EKF HemataStat II Operator's Manual

HemataStat II
Centrifuge
Separation Technology, Inc. An EKF Diagnostics Company 570 Monroe Road, Suite 1008 Sanford, FL 32771 800-777-6668, 407-788-3677
www.separationtechnology.com
TABLE OF CONTENTS
SECTION 1 DESCRIPTION AND INTENDED USE ........................... 2
SECTION 2 INSTALLATION .............................................................. 2
2.1 Unpacking
2.2 Power Supply
2.3 Optional Rechargeable Battery Pack
SECTION 3 SETUP PROCEDURE..................................................... 5
3.1 Display Options
3.2 Setup Menu and Procedure
SECTION 4 OPERATING INSTRUCTIONS ....................................... 8
4.1 Start Up
4.2 Rotor Loading and Balancing
4.3 Tube Preparation
4.4 Tube Centrifugation
4.5 Reading a Capillary Tube
4.6 Hematocrit Determination Reminders
SECTION 5 QUALITY CONTROL AND ASSURANCE ................... 15
5.1 Use of Hematology Reference Control
5.2 Calibration
5.3 Spin Time/RPM Tests
SECTION 6 MAINTENANCE ............................................................ 16
6.1 Cleaning
6.2 Tube Holders
6.3 Inspections
6.4 Service
SECTION 7 TROUBLESHOOTING .................................................. 18
SECTION 8 ACCESSORIES, CONTROLS AND SUPPLIES ........... 19
SECTION 9 WARRANTY ................................................................. 20
SECTION 10 SPECIFICATIONS ........................................................ 21
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SECTION 1
DESCRIPTION AND INTENDED USE
The Separation Technology, Inc. (STI) HemataStat II
Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate microhematocrit determination using capillary or venous blood samples. The HemataStat II is not intended for use with materials other than blood.
The rotor will accommodate up to six standard 75mm capillary tubes. The device will achieve specimen separation in only one minute.
For convenience and ease of use, the HemataStat II system also includes a built-in automatic tube reader and a LCD that displays messages to gui de the operator throughout the testing procedure and then displays the test results.
An optional rechargeable battery pack is available to permit operation in remote locations where alternating current is not available. The HemataStat II has a CLIA '88 W AIVED status.
SECTION 2
INSTALLATION
2.1 UNPACKING
The HemataStat II shipping box contains:
Centrifuge
Package of ten disposable tube holders
Power supply
Operator’s manual
Laminated quick reference procedure guide
Laminated tube placement guide
Instruction video
Read the operator’s manual thoroughly before operating this system.
VIEWING THE INSTRUCTION VIDEO BEFORE PROCEEDING WILL BE HELPFUL FOR PROPER OPERATOR TRAINING.
Place the centrifuge on a convenient, level work surface along with the other items contained in the box.
2
2.2 POWER SUPPLY
Use ONLY the power supply packaged with the HemataStat II. Verify that the ON/OFF switch located on the top of the centrifuge is in the OFF "
" position.
Always plug the power supply into the rear of the device first
and then plug the three­prong end into an electrical outlet. Press the ON/OFF switch to the ON " ʘ" position. The lid will automatically open and the LCD will display the main menu.
2.3 OPTIONAL RECHARGEABLE BATTERY PACK
A. INSTALLATION
For complete portability, the HemataStat II will operate on a rechargeable battery pack, which can be ordered as an option. The battery pack will need to be installed in the device as described below and fully charged before normal operation.
1. Make certain the lid is closed and locked and the centrifuge is unplugged from the electrical outlet. Lock the lid by firmly pressing down on the lid tab.
2. Place the device upside down on a smooth, flat surface and on a cloth or other protective material to prevent scratching the lid.
3. Locate the battery pack cover. Using a small head Phillips screwdriver, remove the screws holding the battery pack cover in place. Retain the screws. Remove the battery pack cover.
4. Connect the battery pack plug into the connector loc ate d in side th e ba tter y pack cavity. Put the connector inside the hole of the housing with the connector release tab facing up. Position the battery pack inside the compartment. Lay the cable along side the batter y pa ck t o av oid cri mpin g.
5. Replace the battery pack cover and secure with the screws provided.
6. Plug in the HemataStat II and fully charge the battery pack.
B. CHARGING THE BAT TERY PACK
The battery pack is always charging whenev er the HemataStat II is plugged into an electrical outlet. Since the battery pack cannot be overcharged, the device may remain plugged in continuously without harm. Charge the battery pack overnight (or an equivalent period of time). The percentage of remaining battery pack capacity may be determined at any time by performing the following procedure.
3
1. Unplug the device from the electrical outlet.
2. Press the ON/OFF switch to the ON position. The LCD should display the main menu.
ENT
ENTER FUNCTION:
READ 1.1 (OR 0.5) SPIN
RUN
3. Press the RUN and ENT buttons simultaneous ly and hold them dow n un til the battery pack capacity is displayed.
When there is 20% capacity remaining, the main menu LCD will flash as an indication that the battery pack is beginning to run down. It will still be possible to operate the device for a few spins but the operator should recharge the battery pack soon. Once there is no longer sufficient capacity to operate the instrument, it will fail to complete a cycle and the message CHARGE BATTERY will be displayed.
4. If the device is plugged into an electrical outlet with the ON /OFF switch in the ON position and the RUN and ENT buttons are pressed simultaneously, the LCD will display either CHARGING when in the process of charging or TRICKLE CHARGING if fully charged.
REGARDLESS OF WHAT THE LCD MAY DISPLAY AT ANY GIVEN TIME DURING THE CHARGING CYCLE, IT IS IMPORTANT TO ALWAYS ALLOW THE BATTERY PACK TO CHARGE OVERNIGHT OR AN EQUIVALENT PERIOD OF TIME TO ENSURE A FULL CHARGE.
A FULLY CHARGED BATTERY PACK WILL GENERALLY PROVIDE 75 SPIN CYCLES IF THE CENTRIFUGE IS TURNED OFF BETWEEN TESTS.
BATT. CAPACITY
XX %
4
SECTION 3
SETUP PROCEDURE
3.1 DISPLAY OPTIONS
This setup procedure will allow the operator to store several functions in the display option memory until a change is required. These functions include the selection of:
Tube size - 1.1mm or 0.5mm Inside Di ameter (ID). The device must be set to the tube size being used. (The ID of capillary tubes may vary slightly - up to
0.1mm.)
Display language - English, Spanish, French, German or Italian
HCT value suffix - Choice of displaying % sign or only the value itself
Decimal point - Choice of displaying hematocrit in whole numbers or with a
decimal point.
Performing this setup procedure eliminates the need to enter these settings into the device each time a test is performed.
3.2 SETUP MENU AND PROCEDURE
A. With the power ON, the LCD will display the main menu:
ENT
ENTER FUNCTION:
READ 1.1 (OR 0.5) SPIN
RUN
B. S imultaneously press and release the ENT and RUN buttons . The LC D
will change to:
ENT
SETUP
TUBE I.D. NEXT
RUN
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C. Press ENT to enter the tube size menu. Press ENT again to choose the
1.1mm size or press RUN for 0.5mm.
ENT
SELECT TUBE I.D.
1.1mm 0.5mm
RUN
When the tube size selection is made, the LCD will return to the main menu.
D. Simultaneously press and release the ENT and RUN buttons. The LC D
will change to:
ENT
SETUP
TUBE I.D. NEXT
RUN
E. Press RUN to enter the language menu. The LCD will display:
ENT
SETUP
LANGUAGE NEXT
RUN
F. Press ENT to select language display, then press RUN repeatedly to
display each of the 5 language options. Press ENT to lock in the desired language. The LCD will return to the main menu.
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