nurse and/or Clinical Specialists

roach nursing at change ofally 7:00am, 3:00 pm, and 11:00

nt Oriented Staff that is familiars people

w anything about regulatorykeep discussions simple

- Relationship between lab andan be adversarial

e Point in POCT may bet

niques and back splatter potential

erator expiration date; Waiting forthey have been exposed to I-Stat)

of data; Infra Red and/or Radiord wiring


PRODUCT INFORMATION

Selling OPTI CCA in the Laboratory

Audience:� Laboratory Director

� POC Coordinator

� Chemistry Supervisor

� Decision Drivers:� Regulatory Concerns-Remaining Compliant

� Connectivity-Maintaining CONTROL

� Performance-Correlations to traditional lab instruments

� Menu


� Connectivity Optionso Makes downloading patient and QC samples simple s

performs the testing

� QC Lockouto Insures that testing is not done on an analyzer that

cannot physically be there

� Analytical Performanceo Show correlation data to traditional instrumentation

� Automatic Aspiration of Sampleo Demonstrates overall ease of use and low training

POC coordinators who are responsible for training acti

Stretched Treengineerinor replaced wmed techs

Defensive - up about slo

Political - Mneed for PO

Powerful- Uin the hospit

Analyzer Fosample

Typical Environment

hin - Many labs have gone through ag project whereby staff has been cutith lab assistants as opposed to

Physicians have been beating themw TAT (hence POCT)

ay not have totally bought into theCT, especially regarding QC issues

sually well connected and respectedal

cused - Experience patient as a

15

o they remain in control no matter who

has not passed QC, even when they

requirements (especially important tovities)

AVL OPTI CCA

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Selling OPTI CCA in the Cardiac Catheterization Lab

Audience:� Medical Director

� Nurse Manager

� Decision Drivers:� Quick results, Ease of Use

� Measured (versus Calculated) O2 Saturation results

� Accuracy


� Quick TAT (Turn Around Time)o Physicians want immediate results during cath procedures i

progress

� Measured versus Calculated tHb and O2 Saturation Resultso Provides physicians with extremely accurate results for their proc

� Electronic Quality Control Testing with the SRCo Quality Control requirements for the OPTI CCA are easy to perfo

time

� Portability of the OPTI CCAo Makes it easy for the nursing staff in transporting the instrumen

cath lab

� Ease of Use with Bar Code Capability and Auto Aspiration Featureo Staff in this area is very busy-high level of interest in time saving

� Single-One Time Use Cassetteso Ability to accommodate the fluctuating testing volumes of the cath

o Costs are very predictable

� Ability to Standardize to One (1) Instrument for both Blood Gas anNeeds

o Standardization to one (1) vendor results in overall cost savings

o Overall cassette volume will increase for the institution, resulting

Cardiac CaLaboratory

AngioplastyOpeningarteries

Stents uarteries

Cardiac CatheteDiagnosinjected with Xra

theterization Procedures

obstructed

sed to “prop”open

rizationtic test-dye isinto coronary arteryys

n order to benchmark their

edures

rm and don’t require a lot of

t from room to room in the

features

lab

d Co-Ox (tHb and O2 sat)

in lower tiered pricing



Selling OPTI CCA in the Small Hospital Setting

Audience:� Laboratory Director� Respiratory Therapy Director� Nurse Manager-ICU and ER� Hospital Administrator

Decision Drivers:� 24 Hour Stat Testing Availability� Ease of Use for Non-Laboratory Personnel� Low Cost System/Predictable Costs� Only pay for reagents when cassette is opened


� Auto Aspiration and Bar Code Capabilityo Reduces the possibility of operator errors related to incorrect patient ID, cassette and quality

control entry information

� Electronic Quality Control Capability with the SCRo Minimal Quality Control Requirements results in the overall ease of use of the OPTI CCA for

non-laboratory personnel


� OPTI CCA Cassette Stabilityo Extensive Shelf Life (six months) and open package stability are compatible with smaller

hospital’s intermittent/sporadic use� Predictable Costso Hospital is able to easily predict all costs associated with Point of Care Testing for budgeting

purposes� Low Cost Systemo OPTI CCA assists small hospitals with low testing volumes in reducing stat laboratory costs� Backup Capabilitieso OPTI CCA is suited for use as a backup analyzero No costs associated with No Use� Minimal Maintenance Requirementso Minimal Maintenance results in overall ease of use for non laboratory personnel performing

Point of Care Testing

AVL OPTI CCA

18

Demonstration Guide

1.0 Intended Use:This guide is intended to provide you with confidence in the AVL OPTI Critical Care Analyzer. By utilizing theprocess described herein you should be able to provide the customer with confidence in our equipment, andprepare yourself for a smooth demonstration. This will help you to avoid both technical and applicationproblems during your demonstartion of the analyzer and its functions.

2.0 Pre-Conditions:

2.1 Supplies:To provide a successful demonstration the following items should be caried to the customer site.

Description Part Number Supplied

AVL OPTI Critical Care Analyzer GD****

Battery BP7007

Power Supply EI7004

Power Cord ******

Gas Bottle BP7001

Cassettes – “B” Type (25 Per Box) BP7562

Cassettes – “E” Type (25 Per Box) BP7587

Cassettes – “E-Ca” Type (25 Per Box) BP7560

Cassettes – “E-Cl” Type (25 Per Box) BP7559

Cassettes – “D-Ca” Type (25 Per Box) BP7572

Cassettes – “D-Cl” Type (25 Per Box) BP7575

Printer Paper HP0070

QC Material – SRC Level 1 BP7536

QC material – SRC Level 2 BP7554

QC Material – SRC Level 3 BP7543

QC Material – OPTI-check, Tri-Level HC7008

Sampling Material – Capillary Tubes (200 µL) MC0024

Sampling Material – Syringes



Demonstration Guide (Cont.)

2.2 Pre-Qualification Before Demonstartion

Prior to the demonstartion the following items should be checked and verified:

♦ Verify current version of software is installed

♦ Clean exterior of analyzer

♦ Clean the Sample Measurement Chamber (SMC)

♦ Optics Lens

♦ Inside SMC Top Cover

♦ Check for sufficient battery power (charge overnight)

♦ Verify peristaltic pump cartridge is < 1 year old (Replace if necessary, P/N BP7012)

♦ Check printer operation (Replace if necessary, P/N BP7011)

♦ Verify gas bottle expiration date

♦ Verify sufficient gas supply

♦ Verify cassette expiration date

♦ Verify gas bottle installation (Bottle is fully threaded into the analyzer)

2.2.1 Verify Quality Control (Analyzer Performance)

2.2.1.1 OPTI-check

♦ Verify OPTI-check expiration date

♦ Be aware that the AVL OPTI can store ONLY one material (OPTI-check or other)

♦ Define the QC ranges for the current lot under setup and compared to targetvalues on the OPTI-check insert sheet

♦ Be sure to wipe the cassette prior to inserting it into the analyzer

♦ Mix the QC material to re-suspend the beads prrior to sampling

♦ Run and verify performance of level 1 OPTI-check



♦ Delete the QC database prior to demonstration

AVL OPTI CCA

20


2.2.1.2 SRC’s

♦ Define the current lot numbers of SRC’s under setup

♦ Verify all three level SRC’s expiration date

♦ Run and verify the performance of level 1 of SRC



♦ Delete the QC database prior to demonstration

2.2.1.3 Patient Sampling

♦ Delete the patient database prior to demonstartion

2.3 Do’s and Don’ts

♦ Don’t leave the analyzer in extreme cold or hot temperatures

♦ Don’t keep cassettes in the back of your car for long periods of time

♦ Do your best to keep them out of extreme hot or cold temperatures (4 – 30 °C) forextended periods of time.

♦ Don’t use colored QC material

2.4 Demonstration

2.4.1 Demonstrating Quality Control

♦ To demonstrate the quality control features verify that both the oPTI-check and SRCvalues are defined under setup.

♦ Compare the target values on the OPTI-check insert sheet with the QC setup


♦ Mix QC material to re-suspend the beads prior to sampling

♦ Best QC results are obtained when sampling directly from the ampoule (syringe adapter)

♦ Make sure you do not hold the QC ampoule too long in your hand (this will cause theampoule to warm-up causing the values to change)




2.4.2 Demonstrating Patient Sampling

♦ Testing should start within five (5) minutes after sample was drawn (refer to the methodsheet in the AVL OPTI Critical Care Analyzer Operator’s Manual)


♦ If you intend to run real blood samples, please carry AVL capillaries

♦ Be sure the syringes being used are heparinized (“balanced Li-heparin”)

♦ Observe the sampling techniques of the customer

♦ Avoid air bubbles in blood specimens

♦ Mix sample well prior to sampling (especially important for accurate tHbmeasurements)

♦ Roll syringe between the palms of your hands

♦ Inverst syringe end-over-end

NOTE: When using OPTI-check in patient mode, be aware that tHb and SO2 will NOT bereported.

2.4.3 Longer evaluations (Days or Weeks)

♦ Always use a new gas bottle

♦ Only use one (1) lot of cassettes

♦ Only use one (1) lot of QC material (OPTI-check)

2.5 Planning and RehearsalPrior to your visit to the customer site it is a good practice to familiarize yourself with both the operator’smanual and the OPTI CCA unit. Before travelling to the client be sure to configure the analyzer. This will helpyou become more comfortable with the analyzer and be capable of answering any questions that may beasked by the customer (refer to the “Common Questions and Answers) section of this guide.

2.6 GeneralBefore your visit with the client, review your customer profile, taking into consideration their needs, the area itwill be used in, and the competition they may be persuing. Practice your demonstartion asking the followingquestions:

♦ Am I meeting the customer’s needs in my demonstration?

♦ Am I highlighting the features of the OPTI that are important to the area that it will be used in?

♦ Am I highlighting the features that are advantages over the competitor’s?

2.7 Demonstration Flow

♦ Review Needs – Find out if anything has changed?

♦ Show the Analyzer – Highlight appropriate features.

♦ Ask how the OPTI CCA compares to any othe ranalyzers that they have seen.

♦ Gain commitment that the OPTI CCA meets all their needs better than the current situation.

♦ Close for next step.

AVL OPTI CCA

22

OPTI CCA Competition

I-Stat

Strengths:� Market Acceptance-POCT pioneer

� Menu-Wide menu available

� Size-Many like the small, “cell phone” look

� Abbott Alliance-This gives new clout and increased coverage

� On Board QC-Electronic QC integrated into system; No need to ru

� BAM Unit (Blood Analysis Module) – I-Stat analyzer is directly cardiac monitor

Weaknesses:

� Refrigeration of Cassettes Required-Cassettes good for 6 montrefrigerator at room temp

� Four Hour Equilibration Time-Cassettes require this time befoout of the refrigerator or fifteen (15) minutes for individual blood ga

� Immediate Use of Cassette Required-Once pouch is opened ca� Limited On Board Data Management-Stores only 50 patients an� No QC Lock Out-Operators risk running samples on analyzers th� Introduction of Sample-Sample must be filled to fill mark upon

overfilling of cassette; Increases training time required.� Calculated Thb and 02 Saturation-Directly measures HCT

problematic in OR settings� Temperature Sensitivity in OR Environment-Unable to maintai

OR suites; Begun providing blanket like “wraps” for use in this are� User ID Feature Offers Minimal Security� Any operator id will work-as long as it is entered twice� Not Menu Driven� Operator must memorize functions that keys represent including 0� No On Board Printer� Printer is separate and must be aligned correctly to transfer data b� Sample Testing Process� Potential for loss of patient sample due to the way sample is intro

then place cartridge in analyzer for calibration)� Cannot Handle Iced Samples

Popular Cassette Configuration

EC 8 EC 7Na+ Na+

K+ K+

Cl- iCa++

Glu pH

pH PC02

PC02 P02

HCT HCT

Calc. tHb Calc. tHb &

Similar

To AVL

E CaCassette

No

P02

with

Glu

n separate SRC like electronic QC

incorporated into Hewlett-Packard

hs in refrigerator; Two weeks out of

re they can be used when broughts cassettes

ssette must be used immediatelyd two weeks of QCat have failed QC introduction; can result in under or

via conductivity which can be

n ambient temperature in the “cool”a

2 therapy areas

y IR

duced; (Insert blood into cartridge

02 Sat.




I-Stat

AVL Advantages to Highlight

� Room Temperature Storage of Cassetteo Eliminates logistics nightmares of re-labeling expiration dates, etc.

� Automatic Aspiration of Sampleo Minimizes training time, overall easier to use

� Out of Pouch Stability of 60 Minuteso If operator is called away after cassette is opened, the cassette is still good

� Flexible Connectivity Options

� Calibration of Cassette is performed PRIOR to the aspiration of the patient sampleo I-Stat introduces the blood sample and then calibrates the cartridge; if cartridge fails

calibration, then sample is lost-especially important in NICU’s where blood is scarce

� Extensive Patient/Demographic/02 Therapy Entryo User can enter FiO2 information only on O2 Therapy Screen

� Bar Code Scanner Capabilityo #1 Source of error with I-Stat is incorrect patient id entry

� Direct Measurement of tHbo HCT via conductivity is a major source of problems in the OR

AVL OPTI CCA

24


I-Stat

I-Stat Position/AVL Response

POSITION:Other instruments are too large to be considered true Point of Care.

AVL RESPONSE:The Opti CCA has the flexibility of being utilized in the battery mode for portable use as well as the AC modefor more stationary use. No need to purchase additional lithium batteries. No risk of loss due to small size.

POSITION:The testing menu of the iSTAT Analyzer is more extensive than any other analyzer.

AVL RESPONSE:There are more testing menu capabilities with iSTAT, however, many hospitals want to be able to standardizeto only a few cassette configurations-too many choices lead to stocking issues and wastage due to incorrectcassette selection by the operator.

POSITION:We have the ability to interface directly to the HP Cardiac Monitors.

AVL RESPONSE:The option of having a POC instrument at every critical care bedside is extremely expensive. Most hospitalswant the flexibility of taking their POC instrument from bedside to bedside.




I-Stat

I-Stat Position/AVL Response (Cont.)

POSITION:It only takes a few drops of blood to perform a patient test.

AVL RESPONSE:

This is true for the electrolyte analysis, however, for blood gas testing, you must have a minimum of 130µl ofblood. Also, after implementation, I-Stat recommends obtaining “extra” blood for pre analytical “drop” onto agauze pad for optimum results.

POSITION:The iSTAT System has no maintenance requirements.

AVL RESPONSE:The OPTI-CCA’s maintenance requirements are minimal. Demonstrate that our maintenance can easily beperformed by both nursing and OR personnel.

POSITION:The iSTAT System interfaces to any HIS/LIS via an “off the shelf” product.

AVL RESPONSE:The iSTAT Central Data Station can be interfaced to all HIS/LIS, however, all interfacing requires thepresence of iSTAT hardware. Interfacing to other POC instruments cannot be easily performed, and in manyinstances, is impossible.

AVL OPTI CCA

26


IL Gem Premier

Strengths:

� Market Leader in the OR

� Menu- ITC POC Coag with ACT (Activated Clotting Time)

� Fast Analysis Time-Blood Gas and Electrolytes in less than 2 minutes

� Low cost of Multiple Cassette Pack if all tests are used

Weaknesses:

� Capital Outlayo List price near $18,000

� Large Size

� Difficult to Accommodate Varied Testing Volumeso Test Packs available in 150 or 300 tests-Many Perfusionists will throw out remaining pack at

end of day which results in a lot of wastage

� One Hour Warm Up Time

� Changing a Cartridge is Time Consumingo It takes a minimum of 1 hour and 15 minutes to perform a cartridge change




IL Gem Premier

Weaknesses (Cont.):

� Calibrations are the same as Bench Top Analyzerso Cals occur every 30 minutes (1Pt.) and (2 Pt.) May be calibrating when a sample is needed

� No Electronic QC Availableo Must run liquid QC per CLIA regulations

� Limited Connectivityo Serial Cable Only


� Small Size and Battery Option of the OPTI CCAo More Flexibility and Portability options

� Electronic Quality Control Testing (SRC) Capabilityo Significantly reduces labor and costs associated with QC

� Bar Code Scanning Capability for entry of Patient ID, QC and Cassette Calibration/LotInformation

o Significant reduction in the potential for operator entry

� Emphasize Minimal Maintenance Requirements of the OPTI CCA

AVL OPTI CCA

28


IL Gem Premier

AVL Advantages to Highlight (Cont.)

� Cassettes are Stable for up to 6 Months and are always immediately ready for use

GEM/AVL Response

POSITION:Multiple pack configuration results in a lower cost per test

AVL RESPONSE:Having only two multiple pack configurations limits flexibility for testing volumes; If all tests are not utilized inthe pack, the result is an increase in the cost per test due to wastage of unused reagent

POSITION:Benchtop technology is more accurate and reliable than optical technology.

AVL RESPONSE:Six point calibration done at the factory along with a calibration prior to each individual cassette use insuresreliability. Also correlation data to bench top technology is excellent.

GEM Position/AVL Response (Cont.):

POSITION:It takes too long to run a test on the OPTI CCA vs. the Gem.

AVL RESPONSE:Extensive warm up time for the Gem when it is turned on, in addition to when a cartridge pack is changedadds to total time system is unavailable. Also, time consuming calibrations and Liquid QC runs contribute tohigh down time of system. Actual testing time is 2 minutes for the Gem and 2.4 minutes for the OPTI CCA.




Diametrics (Agilent/HP)

Strengths:� Alliance with Hewlett-Packard� Glucose strip testing directly incorporated into IRMA� Lightweight (5.5 lbs.)� AVOX Cooximeter� Measures tHb, 02 Sat., MetHb, and COHb� Data Storage Capabilities� 200 Patients and 300 QC Results

Weaknesses:� Injection Technique� Potential for blood splatter� Operator must displace gel which can result in “gel” readings vs. blood readings� More training/inservicing time required� Manual Entry of Cartridge Calibration� Operator must enter cal code, lot information, and patient id which can result in operator errors;

These must be corrected by POCT coordinator at the IDMS (computer) level� Cartridge needs to equilibrate to hospital temperature for 72 hours prior to use� Difficult to use in the OR settingo Cartridges must be used in the operating range of 59°-86°F ; If cartridges are stored outside the

OR suite, then it takes 72 hours to equilibrate to the OR temperature� Cartridge Shelf Life 5 Monthso Diametrics will ship cartridges with only eight (8) weeks of shelf life� Open Pouch Stability 10 Minutes� Not Compatible with Regular Capillary tubeso Must purchase proprietary capillary device at approx. $1.00 each� Interfaces to LIS/HIS are Minimalo Currently interface to Cerner and Sunquest (less than 5 sites)o Having major difficulties interfacing to Meditech

AVL OPTI CCA

30


Diametrics


Automatic Aspiration of Sampleo Eliminates any special techniques required for sample introduction

o Minimizes training requirements

o No chance of blood splatter

o Uses standard capillary tubes-no additional expense

Bar Code Capabilityo Calibration Code entered via bar code on cassette

o Bar Code Reader available for patient data entry

Ability to Edit/Delete/Review Records at Instrument Levelo Irma must be done at Data Management Level

Extensive Shelf Life of Cassetteso 6 Months

Open Pouch Stability of One hour (10 minutes on IRMA)

Eliminates dataentry errors




Diametrics

IRMA Position/Avl Response

Position:AVL OPTI takes too long to calibrate

AVL Position:AVL has a comprehensive calibration process to insure reliability. Although the calibration time may beseconds longer, we make up for it in shelf life, bar code calibration data, ease of sampling, etc.

Position:AVL is too heavy to be POC. It can only be utilized as Near Patient.

AVL Position:The majority of hospitals utilizing IRMA Analyzers are using them as Near Patient devices. It is not financiallyfeasible for a hospital to purchase an IRMA Analyzer for every bedside. The OPTI CCA is still portable.

Position:The OPTI CCA requires a lot of maintenance.

AVL Position:No instrument is totally maintenance free. The maintenance requirements of the OPTI CCA are minimal.

AVL OPTI CCA

32


Radiometer-ABL 70

Strengths:

Fasto Blood Analysis Time is 60 Seconds

Accession # Entry by Bar Codeo Important step saver when interfacing to Cerner or Sunquest Information Systems

(terminal emulation requires a manual entry of the accession #)

Weaknesses:

♦ Cartridge Pack Shelf Life is only 90 days

♦ Opened Cartridge Pack is only 30 days

♦ Potential for wastage/increased cost per test

♦ Aspiration Probe needs to be cleaned after every sample

♦ Time consuming and potential bio-hazardous exposure

♦ Measures HCT via Conductivity

♦ Problems with plasma expanders in OR leading to falsely decreased levels

♦ Many hospitals have said they have never transfused as many patients

♦ Blood Clots are a problem

♦ No clot catchers

♦ No EQC Capabilities

♦ Requiring all Aqueous QC increases labor and costs




Radiometer-ABL 70

AVL ADVANTAGES TO HIGHLIGHT

♦ Single, one-time use cassettes are easier to manage and more cost effective for variable useversus Multi-Use Packs

♦ OPTI CCA is more portable

♦ Doesn’t require the seven (7) minute “Warm Up” time

♦ EQC Testing Capabilities of the OPTI CCA reduces labor (soft) and control (hard) costs

♦ Directly Measured tHb

ABL 70 Position/Avl Response

Radiometer Position:

“There are no shortcuts taken… when it comes to quality control.” EQC is not as complete as an aqueousquality control analysis.

AVL RESPONSE:The use of our approved SRC saves considerable time and expense in comparison to systems that arerequired to utilize all AQC analyses.

Radiometer Position:Testing time is less than sixty (60) seconds

AVL RESPONSE:Testing time takes a little bit longer on the OPTI CCA, however, our analyzer has more flexibility (can betaken to the bedside), directly measures tHb (doesn’t have the issues of hematocrit) and requires no warm uptime (ABL 70 requires a 7 minute warm up phase.

AVL OPTI CCA

34

OPTI CCA – Questions and Answers

Test Parameter Questions

Will the AVL OPTI Critical Care Analyzer have other analytes available?

♦ Glucose, BUN and Urea are scheduled to be added to the OPTI Critical Care Analyzer’sparameter menu, however we do not have a navailability date yet.

How does the OPTI Critical Care Analyzer measure tHb and SO2?

♦ The OPTI CCA utilizes a technology known as optical reflectance using a single laser diodelocated in the cover of the sample measurement chamber. Three different wavelengths areutilized in these measurements, including two for tHb and one for SO2. The wavelengths usedwere chosen to minimize interference from one another.

Can the OPTI technology identify patients who smoke or are suffering from smoke inhalation?

♦ The OPTI CCA’s tHb value includes measurement of Oxy-hemoglobin and Deoxy-hemoglobinlevels. When assessing for smoke inhalation, physicians are interested in Carboxyhemoglobinmeasurements.

Sampling Questions

What types of sample can be measured on the OPTI Critical Care Analyzer?

♦ Whole Blood

♦ Serum

♦ Plasma

♦ Dialysate Solutions (bicarbonate) using the D-Ca and D-Cl Type cassettes which werespecifically designed for this purpose

♦ Non-colored (containing dye) aqueous quality control materials

How does the OPTI handle hemolyzed blood?

♦ The OPTI sensors are not affected. This also applies for the tHb and SO2 analysis.

Is the sample size the same for all cassette types?

♦ Yes, the sample volume is 125 µl for all cassette types available.

Can the OPTI Critical Care Analyzer handle iced samples?

♦ Yes, all samples are heated to 37 °C by the OPTI CCA’s solid state heater. The entire measuringchamber is carefully thermostated. Blood analysis does not begin until the temperature has beenreached and is stable.



OPTI CCA – Questions and Answers (Cont.)

Automatic Sample Aspiration Questions

The AVL OPTI Critical Care Anlyzer has automatic sample aspiration. How does thecompetition compare with this?

♦ The OPTI CCA is the only point of care instrument that contains an automatic sample aspirationfeature. Other point of care competitive systems require an “injection” or “positive pressure”method of sample insertion, resulting in a potential for blood spillage, and contributing to anoverall technique dependent testing process.

Quality Control QuestionsGeneralHow often am I required to run Quality Control material on the OPTI Critical Care Analyzer?

♦ This depends mainly on your regulatory agency (CAP, JCAHO, COLA). please refer to the OPTIregulatory information. In general most of the agencies, accept electronic QC for daily qualitycontrol and liquid control as a verification at an established interval, whenever the on-board gasbottle is changed, or whenever a new lot ofpatient sample cassettes is introduced.

Can I run two (2) different quality control materials interchangeably on the OPTI Critical CareAnalyzer?

♦ Yes, but the OPTI will not store the results in its QC database and will therfore neither calculatenor print any QC statistics.

Can I run two (2) levels of controls in the same cassette?

♦ No, The AVL OPTI cassette is designed to run only one sample or liquid quality control.

Why do colored controls interfere but not blood?

♦ Colored controls have small molecules, which interfere with the sensors. Blood has much largermolecules.

Standard reference Cassetts (SRC’s)What is an Standard reference cassette (SRC)?

♦ The Standard reference Cassette is used to verify the performance of the AVL OPTI for allanalytes over its entire measurement range.

How do the Standard reference cassette’s work? How long do they last?

♦ SRC’s are designed from a reflective material to challenge the optical module, and to verify theinstrument’s ability to measure cassettes accurately and precisely. The SRC’s are multi usedevices available in three (3) levels. The shelf life of the SRC’s is minimally 12 months. expirationdetails are printed on the SRC barcode.

AVL OPTI CCA

36


Can the SRC’s be utilized for daily quality control testing requirements?

♦ Using SRC’s for daily quality control complies with most of the regulations. However, this mayvary from state to state.

OPTI-checkCan I run OPTI-check as a patient sample?

♦ Yes, however the results will not be stored in the correct QC database and the results for tHb andSO2 will be suppressed since the analyzer knows it is not running a whole blood sample.

Technology QuestionsWhat is the analysis methodology used by the OPTI Critical Care Analyzer?

♦ Optical Fluorescence for the direct measurement of pH, PCO2, PO2, Na+, K+, Ca++, and Cl-

♦ Optical Reflectance for the direct measurement of tHb and SO2

What does the technology provide that others don’t?

♦ Optical Fluorescence does not require a reference electrode nor any maintenance, nor does it consumeoxygen in the PO2 sensor. It is also inherently more stable (very low drift).

Is this methodology new?

♦ No, Optical sensors based on AVL’s license, have been used for many years in the extra-corporalpH/blood gas analyzers of 3M/CDI.

Why isn’t a reference electrode utilized in the OPTI Critical Care Analyzer?

♦ In the fluorescence method, the OPTI CCA measure changes in light intensity. The AVL OPTI CCAcassette contains a small amount of a known concentration of buffer. Light with a known intensity isprojected onto the optode. Based on the concentration of the buffer, the optode fluorescence emits lightof a different intensity. This intensity is then compared to the original calibration. an unknown sample canthen be aspirated into the AVL OPTI cassette. The intensity of light emitted by the sample is compared tothe calibration curve and the analyte concentration is calculated.

Why is a humidifier no longer used?

♦ The AVL OPTI cassette contains a liquid buffer that is used for calibration verification. The evaporatedwater from this buffer saturates the whole sample path with water vapor. This vapor is used to humidifythe calibration gas.




When was the OPTI Critical Care Analyzer introduced?

♦ July 17, 1998

♦ The OPTI 1 Analyzer, which measured pH, PCO2 and PO2 using the same technology as the OPTI CCAAnalyzer, was introduced in 1995.

Feature Questions

What is the difference between disabling and blanking a parameter?

♦ Disabling – This feature is configured under Setup. It allows the administrator to remove parameters(tHb/SO2, iCa++, or Cl- only) from the display, printout and export. It also removes any calculatedparameters which utilize this measured parameter. Disabled parameters are not QC controlled.

♦ Blanking – This feature is configured under Setup. It allows the user to remove any parameter from theprintout and export during the measurement run time. Blanked parameters are still displayed and areunder QC control.

What is the purpose of the four (4) digit PIN #?

♦ The 4-digit PIN# offers true security, If enabled under Setup, the user will be prompted for his/her PIN#,however the users’ ID number is what will be printed on the patient report. This prevents anyone fromutilizing a number on the printout to gain unauthorized access to the analyzer.

What does the status light indicate?

♦ The status light may indicate one of the four (4) following conditions:

♦ Solid Green – Instrument is ready to use

♦ Blinking Green – Instrument is busy

♦ Solid Red – An instrument error has occurred

♦ Blinking Red – Operator intervention required before continuing

AVL OPTI CCA

38


Maintenance Questions

How long does the battery maintain its charge?

♦ The battery has been designed to last for up to eight (8) hours depending on sample throughput.

How long will it take to charge the battery?

♦ It normally takes six (6) hours to recharge the battery. we recommend keeping a spare battery for highsample throughput. For that reason, an external battery charger is available.

How often do I need to change the peristaltic pump cartridge?

♦ The peristaltic pump cartridge will need to be changed once a year.

How often do I need to run the tHb Calibrator cassette?The tHb calibration cassette will need to be run once every three (3) months. The analyzer will prompt youwhen this needs to be done.



Maintenance

For Month: Year:

Week 1 Week 2 Week 3 Week 4

Date Initial Date Initial Date Initial Date Initial

Weekly

Clean sample Measurement Chamber

Every 3 Months

Perform tHb Calibration

Using the AVL-Calibrator

Every Year

Replace Peristaltic Pump Kit

As Needed

Clean Analyzer Surfaces

Change Gas Bottle

Change Printer Paper

Discharge Battery *

Clean Barcode Assembly

* To initialize a proper recharge

Copies of this form may be used for maintenance schedules and log.

AVL OPTI CCA

40

Ordering Information

Analyzers PartNumber

AVL OPTI Critical Care Analyzer – English Int. *System Includes:

Power Supply, IEC Compliant (EI7004), Battery (BP7007), SRC High (BP7543), SRC Low(BP7536), tHb Calibrator Cassette (BP7542), Printer Paper (HP0070), Operator’s Manual– English (PD7018), Quick Reference Guide – English (AT7017)

GD7012

AVL OPTI Critical Care Analyzer – German *System Includes:

Power Supply, IEC Compliant (EI7004), Battery (BP7007), SRC High (BP7543), SRC Low(BP7536), tHb Calibrator Cassette (BP7542), Printer Paper (HP0070), Operator’s Manual– German (PD7018), Quick Reference Guide – German (AT7024)

GD7008

AVL OPTI Critical Care Analyzer – French *Power Supply, IEC Compliant (EI7004), Battery (BP7007), SRC High (BP7543), SRC Low(BP7536), tHb Calibrator Cassette (BP7542), Printer Paper (HP0070), Operator’s Manual- French (PD7015), Quick Reference Guide – English (AT7017)

GD7009

AVL OPTI Critical Care Analyzer – Spanish *Power Supply, IEC Compliant (EI7004), Battery (BP7007), SRC High (BP7543), SRC Low(BP7536), tHb Calibrator Cassette (BP7542), Printer Paper (HP0070), Operator’s Manual– Spanish (PD7016), Quick Reference Guide – English (AT7017)

GD7010

AVL OPTI Critical Care Analyzer – Italian *Power Supply, IEC Compliant (EI7004), Battery (BP7007), SRC High (BP7543), SRC Low(BP7536), tHb Calibrator Cassette (BP7542), Printer Paper (HP0070), Operator’s Manual– Italian (PD****), Quick Reference Guide – English (AT7017)

GD****

AVL OPTI Critical Care Analyzer – Japanese **Power Supply, IEC Compliant (EI7004), Battery (BP7007), SRC High (BP7543), SRC Low(BP7536), tHb Calibrator Cassette (BP7542), Printer Paper (HP0070), Power Cord(EX0197), Quick Reference Guide – English (AT7017)

GD7017

* Note: The above configurations do not include cassettes and power cords – Please order separately. Thenormal level SRC (BP7554) is optional – please order separately.

** Note: The above configurations do not include cassettes – Please order separately. The normal level SRC(BP7554) is optional – please order separately.




Cassettes Quantity PartNo.

Sensor Cassettes – B Type

For measurement of pH, PO2, PCO2, tHb, SO2 with the AVL OPTI CCAportable analyzer. Each single use cassette contains up to 6 optical sensors,and 0.2 ml of aqueous phosphate buffer. Storage is at room temperature.Expiration date and lot number is bar-coded and printed on each sensorcassette pouch label.

25 pcs. BP7562

Sensor Cassettes – E Type

For measurement of pH, PO2, PCO2 , tHb, SO2 , Na+ , K+ with the AVL OPTICCA portable analyzer. Each single use cassette contains up to 6 opticalsensors, and 0.2 ml of aqueous phosphate buffer. Storage is at roomtemperature. Expiration date and lot number is bar-coded and printed oneach sensor cassette pouch label.

25 pcs. BP7587

Sensor Cassettes – E-Ca Type

For measurement of pH, PO2, PCO2 , tHb, SO2 , Na+ , K+, Ca++ with the AVLOPTI CCA portable analyzer. Each single use cassette contains up to 6optical sensors, and 0.2 ml of aqueous phosphate buffer. Storage is at roomtemperature. Expiration date and lot number is bar-coded and printed oneach sensor cassette pouch label.

25 pcs. BP7560

Sensor Cassettes – E-Cl Type

For measurement of pH, PO2, PCO2 , tHb, SO2 , Na+ , K+, Cl- with the AVLOPTI CCA portable analyzer. Each single use cassette contains up to 6optical sensors, and 0.2 ml of aqueous phosphate buffer. Storage is at roomtemperature. Expiration date and lot number is bar-coded and printed oneach sensor cassette pouch label.

25 pcs. BP7559

Sensor Cassettes – D-Ca Type

For measurement of pH, PCO2 , tHb, SO2 , Na+ , K+, Ca++ in dialysatesolutions with the AVL OPTI CCA portable analyzer. Each single usecassette contains up to 6 optical sensors, and 0.2 ml of aqueous phosphatebuffer. Storage is at room temperature. Expiration date and lot number is bar-coded and printed on each sensor cassette pouch label.

25 pcs. BP7572

Sensor cassettes – D-Cl Type

For measurement of pH, PCO2 , tHb, SO2 , Na+ , K+, Cl- in dialysatesolutions with the AVL OPTI CCA portable analyzer. Each single usecassette contains up to 6 optical sensors, and 0.2 ml of aqueous phosphatebuffer. Storage is at room temperature. Expiration date and lot number is bar-coded and printed on each sensor cassette pouch label.

25 pcs. BP7575

AVL OPTI CCA

42


SuppliesGas Bottle

For calibration of PCO2 and PO2. Each disposable container has a lowpressure content of 2 liter at 140 psi (9.7 bar). The Oxygen is at 14% ±0.02%, and the Carbon Dioxide 6% ± 0.02%. The balance is Nitrogen.Storage is safe between minus 20 and plus 60°C.

1 pc. BP7001

Standard Reference Cassette - Level 1, for daily QC of OPTI CCA 1 pc. BP7536



tHb-Calibrator Cassette 1 pc. BP7542

AVL OPTI-check, tri-level, liquid QC material for the measurement ofpH, PO2, PCO2 , Na+ , K+, Ca++, Cl-, ctHb, SO2 with OPTI CCA

3x10amps.

HC7008

Peristaltic pump kit 1 pc. BP7012

Thermal printer paper 1 roll HP0070

Capillary tubes, standard heparinized, 200µl 250 pcs MC0024

AVL MICROSAMPLER, for arterial sampling, with needle – sterile packed 50 pcs MC0017

AVL MICROSAMPLER, for arterial sampling, with needle - non-sterile packed 50 pcs MC0013

AVL MICROSAMPLER, for arterial sampling, with needles - non-sterile, bulkpackage

300 pcs MC0015

AVL MICROSAMPLER, for arterial sampling, w/o needles - non-sterile, bulk 500 pcs CH0077

Accessories PartNo.

Battery, Rechargeable BP7007

Power Supply, IEC Compliant EI7004

External Battery Charger, 110 Volt BP7036

External Battery Charger, 220 Volt BP7025

Carrying Case – OPTI Critical Care Analyzer YB7025

Computer Interface Cable – OPTI CCA – for troubleshooting , and data export BK7002

Power Cord, Schuko EX0173

Power Cord, USA EX0197




Technical ServiceRecommended spares for 1 to 5 instruments

Quantity PartNo.

Assembly, Battery 2 BP7007Assembly, Printer 1 BP7011Assembly, Peristaltic pump kit 2 BP7012Assembly, Fan Exhaust 1 BP7013Assembly, SMC, OPTI CCA 1 BP7018Assembly, Gas Module 1 BP7015Assembly, Display OPTI CCA 1 BB7013Assembly, Receptacle Battery 1 BP7017Assembly, Motor Valve Drive 1 BP7020Assembly, Motor Pump 1 BP7027Software kit AVL OPTI CCA (2 chips on sockets) 1 BP7060Handle, Complete AVL OPTI 1 BP7030Spring, Compression, SMC Cover 2 DF7002Cap, Black, A/B*8 Custom 4 DZ7005Reader, Barcode 1 EL7001Valve, Gas 1 MB7002Foot, Adhesive 4 MB7005Plate, Hinge retainer shaft 1 RE7009Guide, Barcode 1 RE7018Compartment Storage 1 RE7023Door, Compartment, Storage 1 RE7024Latch, SMC Cover 1 RE7025Receptacle Pump Cartridge 2 RE7026Lens, Barcode 1 RE7027Cover, Printer Access 1 RE7028Cover, Eprom 1 RE7029Seal, Gas 1/0 Port, SMC 1 RE7030Retainer, Cover, Printer Access 2 RE7034Fitting, Tubing Reducer Valve, Plastic 1 YB5012Panel, Control 1 YB7001

For more detailed information on spares parts, please consult the Spares Parts List or the Service Manual

AVL OPTI CCA

44


Manuals and Brochures Language Part No.Operator’s Manual, AVL OPTI CCA English PD7018Operator’s Manual, AVL OPTI CCA German PD7014Operator’s Manual, AVL OPTI CCA French PD7015Operator’s Manual, AVL OPTI CCA Spanish PD7016Operator’s Manual, AVL OPTI CCA - produced in Japan Japanese PD7017Operator’s Manual, AVL OPTI CCA Italian *Quick Reference Guide English AT7017Quick Reference Guide German AT7024Service Manual, AVL OPTI CCA English PD7005Service Manual, AVL OPTI CCA German *Flyer, AVL OPTI CCA English CH3643Flyer, AVL OPTI CCA German CH3647Flyer, AVL OPTI CCA French *Flyer, AVL OPTI CCA Spanish *Flyer, AVL OPTI CCA Italian *Brochure, AVL OPTI CCA (8 pages) English CH3645Brochure, AVL OPTI CCA (8 pages) German CH3646Brochure, AVL OPTI CCA (8 pages) French *Brochure, AVL OPTI CCA (8 pages) Spanish *Brochure, AVL OPTI CCA (8 pages) Italian *

Videos

Video, Operation of the analyzer (VHS/NTSC) English PV7002Video, Operation of the analyzer (VHS/PAL) English *

*Not yet available

AVL MEDICAL INSTRUMENTS AGStettermerstrasse 28CH-8207 Schaffhausen/SwitzerlandPhone [+41] 848 800 885, Fax [+41] 848 800 875e-mail: [email protected]

AVL LIST GMBHHans-List-Platz 1A-8020 Graz/AustriaPhone [+43] 316 787 500, Fax [+43] 316 787 495

AVL SCIENTIFIC CORPORATION235 Hembree Park DriveRoswell, GA 30076-1447, USAPhone: [+1] 800 421 4646 or [+1] 770 587 4040, Fax [+1] 770 587 4163

www.avlmed.com

November 1999 – PRi/MCa - For internal use only.

AVL Reference No: DOC.1.022.C

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