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PRODUCT REFERENCE MANUAL

FOR HEMAVET®

HV950

MULTISPECIES HEMATOLOGY

INSTRUMENTS

Part Number M-950HV

P R O D U C T R E F E R E N C E M A N U A L

F O R HEMAVET ®

HV950

M U L T I S P E C I E S H E M A T O L O G Y

I N S T R U M E N T S

Customer Support Line (800) 433-0945 (214) 210-4900

© 2011 Drew Scientific, Inc. (all rights reserved), Printed in the United States No part of this manual or the products it describes may be reproduced by any member or in any form without prior consent in writing from Drew Scientific Inc. The Hemavet (HV) 950 analyzers are for In Vitro Diagnostic Use. All correspondence relating to the HV 950 Analyzer or this manual should be addressed to: Product Support Department of Drew Scientific, Inc. 4230 Shilling Way Dallas, TX 75237 USA Manufactured in USA by Drew Scientific, Inc. The information in this manual was correct at the time of printing. However, the HV950 is subject to continuous development and improvement of products and Drew Scientific reserves the right to change components types, equipment manufacturers, sources of supply, technical specifications, and maintenance procedures at any time without notice. If the system is used in a manner differently than specified by Drew Scientific, the protection provided by the equipment may be impaired. See warnings and hazard statements.

REVISION RECORD

Revisions Page Date Description A 6-9 December 2, 2000 P1 changed to P2 B 2-10 March 1, 2001 Specimen mixing time changed to 10 minutes. B 5-2 March 1, 2001 MULTI-TROL mixing procedure revised C Various December 1, 2002 Manufacturer references changed to reflect

Drew Scientific D All March 1, 2003 Page format aligned with Drew Scientific format E Various June 10, 2003 Non-procedural changes dictated by TUV

Recommendations

F

Various

January 2006 Updated to include External Keyboard, Dual Positions manual mode, Select-A-Species™, and Diagnostic Considerations option revisions.

G (Draft ONLY).

Various December 2007 Procedural/Non-Procedural Changes.

G (Draft ONLY).

Various March 12, 2008 Procedural changes to Section 5 & Section 8.

H Various August 15, 2008 Pictorial Updates, Alignment issues, Procedural/Non-Procedural Changes.

I Various July 29, 2009 Remove un-necessary information from page 1, Update picture on page 2-2, added note in section 8.3.2, re-word section 8.3.5, added section 8.4.4., update picture in page 12 and clarify text in page 16 of section 5.7. Operating Instructions, Summary and Menus. Remove address from back page and add web address.

J Various Jan. 24, 2011 Clarify calibration section 4

TABLE OF CONTENTS

SECTION SUBJECT PAGE NO. I PRINCIPLES OF OPERATION

Intended Use 1-1 Methodology and Method History 1-3

II SYSTEM DESCRIPTION

Familiarization 2-1 Specifications 2-4 Performance Specifications 2-6 Performance Characteristics 2-7 Specimen Collection and Handling 2-9

III INSTALLATION AND SPECIAL REQUIREMENTS

Special Requirements 3-1 Installation 3-2

IV CALIBRATION

General 4-1 Preliminary Procedures 4-1 Calibration 4-2

V OPERATING INSTRUCTIONS

Operator's Responsibilities 5-1 Daily Start-Up Cycle 5-1 Daily Control Procedure 5-2

Sample Analysis 5-3 Daily Clean Procedure 5-3 Weekly Clean Procedure 5-4 Operating Instructions and Summary 5-4

VI DATA INTERPRETATION AND FLAGGING

General 6-1 Interpreting Printed Results 6-1

VII TROUBLESHOOTING GUIDE

Purpose 7-1 Fault Isolation Tables 7-1

VIII SPECIAL PROCEDURES

Cleaning Procedures 8-1 Replacement Procedures 8-2 Optional Procedures 8-8 Shipping Instructions 8-8

APPENDIX

Operator's Logs A1 thru A6

Table of Contents Page I HEMAVET HV950 Product Reference Manual Jan. 2011

Principles of Operation Page 1-1 HEMAVET HV950 Product Reference Manual Jan. 2011 1.1. INTENDED USE

1.1.1. The Drew Scientific HEMAVET ®

Multispecies Hematology Analyzer (Figure 1-1) is a clinical laboratories. The HEMAVET system is intended for determining a variety of quantitative, automated multispecies hematology analyzer for in vitro diagnostic use in hematological parameters on multiple species, including:

WBC - White Blood Cell or leukocyte count

RBC - Red Blood Cell or erythrocyte count

Hb - Hemoglobin concentration

HCT - Hematocrit or relative volume of erythrocytes

MCV - Mean Corpuscular (erythrocyte) Volume

MCH - Mean Corpuscular (erythrocyte) Hemoglobin

MCHC - Mean Corpuscular (erythrocyte) Hemoglobin Concentration

RDW - Red Cell (erythrocyte volume) Distribution Width

RETICS# - Reticulocyte count

RETICS% - Reticulocyte percent

PLT - Platelet or thrombocyte count

MPV - Mean Platelet Volume

NE# - Neutrophil count

NE% - Neutrophil percent

LY# - Lymphocyte count

LY% - Lymphocyte percent

EO# - Eosinophil count

EO% - Eosinophil percent

MO# - Monocyte count

MO% - Monocyte percent

BA# - Basophil count

BA% - Basophil percent NRBC# - Nucleated Red Blood Cell count

NRBC% - Nucleated Red Blood Cell percent

Principles of Operation Page 1-2 HEMAVET HV950 Product Reference Manual Jan. 2011

FOCUSED FLOW DESIGN

1. The injector tube positions and directs the blood sample flow into the counting chamber for analysis. 2. The bloodsample is injected through the sensing zone using a positive displacement syringe system, ensuring a steady,

continuous sample flow without subjecting the cells to shear forces, which can distort the cells. 3. Patented front sheath fluid surrounds the blood sample in a vortex and constricts the sample flow to approximately 15

microns as it approaches the sensing zone, providing for a single-cell analysis. 4. Cells are injected in a uniform field. Uniformity is maintained by the design of the counting orifice and by directing the

cells into a narrow region of the sensing zone. 5. Integrity of the cells is maintained by combining single-cell analysis, uniformity of the sensing zone, and reagents that

work in concert with cell membrane physiology. This integrity provides clean separation of the cell populations (narrow and accurate distribution widths) and a clear depiction of cell distribution.

6. The rear sheath fluid vortex restricts the sample column to a narrow beam and prevents recirculation of the cells as they exit the sensing zone.


Figure 1-1. HEMAVET System

1.1.2. The purpose of the HEMAVET system is to accurately determine values for

hematologic parameters in order to distinguish between normal patients and those who need additional study of any of these parameters. The HEMAVET system is designed to automatically flag for hematologic abnormalities, on a species-by-species basis.

1.1.3. Since no single Quality Control technique can routinely provide sufficient data for

effective quality assurance, the recommended Quality Control Program for the HEMAVET system includes the following three techniques:

Daily Instrument Checks Use of Approved Commercial Controls Manual Review of Patient Samples

These techniques, used in combination, will provide a comprehensive Quality Control Program for the HEMAVET system and its user(s).


1.2. METHODOLOGY AND METHOD HISTORY

1.2.1. The invention of the microscope in the 17th Century and its application to the study of biology provided an opportunity to gain insight into a totally unsuspected and, until then, unseen world. Anton van Leeuwenhoek, in what was probably the first measurement of blood components, wrote: "The red globules of the blood I reckon to be 25,000 times smaller than a grain of sand, which perhaps to many seems incredible." This remarkably accurate observation was made with an instrument that was very simple. Visual hemocytometry, originated in 1855 with Cramer's description of a counting chamber. Hemocytometry continues to play an important role in many clinical and research facilities; however, it is a labor-intensive and imprecise method, requiring much patience and time.

1.2.2. The methods employed in the HEMAVET system, to derive the many hematologic

parameters, are refinements of well-established methods of counting and sizing, in combination with an automatic diluting and mixing device for sample processing and single-beam photometer for hemoglobinometry. The HEMAVET Multispecies Hematology System incorporates a proprietary, patented Focused Flow

TM

design (See Figure at the beginning of this Section) using a positive displacement syringe system, which delivers:

cell-by-cell analysis that occurs over an extended operating range, ensuring accuracy even for species with very high cell counts;

sample volume metering via the syringe system, ensuring precision of results.

1.2.3. Effective operation of the HEMAVET requires the use of FS-PAKTM

/LV-PAKTM

multispecies hematology reagents which have well-controlled properties. A diluent (MULTI-CELL

3TM

DILUENT) is required to disperse the erythrocytes, leukocytes, and thrombocytes without fixing or distorting these cells during analysis. Because cell size (volume) is measured, the effect of the diluents due to osmosis or other phenomenon must be tightly controlled. Also, the diluents must be particle-free and contain antimicrobial agents to prevent the growth of bacteria and fungi.

1.2.4. In order to count the leukocytes and measure hemoglobin, the lysing agents (CELLYSE

XI3TM

and CELLYSE XII3TM

) simultaneously lyse the erythrocytes and convert the hemoglobin to a stable pigment while allowing the leukocytes to remain intact. The hemolysis which occurs renders the cell stroma transparent. The lysing agent converts the hemoglobin released by the lysing to a stable cyanmethemoglobin pigment. The absorption of cyanmethemoglobin is directly proportional to the hemoglobin concentration of the sample. The accuracy of this method is equivalent to that of the cyanmethemoglobin method (the reference method for hemoglobinometry) recommended by the International Committee for Standardization in Hematology (ICSH Standard EP 6/2: 1977).

System Description Page 2-1 HEMAVET HV950 Product Reference Manual Jan. 2011

2. FAMILIARIZATION 2.1 Refer to Figures 2-1 through 2-4 below, to become familiar with the location of various components comprising your HEMAVET instrument. The components illustrated in the following figures are referenced throughout this manual. Note, in Figure 2-2, the instrument cover has been removed to show the components located on the inside.

1. Display 2. Key Pad 3. Sample Holder 4. Keyboard

Figure 2-1. HEMAVET Instrument - Front Panel

1

2

3

4


Figure 2-2. HEMAVET Instrument - Left Side 1. Syringe Module 6. Hemoglobin Cuvette 2. Hemoglobin Module 7. 1 mL Syringe 3. Transducer 8. 5 mL Syringe 4. Peristaltic Pumps 9. 250uL Syringe

5. Valve Matrix

1

8

6 3

2

9 7 5

4

4


Figure 2-3. HEMAVET Instrument - Rear View with Serial Ports

1. Cooling Fan & Air Filter 4. ON/OFF Switch 7. Serial Keyboard Port 2. Printer Port 5. Fuse Holder 8. USB Keyboard Port

3. AC Power Input 6. DMS Port

Figure 2-4. HEMAVET Instrument - Rear View with USB Keyboard Port

5

1

23

4

6

7

8


2.2 SPECIFICATIONS 2.2.1 The physical specifications of the HEMAVET System are as follows:

Power:

Input Supply Requirements* 47 - 63 Hz 95 – 264 vAC

Consumption < 110 W

Temperature (ambient operating): 17o to 32o C (62o to 90o F)

Humidity: 0 to 95% without condensation

Dimensions (approximate):

Unit Height Width Depth Analyzer 30.5 cm

(12 ") 27 cm

(10.5") 43 cm

(17")

Weight (approximate):

Unit Weight Analyzer 11.5 kg (25 lb)

Waste: 20 liter waste container or a chemically resistant open drain. (See Section III)

Recommended reagent kit: FS-PAKTM or LV-PAKTM Multispecies Reagent Kit. Contains MULTI-CELL3TM DILUENT or MULTICELL LV, CELLYSE XI3TM or CELLYSE 11LV, CELLYSE XII3TM or CELLYSE 12LV and C D CleanTM

Sample Volume Required: 20 micro-liters whole blood

Automatic Startup: 5 minutes

Automatic Clean: 30 minutes

*To minimize the possible effects of power line transients and other interference that may be induced into the power lines by various kinds of electrical equipment, Drew Scientific recommends that an input power line capable of supplying 15 A (8 A for the 230 V configuration) be used. The ground line should be free of transient currents that might be induced from other electrical equipment.


2.2.2 HEMAVET System dilutions and measurements:

Dilutions: RBC and PLT counts: 1 part whole blood in a total volume of 4000 parts

WBC count: 1 part whole blood in a total volume of 75 parts (after lysing)

Hb: 1 part whole blood in a total volume of 75 parts (after lysing)

Hemoglobin Measurement:

Wavelength 540 nanometers

Bandwidth 5 nanometers

Focused Flow: 15 micrometers

Flagging Criteria:

Each parameter is printed, provided that the results are within the established statistical range and alarm limits.

Cells Count per Operating Cycle:

WBC 10,000 (typical) at 10.0 x 103 cells/mm3

RBC 50,000 (typical) at 7.50 x 106 cells/mm3

PLT 2,000 (typical) at 300 x 103 cells/mm3

2.2.3 HEMAVET analyzer performance specifications:

Display (LCD): Displays messages and menus.

Cycle time: Results are available in 2 minutes.

Electronic Stability: Change in calibration of the electronic measurement system is less than 1 % per month when measured in accordance with this manual and compared at monthly intervals.


Carryover: Carryover of all HEMAVET System parameters is less than 2.0%. Verification of such a low carryover requires the averaging of the results of at least 10 carryover assays. Output Capabilities:

High Resolution Bubble Jet Printer or HP compatible (or equivalent) Data Output: RS232C compatible (optional)

2.3 PERFORMANCE SPECIFICATIONS 2.3.1 The performance specifications listed for this instrument apply only to an instrument

that has been properly maintained, as indicated in this manual, and uses the FS-PAKTM or LV-PAKTM reagent kit. If the average room ambient temperature should vary more than 10o F from the calibrating temperature, verify calibration and recalibrate if necessary to ensure conformance to specifications.

2.3.2 Precision. Precision is defined as a Coefficient of Variation (CV) based on at least 31

determinations of the same sample. (See Table 2-1.)

TABLE 2-1. PRECISION (n > 31)

2.3.3 Accuracy. The HEMAVET System can be adjusted, within the resolution of the readout, to agree with a predetermined reference value at any point in the operating range.

2.3.4 Operating Range Linearity Limits. When tested using dilutions made from a sample having no interfering substances, the HEMAVET System's value will be equal to the expected value within the limits given in Table 2-2. To obtain the same results, multiple readings must be taken at each point in order to eliminate the statistical effects of imprecision. Linearity of size measurements (e.g. MCV) are tested using appropriate techniques.

Parameter CV WBC at 10.0 x 103 cells/mm3 < 3.0% RBC at 7.00 x 106 cells/mm3 < 3.0%

Hb at 14.0 g/dL < 2.0% MCV at 60.0 fL < 1.0%

PLT at 500 x 103 cells/mm3 < 5.0%


TABLE 2-2. LINEARITY LIMITS

2.4 PERFORMANCE CHARACTERISTICS 2.4.1 Precision. Precision studies were performed on typical systems using fresh whole blood. The values were close to the midpoint of the normal range. Between 31 and 50 replicates were performed. The CVs reported are the average values on 10 different instruments. TABLE 2-3. PRECISION 2.4.2 Accuracy. Results of accuracy comparisons with reference methods are given in Table

2-4. Included in the study were samples from dogs (n=30), rats (n=46), mice (n=45), sheep (n=24), non-human primates (n=16), cats (n=18), horses/donkeys (n=5) and goats (n=13), as well as several exotic species.

SYSTEM vs. Reference Methods

Parameter Clinical Specimen Range r WBC x 103 cells/mm3 0.2 to 48 0.96 RBC x 106 cells/mm3 0.9 to 18.85 0.99

Hb g/dL 3.2 to 20.6 0.97 MCV fL 15 to 448 0.99 HCT % 12 to 64 0.99

PLT x 103 cells/mm3 13 to 1800 0.93

TABLE 2-4. ACCURACY

Parameter Linearity Range Limits (whichever is greater) WBC x 103 cells/mm3 0.1 to 200 0.4 or 3.0%

RBC x 106 cells/mm3 0.01 to 20.00 0.06 or 2.0% Hb g/dL 0.1 to 35.0 0.3 or 2.0% MCV fL 30 to 300 1.5 or 2.0%

PLT x 103 cells/mm3 1 to 4000 15 or 10%

Parameter CV WBC 2.3% RBC 2.0% Hb 1.3%

MCV 0.4% PLT 3.3%


2.4.3 Linearity. Linearity studies on WBC, RBC, Hb, and PLT parameters were performed

using fresh whole blood samples. The results are shown in Table 2-5.

TABLE 2-5. LINEARITY 2.4.4 Known Interfering Substances. The known interfering substances regarding the

parameters of the HEMAVET Series are as follows:

WBC Certain unusual RBC abnormalities that resist lysing, nucleated RBC, clumped platelets, fragmented WBC, any unlysed particle greater than 35 fL may cause flagging conditions. Heparin may cause the WBC differentials to be inaccurate.

RBC Very high WBC count, high concentration of very large platelets, agglutinins.

Hb Very high WBC count, severe lipemia, heparin, certain unusual RBC

abnormalities that resist lysing.

MCV Very high WBC count, high concentration of very large platelets, agglutinins.

PLT Very small erythrocytes or leukocytes, or cell fragments may cause flagging conditions in some cases. The System provides accurate PLT counts in the presence of most hemolytic disorders. Chemotherapy may affect certain samples.

HCT, MCH, MCHC, NE, Known interferences related to the parameter used in the

LY, EO, MO, computation of these parameters. BA, NRBC

Parameter Range r WBC x 103 cells/mm3 0.3 to 122.3 0.99 RBC x 106 cells/mm3 0.6 to 24.4 0.99

Hb g/dL 0.4 to 22.2 0.99 PLT x 103 cells/mm3 22 to 3553 0.99


2.5 SPECIMEN COLLECTION AND HANDLING 2.5.1 Approximately 20 micro-liters of whole blood is introduced undiluted into the

instrument. Collect and prepare the specimen as follows:

1. Collect the specimen by venipuncture and use tripotassium ethylene- diaminetetraacetic acid (K3 EDTA) as the anticoagulant. For detailed information on the collection of whole blood by venipuncture, refer to "Standard Procedures for

the Collection of Diagnostic Blood Specimens by Venipuncture" (ASH-3), published by the National Committee for Clinical Laboratory Standards.

1. Mix the blood specimen and the K3 EDTA carefully, and thoroughly as follows:

a. Place the specimen on Speci-Mix blood rocker for a minimum of ten (10) minutes.

b. Remove the specimen from rocker and gently invert the tube three (3) times.

c. Observation of the specimen before and during mixing can lead to detection of

problems such as gross hemolysis, lipemic plasma, or blood clots. 2.5.2 Specimen Storage. Since blood platelets disintegrate rapidly, whole-blood cell counts

that include PLT should be performed within 4 hours after drawing for optimum results. Whole-blood specimens for PLT and differential counts must be run at room

temperature.

2.6 FS-PAKTM / LV-PAKTM REAGENT SYSTEMS

Reagent Subsystem. The HEMAVET instrument requires specialized reagents consisting of a diluent, an enzymatic cleaning agent, and multispecies lytic agents, which are introduced into the instrument via the tubing supplied. The reagents are drawn from the reagent kit's individual containers and are dispensed automatically in precise, measured amounts during each operating cycle.

Warning

IMPORTANT: The use of heparin may cause a bias in WBC, Hb and Differential readings.

Caution

IMPORTANT: The FS-PAKTM or LV-PAKTM reagent system was specially developed for use in the HEMAVET Series instrumentation. This reagent system is not compatible with other hematology reagent systems.

DO NOT MIX REAGENT SYSTEMS!


Drew Scientific recommends the following reagents for use on the HEMAVET System. All listed performance characteristics refer to the HEMAVET System using only the FS-PAK or LV-PAK line of reagents. Refer to the container's label for detailed information before using the reagent; however, once the container is opened, the optimum freshness stability is 30 days. DILUENT. Drew Scientific manufactures an azide-free, isotonic stabilizing electrolyte diluent, (MULTI-CELL3TM / LV DILUENT), intended to dilute whole blood in the instrument. LYTIC AGENTS. Drew Scientific manufactures multispecies lytic agents, (CELLYSE XI3TM, 11LV, CELLYSE XII3TM , and 12LV), intended for use with the HEMAVET System. These azide-free reagents rapidly lyse erythrocytes, freeing the Hb and reducing the size of cellular debris to a level that does not interfere with leukocyte counts. They also cause a conversion of hemoglobin to a stable cyanmethemoglobin pigment, the absorbance of which is directly proportional to the Hb concentration over the clinically useful range.

CLEANING AGENT. Drew Scientific manufactures a cleaning agent, (CD CleanTM), intended for use with the HEMAVET System. This enzymatic deproteinizing reagent effectively cleans and rinses the instrument's cuvettes and tubing. It removes blood components and residue, and reduces the residual particulate count to an insignificant level. The enzymatic deproteinizing solution must be used with the FS-PAKTM or LV-PAKTM reagents.

2.7 CELL CONTROL

1.7.1 When establishing Quality Control standards for the HEMAVET System’s performance, a stable reference control must be used. Drew Scientific offers a cell control (MULTI- TROLTM) for use with the HEMAVET Series instrumentation. Read all package inserts and product information before using MULTI-TROLTM.

Installation and Special Requirements Page 3-1 HEMAVET HV950 Product Reference Manual Jan. 2011

3. SPECIAL REQUIREMENTS 3.1 The HEMAVET System is intended for use in a conventional clinical laboratory environment. Before deciding on a location for this instrument, consider all of the following special requirements: 3.1.1 Space and Accessibility. In addition to the space required for the individual unit(s),

make sure the location you choose offers:

A. Comfortable working height. Beyond a matter of convenience, proper work height helps provide for the most efficient operation of the HEMAVET System.

B. Easy access to the left side and rear of the HEMAVET instrument, which is

required for maintenance and servicing.

3.1.2 Electrical Input. The HEMAVET System should be powered with electricity from an

independent, protected circuit. A three-wire outlet furnishing 95 to 264 vAC, 47 to 63 Hz, 15 A, single-phase input power is required. Current carrying a capacity of 15 A is recommended, although the actual power consumption is less than 110 W (see Specifications, Section II). The ground path must be capable of carrying the full current of the circuit (confirmed third-wire earth ground). The 1.5 m (6 ft) primary power cord on the rear of the instrument must be plugged directly into the electrical outlet. Do not use an extension cord.

3.1.3 Ambient Temperature and Humidity. The instrument can be installed in a room

with a temperature range of 17oC to 32oC (62oF to 90oF). Humidity may be up to 95% without condensation.

3.1.4 Ventilation. The analyzer's ventilation fan, located on the rear panel of the HEMAVET,

must be placed at least 8 cm (3 in.) away from any wall or obstruction which could interfere with air flow. Failure to do so can result in inadequate cooling of the instrument and system malfunctioning.

IMPORTANT: Make certain to provide enough space for placement of the FS-PAKTM or LV-PAKTM reagent kit on the left side of the instrument. REAGENTS MUST BE AT THE SAME HEIGHT AS THE INSTRUMENT.


3.1.5 Drainage. The waste drain tubing located on the left side of the instrument can be connected to either:

a) a chemically resistant open drain less than 76 cm (30 in.) above the floor, or b) a waste container with a minimum capacity of 10 liters (2.5 gal.). In either case, the maximum waste line length is 3.7 m (12 ft). When using a

drain, be sure the end of the waste tube is above the normal drain level.

3.1.6 Connectors. The HEMAVET System is supplied with all necessary power cables, signal cables, tubing and lines. 3.2 INSTALLATION 3.2.1 Drew Scientific tests every HEMAVET System before it is shipped from the factory.

Shipping cartons and containers include all necessary international symbols and/or. special handling instructions to inform the carrier(s) of precautions and care applicable to the HEMAVET System.

3.2.2 Upon receipt of the HEMAVET System, carefully inspect the carton(s) and all packaging for evidence of damage or mishandling. If signs of mishandling or damage are evident, notify Drew Scientific immediately.

3.2.3 Drew’s Scientific Representative is responsible for initially removing the HEMAVET System from its shipping carton and installation of the system. 3.2.4 If the instrument has been returned to Drew Scientific for servicing or updates, it must, upon return to your facility, undergo a set-up procedure as follows:

1. Using a new FS-PAKTM or LV-PAK™ Reagent Kit that has been stored at room temperature, connect the tubing between the MULTI-CELL3 DILUENT and C D Clean reagents and the instrument. Make certain the tubing is extended all the way to the bottom of the reagent containers and that the tubing at the instrument is connected as indicated on the instrument template.

Warning

IMPORTANT: Disposal of any chemical or biohazardous wastes must be in accordance with all applicable environmental laws.

Caution

IMPORTANT: Make certain to save and safely store the shipping carton. It may be needed at a later date for service purposes or for instrument updates.

DO NOT THROW CARTON AWAY.


2. Connect the appropriate tubing between the CELLYSE XI 3 and CELLYSE XII3 and the instrument; making sure the tubing is extended to the bottom of each bottle.

3. Connect the tubing between the waste container and the instrument.

4. Verify that the waste line, the MULTI-CELL3 DILUENT line, the CELLYSE XI3,

CELLYSE XII3, and the C D Clean lines are connected to the colored fittings as follows:

White = MULTI-CELL3 or MULTICELL LV DILUENT Blue = C D Clean Green = CELLYSE XI3 or CELLYSE 11LV Red = CELLYSE XII3 or CELLYSE 12LV Black = Waste

Also verify that lines are not bent or kinked, and that there are no obstructions in the tubing.

5. Plug the instrument power cord into the rear of the instrument and the other end

into a 95 to 264 vAC, 47 to 63Hz wall outlet. 5.1. Connect printer to printer port on the back of the Instrument.

6. Power-Up the instrument by pressing ON/OFF button (rear of instrument) to the ON position. The power-up cycle takes about 2 minutes.

7. When HEMAVET MAIN MENU appears on the display, press the SPEC'L key

to access the SPECIAL MENU, then select 1: Initialize to cycle the valves and syringes. Verify all valves click prior to proceeding to Step 8. 7.1. Select 7: Diagnostics, 2: Printers then select the appropriate key to enable

the type of printer in use.

8. From the SPECIAL MENU, select 3: Reagents to display REAGENT MENU. Then press 2: Change Reagents and proceed as follows:

a: Press CLEAR key to enter 4 digit Reagent Lot Number that is shown on the Reagent Kit box. Then press the ENTER key followed by the EXIT key.

b: Press CLEAR key to enter 6 digit Reagent Expiration Date that is shown on the Reagent Kit box. Then press the ENTER key followed by the EXIT key.

c: Press CLEAR key to enter 9 digit Reagent Kit Number that is shown on the Reagent Kit box. Then press the ENTER key followed by the EXIT key.


9. From the REAGENT MENU, press 1: Prime All, to prime the Diluent, and CELLYSE reagents. Repeat the prime cycle by pressing the 1 key again. Then press the 0 key to return to the SPECIAL MENU.

10. From the SPECIAL MENU, run a short clean cycle by pressing the CLEAN key. After the clean cycle is completed, press the 0 key to return to the MAIN MENU.

11. Run the Start-Up cycle from the MAIN MENU by pressing the START key.

12. At the completion of the Start-Up cycle, run a background by pressing the

“OTHER” species key and review the background results to ensure the values are within acceptable limits, (Refer to page 5-1), then proceed with the Daily Quality Control check, and Sample Analysis.

Calibration Page 4- HEMAVET HV950 Product Reference Manual Jan. 2011

1

4. GENERAL 4.1 This section describes the calibration procedures required to maintain your HEMAVET

System within optimal operational tolerances. The HEMAVET System incorporates an on- board calibration capability. This feature, when used in conjunction with Drew Scientific proprietary FS-PAKTM and LV-PAKTM reagent kits and MULTI-TROL reference controls, provides for simple and accurate calibration verification.*

*(The material or method used for calibration is at the discretion of the end user. This should be based on requirements set forth by individual Lab Protocol).

4.1.1 Your Drew Scientific Service Representative performs calibration and validation procedures at the time your instrument is initially installed. The Key Operator is then responsible for follow-up calibration and recording of calibration factors. 4.1.2 Re-calibration is sometimes required when any component that involves the dilution

characteristics (such as the syringes) or primary measurements (such as the transducer, or hemoglobin module) is replaced. If one of the components affecting calibration has been replaced, before re-calibrating, run a sample analysis using MULTI-TROL cell control as directed in Section V under Daily Control Procedure, to verify the need for re-calibration. Re-calibration may also be required if the results of the daily quality control check (refer to Section V) do not fall within the specified ranges for the control's assay sheet reference values. If re-calibration appears necessary, Do Not re-calibrate the instrument before going through the applicable troubleshooting procedures as given in the Section VII, Troubleshooting Guide. This will eliminate the possibility that a procedural error or component malfunction is responsible for producing inaccurate analysis results. If after completing the troubleshooting procedures, re-calibration is still indicated, then perform the Preliminary Procedures, followed by the Calibration Procedures as described in the following paragraphs.

4.2 PRELIMINARY PROCEDURES 4.2.1 Inspect the reagents and run a clean cycle as follows:

1. Inspect the liquid levels in the diluent, cleaning agent and lysing agent containers. If there is insufficient fluid, or the reagents have reached their expiration date, replace the reagents as instructed in Section VIII.

2. Check that the reagents do not contain precipitate, turbidity, particulate matter, or unusual color. If any of these is evident, replace the reagents.

3. Check for disconnected tubing and reconnect as required. 4. Run a full clean cycle from the MAIN MENU by pressing the CLEAN key. 5. Run a Start-Up cycle, then run a background by pressing the “OTHER” species

key and review the background results to ensure the values are within acceptable


2

limits, (Refer to page 5-1). 4.3 CALIBRATION

4.3.1 Although the instrument is relatively insensitive to minor room temperature changes, the calibration should be performed when the room temperature is stable and within the normal ambient temperature range.

In the normal process of tracking data for an extended period of time, your laboratory

may make a specific decision to re-calibrate a given parameter. Never adjust to a specific value for an individual sample.

If any problems or malfunctions are encountered while performing calibration, refer to

Section VII, Troubleshooting Guide. If the corrective actions fail to eliminate the problem, call Drew Scientific Customer Service immediately.

4.3.2 Perform calibration verification as follows:

1. Run a minimum of three sample analyses using MULTI-TROL cell control as directed in Section V under Daily Control Procedure. Record the values for each run in the appropriate parameter column on Table 4-1 Calibration Form at the end of this section.

2. Record the total of all runs for each parameter on Line 6 of the form.

3. Determine the Mean Value (MV) by dividing the values recorded on Line 6 by

the number of samples run. Record the results on Line 7.

4. One Line 8, record the target Assay Values (AV) listed on the MULTI-TROL Reference Control form that is provided with the cell control being used.

5. Divide the (AV) values by the (MV) values for each parameter and record the

results on Line 9.

6. At the HEMAVET MAIN MENU, press the CAL. key to view the Previous Calibration Factor (PC). Record the value on Line 10. Press EXIT key to view each succeeding parameter and record the value on Line 10.

NOTE: It is suggested that Table 4-1 be photocopied and that the copy be

used to make the calibration notations.


3

7. To obtain the new calibration factor (NC), multiply Line 9 (AV/MV) by Line 10 (PC) and record values on line 11 for each parameter.

8. To change the calibration factors, press CAL key to display the first parameter.

Then press the CLEAR key which allows the use of the numeric keys to enter the new calibration (NC) from Line 11. Press the ENTER key to accept the new value. Then press the EXIT key to go to the next parameter. Repeat this procedure to change each of the factors.

9. Record the new calibration factors on the Calibration Log sheet, located in the

Appendix, and include the Lot No. of the reagents used, your initials and today's date.

NOTE: The new calibration (NC) factor for RBC and PLT should be nearly identical. Use the RBC new calibration factor for both RBC and PLT.


4

Line No.

Entry WBC

RBC

Hb

MCV

PLT

1

Sample 1

2 Sample 2

3 Sample 3

4 Sample 4

5 Sample 5

6 Total

7 MV = (Mean Value)

8 AV = (Assay Target or Reference Value)

9 AV/MV

10 PC = (Previous Calibration Factor)

11 NC = AV/MV x PC = (New Calibration Factor)

TABLE 4-1. CALIBRATION ADJUSTMENT

Operating Instructions Page 5-1 HEMAVET HV950 Product Reference Manual Jan. 2011

5. GENERAL The operating procedures detailed in this section were developed to ensure optimum

performance of the HEMAVET System and, therefore, reliable results within the instrument's specifications and performance characteristics (Section II). These procedures are based on the assumption that the instrument is left turned on, as recommended. 5.1 OPERATOR'S RESPONSIBILITIES

5.1.1 It is the operator's responsibility to:

1. Become thoroughly familiar with the information in this section before operating the HEMAVET System.

2. Perform the recommended procedures as described in the Special Procedures in Section

VIII, as required. 3. Refer to Section VII, Troubleshooting Guide when:

A. The instrument does not perform as described in this section. B. The variation from the performance characteristics and specifications exceeds the tolerance established by your laboratory. C. The instrument produces unacceptable data.

5.2 DAILY START-UP CYCLE

5.2.1 Prior to the Start-Up cycle, Make certain the printer is turned on and the POWER light is lit. Also, make sure there is a stack of paper loaded in the sheet feeder. (Refer to printer Quick Start Guide.)

The Start-Up Cycle in the HEMAVET System is fully automated to provide optimum performance and maximum convenience for the operator. To activate the automated Start-Up Cycle, simply press the START key. The instrument will automatically perform an initialization, a priming, and a background check. There will be no printout following a start-up cycle. To produce a report of the background count, which is optional, press the OTHER key.

Caution

NOTE: The background check verifies the cleanliness of the diluent and rules out the presence of contaminants, electrical interference, and microbubbles. In order to view a report of the background check, press the OTHER key. Acceptable Limits for the Background Check* are as follows:

WBC 0.2 or less RBC 0.02 or less Hb 0.2 or less PLT 20 or less * Background counts assayed using “OTHER” species key.


5.3 DAILY CONTROL PROCEDURE

5.3.1 Although not strictly required for optimum performance, Good Laboratory Practice dictates that a Quality Control check should be performed at the beginning of each day. A daily Quality Control check provides assurance that the instrument is operating within design specifications. In addition, for facilities running more than eight (8) hours at a time, a Quality Control check should be performed at the beginning of each 6 or 8-hour shift.

5.3.2 Mix controls as follows:

1. After removing a vial of MULTI-TROL from the refrigerator, allow material to reach room temperature.

2. Hold the vial, with the cap up, between the palms of your hands and roll it gently at

least ten (10) times.

3. Invert the vial and roll at least ten (10) times between the palms, once again.

4. Position the vial between the thumb and forefinger and gently invert 10 times.

5. Observe the bottom and sides of the vial during the mixing procedure. If any material can be seen adhering to the glass, the mixing procedure should be repeated.

5.3.3 Cycle the controls as follows:

1. After performing Daily Start-Up, analyze the MULTI-TROL Reference Control material under the species key that corresponds with the species listed on the control's assay sheet (eg: run "DOG" control using "DOG" key, etc.).

2. Record the results on the Quality Control Check log, located in the Appendix.

3. Verify the results against the control's assay sheet reference ranges. Disregard any

Hematological Abnormalities that appear on the printout.

NOTE: Quality Control Material should be run using the Manual Mode. See page 8-9, section 8.4.1.


5.4 SAMPLE ANALYSIS

5.4.1 Perform Sample Analysis in accordance with the sequential steps given in the detailed Operating Instructions at the end of this section. If the instrument has been idle for 4 hours or more, it will automatically revert to the Standby Mode and the message HEMAVET is in STANDBY Mode Push "0" to Cycle Valves and Return to MAIN MENU will appear. Press the "0" key, and once the valve cycling is completed, proceed with Sample Analysis. If 10 hours or more have elapsed since the last Sample Analysis was performed, the instrument will have reverted to the Shutdown Mode and the message Push "START" or "CLEAN" to Cycle and Return to MAIN MENU will be displayed. Press the "START" key to run the Start-Up cycle, or press the "CLEAN" key to run a full clean cycle, before proceeding with Sample Analysis.

5.5 DAILY CLEAN PROCEDURE

5.5.1 In order to prevent the build-up of blood components in the HEMAVET System's tubing and cuvettes, a daily clean procedure must be performed. The cleaning operation flushes cleaning reagent throughout the system to remove any residue and thus reduces the residual particulate count to an insignificant level. The following step should be performed at least once every 24 hours on days when samples are run.

At the HEMAVET MAIN MENU, press the CLEAN / ENTER key to start the automatic

clean cycle. The Mixing Cuvette will be filled with cleaning reagent and after about 15 minutes, the cleaning reagent is removed and the Mixing Cuvette is filled with fresh diluent for a background check.

5.5.2 An alternate method for performing daily clean is to enable the Auto-CLEAN cycle which

will automatically occur each day, and includes a start-up cycle. Auto-CLEAN is enabled or disabled as follows:

1. From the MAIN MENU, access the SPECIAL MENU, by pressing the SPEC'L key. 2. When the SPECIAL MENU appears, press 8 to display the SETUP MENU.

3. From the SETUP MENU, press 4 to display the OPTIONS MENU, If Auto-CLEAN,

is currently disabled, the ❏symbol appears. If Auto-CLEAN is enabled, the ■symbol appears.

NOTE: If processing more than 25 samples per day, perform cleaning procedures in Section VIII, Special Procedures.

NOTE: When the Auto-CLEAN cycle is enabled, there is no need to run daily start-up or clean cycles.


4. If Auto-CLEAN is disabled, which is the default setting, and you want to enable it, press 1 to bring up a sub-menu showing the current Auto-CLEAN time.

a. To accept current time, press EXIT key or START / CLEAR key to change

time. The default time is 06:30:00 (6:30 AM). b. Pressing the START / CLEAR key presents a sub-menu allowing use of the

numeric keys to enter a new time. Example: enter 08 15 00 to change the Auto-CLEAN start time to 8:15 AM.

c. Press EXIT key to return to OPTIONS MENU.

5. If Auto-CLEAN is currently enabled as indicated by ■ symbol, and you want to disable it, press 1 to display ❏ symbol.

6. Press 0 key three times to return to the MAIN MENU.

5.6 WEEKLY CLEAN PROCEDURE

5.6.1 Once per week, sample PROBECLENZ by performing a CLEAN cycle.

5.6.2 Clean external surfaces including the carriage assembly using D.I. water.

5.6.3 Clean fan filter (Refer to Section VIII),

5.7 OPERATING INSTRUCTIONS, SUMMARY AND MENUS

5.7.1 There are three attachments at the end of this section that can be removed, photocopied, and kept near the instrument for quick reference. These attachments include an Operating Summary Page, Detailed Operating Instructions and HEMAVET System Menu Tree that which presents all the menus needed to access the various HV950 functions.

DREW SCIENTIFIC HEMAVET ® SYSTEM OPERATING SUMMARY This summary is intended for use only after the operator is thoroughly familiar with the complete operating instructions and special procedures in Sections V and VIII of the reference manual. A. Instrument. Check that power is on and HEMAVET MAIN MENU is displayed.

NOTE: The internal clock operates in the 24-hour format, i.e., 1:15 PM is entered as 13:15 00.


B. Daily Start-Up Cycle. Press the START key.

After Start-Up is complete run a background count using the “OTHER” species key and verify that counts are within acceptable limits (Optional):

WBC 0.2 or less Hb 0.2 or less RBC 0.02 or less PLT 20 or less

* Background counts assayed using “OTHER” species key.

C. Daily Control Procedure. At beginning of day, run sample analysis using MULTI-TROLTM Reference Control and verify results against control assay sheet.

D. Sample Analysis. Mix specimens carefully and thoroughly. Place sample on Rock and Roller

blood rocker for a minimum of 10 minutes. Prior to aspirating sample, remove sample from rocker, and gently invert the tube three (3) times.

E. Daily Clean Procedure. At the end of the day that samples are run, press the CLEAN key.

F. Weekly Clean Procedure. Once per week, sample PROBECLENZTM by performing a CLEAN

cycle. Also, Once per week, remove and inspect fan filter from back of instrument. Order replacement filter if tears or damage is visible, clean and re-install.

NOTE: If the instrument has been idle for 4 hours or more, it will automatically revert to the Standby Mode. Follow directions on the display to return to the MAIN MENU.


NOTE: Sample PROBECLENZTM by performing a CLEAN:Short cycle after every 25 samples.

DREW SCIENTIFIC HEMAVET ® SYSTEM

HV950 OPERATING INSTRUCTIONS

1

INITIAL INSTRUMENT START-UP

NOTE: During initialize, priming,clean and start-up cycles variousmessages will appear on thedisplay, but no operatorinteraction is required.

MAIN MENU HEMAVET 950FS

Select Labeled Key Function

NOT RDY

SPECIAL MENU Select or Push "0" To End1: Initialize 2: Valve Test 3: Reagents4: Status Log 5: Results 6: Data Storage7: Diagnostic 8: Setup CLEAN: Short

HEMAVET 950FS

TESTING

Prior to powering-up the instrument,make sure the FS-PAK or LV-PAKReagent Kit is properly connected.Refer to Section III.Power-up instrument by pressing ON/OFF button (rear of instrument) to ONposition. Power-up may take up to 2minutes.When HEMAVET MAIN MENUappears, press 9:SPEC'l key todisplay SPECIAL MENU, then press1:Initialize.

The following procedures must be accomplished at initial instrumentinstallation.

2

INITIAL INSTRUMENT START-UP (Continued)

After valves and syringesfinish cycling (approx. 1.5min.), press 3:Reagents,to display REAGENT MENUthen press 2:Change Reagents


REAGENT MENU Select or Push "0" TO End1: Prime All2: Change Reagents3: Print Reagent Log

3

ENTER Lot NumberCurrent Value [ 0]Keys: CLEAR EXIT

Press CLEAR key to enterthe 4 digit Reagent LotNumber that is shown on theReagent Kit box. Then pressthe ENTER key followed bythe EXIT key. NOTE: If youmake a mistake, press theCLEAR key to re-enter thenumber.


ENTER Lot NumberCurrent Value [ 1234]Keys: CLEAR 0 - 9 ENTER

4

ENTER Expiration DateCurrent Value [ 0]Keys: CLEAR EXIT

Press CLEAR key to enterthe Reagent Expiration Datethat is shown on the ReagentKit box. Then press theENTER key followed by theEXIT key. NOTE: If you makea mistake, press the CLEARkey to re-enter the date.


ENTER Expiration DateCurrent Value [ 12/31/02]Keys: CLEAR 0 - 9 ENTER

5

ENTER Kit NumberCurrent Value [ 0]Keys: CLEAR EXIT

Press CLEAR key to enterthe 9 digit Reagent KitNumber that is shown on theReagent Kit box. Then pressthe ENTER key followed bythe EXIT key to return to theREAGENT MENU. NOTE: Ifyou make a mistake, pressthe CLEAR key to re-enter thenumber.


ENTER Kit NumberCurrent Value [ 360501040]Keys: CLEAR 0 - 9 ENTER

6


REAGENT MENU Select or Push "0" To End1: Prime All2: Change Reagents3: Print Reagent Log

PRIME CYCLE

PRIMING

Press 1:Prime All. At thecompletion of the primecycle (approx. 5 min.), press1 key again.

7



CLEAN CYCLE

CLEANING

When the second prime cycleis complete, press the 0 key toreturn to the SPECIAL MENU,then run a Short Clean bypressing the CLEAN key.

8


SPECIAL MENU Select or Push "0" To End1: Initialize 2: Valve Test 3: Reagents4: Status Log 5: Results 6: Data Storage7: Diagnostic 8: Setup CLEAN: Short After CLEAN CYCLE is

completed (approx. 10 min.),press 0 key to return to MAIN MENU. Run STARTUP CYCLEfrom MAIN MENU by pressingSTART key.



READY / !!! MIX SAMPLE !!!

STARTUP CYCLE

TESTING

9




INITIAL INSTRUMENT START-UP (Continued)At completion of STARTUPCYCLE (approx. 5 min.), runa report of the backgroundcount by pressing OTHERkey.When SAMPLE ANALYSISCYCLE is completed (approx. 2min.) a report of the backgroundcount will be printed out.Disregard any hematologicalabnormalities that appear onthe report.Acceptable limits for thebackground count are asfollows:

WBC 0.2 or less

RBC 0.02 or less

Hb 0.2 or less

PLT 20 or less

SAMPLE ANALYSIS CYCLE

ANALYZING SAMPLE

Initial Instrument Startup of your HEMAVET instrument is nowcompleted. Perform Daily Quality Control check and run SampleAnalysis as instructed on the following pages.

NOTE: For maximum stability, it is highly recommended thatthe instrument remain powered-up at all times. Powerconsumption is relatively low (less than 45 Watts in theidle mode).

10

If the instrument is shut-down after initial start-up hasbeen accomplished, then when it is powered-up again,it is necessary only to press the START key from theMAIN MENU to put the instrument in the ready mode.

11

DAILY QUALITY CONTROL PROCEDURE

Remove MULTI-TROL™ vialfrom refrigerator and allow toreach room temperature.(Approx. 15 min.)

Hold vial with cap up betweenthe palms of your hands androll gently 10 times.

Invert vial and roll 10 timesbetween palms, once again

Note: Before running Control, make sure that the LOT# has not expired, and the assay sheet matches the controls you’re using.

12

DAILY QUALITY CONTROL PROCEDURE (Continued)

Position the vial between thethumb and forefinger andgently invert 10 times.

If any material can be seen adhering to the glass, the mixing procedure should be repeated.

13

DAILY QUALITY CONTROL PROCEDURE (Continued)Cycle Controls as follows:

A. Uncap MULTI-TROL vial, and run using the "Manual Mode." See Section 5.3., pg.5-2.

B. Press animal species key listed on the control's assay sheet (example: run "DOG" control using

"DOG" key, etc.).

C. The sample analysis takes approx. 2 minutes. At the end of this period, the results of the analysis are automatically printed out. Verify the results against the control's assy reference ranges. Disregard any hematological abnormalties that appear on the report.

D. If the control values are not within the range listed on the assay sheet (Refer to Section VII).

E. Wipe outside threads of vial and inside threads of cap with tissue or gauze, then cap vial.

14

SPECIMEN COLLECTION AND HANDLING Collect the specimen by venipuncture. The recommended anticoagulant is K3 EDTA. Mix the blood specimen and anticoagulant as follows:

1. Place the specimen on Speci-Mix blood rocker for a minimum of 10 minutes. 2. Remove specimen from rocker and gently invert tube 3 times. Note: Observe specimen carefully to detect any problems such as gross hemolysis, lipemic plasma, or blood clots.

Caution

Whole blood specimens for platelet and differential counts must be run at room temperature, and within 4 hours after sample collection for optimum results.

15

MANUAL SAMPLE ANALYSIS PROCEDURE 15.1

Perform Manual Sample Analysis asfollows:

A. Remove sample holder from the Hemavet, exposing the mixing cuvette.

B. From the main menu push 2: NEXT key. The probe will come down to a stationary position. On later model HV950's, the probe will go down to it's lowest point by pushing the 2: NEXT key a second time.

C. Hold sample vial under the probe, submerge probe into the sample.

D. Select Species key, Example "DOG." The probe will draw in the sample and retract.

E. Remove sample vial and when sampling is complete, reinstall the sample holder.

NOTE: The instrument willautomatically assign a testnumber to each sample analysis.The operator can also assign aunique I.D. number to each test.Refer to the HV950FS Menus atthe end of this section.

16

DAILY CLEAN PROCEDURE

1. Push the CLEAN / ENTER key at least once daily on days when samples are run.

Note: When the Auto-CLEAN cycle is enabled, there is no need to press the CLEAN key daily. (Refer to the HV950 Menus at the end of this section.)

2. After processing 25 samples, place a clean vial filled with PROBECLENZ in the sample holder and perform a CLEAN: Short cycle, from the Main Menu press the # 9 key (Special) followed by the CLEAN / ENTER key. PROBECLENZ may be also sampled via the manual mode by pressing the #2 key from the Main Menu present the PROBECLENZ vial to the sample probe needle press the # 9 key (Special) followed by the CLEAN/ENTER key.

(NOTE: if a clear vial is used it must be refilled with fresh PROBECLENZ on a weekly basis. The Sodium Hypochlorite ingredient in the PROBECLENZ is light sensitive)

WEEKLY CLEAN PROCEDURE

1. Once per week, sample PROBECLENZ by performing a CLEAN cycle as described in the step (2) above.

2. Clean external surfaces, including the Carriage assembly using D.I. water.

3. Clean fan filter (Refer to Section VIII).

MENUS TO ACCESSHEMAVET HV950 FUNCTIONS

MAIN MENU HEMAVET 950


NOT RDY

Key(s) Function

None

Result

MAIN MENU HEMAVET 950



1

Key(s) Function Result

2


3


4

ACTIVE KEYS

Software Version

TESTING 2

DATETEST #

CAL.SPEC'LSTART

2

Displays DATE/TIME MENUDisplays TEST #/I.D. # MENUDisplays WBC CALIBRATION ScreenDisplays SPECIAL MENUBegins Start-Up Cycle and Returns toMAIN MENUPlaces Instrument into manual mode

51015253

SPECIESDATE

TEST #CAL.

SPEC'LSTART

2

Begins Sample Analysis CycleDisplays DATE/TIME MENUDisplays TEST #/I.D. # MENUDisplays WBC CALIBRATION ScreenDsiplays SPECIAL MENUBegins Start-Up Cycle and Returns toMAIN MENUPlaces Instrument into manual mode

451015253

SAMPLE ANALYSIS CYCLE

ANALYZING SAMPLENone 3

MAIN

Runs Sample Analysis Cycle andReturns to MAIN MENU


6

7

8

9

ACTIVE KEYS

HEMAVET 950ENTER Date

Current Value [ 03/12/96 ]Keys: CLEAR EXIT CLEAR

EXITDisplays ENTER Date Sub-ScreenReturns to DATE/TIME MENU

75

HEMVET 950ENTER Date[ 03/12/96 ] <===

Keys: CLEAR 0 - 9 ENTER


0 - 9CLEARENTER

Active Keys to Enter DateClears EntryReturns to Previous Screen

--6

HEMAVET 950ENTER Time

Current Value [ 09:37:01 ]Keys: CLEAR EXIT


CLEAREXIT

Displays ENTER Time Sub-ScreenReturns to DATE/TIME MENU

95

HEMAVET 950ENTER Time[ 09:37:01 ] <===

Keys: CLEAR 0 - 9 ENTERKey(s) Function Result

0 - 9CLEARENTER

Active Keys to Enter TimeClears EntryReturns to Previous Screen

--8


5DATE/TIME MENU Select or Push "0" To End

1: Date 2: Time120

Displays ENTER Date ScreenDisplays ENTER Time ScreenReturns to MAIN MENU

683

DATE / TIME

10

11

12

13

14

ACTIVE KEYS

TEST # / I.D. #

TEST # / ID # MENU Select or Push "0" To End

1: Test # 2: I. D. # Key(s) Function Result

1

2

0

Displays ENTER Test NumberScreenDisplays ENTER I.D. NumberScreenReturns to MAIN MENU

11

13

3

HEMAVET 950ENTER Test Number ( 1 - 9999 )

Current Value [ 12 ]Keys: CLEAR EXIT


CLEAR

EXIT

Displays ENTER Test Number Sub-ScreenReturns to TEST #/I.D. # MENU

12

10

HEMAVET 950ENTER Test Number ( 1 - 9999 )

[ 12 ] <=== Keys: CLEAR 0 - 9 ENTER


0 - 9CLEARENTER

Active Keys to Enter Test NumberClears EntryReturns to Previous Screen

--

11

HEMAVET 950ENTER SAMPLE I.D. ( 10 Char. Max )

Current Value [1234 ]Keys: CLEAR EXIT


CLEAR

EXIT

Displays ENTER I.D. Number Sub-ScreenReturns to TEST #/I.D. # MENU

14

10

HEMAVET 950ENTER SAMPLE I.D. ( 10 Char. Max )

[ 12 ] <=== Keys: CLEAR 0 - 9 ENTER


CLEAR0-9

Clears EntryActive keys to enter I.D. number. Ifequipped with external Keyboard,both alpha and numeric I.D. numberscan be entered.

--

15

16

17

18

19

ACTIVE KEYSCALIBRATION

ENTER WBC Calibration Factor Current Value [ 1.750 ] Keys: CLEAR EXIT


CLEAR

EXIT

Displays ENTER WBC CalibrationSub-ScreenAdvances to RBC Calibration Screen

16

17


0 - 9

CLEARENTER

Active Keys to Enter CalibrationFactorClears EntryReturns to WBC Calibration Screen

-

-15

CALIBRATION

CALIBRATIONENTER WBC Calibration Factor

[ 1.750 ] <=== Keys: CLEAR 0 - 9 ENTER

CALIBRATIONENTER RBC Calibration Factor

Current Value [ 1.220 ] Keys: CLEAR EXIT


CLEAR

EXIT

Displays ENTER RBC CalibrationSub-ScreenAdvances to Hb Calibration Screen

18

19

CALIBRATIONENTER RBC Calibration Factor

[ 1.220 ] <=== Keys: CLEAR 0 - 9 ENTER


0 - 9

CLEARENTER

Active Keys to Enter CalibrationFactorClears EntryReturns to RBC Calibration Screen

-

-17

CALIBRATIONENTER Hb Calibration Factor



CLEAR

EXIT

Displays ENTER Hb Calibration Sub-ScreenAdvances to MCV Calibration Screen

20

21

20

21

22

23

ACTIVE KEYS


0 - 9

CLEARENTER

Active Keys to Enter CalibrationFactorClears EntryReturns to Hb Calibration Screen

-

-19

CALIBRATION (Cont.)

CALIBRATIONENTER Hb Calibration Factor

[ 1.065 ] <=== Keys: CLEAR 0 - 9 ENTER

CALIBRATIONENTER MCV Calibration Factor



CLEAR

EXIT

Displays ENTER MCV CalibrationSub-ScreenAdvances to PLT Calibration Screen

22

23

CALIBRATIONENTER MCV Calibration Factor

[ 1.250 ] <=== Keys: CLEAR 0 - 9 ENTER


0 - 9

CLEARENTER

Active Keys to Enter CalibrationFactorClears EntryReturns to MCV Calibration Screen

-

-21

CALIBRATIONENTER PLT Calibration Factor



CLEAR

EXIT

Displays ENTER PLT CalibrationSub-ScreenReturns to MAIN MENU

24

3

24CALIBRATION

ENTER PLT Calibration Factor [ 1.220 ] <=== Keys: CLEAR 0 - 9 ENTER


0 - 9

CLEARENTER

Active Keys to Enter CalibrationFactorClears EntryReturns to PLT Calibration Screen

-

-23

HEMAVET 950

TESTING

Key(s) Function

1:2:3:4:5:6:7:8:

CLEAN:0

Result

REAGENT MENU Select or Push "0" To End1: Prime All2: Change Reagents3: Print Reagent Log

25


26

28

30

ACTIVE KEYS

SPECIAL MENU Select or Push "0" To End 1: Initialize 2: Valve Test 3: Reagents 4: Status Log 5: Results 6: Data Storage 7: Diagnostic 8: Setup CLEAN: Short

262628384550536171

None After Cycling, Returns to SPECIALMENU

25

PRIME CYCLE

ANALYZING SAMPLE

SPECIAL

Exercises Valves and Cycles SyringesExercises ValvesDisplays REAGENT MENUDisplays STATUS MENUDisplays RESULTS MENUDisplays PATIENT STORAGE MenuDisplays DIAGNOSTICS MenuDisplays SETUP MENURuns Short Clean CycleReturns to MAIN MENU

31

PRIME CYCLE

CALCULATING RESULTS . . .


Primes Reagents and RunsBackground CycleDisplays ENTER Lot Number Sub-ScreenPrints Reagent Log

29

32

-


Runs Background Cycle 31


Perfroms Background Count andReturns to SPECIAL MENU

25

1

2

3

None

None

PRIME CYCLE

PRIMING

29


Primes Reagents 30None


32

33

34

35

ENTER Lot NumberCurrent Value [ 0 ]Keys: CLEAR EXIT CLEAR

EXIT

Displays ENTER Lot Number Sub-ScreenDisplays ENTER Expiration DateSub-Screen

33

34

ENTER Lot Number[ 1234 ] <===



0 - 9CLEARENTER

Active Keys to Enter Lot NumberClears EntryReturns to Previous Screen

--

32

ENTER Expiration DateCurrent Value [ 0 ]Keys: CLEAR EXIT


CLEAR

EXIT

Displays ENTER Expiration DateSub-ScreenDisplays ENTER Kit Number Sub-Screen

35

36

ENTER Expiration Date[ 12/31/02 ] <===



0 - 9CLEARENTER

Active Keys to Enter Expiration DateClears EntryReturns to Previous Screen

--

34

REAGENT MENU Selection 2:

SPECIAL (Cont.)

ACTIVE KEYS

36

37

ENTER Kit NumberCurrent Value [ 0 ]Keys: CLEAR EXIT


CLEAR

EXIT

Displays ENTER Kit Number Sub-ScreenReturns to REAGENT MENU orDisplays Error Message if Invalid KitNumber is Entered.

37

28

ENTER Kit Number[ 123456789 ] <===



0 - 9CLEARENTER

Active Keys to Enter Kit NumberClears EntryReturns to Previous Screen

--

36

REAGENT MENU Selection 2: Cont.

SPECIAL (Cont.)

ACTIVE KEYS

STATUS HISTORY Push NEXT or "0" To End2157 118-030-000-05/S 70 HB5084 118-055-000-01/H 69 STMCCW2147 118-055-000-01/H 68 STMCCW

Key(s) Function

1:2:

3:4:0

Result

STATUS ON CURRENT SAMPLE Push "0" To End

2157 118-030-000-05/S 70 HB

38


39

40

41

ACTIVE KEYS

STATUS MENU Select or Push "0" To End1: History 2: Current 3: Last4: Clear Status Log 39

40

414225

NEXT0

Scrolls Thru Error MessagesReturns to STATUS MENU

-38

LAST STATUS Push "0" To End

2157 118-030-000-05/S 70 HB

SPECIAL (Cont.)

Displays STATUS HISTORYDisplays STATUS ON CURRENTSAMPLEDisplays LAST STATUSDisplays Password ScreenReturns to SPECIAL MENU

42

PASSWORD NEEDED FOR THIS FUNCTIONENTER PASSWORD

Current Value [ 0]Keys: CLEAR EXIT


Returns to STATUS MENU 38


Returns to STATUS MENU 38


Displays Password Sub-ScreenDisplays ERROR Message Screen ifPassword Has Not Been Entered,Otherwise Clears Status Log andReturns to STATUS MENU

4344

38

0

0

CLEAREXIT

SPECIAL MENU Selection 4:


44

45

46

ACTIVE KEYS

None 38

WBC 12.35 Push NEXT or "0" To EndNE# 9.00 EO# 1.26LY# 1.79 BA# 0.06MO# 0.24 NR#

SPECIAL (Cont.)

43


Current Value [ 0] <===Keys: CLEAR ENTER


Displays WBC # ScreenReturns to SPECIAL MENU

4625


Displays WBC % ScreenReturns to SPECIAL MENU

4725


Active Keys to Enter PasswordClears EntryReturns to Previous Screen

--

42

NEXT0

NEXT0

0 - 9CLEARENTER

47


Displays RBC ScreenReturns to SPECIAL MENU

4825

NEXT0

PASSWORD NEEDED FOR THIS FUNCTION

ERROR

RESULTS MENU Push NEXT or "0" To EndPatient ID: 1234Type: DOG Date: 03/12/96Test No: 3 Time: 09:37:01


WBC 12.35 Push NEXT or "0" To EndNE% 72.84 EO% 10.23HLY% 14.53 BA% 0.45MO% 1.94L NR%

ERROR Message Flashes, ThenReturns to STATUS MENU


49

ACTIVE KEYS

NEXT0

4525

SPECIAL (Cont.)

48


RBC 6.22 Push NEXT or "0" To EndHb 15.4 MCH 24.8H RSDHCT 47.6 MCHC 32.4 RT#MCV 76.5H RDW 19.64 RT%


Displays PLT ScreenReturns to SPECIAL MENU

4925

NEXT0

PLT 291 Push NEXT or "0" To EndPCTMPV 7.5PDW

Returns to RESULTS MENUReturns to SPECIAL MENU

Key(s) Function

1:2:3:4:0

ResultPATIENT STORAGE Number of Records 501: Display List 2: Initialize3: 4: 51

52--

25

Displays List of Patient RecordsClears List of Patient RecordsNoneNoneReturns to SPECIAL MENU

50

Select or Push "0" to END

Idx Patient ID Test # Date Time 1 PATIENT 00 3 01/15/03 10:45 2 PATIENT 00 4 01/15/03 11:15


CATDOG

ENTER

EXIT

--

45

25

Scrolls Down Through the ListScrolls UP Through the ListSelects the Patent and displaysRESULTS MENUReturns to SPECIAL MENU

51

INITIALIZE PATIENT STORAGE**THIS WILL CLEAR ALL PATIENTS RECORDS**

Press CLEAR TO Intializeor "0" to EXIT


0 50Returns to PATIENT STORAGEMenu

52

53

54

CODE REV MENU Push "0" To EndCOPYRIGHT 2002 Drew Scientific

OS/REV: ISS/REV:


Displays CODE REV MENUDisplays PRINTER DIAGS. MenuDisplays DMS DIAGNOSTIC Sub-MenuNoneDisplays Auto Sampler Menu

545558

60


Returns to DIAGNOSTICS Menu 53

1:2:3:

4:5:

0

55


Displays THERMAL PTR MenuDisplays BUBBLE JET PTR MenuEnables HP PrinterEnables Epson PrinterReturns to DIAGNOSTICS Menu

5657--

53

12340

DIAGNOSTICS Select or Push "0" To End1: Code Rev. 2: Printer 3: DMS4: Data/Flags 5: Auto Smplr 6:7: 8: 9:

PRINTER DIAGS. Select or Push "0" To End1: Thermal. 2: Bubble Jet 3:Enable HP4: Enable Epson

SPECIAL (Cont.)SPECIAL MENU Selection 7:


57

1234560

----

55

56


Initializes Printer PortPrints ReportResets PrinterDisplays Port StatusReturns to PRINTER DIAGS. Menu

----

55

12340

THERMAL PTR Select or Push "0" To End1: Initialize 2: Print 3: Reset4: Status 5: 6:STAT 0028H CST 0508H

BUBBLE JET PTR Select or Push "0" To End1: Initialize 2: Print 3: Make Form4: Status 5: Clear Que 6: --- more ---StatB 0008H StatD 0000H

Initializes Printer PortPrints ReportBuilds Report FormDisplays Port StatusNoneNoneReturns to PRINTER DIAGS. Menu

ACTIVE KEYS

SPECIAL (Cont.)

58


Positions Probe and Carriage in"Home" PositionMoves Probe to Down PositionMoves Probe to Up PositionMoves Carriage to In PositionMoves Carriage to Out PositionReturns to DIAGNOSTICS Menu

------

53

1

23450

Auto Sampler Select or Push "0" To End1: Initialize 2: Probe Down 3: Probe Up4: Carriage In 5: Carriage Out:


Initializes Data StreamSends DataRe-Sends DataDisplays StatusDisables Data StreamDisplays DMS DIAGS. 2 Sub-MenuReturns to DIAGNOSTICS Menu

-----

5953

1234560

DMS DIAGNOSTIC Select or Push "0" To End1: Initialize 2: Send 3: Retry4: Status 5: Disable 6: --- more ---STAT 6000H CST 0000H CFG 0000H CTL 0000H

59


Displays StatusReturns to Previous Screen

-58

10

DMS DIAGS. 2 Select or Push "0" To End1: Status 2: 3:4: 5: 6:# TRN 0 MAX 0 AVG 0 RTY 0

DIAGNOSTICS Selection 5:

60

61

62


Displays BUBBLE JET PTR MenuNoneDisplays Password ScreenDisplays OPTIONS MENUReturns to SPECIAL MENU

62

636825


-

-

-

-

61

12340

1

2

3

4

063

SETUP MENU Select or Push "0" To End1: Printers 2: DMS 3: Factors4: Options 5: 6:7: 8: 9:

BUBBLE JET PTR Select or Push "0" To End1: Enable 3D 2: Disable 3D3: Enable DC 4: Disable DC

Enables Histogram Printing andDisplays "COMPLETE" MessageDisables Histogram Printing andDisplays "COMPLETE" MessageEnables Diagnostic Considerations onReport formDisables Diagnostic Considerationson Report formReturns to SETUP MENU


Current Value [ 0]Keys: CLEAR EXIT


Displays Password Sub-ScreenDisplays ERROR Message Screen ifPassword Has Not Been Entered,Otherwise Displays FACTORSSETUP Screen

6465

66

CLEAREXIT

ACTIVE KEYS

SPECIAL (Cont.)


65

None 61

64


Current Value [ 0] <===Keys: CLEAR ENTER


Active Keys to Enter PasswordClears EntryReturns to Previous Screen

--

63

0 - 9CLEARENTER

PASSWORD NEEDED FOR THIS FUNCTION

ERROR


ERROR Message Flashes, ThenReturns to SETUP MENU

66

67

ACTIVE KEYS

SPECIAL (Cont.)


Displays FACTORS SETUP Sub-MenuReturns to SETUP MENU

67

61


Active Keys to Enter FactorClears EntryReturns to Previous ScreenNote: If invalid factor is entered,[ERROR!!!] Message Appears

--

66

CLEAR

EXIT

0 - 9CLEARENTER

FACTORS SETUP Histogram Mean: 154:00flENTER Current Source Cal. Factor

Current Value [ 1.000]Keys: CLEAR EXIT

FACTORS SETUP Histogram Mean: 154:00flENTER Current Source Cal. Factor

[ 1.000] <===Keys: CLEAR 0 - 9 EXIT

OPTIONS MENU Select or Push "0" To End1: Auto-CLEAN 2: 3:4: 5: 6:7: 8: 9:


6961

10

Displays ENTER Time ScreenReturns to SETUP MENUNOTE: If Auto-CLEAN is currently set ON ( symbol), pressing key 1 will change setting to OFF ( symbol)

68

69

70

OPTIONS MENU ENTER Time

Current Value [ 06:30:00 ]Keys: CLEAR EXIT


CLEAREXIT

Displays ENTER Time Sub-ScreenReturns to OPTIONS MENU

7068

OPTIONS MENU ENTER Time

[ 06:30:00 ] <=== Keys: CLEAR 0 - 9 ENTER


0 - 9CLEARENTER

Active Keys to Enter TimeClears EntryReturns to Previous Screen

--

69

SETUP Selection 4

71


Runs a Short Clean Cycle, PrimesFresh Diluent, Performs BackgroundCycle, and Returns to SPECIAL MENU

25None

CLEAN CYCLE

CLEANING

CLEAN CYCLE

PRIMING

CLEAN CYCLE

ANALYZING SAMPLE

SPECIAL (Cont.)SPECIAL MENU Selection CLEAN:

72

73

ACTIVE KEYS

TIMEOUT MESSAGES


Runs Start-Up Cycle and Returns toMAIN MENURuns Full Clean Cycle and Returnsto MAIN MENUReturns to MAIN MENU


Cycles Valves and Returns to MAINMENUAborts Valve Cycling and Returnsto MAIN MENU

START

CLEAN

EXIT

0

EXIT

HEMAVET 950Is in SHUTDOWN Mode

Push "START" or "CLEAN" To Cycleand Return To MAIN MENU

4 Hours

HEMAVET 950Is in STANDBY Mode

Push "0" To Cycle Valvesand Return To MAIN MENU

10 Hours

74

75

ACTIVE KEYS

Select-A-SpeciesTM (optional)


Display list of available species ininstrument


Scrolls up by one species position

Scrolls down by one speciesposition

Page down - Scrolls down by threespecies

Exits Dial-A-Species withoutrunning a CBC cycle.

Runs selected species CBC

Note: The symbol indicates theselected species. In the example tothe left, 'OTHER' is the selectedspecies.

OTHER

2 / NEXT

3 / EXIT

ENTER

MAIN MENU HEMAVET 950 Select Labeled Key Function


Press ENTER to run selected SPECIES CBCOTHERDOGCAT

77

77

76

Data Interpretation and Flagging Page 6-1 HEMAVET HV950 Product Reference Manual Jan. 2011

6.0 GENERAL 6.0.1 This section provides information that will help you interpret sample analysis results. 6.1 INTERPRETING PRINTED RESULTS 6.1.1 Table 6-1 lists the parameters reported by the HEMAVET system, their definitions, the

international units of measure, the HEMAVET system units of measure, and the formulas for equivalent unit conversion.

Table 6-1. HEMAVET System Parameter Table

PARAMETER

DEFINITION

SI

UNIT OF MEASURE

HEMAVET

SYSTEM UNIT OF

MEASURE

EQUIVALENT

UNIT CONVERSION

WBC

White Blood Cell

(leukocyte) Count

Number of leukocytes in the specified volume of whole blood. Directly Measured.

Billions of leukocytes per liter of whole blood: 109 cells / liter

Thousands of leukocytes per microliter of whole blood: K/L

109/liter = 103/L =

K/L

RBC Red Blood Cell (erythrocyte)

count

Number of erythrocytes in the specified volume of whole blood. Directly measured.

Trillions of erythrocytes per liter of whole blood: 1012 cells / liter

Millions of erythrocytes per microliter of whole blood: M/L

1012/liter = 106/L=

M/L

Hb Hemoglobin

Mass or weight of hemoglobin in the specified volume of whole blood. Directly measured.

Grams of hemoglobin per deciliter of whole blood: g/dL

Grams of hemoglobin per deciliter of whole blood: g/dL

g/L = g/dL x 10

HCT Hematocrit

Relative volume of erythrocytes. Computed from RBC and MCV: (RBC x MCV) 10

Percent: %

Percent: %

L/L = % 100

MCV Mean

Corpuscular (erythrocyte)

Volume

Average volume of individual erythrocytes in whole blood. Directly measured.

Femtoliter: fL or 10-15 liter


fL = 3


PARAMETER

DEFINITION

SI

UNIT OF MEASURE

HEMAVET

SYSTEM UNIT OF

MEASURE

EQUIVALENT

UNIT CONVERSION

MCH Mean

Corpuscular (erythrocyte) Hemoglobin

Mass or weight of hemoglobin in the average individual erythrocyte. Computed from Hb and RBC: 10 x (Hb RBC)

Picrograms of hemoglobin per erythrocyte: pg or 10-12g

Picograms of hemoglobin per erythrocyte: pg or 10-12g

None

MCHC Mean

Corpuscular (erythrocyte) Hemoglobin

Concentration

Average mass or weight of hemoglobin in specified volume of erythrocytes. Computed from Hb and Hct: 100 x (Hb Hct)

Grams of hemoglobin per deciliter of erythrocytes: g/dL

Grams of hemoglobin per deciliter of erythrocytes: g/dL

g/L = g/dL x 10

RDW

Red cell (erythrocyte

volume) Distribution

Width

The size-distribution spread of the erythrocyte population expressed as the coefficient of variation of the red cell distribution.

Percent %

Percent %

None

RSD

Red Cell (erythrocyte)

Standard Deviation

The size-distribution spread of the erythrocyte population expressed as the standard deviation of the red cell distribution. Directly measured.



fL = 3

RETICS #

(Reticulocytes)

Number of immature nonnucleated erythrocytes in the specified volume of whole blood. Directly measured and flagged.

Trillions of reticulocytes per liter of whole blood: 1012 cells / liter

Millions of reticulocytes per microliter of whole blood: M/L

1012/liter = 106/L=

M/L

RETICS %

(Reticulocytes)

Percent of immature nonnucleated erythrocytes in the specified volume of whole blood. Flagged.

Percent %

Percent %

None

PLT

Platelet (thrombocyte)

Count

Number of platelets (thrombocytes) in the specified volume of whole blood. Directly measured.

Billions of thrombocytes per liter of whole blood: 109 cells / liter

Thousands of thrombocytes per microliter of whole blood: K/L

109/liter = 103/L =

K/L


PARAMETER

DEFINITION

SI

UNIT OF MEASURE

HEMAVET

SYSTEM UNIT OF

MEASURE

EQUIVALENT

UNIT CONVERSION

PCT

Plateletcrit

Relative volume of platelets (thrombocytes). Computed from PLT and MPV: (PLT x MPV) 10

Percent: %

Percent: %

L/L = % 100

MPV

Mean Platelet (thrombocyte)

Volume

Average volume of individual platelets (thrombocytes) in whole blood. Directly measured.



fL = 3

PDW

Platelet (thrombocyte

volume) Distribution

Width

The size distribution spread of the platelet (thrombocyte) population expressed as the coefficient of variation of the platelet distribution

Percent %

Percent %

None

NE #

NE %

LY #

LY %

Absolute number of leukocytes that are neutrophils. Directly measured. Percent of leukocytes that are neutrophils. Absolute number of leukocytes that are lymphocytes. Directly measured. Percent of leukocytes that are lymphocytes.

Billions of neutrophils per liter of blood: 109 cells / liter Percent % Billions of lymphocytes per liter of blood: 109 cells / liter Percent %

Thousands of neutrophils per microliter of blood: K/L Percent % Thousands of lymphocytes per microliter of blood: K/L Percent %

109/liter = 103/L =

K/L

None

109/liter = 103/L =

K/L

None


PARAMETER

DEFINITION

SI

UNIT OF MEASURE

HEMAVET

SYSTEM UNIT OF

MEASURE

EQUIVALENT

UNIT CONVERSION

MO #

MO %

Absolute number of leukocytes that are monocytes. Directly measured. Percent of leukocytes that are monocytes.

Billions of monocytes per liter of blood: 109 cells / liter Percent %

Thousands of monocytes per microliter of blood: K/L Percent %

109/liter = 103/L =

K/L

None

EO #

EO %

BA #

BA %

NRBC #

NRBC %

Absolute number of leukocytes that are eosinophils. Directly measured. Percent of leukocytes that are eosinophils. Absolute number of leukocytes that are basophils. Directly measured. Percent of leukocytes that are basophils. Absolute number of erythrocytes that are immature nucleated red blood cells. Directly measured and flagged. Percent of erythrocytes that are nucleated red blood cells. Flagged.

Billions of eosinophils per liter of blood: 109 cells / liter Percent % Billions of basophils per liter of blood: 109 cells / liter Percent % Billions of NRBC's per liter of blood: 109 cells / liter Percent %

Thousands of eosinophils per microliter of blood: K/L Percent % Thousands of basophils per microliter of blood: K/L Percent % Thousands of NRBC's per microliter blood: K/L Percent %

109/liter = 103/L =

K/L

None

109/liter = 103/L =

K/L

None

109/liter = 103/L =

K/L

6.1.2. Leukocyte Differential. The HEMAVET system generates a WBC differential by constructing a distribution cytogram based on the relative size and complexity of cells in a blood sample. Each cell passing through the instrument's sensing zone is analyzed, compared to known criteria, and placed in a corresponding area in the cytogram, based on these criteria. For example, a cell with the size and internal complexity of


neutrophils is placed in the neutrophil "area" in the cytogram. Percentages and absolute cell numbers are then calculated. The nine leukocyte populations enumerated by this system include: less than fully mature neutrophils, mature and segmented neutrophils (NE); normal and variant lymphocytes (LY); monocytes (MO); eosinophils (EO) and basophils (BA). Figure 6-1 shows a typical WBC cytogram * that reflects these populations in order of increasing size and complexity. The cytograms illustrate typical distribution of a "normal" blood sample. Abnormal blood samples may show a different distribution. Clumps of platelets, if present, appear on the WBC cytogram as the peak farthest to the left. They are subtracted from the total WBC count and differential analysis. Nucleated red cells (NRBC), if present, are the next largest cell type and appear as the second population slightly to the right of platelet clumps. They are also excluded from the differential and WBC count. Lymphocytes are the smallest leukocyte and are represented by the third peak on the cytogram. Variant lymphocytes are slightly larger and make up the fourth population. The fifth population represents monocytes. The sixth and seventh populations are less than mature neutrophils, mature and segmented neutrophils, respectively. Eosinophils occupy the eighth population, and basophils are the ninth. Less than mature neutrophils, mature and segmented neutrophils are combined into the NE count, with a left shift being designated by a W3 flag. (See flagging criteria below.) The LY designation contains both normal and variant lymphocytes. Cells in the NE, LY, MO, EO and BA areas are reported with numeric information for both the absolute count and percentage. NRBCs are not enumerated, but a "ELEV" flag in this parameter signals the operator to suspect the presence of these cells. 6.1.3. Erythrocyte/Thrombocyte Analysis. Erythrocyte and platelet enumeration is accomplished in

much the same way as the WBC count and differential. Cells passing through the instrument are analyzed, placed in a corresponding area in the cytogram, and compared to known criteria for identification. See Figure 6-1 for an illustration of populations defined on the RBC/platelet cytogram *. Mature RBCs (normocytes) and platelets are reported with numeric values. Reticulocytes are flagged for dog samples only. Reticulocytes (Retics) are not enumerated, but are indicated by an "ELEV" flag if the instrument detects the presence of these cells in numbers above the species specific normal range as shown on the Hematology Profile. The remaining RBC parameters are either measured directly by the instrument or calculated from measured values. MCV is measured directly and represents the average volume of the erythrocytes passing through the instrument. RDW (red cell distribution width) is a measure of the variation in red cell size throughout the RBC population (i.e. increased RDW indicates more variation in cell size than normal). RBC is the number of erythrocytes per microliter of blood. Hemoglobin (Hb) is measured by lysing all the RBCs in a known quantity of blood and measuring the amount of hemoglobin liberated. HCT, MCH and MCHC are then calculated using these measured values.

* The reported cytogram populations on the HEMAVET series hematology analyzer are not based on the morphology of humans or non human primates, such as monkey. When running these, or any other species that is not currently optimized, it is the responsibility of the operator to determine the morphology of that species and to properly identify the various populations of the cytogram.


WBC Cytogram

RBC Cytogram

PLT / Debris

NRBC

LY

VLY MO

IMG

NE EO BA

Figure 6-1.

PLT

MICRO

NORMO

MACRO

RETICS


6.1.4 Flagging Criteria. Certain conditions and cell size distributions trigger the following flags

to alert the operator that abnormal conditions may exist.

The following suspect flags may appear adjacent to the leukocyte parameters: * Indicates that the mean of the WBC cytogram has shifted abnormally due to cell fragility.

Examine blood smear.

P1 Indicates that debris due to incomplete lysis of RBCs and/or platelet clumps are present.

*P1 Indicates excessive debris or cellular fragments. Examine blood smear.

W3 Indicates that neutrophils have collapsed in vitro due to anemia or a delay in processing, or that immature granulocytes are present. Review the blood smear to

evaluate RBC and WBC morphology and differential.

W5 Indicates that very large particles or many small platelet clumps have been detected. Review the blood smear to determine cause.

The following suspect flags may appear adjacent to the erythrocyte parameters:

* Indicates that RDW is beyond instrument linearity limits (8% - 55%).

R1 Indicates that platelet clumps, microcytic RBCs or RBCs that have collapsed due to

autohemolysis have been detected. Review the blood smear to determine cause. R1 and P2 flags appearing together indicates difficulty in separating platelet and RBC populations because of small RBCs and/or platelet clumps. Review blood smear to determine cause.

R5 Indicates the presence of an unusual population in the RBC cytogram.

R7 Indicates that very large cells relative to RBCs have been detected. WBCs appearing on

RBC cytogram in cases of marked leukocytosis often trigger this flag. Review blood smear to determine cause.

RM Indicates that multiple region alarms have been triggered.

The following suspect flags can appear adjacent to the hemoglobin (Hb) parameter:

* Indicates that the Hb lamp is aging and will need to be replaced soon. Hb results are

still valid.

*B Indicates that the Hb lamp is failing. Hb results are blanked out. Lamp needs to be replaced.

The following suspect flags may appear adjacent to the thrombocyte parameters:

*P1 Indicates that MPV is below instrument linearity limit (2.0 fL).

P2 Indicates that very large platelets or platelet clumps are present. Examine blood smear to determine cause.

*P2 Indicates that MPV is above instrument linearity limit (30.0).


The following suspect flags may appear adjacent to the leukocyte, erythrocyte, or thrombocyte parameters:

L Indicates that the flagged number or percentage is below the preset normal range for

that species.

H Indicates that the flagged number or percentage is above the preset normal range for that species.

If a particular leukocyte, erythrocyte or thrombocyte parameter is above the instrument's linearity limit, the word "HIGH" will appear in place of a numeric result.

If an error occurs in the calculation of a particular leukocyte, erythrocyte or thrombocyte parameter, dashes (-----) will appear in place of the numeric result.

6.1.5 Diagnostic Considerations. The messages that can appear in the Diagnostic Considerations

section of the hematology report are given in attachment at the end of this section. 6.1.6 Data Checks. As the Key Operator, you should review the patient sample analysis results. Following are suggested guidelines you may want to include in your review.

Before reporting any patient sample analysis results, check the printout using the checklist below.

1. Is the ID number on the printout the same as the patient ID number?

2. Is the printout normal? Normal includes:

a. Within normal ranges, or within your laboratory's normal range.

b. No flags. If suspect flags are present, it is recommended that operator review the blood film.

3. Is the relationship between associated parameters possible? (RBC, Hb,

Hct). For example: an Hb of 12.0 g/dL with an Hct of 50% is not "believable". Normally, there is approximately a 1:3 ratio for Hb to Hct.

4. Are the results physiologically possible? For example: an MCHC of 50.2

g/dL is highly improbable. For most mammalians the MCHC ranges from 31.0 to 37.0

5. Are the results consistent with the previous reports available on the

patient? If not, check the consistency of the results with the patient condition.

6. Are any of the parameters flagged, indicating results should be verified?


Diagnostic Considerations

Dog

Cat

Horse

Cow

Flag/Trigger

Message

X

X

X

X

P1

REVIEW SLIDE

X

X

X

X

W5

REVIEW SLIDE

X

X

X

X

W3

REVIEW SLIDE

X

X

X

X

Severe MCHC

RERUN SAMPLE

X

X

X

X

Severe MCHC

RERUN SAMPLE

X

X

X

X

(Any Suspects)

SUSPECT

X

X

X

X

W3 + Mild HCT

corticosteroid-induced response

X

X

X

Mild HCT + Retics

regenerative anemia

X

X

X

Mild HCT + Norm retics

non-regenerative anemia

X

Mild HCT + Mild MCV

regenerative anemia

X

Mild HCT

anemia

X

X

X

X

Mild HCT

epinephrine effect or dehydration

X

X

X

X

Mild MCV

iron deficiency

X

X

X

X

Mild NE

mild/chronic inflammation

X

X

X

X

Mild NE + Norm or Mild LY

epinephrine-induced response

X

X

X

X

Mild NE + Mild LY

corticosteroid-induced response

X

X

X

X

Mild NE

severe inflammation

X

Severe NE

viral/rickettsial disease, drug effect

X

X

X

Severe NE

bone marrow disease

X

X

Severe MO

inflammation, leukemia

X

Severe LY

rickettsial disease

X

X

Severe LY

lymphocytic leukemia

X

X

Severe LY

lymphoid neoplasia

X

X

X

Severe EO

neoplasia

X

X

X

Mild EO

parasitism, hypersensitivity reaction

X

Mild EO

parasitism, hypersensitivity reaction, hypereosinophilic syndrome

X

X

X

X

Mod PLT immune-mediated platelet destruction

X

Mod PLT

bone marrow disease


Dog

Cat

Horse

Cow

Flag/Trigger

Message

X

Mild PLT

rickettsial disease

X

Mild PLT

plant toxin

X

X

X

Mild PLT

viral disease

X

X

X

X

Mild PLT

DIC

Troubleshooting Guide Page 7- HEMAVET HV950 Product Reference Manual Jan. 2011

1

7. PURPOSE

7.0.1 The purpose of the Troubleshooting Guide is to provide corrective actions for operating problems that may occur, so that normal operation can be resumed as quickly as possible. In

order to properly detect abnormal operation, it is important that the operator be thoroughly familiar with normal operation as detailed in Section V, Operating Instructions.

7.1 FAULT ISOLATION TABLES

7.1.1 The Troubleshooting Guide (Table 7-1) consists of fault isolation tables containing a listing of the most commonly encountered problems, their probable causes, and corrective actions. Record corrective actions performed in the Corrective Action log, located in the Appendix, by entering

the date, condition noted, action taken, and your initials.

TABLE 7-1. TROUBLESHOOTING GUIDE

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

No power to instrument.

ON/OFF button is in the OFF position.

Press ON/Off button to the ON position.

The power cord is unplugged or loosened from the wall outlet, or rear of instrument.

Plug power cord firmly into wall outlet, or rear of instrument.

Power to the wall outlet is off.

Check circuit breaker or fuses in your laboratory.

Instrument fuse is blown.

Remove fuse holder (refer to Section VIII) and visually inspect fuse. Replace if blown.

IMPORTANT: Do not attempt to correct a problem that is beyond the scope of the problems listed in the following tables. If you can't correct the problem using this troubleshooting guide, then immediately call Drew Scientific Customer Support at (800) 433-0945 or (214) 210-4900.


2

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

Background check values are not within acceptable limits.

Bubbles in system.

Run another background check by pressing the OTHER key If background count is still not within limits, inspect all visible tubing for bubbles. To remove bubbles, run a Short Clean cycle from the SPECIAL MENU by pressing SPEC'L, then CLEAN. If the background check values are still not within limits, remove the instrument cover and check transducer for bubbles. If bubbles are seen, select 1:Prime All from the REAGENT MENU. (Refer to Section V.)

Insufficient or contaminated reagents.

Replace reagents with a new FS-PAK™ / LV-PAK™ Reagent Kit. (Refer to Section VIII.) CAUTION: When replacing reagents, discard remaining portion of reagents from the old kit. Do not mix with the new kit.

Electrical Interference.

HEMAVET System must be powered from an independent, protected circuit. (Refer to Section III.)

Quality Control check values do not match Control Assay Sheet values.

Residual blood components causing excessive particulate count, or protein build-up in Sample Probe causing fluidic restriction.

Place PROBECLENZ in the Sample Holder and perform Sample Analysis cycle by pressing OTHER key. Then run a Short Clean cycle from the SPECIAL MENU by pressing SPEC'L, then CLEAN. (Refer to Section V.)


3

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

Improper mixing of Control.

Follow procedures for mixing Controls described under Daily Control Procedure (Refer to Section V).

Improper storage or handling of Control.

Use new Control to perform quality control check. Be sure that controls are stored and handled in accordance with MULTI-TROL directions printed on reverse side of Assay Sheet.

Disconnected tubing or leaks.

Check for disconnected tubing on the fluidics panel and syringe area. Also check for leaks at the syringe assemblies. Reconnect tubing as required. Leaks at the syringes require replacement of the syringes. Call Drew Scientific for servicing.

Instrument out of calibration.

Re-calibrate (Refer to Section IV).

Lot number expired.

Replace controls.

Vial beyond 2 weeks after opening.

Open new vial and add date opened.

Reagent Kit low.

Change Reagents (Refer to Section VIII).

Sample Analysis Hb parameter abnormally low. Printout reads "0", "---", or "Blank*B”.

Hemoglobin lamp intensity low or lamp burnt out.

Remove instrument cover and check if lamp is lit, if not lit, replace hemoglobin lamp (Refer to Section VIII). If lamp is lit, then perform Corrective Actions listed below for "Sample Analysis parameters abnormally high or low". If Hb parameter continues to read


4

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

"0", "---", or "Blank * B”, then replace lamp.

“O” Cal factor was erased

Call for service to recalibrate

Sample Analysis WBC and Hb parameters abnormally high or printout reads "HIGH"

Lysing agents not being dispensed properly.

Check that there is sufficient Lyse in the bottles, and that CELLYSE-XI and CELLYSE-XII tubing is connected as indicated on the instrument template. Also check that the tubes are inserted to the bottom of each bottle, and that there is no air in the Lyse lines. If Lyse checks OK, then perform Corrective Actions listed below for "Sample Analysis parameters abnormally high or low".


5

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

Sample Analysis parameters abnormally high or low.

Protein build-up within the system.

Perform the following procedures in sequence (refer to Section V) as follows: 1. Place PROBECLENZ in the Sample Holder and perform Sample Analysis cycle by pressing OTHER key. 2. Run a Short Clean cycle from the SPECIAL MENU by pressing SPEC'L, then CLEAN key. 3. Run the Start-Up cycle from the MAIN MENU by pressing the START key. 4. Run Daily Quality Control check.

Syringes leaking.

Inspect syringes. Leaks at the syringes require replacement of the syringes. Call Drew Scientific for servicing.

Disconnected tubing or leaks.

Check for disconnected tubing or leaks on fluidics panel and syringe area. Reconnect any loose or disconnected tubing, or tighten fittings as required. NOTE: A good indicator of small leaks is the presence of salts (crystallization). Inspect for this condition at the transducer, hemoglobin cuvette and syringes.

Instrument locked-up and keypad doesn't work.

Power Surge.

Power-Down, and Power-Up, then press START key from the MAIN MENU. (Refer to Section V.)


6

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

Error message is displayed during normal operation.

Error messages can occur when event sequencing is inconsistent with the instrument software program. Normal operation can usually be resumed, once the message is cleared and logged

Press "0" key to clear the error message. The message is automatically logged for later diagnostic reference. Press START key to resume normal operation. If message is repeated, Power-Down and Power-Up, then press START key from the MAIN MENU. If message continues to occur, call Drew Scientific Customer Support.

"NOT RDY" message appears during normal operation.

Momentary power interruption detected by instrument.

Press START key to resume normal operation. If system does not reset, Power-Down and Power-Up, then press START key from the MAIN MENU.

Reagent Lines not in reagents

Check level of reagents and make sure reagent lines are in the bottom of the reagent bottles. Perform PRIME ALL (Refer to Section V).

Sample not aspirating.

Clogged Sample Probe. Air in System

Place PROBECLENZ in the Sample Holder and perform Sample Analysis cycle by pressing the OTHER key. Then run a Short Clean in the f SPECIAL MENU by pressing SPEC'L, followed by the CLEAN key. (Refer to Section V.) If clogged probe call for service. Check & Verify reagent lines are in the fluid. Perform Prime All by pushing the SPEC’L key, 3: Reagent Menu 1: Prime All. (Refer to Section V).


7

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

Mixing cuvette overflowing.

Kink in tubing to waste container, or reagent bottles.

Straighten tubing to remove kink, then check for tubing that might have blown off on fluidics panel or syringe area; to do this, you must remove the cover. Reconnect tubing or fittings as required, then run a Short Clean cycle from the SPECIAL MENU by pressing SPEC'L, then CLEAN.

Peristaltic Pump not functioning.

Call Drew Scientific for servicing.

Clots in mixing cuvette

Remove any debris in the mixing cuvette. Remove cover of the hemavet to expose the fluidics panel. On the lower front peristaltic pump, remove the clear tubing from the black fitting and back flush using D.I. water in a syringe. Make sure to cover the cuvette to prevent splatter. Once debris is removed, reinstall tubing on the black fitting and re-install cover.

Printer not printing. POWER light not lit.

Printer not getting power.

Make sure the printer is turned on and AC power cord is plugged securely into wall outlet.

Printer not printing. POWER light lit.

Interface cable not connected properly at printer or instrument.

Make sure interface cable connections are secure at rear of printer and instrument.

Hematology Report printout is faded or has white streaks.

Print head is clogged or out of ink.

Clean print head or replace ink cartridge. Refer to Printer Quick Start Guide.

Clots in bottom of mixing cuvette.

Clumps in sample

Remove any debris in the mixing cuvette. Remove cover


8

PROBLEM

PROBABLE CAUSE

CORRECTIVE ACTION

of the HEMAVET to expose the fluidics panel. On the lower front peristaltic pump, remove the clear tubing from the black fitting and back flush using D.I. water in a syringe. Make sure to cover the cuvette to prevent splatter. Once debris is removed, reinstall tubing on the black fitting and re-install cover

Probe locked in up position.

Salt/Saline deposits

Clean under rinse block and around bottom of probe with DI water and dampen kim wipe. If salt/saline buildup, Place a droplet on the debris, and clean as above. Remove wash block cover above the sample holder. Inspect washblock for debris around probe and / or any cracks in wash block, call for service. NOTE: On some models the Washblock cover is glued; Call service for assistance.

Belt off or broken

Call for service

Carriage doesn’t move “In” or “Out.”

Debris from leakage

Cycle carriage (Refer to Section V), using D.I. water clean area around carriage assembly.

Center screw loose or “Off”

Tighten center screw under front of the instrument. If “off,” Call for service

Belt “Off” or broken.

Call for service.

Special Procedures Page 8 - 1 HEMAVET HV950 Product Reference Manual Jan. 2011

8. GENERAL 8.0.1 This section details the cleaning, replacement and other procedures necessary for the proper

upkeep and operation of the HEMAVET instrument. All procedures are the responsibility of the operator. Frequently used procedures are detailed below.

8.1 CLEANING PROCEDURES

8.1.1 Each time a cleaning procedure is performed, make sure to record the date and your initials in the Corrective Action Log, located in the Appendix. For optimum performance on your HEMAVET instrument, run the Daily Start-Up cycle in Section V, Operating Instructions, after performing any of the following cleaning procedures.

The cleaning procedures are summarized below:

1. Push the CLEAN / ENTER key at least once daily on days when samples are run.

2. After processing 25 samples, sample PROBECLENZ ™ by performing a CLEAN: Short cycle.

3. Once per week, sample PROBECLENZ ™ by performing a CLEAN cycle. Also clean

the carriage and rinse block by using a slightly dampened kim-wipe with De-ionized water to wipe away spills and dried saline build-up that occurs over a period of time.

4. Clean the air filter as needed. Check weekly.

NOTE: When the Auto-CLEAN cycle is enabled, there is no need to press the CLEAN key daily.

(Refer to Daily Clean Procedure in Section V, Operating Instructions)

PLEASE NOTE

After cleaning the rinse block, it may be necessary to proceed to the menu choice buttons by selecting <#9>Specl Menu, then <#7> Diagnostics, <#5> Auto –Sampler, Initialize, <#2> Probe down, to rinse off the sample probe completely with water. Also, remove the shield that covers the prove and place a few drops of De-ionized water on the white grommet of the wash block. Wait a FULL 2 minutes and operate as normal. Wipe off any excess fluids.

WARNING

NOTE: Please perform weekly preventative maintenance (PM) cleaning, to avoid typical issues that occurs with everyday use of the unit.


8.2.2 Air Filter. The HEMAVET instrument's air filter must be kept clean. Torn and/or shredded

filters should be discarded and replaced. Check the filter regularly (minimally once a week) for cleanliness and signs of wear. Frequency of cleaning the air filter will be dependent on the amount of airborne debris (animal hair, dust, etc.) at your facility. Clean/replace air filter as follows:

( NOTE: Back Panel port configuration may be different than pictured depending on options purchased)

1. Remove grille covering the air filter by grasping at top and pulling straight out. 2. Wipe dust off grille. Wash filter in

mild soap and water, rinse, and let air dry completely.

3. Position filter on grille, and snap grille

into place on fan assembly. 4. Power-Up instrument and run Start-Up

cycle.

WARNING

IMPORTANT: Neglect of air filter can damage instrument and invalidate your warranty; Check weekly. WARNING: Power-Down instrument before checking or removing air filter.


8.3 REPLACEMENT PROCEDURES

8.3.1 The following items may be replaced by the operator as a part of the HEMAVET System’s routine operation. Table 8-1 lists these items along with the Part Number (PN).

Item PN

FS-PAK / LV-PAK Reagents 200106 / 200108MULTI-CELL3 / LV DILUENT

C D Clean Not CELLYSE XI3 / 11LV Sold Separately.CELLYSE XII3 / 12LV

AIR FILTER 014-1211-302WASTE CONTAINER S-0002HEMOGLOBIN LAMP CDC-8030-001INSTRUMENT FUSE AGC 2A – 250V

TABLE 8-1. OPERATOR-REPLACEABLE PARTS

WARNING

Some replaceable items, such as the reagents and waste container, may have come in contact with residual biological material. Dispose of these items in accordance with acceptable laboratory procedures and applicable environmental laws. The instrument battery (CR 2032 – 3V) mounted on the CPU board is not normally field replaceable and should never be replaced with another type of battery. IMPORTANT: The FS-PAK ™ / LV-PAK ™ line of reagents are specially formulated to be used as a system. This reagent systems are not compatible with other reagent systems. DO NOT MIX with other manufacturers’ reagents.


8.3.2 Reagent Kit: Replace the FS-PAK ™ / LV-PAK ™ Reagent Kit, consisting of MULTI-CELL3 / LV DILUENT, C D Clean, CELLYSE XI3 / 11LV AND CELLYSE XII3 / 12LV (the recommended diluent, cleaning agent, and lysing agents) as follows:

1. Make sure the new reagents have been stored at room temperature, and do not contain

precipitate, turbidity, particulate matter, or unusual color. If any of these is evident, DO NOT use the reagent.

2. Record in the Reagent Log, located in the Appendix, the new FS-PAK ™ / LV-PAK ™

reagent's lot number, expiration date, today's date, and your initials.

3. Remove tops from the new Diluent and Cleaning reagents. Remove tubes and tube caps from empty reagents and wipe clean. Insert tubes through tube cap, one at a time, and push all the way to the bottom of the new reagents. Check the template on left side of instrument to be certain that the Diluent and the Cleaning reagent tubes are inserted in the proper reagent bottle.

4. Make sure the appropriate tubing is connected to the CELLYSE-XI3 and CELLYSE-XII3

bottles and that the tubes are inserted completely to the bottom of each bottle. 5. Place another unused FS-PAK ™ / LV-PAK ™ next to the one that was just connected.

This will eliminate the likelihood that recently shaken reagents will be connected to the instrument during the next replacement. Connecting recently shaken reagents to the HEMAVET System can introduce bubbles into the syringe pump assembly and should be avoided.

6. From the SPECIAL MENU, select 3: Reagents to display REAGENT MENU. Then

press 2: Change Reagents and proceed as follows: a: Press CLEAR key to enter 4 digit Reagent Lot Number that is shown on the

Reagent Kit box. Then press the ENTER key followed by the EXIT key. b: Press CLEAR key to enter Reagent Expiration Date that is shown on the Reagent Kit box. Then press the ENTER key followed by the EXIT key. c: Press CLEAR key to enter 9 digit Reagent Kit Number that is shown on the Reagent Kit box. Then press the ENTER key followed by the EXIT key.

NOTE: Optimum reagent open bottle stability has been tested up to 30 days. Laboratory conditions such as temperature, humidity, lab cleanliness, etc. can affect reagent stability.


7. From the REAGENT MENU, press 1: Prime All to prime the Diluent, and CELLYSE reagents. In observance, if any reagents line are empty or contains bubbles, repeat the prime cycle by pressing the “1” key again. Then Press the “0” key to return to the SPECIAL MENU.

8. Run the Start-Up cycle from the MAIN MENU by pressing the START key.

8.3.3 Waste Container. Replace the waste container as follows:

1. Unscrew the pickup tube assembly from the old container. 2. Lift the pickup tube assembly straight out of the old container. 3. Place the pickup tube assembly straight into the new container, and screw the pickup tube into position. 4. Check that the tubing to and from the new container is connected properly.

8.3.4 Hemoglobin Lamp. Replace the Hemoglobin lamp as follows:

WARNING

The contents of the old waste container and its associated tubing may include residual biohazardous material and must be handled with great care. Avoid skin contact and clean up spills immediately. Dispose of the waste container, its contents, and any chemical or biohazardous waste in accordance with acceptable laboratory procedures and applicable environmental laws.

WARNING

Power-Down instrument and remove line cord prior to replacing lamp.


8.3.5 Printer: Follow the instructions in the printer Quick Start Guide for installing a new ink /

toner cartridge and for cleaning the print head. Replacement ink / toner cartridges may be purchased at a local computer supply store. It is suggested that at all times you have a spare cartridge available for replacement.

4. Carefully pull the module away from its mounting position and loosen screw securing the lamp. Remove lamp.

5. Insert new lamp in module,

making sure it is fully seated, and tighten screw

(Do Not Overtighten)..

6. Re-position module to align with

mounting holes, and tighten screws.

7. Reconnect connector.

8. Reinstall cover. Then power Up the instrument and run Start-Up cycle.

1. Remove twelve (12) screws securing the instrument cover, and remove cover.

2. Disconnect lamp connector 3. Hold Hemoglobin Module while

loosening two screws.

1

2

1

2

3

New Lamp

3

2

1

3


8.3.6 Sample Probe. Replace sample probe as follows: Note: CALL TECHNICAL SUPPORT PRIOR TO REMOVING FRONT BEZEL.

.025 Inch

RinseBlock

Probe

1. Remove the instrument cover, next remove the six screws securing the front bezel (4 on the bottom of the bezel and 2 on the top inside). Do not touch the center bottom screw. Swing the bezel out of the way to the right.

2. Remove the shield covering the probe.

3. Disconnect tubing from top of probe.

4. Loosen the screw and remove probe from adapter arm.

5. Insert new probe through adapter arm and position it approximately as shown. Lightly tighten screw.

6. With the instrument powered-up, press the SPEC’L, 1, EXIT keys to put the probe in the “home” position. Adjust probe as shown in drawing below.

7. Reconnect tubing to probe and

reinstall shield, front bezel and instrument cover.


8.3.7 Instrument Fuse. Replace fuse as follows:

( NOTE: Back Panel port configuration may be different than pictured depending on options purchased)

1. Use small screwdriver to lift retaining tab on fuse holder, allowing holder to pop out.

2. Remove fuse from holder and replace with

new fuse having the same rating as the old fuse. 3. Re-insert fuse holder into receptacle and push

in until it snaps into place. 4. Power-Up instrument and run Start-Up cycle.

WARNING: Power-Down instrument and remove power cord before replacing fuse.


8.4 OPTIONAL PROCEDURES

8.4.1 Operating Instrument in Manual Mode.

1. Squeeze the levers on both sides (if equipped) of the sample holder and pull straight out to remove the assembly.

2. From the MAIN MENU press the 2 key to extend the sample probe.

3. Uncap the specimen tube and present the specimen to the sample probe. If necessary, the 2 key can be pressed a second time to lower the probe further.

4. Press the appropriate species key (Example: MOUSE) to draw the blood sample into the probe. Remove and cap the specimen tube when the probe retracts. The sample analysis cycle will begin and a report will be printed out automatically.

8.4.2 Operating Instructions for running Select-A-Species (Instrument Option)

1. Press the “OTHER” key on the HEMAVET keypad.

a. Displays the first three available species. 2. Use the ‘2’ (NEXT) key to page down by three species.

a. Displays next three available species 3. Use the ‘’ and ‘’ keys to scroll up or down by one species. The solid black box ‘’ 4. indicates the current selected species. Continue until the desired species is selected.

a. Moves curser ‘’ up or down by one position. 5. Place the tube containing the sample into the tube holder. Press the ‘ENTER’ key when

the desired species is selected. a. Begins CBC cycle for selected species.

6. To EXIT out of Select-A-Species option without running a CBC cycle, press the ‘3’ (EXIT) key.

a. Displays Main Menu

8.4.3 Initializing DMS On Occasion, especially after a power interruption to the instrument, it may be necessary to re-initialize the communication port for the DMS transfer. The DMS capture program must be opened prior to initializing. From the Main Menu press:

Key 9 (Special Menu) Key 7 (Diagnostics) Key 3 (DMS) Key 1 (Initialize) Key 2 (send)


8.4.4 Re-Transmitting Data If the instrument is ISS/REV H5J files can be re-transmitted from the Data Storage to the DMS Capture Program.

From the Main Menu press: Key 9 (Special Menu) Key 6 (Data Storage Key 1 (Display List) At this point the highlighted file can be re-transmitted by pressing Key #6. Use the Up / Down keys to highlight another file for transmission. Each file must be re-transmitted separately.

8.5 SHIPPING / SHUTDOWN INSTRUCTIONS

8.5.1 Preparing Instrument for Shipment OR Extended Periods of Inactivity. If the instrument needs to be returned to Drew Scientific for servicing or updates, the following procedures must be performed to insure that the instrument is maintained in working condition during shipment. For extended periods of inactivity follow steps 1-8.

1. Fill a clean container with deionized or sterile water.

2. Remove the Diluent and Clean reagent lines from their bottles and place ends in the bottle

containing the deionized water. 3. Remove the Cellyse XI and Cellyse XII lines with caps attached from their bottles and

place ends in bottle containing the deionized water. 4. With the HEMAVET’s MAIN MENU displayed, press the SPEC'L key to access the

SPECIAL MENU, then select 3:Reagents followed by 1: Prime All to prime the deionized water into the system. Repeat the prime cycle by pressing the 1 key again. Next, press CLEAN SHORT in SPECIAL MENU to clear clean line.

5. Remove the Diluent and Clean lines from the bottle, then disconnect the lines from the

instrument. Leave the Cellyse lines in the deionized water.

6. From the REAGENT MENU, press the 1: Prime All key to introduce air into the system.

NOTE: It is recommended that you use empty Diluent or Clean reagent bottle that has been thoroughly rinsed and filled with deionized water. However, any clean plastic or glass container of similar capacity can be used.

NOTE: To prevent contamination of the reagent lines, place them in a sealable plastic bag after they are removed from the instrument.


7. Power-Down the instrument. 8. Remove the Cellyse lines from the bottle, then disconnect the Cellyse and Waste lines

from the instrument and place tubing in a clean zip-lock bag. 9. Unplug the power cord from the wall outlet, then remove cord from the instrument.

10. Use a plastic pipette to remove any residual fluid from the Mixing Cuvette. 11. Place the instrument in the original shipping carton, making sure to use the original

cushioning material. Carefully seal carton closed with packaging tape.

NOTE: Ship only the instrument. Keep the reagent lines, waste line and power cord.

* IMPORTANT *

Please Read Carefully

You will be liable for damages as a result of shipping the instrument without its original box as well as possibly voiding the warranty.

In the event that you do not have the original box and

packing material, you can purchase them by calling:

(800) 433-0945 or (214) 210-4900

Appendix Page A-1 HEMAVET HV950 Product Reference Manual Jan. 2011 Appendices A-D

FOR HEMAVET SERIES INSTRUMENTS

OPERATOR’S LOGS

Appendix A Page A-2 HEMAVET HV950 Product Reference Manual Jan. 2011

CALIBRATION LOGSHEET

CALIBRATION SETTINGS

REAGENTS USED (LOT NO.)

DATE & TECH

WBC

RBC

Hb

MCV

PLT

DILUENT

LYTIC

AGENT

CALIBRATION

MATERIAL

Appendix B-2 Page A-4 HEMAVET HV950 Product Reference Manual Jan. 2011

QUALITY - CONTROL CHECK

Page 1 of 2

DATE

CELL

CONTROL LOT NO.

T E C H

WBC

RBC

Hb

HCT

MCV

MCH

MCHC

RDW

PLT

Appendix B-2 Page A-4 HEMAVET HV950 Product Reference Manual Jan. 2011

QUALITY - CONTROL CHECK Page 2 of 2

NE

LY

MO

EO

BA

DATE

CELL

CONTROL LOT NO.

T E C H

K/µL

%

K/µL

%

K/µL

%

K/µL

%

K/µL

%

Appendix C Page A-5 HEMAVET HV950 Product Reference Manual Jan. 2011

CORRECTIVE ACTION

DATE

CONDITION NOTED

TECH

DATE

ACTION TAKEN

TECH

Appendix D Page A-6 HEMAVET HV950 Product Reference Manual Jan. 2011

REAGENT LOG

DILUENT

LYTIC AGENT

DETERGENT REAGENT

DATE

OPENED

LOT

NUMBER

EXPIR. DATE

TECH

(INITIALS)

DATE

OPENED

LOT

NUMBER

EXPIR. DATE

TECH

(INITIALS)

DATE

OPENED

LOT

NUMBER

EXPIR. DATE

TECH

(INITIALS)

DREW SCIENTIFIC HEMAVET ® SYSTEM OPERATION SUMMARY

This summary is intended for use only after the operator is thoroughly familiar with the complete operating instructions and special procedures in Sections V and VIII of the reference manual. A. Instrument. Check that power is on and HEMAVET MAIN MENU is displayed. B. Daily Start-Up Cycle. Press the START key.

After Start-Up is complete run a background count using the “OTHER” species key and verify that counts are within acceptable limits (Optional):

WBC 0.2 or less Hb 0.2 or less

RBC 0.02 or less PLT 20 or less

* Background counts assayed using “OTHER” species key. C. Daily Control Procedure. At beginning of day, run sample analysis using MULTI- TROLTM Reference Control and verify results against control assay sheet.

D. Sample Analysis. Mix specimens carefully and thoroughly. Place sample on Rock and Roller blood rocker for a minimum of 10 minutes. Prior to aspirating sample, remove sample from rocker, and gently invert the tube three (3) times.

E. Daily Clean Procedure. At the end of the day that samples are run, press the

CLEAN/ENTER key to perform a clean cycle.

F. Weekly Clean Procedure. Once per week, sample PROBECLENZTM by performing a CLEAN cycle. Also, Once per week, remove and inspect fan filter from back of instrument. Order replacement filter if tears or damage is visible, clean and re-install.

Caution

NOTE: If the instrument has been idle for 4 hours or more, it will automatically revert to the Standby Mode. Follow directions on the display to return to the MAIN MENU.


NOTE: Sample PROBECLENZTM by performing a CLEAN: Short cycle, after every 25 samples.

DREW SCIENTIFIC HEMAVET ® SYSTEM FLAGGING CRITERIA Flagging Criteria. Certain conditions and cell size distributions trigger the following flags to alert the operator that abnormal conditions may exist.

The following suspect flags may appear adjacent to the leukocyte parameters:

* Indicates that the mean of the WBC cytogram has shifted abnormally due to cell fragility. Examine

blood smear.

P1 Indicates that debris due to incomplete lysis of RBCs and/or platelet clumps are present.

*P1 Indicates excessive debris or cellular fragments. Examine blood smear.

W3 Indicates that neutrophils have collapsed in vitro due to anemia or a delay in processing, or that immature granulocytes are present. Review the blood smear to evaluate RBC and WBC morphology and differential.

W5 Indicates that very large particles or many small platelet clumps have been detected. Review the

blood smear to determine cause.

The following suspect flags may appear adjacent to the erythrocyte parameters:

* Indicates that RDW is beyond instrument linearity limits (8% - 55%).

R1 Indicates that platelet clumps, microcytic RBCs or RBCs that have collapsed due to autohemolysis have been detected. Review the blood smear to determine cause. R1 and P2 flags appearing together indicates difficulty in separating platelet and RBC populations because of small RBCs and/or platelet clumps. Review blood smear to determine cause.

R5 Indicates the presence of an unusual population in the RBC cytogram.

R7 Indicates that very large cells relative to RBCs have been detected. WBCs appearing on RBC

cytogram in cases of marked leukocytosis often trigger this flag. Review blood smear to determine cause.

RM Indicates that multiple region alarms have been triggered.

The following suspect flags can appear adjacent to the hemoglobin (Hb) parameter:

* Indicates that the Hb lamp is aging and will need to be replaced soon. Hb results are still valid.

*B Indicates that the Hb lamp is failing. Hb results are blanked out. Lamp needs to be replaced.

The following suspect flags may appear adjacent to the thrombocyte parameters:

*P1 Indicates that MPV is below instrument linearity limit (2.0 fL).

P2 Indicates that very large platelets or platelet clumps are present. Examine blood smear to determine

cause.

*P2 Indicates that MPV is above instrument linearity limit (30.0).

The following suspect flags may appear adjacent to the leukocyte, erythrocyte, or thrombocyte parameters:

L Indicates that the flagged number or percentage is below the preset normal range for that species.

H Indicates that the flagged number or percentage is above the preset normal range for that species.

If a particular leukocyte, erythrocyte or thrombocyte parameter is above the instrument's linearity limit, the word "HIGH" will appear in place of a numeric result. If an error occurs in the calculation of a particular leukocyte, erythrocyte or thrombocyte parameter, dash (-----) will appear in place of the numeric result.

4230 Shilling Way ▪ Dallas, TX 75237 ▪ Tel (214) 210-4900 ▪ Fax (214) 210-4949

OPERATOR INSTRUCTIONAL GUIDE

HEMAVET Facility ____________________________ Director ____________________________________

Address ____________________________ Operator ____________________________________

City ____________________________ Model # ____________________________________

State __________ Zip ______________ Serial # ____________________________________

Phone ____________________________ Date ____________________________________

Notes _______________________________________________________________________________

Species __________________________________________________ Current______________________

Cal. Factors: WBC_________ RBC_________ HB_________ MCV_________ PLT_________

FS-PAK SET Lot No.___________ Cellyse XI Lot No.___________ Cellyse XII Lot No.__________

The Drew Scientific representative will explain the performance of the procedures listed below. Check off each item as it is explained to you. Daily Operation Start-up Overview of

Components Sample Analysis Sample Path Clean

General Operation Operator Interface Keyboard Menus Printer Reagents Installation Names Tubing

Maintenance Daily Clean / Start-up Weekly Fan Filter Probe Clenz As Needed Sample Probe External Surface Printer Mixing Cuvette

Quality Control

Background Test Quality Control Material Precision Test Calibration

(System out of control or major module change)

Operator's Manual

How to contact Drew Scientific Customer Support Center

Log Sheets Specimen Collection &

Handling

Dilution Module Complete Assembly Sample Probe Mixing Cuvette

Transducer Assembly Complete Assembly Aperture A Chamber Block B Chamber Block

Syringe Pump Assy. Complete Assembly Syringes

Hemoglobin Module Complete Assembly Hemoglobin Lamp Hemoglobin Cuvette Electronics Module Fuses Line Cord Surge Protector

Printer Complete Assembly Cartridge Paper

Miscellaneous Save Shipping Carton

S/O Consumables

Rinse Block Operation

__________________

__________________

__________________

__________________

__________________

__________________

I have performed the operations listed on this form: These operations have been performed / explained to my satisfaction: _________________________________________________________ ___________________________________________________________ Drew Scientific, Inc. Representative Date Laboratory Representative Date

Rev. 01/2011

drew-scientific.com

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