Automated Coagulation Timer II Operators Manual Rev 3

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This document contains proprietary information to Medtronic Perfusion Systems. Its receipt or possession does not convey any rights to reproduce or disclose its contents, or to manufacture or sell any products described. Reproduction, disclosure, or use other than for the intended purpose, without specific written authorization of Medtronic Perfusion Systems, is strictly forbidden. The Automated Coagulation Timer II is manufactured under patents #45992319, #4752449, and #5314826.

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EXPLANATION OF SYMBOLS ON PRODUCT LABELING UL Classified to U.S. and Canadian Safety Standards (UL2601-1, and CAN/CSA C22.2 No. 601.1) by Underwriters Laboratories Inc. for electrical shock, fire, and mechanical hazards only 71NL.

w ; v

Attention, See Instructions for Use

Alternating Current

Fuse

Protective Earth (ground)

C D 1

Off

On

1 1

_ n j

Serial Port Quantity

Serial Number

Catalog Number

For US audiences only

Temperature

m

Date of Manufacture

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Table of contents Chapter 1 - Use or Function Intended Use

5

5

Test Methodology

5

Instrument Controls

6

Front Panel 6 Actuator 7 Rear and Bottom Panel Displays and Indicators System Error Codes

8 10

11

Chapter 2 - Installation Procedures and Special Requirements Electrical Requirements Unpacking

12

12

12

Initial Checkout Procedure

12

Chapter 3 - Principles of Operation Test Cartridge

14

14

Reagent Chamber 14 Reaction Chamber 15 Plunger Assembly 15 Principle of Clot Detection Display Format

15

16

Test Termination and Display Indications

16

Chapter 4 - Performance Characteristics and Specifications Automated Coagulation Timer II

17

17

Electrical 17 Physical 17 Environmental 18 Serial Data Port 18

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Table of contents Accessories

18

Pipettors 18 Auxiliary Heat Block and Heater Chapter 5 - Operating Instructions Power On

18

19

19

Sample Type - Incubated Versus Non-Incubated Sequence of Operation

19

20

Fresh Whole Blood Tests 20 Citrated Whole Blood, Plasma Tests, or Control Blood Samples Test Termination 21 Chapter 6 - Calibration Procedures

22

Heat Block Temperature Calibration Routine Cleaning

23

Functional Tests

23

22

Chapter 7 - Operational Precautions and Limitations General Precautions

24

24

Precautions for Use of Cartridges and Controls Chapter 8 - Warnings and Hazards Explosive Anesthetics

25

Blood Handling Risks

25

No User Serviceable Parts Sterilizing and Cleaning

25

25

Cleaning the Instrument and Actuator Preventive Maintenance

2

26

26 27

28

English

86293

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Technical Service Information Chapter 10 - References

24

25

Chapter 9 - Service and Maintenance Information

Fuse Replacement

20

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List of Figures

List of Figures Figure 1.

Front Panel of ACT II

6

Figure 2.

Rear Panel of ACT II

8

Figure 3.

Dip Switches

Figure 4.

Temperature Calibration Screw

Figure 5.

Test Cartridge

Figure 6.

Filling Test Cartridge

Figure 7.

Cleaning the Actuator Assembly

Figure 8.

Fuse Replacement

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Intended Use

Chapter 1 - Use or Function Intended Use The Automated Coagulation Timer II by Medtronic Perfusion Systems is a microprocessor controlled electromechanical coagulation instrument intended for determining coagulation endpoints in whole blood, citrated whole blood, and plasma samples.

Test Methodology Coagulation tests are performed using disposable two-channel test cartridges. The instrument is portable and is operated by power from an AC line cord. Individual clotting times or the average and difference for the two channels are displayed in red on the front panel in seconds. Front panel displays show whether individual clotting times or the average clotting time is being displayed. A front panel switch controls the incubation stage. An associated indicator shows if the incubation stage is being used. The temperature of the actuator heat block is displayed in green in the lower right hand corner. Each dual channel test cartridge contains a reagent and a reaction chamber. The cartridge is designed for duplicate tests on a blood sample or the channels can be separated and a single channel test performed. A cartridge (dual or single channel) is either prewarmed in an external heat block or warmed in the instrument. For testing, the warmed cartridge is removed, filled with the sample and inserted into the actuator heat block. The actuator heat block is then rotated back into its closed position. When the actuator block is closed, the test is either initiated immediately or the incubation mode is initiated followed by the start of the test. Initiation of the test mode causes automatic injection of the reagent chamber contents into the reaction chamber and initiates the test sequence. A lift wire engages the flag of each plunger assembly. The plunger is raised and lowered through the sample at predetermined intervals. The action of the plunger assembly is two-fold. It mixes the sample with the reagent, and it tests for clot formation. When a clot forms, the downward motion of the plunger is decreased. The decrease in the fall rate of the plunger is detected by the photo-optic system in the actuator cover and the formation of a clot is signaled.

Use or Function

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Instrument Controls Lift Wire

Manual Start/ Stop Lever

Actuator Heat Block Channel 1 Average

On Incubate

Incubate Switch

Channel 2 Difference Temp ˚C

Stop Switch

Stop

Display

Heat Block Temperature Display

FOR IN-VITRO DIAGNOSTIC USE ONLY

Display Switch Main Displays

Figure 1. Front Panel of ACT II

Instrument Controls Front Panel Controls located on the front panel are the Incubate switch, the Stop switch, the Display switch, and the manual Start/Stop lever. INCUBATE SWITCH: If the rear panel dip switch is down (continuous incubate on), On is initially illuminated. On is never illuminated while a test is in progress. If the rear panel dip switch is up (continuous incubate off), the instrument incubate mode can be cycled by pressing the Incubate switch. The status of the incubate mode (ON or OFF) is indicated by On either being illuminated (ON) or not being illuminated (OFF). When a test which uses the incubate mode is being performed, the time remaining in the incubation phase is indicated by the main panel displays. The incubation phase starts at 300 seconds and counts down until "0" is reached. The clot testing phase of the test automatically begins when this occurs. The incubation may be terminated at any time during the countdown by pressing the Incubate switch. This initiates the clot timing phase of the test. The incubate mode is to be used to run tests with citrated whole blood, plasma, or quality control samples. The incubate mode is not to be used when running fresh whole blood tests. The action of the actuator mechanism is determined by the incubate condition. When the incubate ON status is engaged, the actuator mechanism does not perform a platelet activation mix cycle. When the incubate OFF status is engaged, the actuator mechanism performs a platelet activation cycle during the initial phase of a test. This activation cycle is only critical during the performance of fresh whole blood activated clotting times.

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Instrument Controls STOP SWITCH: The switch is a push button type switch. When a test is in progress or the actuator block is in the closed position, pressing the Stop switch will terminate the test in progress and the actuator heat block will automatically rotate to the open position. When the actuator block is in the open position, pressing the Stop switch will emit three short audio beeps indicating that the actuator is already in the open position. If a test is stopped prior to clot detection, then the displays will flash the time the test was aborted. MANUAL START/STOP LEVER: The manual Start/Stop lever is located on the upper left side of the actuator heat block. The lever is used to initiate a test by using the lever to rotate the heat block to the closed position. The lever can also be used to rotate the actuator heat block to the open position in order to stop a test that is in progress. DISPLAY: The switch is a push-button switch. The Display switch controls the information that is displayed in the main front panel display windows. Sequentially depressing the switch cycles the front panel displays between the individual clotting times for channels one and two, or the average and the difference of the two channel clotting times. The default status of the main displays is indicated by illuminated "Channel 1" and "Channel 2" (clotting times), or "Average" and "Difference". While a test is in progress, the main front panel displays are locked to displaying the test run time(s) and the Display switch can be used to alter the default display status of the displays. Actuator The actuator heat block is the receptacle for test cartridges. The actuator heat block rotates between an open and a closed position. Cartridges can be inserted into the heat block and removed when the heat block is in the open position. Clotting tests are performed when the actuator heat block is in the closed position. The operator initiates a clotting test by rotating the actuator heat block to the closed position. This can be accomplished by either using the manual Start/Stop lever on the upper left side of the heat block, or by using the tabs on the cartridge once the cartridge is in the heat block. At the termination of a test, the actuator heat block will automatically rotate to the open position. Rotating the actuator heat block to the closed position without a cartridge in the heat block will cause the actuator lift wire to cycle once and the actuator will automatically rotate to the open position. An error code "1" will be displayed in Channel 2, left-justified. Manual test termination is possible by using the front panel Stop switch. Depressing this switch terminates the test and the actuator heat block rotates to the open position. The test may also be terminated by manually rotating the actuator heat block to the open position by using either the manual Start/Stop lever or the tabs on the cartridge body.

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Instrument Controls Rear and Bottom Panel

Main Power Switch DANGER POSSIBLE EXPLOSION HAZARD IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS DANGER RISQUE D' EXPLOSION, NE PAS EMPLOYER EN PRESENCE D' ANESTHESIQUES INFLAMMABLES

WARNING FOR CONTINUED PROTECTION AGAINST FIRE HAZARD, REPLACE WITH SAME TYPE AND RATING OF FUSE

o w 71NL

UL2601-1

250V 2ASB 3AG

CAUTION ELECTRICAL SHOCK HAZARD. DO NOT REMOVE COVER. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL

w

Attention: See Instructions for Use

Power Inlet

P/N 405-204062-5.0

ACT II™

Automated Coagulation Timer

j 400-15 n 8006022 m 200107 ; 100-240

: Amps: Hz :

.66 - .33 50/60

C22.2 No. 601.1 Risk Class 2G Medtronic, Inc. Minneapolis, MN 55432-5604 USA 86287, Rev 1.0

RS 232 Port

Dip Switch Bank

Figure 2. Rear Panel of ACT II

The rear panel contains the Main Power switch, Incubate Continuous On dip switch, Incubate Time Select dip switch, Default Display Mode dip switch, Serial Data Port and its associated dip switches, and the Serial Number Plate. Replaceable fuses are located in the power inlet module in which the Main Power switch is located. MAIN POWER SWITCH: The Main Power switch is a rocker type switch and is used to turn the instrument on and off. ON is indicated by the symbol "|", OFF is indicated by the symbol "O". INCUBATE CONTINUOUS ON: This is dip switch 1. The switch is used to override the front panel Incubate selection switch. When this switch is in the down position (incubate continuous on), the front panel incubate On indicator will be illuminated, except during the actual performance of a test. All tests performed while the dip switch is in this setting will have an incubation phase. When dip switch 1 is in the up position, the incubate status is controlled by the front panel Incubate switch. To perform a test which requires either an incubation phase, or requires the actuator motion engaged by the incubate phase, the incubate On indicator must be illuminated. The dip switch setting is read continuously when the unit is not testing.

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Instrument Controls

Figure 3. Dip Switches

INCUBATION TIME SELECT: Dip switch 2 is used to set the length of incubation to either 300 seconds (5 minutes) or to 0 seconds (no incubation). When the dip switch is in the down position, the length of incubation will be 300 seconds, when it is in the up position, there will be no incubation. This is to allow performance of tests such as the aPTT (activated Partial Thromboplastin Time) or PT (Prothrombin Time) when both samples and test cartridges have been prewarmed to 37 °C. DEFAULT DISPLAY MODE: Dip switch 3 controls the default status of the front panel main displays when power to the instrument is first turned on. There are two modes for the main front panel displays, either the individual channel clotting times are displayed, or the average and the difference between the two channels. When dip switch 3 is in the down position the power on status will show the individual clotting times for tests that are run. If the dip switch is in the up position, the power on status will be the average and difference of the channel clotting times. This dip switch only affects the status of the displays at initial power on. SERIAL DATA PORT: The serial data port is used to connect the ACT II to an external device that is capable of accepting serial data transmission. It is a standard female DB-9 connector. Pin connections conform to RS-232-C standards. Data and Handshake signals conform to the RS-232-C standard with hardwire handshake lines RTS, CTS, DTR, and DSR. The BAUD rate for data transmission is controlled by dip switch 4 which can be set to either 9600 or 2400 baud. The baud rate is 9600 in the up position, 2400 baud in the down position. The Data Format dip switches are used to select the format of the serial data transmission. These switches are labeled "5" and "6". A detailed description of the settings for these dip switches is given in Chapter 4. TEMPERATURE CALIBRATION: The temperature calibration screw is located on the bottom panel near the left front of the instrument. This is used to calibrate the temperature of the actuator heat block. Turning the adjustment screw clockwise decreases the actuator heat block temperature. Turning the adjustment screw counterclockwise increases the actuator heat block temperature.

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Displays and Indicators

Figure 4. Temperature Calibration Screw

Displays and Indicators The front panel contains all indicators and displays. The large red display indicates the clotting times of channels 1 and 2, or the average and difference of channels 1 and 2. When a test is being run which uses the incubate mode, the clotting time displays report the elapsed test time between 6 and 100 seconds in tenths of a second. When 100 seconds of elapsed time is reached, the display drops the tenth of a second indication. When a test is run in the nonincubate mode, the display only shows the elapsed time in whole seconds. The condition of the average and difference displays on tests run in the incubation mode is indicated in the following table. Average and Difference Displays In the Incubate Mode Channel 1 Clotting Time

Channel 2 Clotting Time

Average Display

Difference Display

67.2

68

67.6

0.8

98.4

102

100.0

4.0

102

104

103

2

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System Error Codes During a test, each display runs continuously until a clot is detected in that channel, the test is manually terminated, or the test times out at 999 seconds. If a time-out occurs (999), the average and difference will not be displayed. Four amber back lit indicators show whether the red displays are indicating the channel clotting times ("Channel 1" and "Channel 2" are illuminated), or the average and difference ("Average" and "Difference" are illuminated). The temperature of the actuator heat block is indicated by the green display in the lower right corner of the front panel. The status of the instrument with respect to incubate or nonincubate of the Automated Coagulation Timer II is indicated by the illumination status of the incubate On.

System Error Codes The instrument's microprocessor contains several diagnostic programs. During initial power up and during the performance of a test, various operating parameters of the instrument are evaluated. If a fault condition is discovered, an error code is displayed left justified in the main display on the front panel. If an instrument fault is discovered during the performance of a test, all test data will be lost and the error code will be displayed. If a single channel is affected (e.g., error code "4" or bad reference), the other channel will continue to give valid results. ERROR#

Description No cartridge detected

Place a cartridge in the Actuator.

2

Microprocessor failure

Call Service Department.

3

Microprocessor failure

Call Service Department.

4

Light Path Failure

Remove cartridge. Clean light path holes in actuator cover. If error is not corrected, call Service Department.

8

Stepper motor stall, recoverable

Turn the instrument off, remove and discard the cartridge. Restart the instrument and repeat the test.

9

Stepper motor stall, unrecoverable

Call Service Department.

---

Bad reference

Remove and discard the cartridge, repeat the test.

E00

Temperature Display Temperature is less than 5° C.

Adjust ambient room temperature to instrument operating range or call Service Department.

E99

Temperature Display Temperature is greater than 44° C.

Adjust ambient room temperature to instrument operating range or call Service Department.

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Electrical Requirements

Chapter 2 - Installation Procedures and Special Requirements Electrical Requirements The Automated Coagulation Timer II requires single phase AC power between 100-240 volts at 50/60 Hz.

Unpacking The instrument is shipped in a cardboard container with the Operator's Manual, Temperature Verification Cartridge, and Actuator Cleaning Kit. Check the box for damage and report any damage to the carrier. Remove the protective bag and set the instrument in place for use. Check the instrument for visible damage and retain all shipping materials. Plug the instrument into a source of AC power with the voltage rating listed on the serial plate found on the rear of the instrument.

Initial Checkout Procedure 1. Connect the power cord. Rotate the actuator heat block to the closed position and place the rear panel Power switch in the on position. The actuator heat block should rotate to the open position. This should be followed by the full illumination of all front panel displays and indicators. The displays should then display their default conditions and the main front panel display should show "0's". The green temperature display will indicate the current heat block temperature. This sequence should be accompanied by the sounding of an audible tone indicating self test termination. Rotate the actuator heat block to the closed position. The main front panel displays should blank, the actuator motor should cycle once, then the actuator heat block should rotate to the open position. The main front panel display should now indicate a left-justified "1" in the bottom display indicating that no cartridge was present in the actuator heat block when it was closed. If any other sequence occurs, contact a Medtronic Service Representative. 2. Insert a cartridge (filled with water to just above the fill lines) into the instrument. Rotate the actuator heat block to the closed position. The instrument should begin a test. Terminate the test by pressing the Stop switch. The actuator heat block should rotate to the open position. Press the Incubate switch so that On is illuminated. Insert a cartridge (filled) and rotate the actuator heat block to the closed position. Verify that the displays show 300 seconds and starts counting down. Press the Incubate switch so that On is no longer illuminated. Verify that the actuator motor begins running and a test is initiated.

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Initial Checkout Procedure 3. Depress the Display switch so that "Channel 1" and "Channel 2" are illuminated. Determine that the timers for channels 1 and 2 are functioning properly by verifying that timer initiates at zero and continues to count up. 4. Depress the Display switch so that "Average" and "Difference" are illuminated. The average counter (the top display) and the difference counter (lower display) should continue counting as did the individual channels. The instrument will time-out at 999 seconds. A series of audible tones should sound to indicate that a time-out has occurred and testing has ceased. Check to see that the individual channels each read 999 seconds and that the average and the difference read ". . .". 5. Insert the temperature verification cartridge. After 10 minutes, check to see that the front panel temperature indicator reads 37 ± 0.5° C and that the temperature verification cartridges indicates 37 ± 0.5° C. Adjust the temperature if necessary. (See Chapter 6 for detailed instructions.) 6. If the instrument does not function properly, contact a Medtronic Service Representative as listed in Chapter 9 of this manual.

Installation Procedures and Special Requirements

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Test Cartridge

Chapter 3 - Principles of Operation

Flag Plunger Reaction Chamber Daisy Reagent Chamber Bottom Plug Figure 5. Test Cartridge

Test Cartridge The cartridge operates by dropping a plunger assembly through the test sample at programmed time intervals. When clotting occurs, the clot impedes the fall of the plunger assembly. This change in the fall rate of the plunger is detected photo-optically. This type of detection system is insensitive to the optical properties of the test sample. Reagent Chamber Each cartridge channel is segregated into two sections by a diaphragm. The bottom section is referred to as the reagent chamber. The reagent chamber is enclosed on the top by the "daisy." The "daisy" is attached to the bottom portion of the plunger assembly and is seated in the diaphragm. The bottom of the reagent chamber consists of a flexible bottom plug.

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Principle of Clot Detection Reaction Chamber The reaction chamber is located above the reagent chamber. Before a test, the operator injects the test sample into the reaction chamber. When the test is initiated, the plunger assembly is lifted and the bottom plug of the reagent chamber is pushed up, injecting the reagent chamber contents into the reaction chamber. This initially mixes the reagents with the test sample. Plunger Assembly The plunger assembly consists of two distinct parts: the "daisy" and the main body of the assembly which includes the "flag." Daisy. The daisy is so named because of its shape. Besides providing the upper seal for the reagent chamber, the daisy is the mechanical sensing element for the formation of a clot. As the plunger rises and falls, the daisy moves up and down through the mixed test sample. When a clot forms, the movement of the daisy down through the sample is impeded. Flag. The motion of the plunger through the blood sample is tracked by a photo-optical system that follows the position of the flag located on the top portion of the plunger. The optical system senses when the plunger fall rate decreases. When this occurs, a detect is signaled and the timer stopped.

Principle of Clot Detection The formation of a blood clot in vivo is a complex process involving a number of components. The in vitro formation of a clot is not as complex as in vivo clot formation but the number of components involved is still impressive. The result of the action of all these components is the conversion of fibrinogen to fibrin. Clot detection mechanisms try to relate their detection of clot formation to the presence of polymerized fibrin. When fibrin polymerizes, optical turbidity increases (photo optical plasma based clotting instruments), viscosity increases (viscometric clotting instruments), and ultimately either fibrous strands or a gel forms (mechanical clotting instruments). The clot detection mechanism of the ACT II depends on strand and gel formation. If the formation of a clot is rapid, normally a gel will form. This simply supports the plunger of the test cartridge leading to a detection of a clot. If fibrin strands form, the plunger utilizes the physical properties of the daisy to detect clot formation. The fibrin strands preferentially adhere to the daisy due to its chemical composition. This fills in the petals of the daisy causing increased resistance to movement as the daisy falls through the blood sample. The slowing in the fall rate is sufficient to allow a detection.

Principles of Operation

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Display Format

Display Format The instrument has two display formats controlled by the front panel Display switch. When the switch is depressed so that "Channel 1" and "Channel 2" are illuminated, the main display shows the individual channel clotting times (channel 1 or the left-hand channel is the upper display, channel 2 or the right-hand channel is the lower display). When the Display switch is depressed so that "Average" and "Difference" are illuminated, the upper display shows the average of the clotting times of channels 1 and 2, and the bottom display shows the difference (in seconds) between the clotting times of channels 1 and 2. If a single channel is being run the Display switch does not affect the display (the average and difference are not displayed).

Test Termination and Display Indications The following table indicates the various main display indications which can occur during the performance of a test or at test termination. Clotting Time Display TEST Condition

CH 1

CH 2

Average/Difference Display Average ■

Difference

Time Out (999)

999

999

■

■

■

■

■

999 + detect

999

130

130

■

■

■

■

■

Single Channel Detect

blank

345

345

■

Detect + Abort

230

Flashing 330

230

■

■

■

Bad Reference + Detect

---

456

456

■

■

■

Bad Reference + Abort

---

Flashing 320

■

■

■

■

■

■

---

999

■

■

■

■

■

■

Abort + Abort

Flashing 320

Flashing 320

■

■

■

■

■

■

Motor Error

blank

"8"

■

■

■

"8"

2 Normal Detects

230

235

233

5

Bad Reference + 999

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Automated Coagulation Timer II

Chapter 4 - Performance Characteristics and Specifications Automated Coagulation Timer II Number of Channels

2

Timing Range (seconds)

6 - 999

Heat Block Temperature

37 ± 0.5° C

Heat Block Warm-up Time (minutes)

15

Electrical Power Inlet Module:

Contains main switch, fuses, CEE-322 plug

Fuse Requirement:

2 : 3 AG/2A or IEC 5x20 mm/2A

Power Cord:

Removable 6 ft. hospital grade, CEE-322 plug

Voltage:

100 - 240 VAC

Phase:

1

Frequency:

50/60 Hz

Operating Current:

0.25-0.5 Amps

Leakage Current:

< 100 micro amps

Classification: UL2601-1:

Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 2601-1: Class 1, ordinary, continuous operation

Physical Height: 6.5 inches (16.5 cm) Width: 8 inches (20.3 cm) Depth: 9.5 inches (24.1 cm) Weight: 7.5 pounds (3.4kg)

Performance Characteristics and Specifications

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Accessories Environmental Atmosphere:

Nonexplosive, noncorrosive gases or anesthetics

Moisture:

Nonsubmersible

Humidity:

10% to 90% without condensation

Temperature:

+12 to +32° C/+54 to 90° F Adequately Ventilated -50 to 60° C/ -58 to 140° F

(Operating Range) (Storage Range)

Serial Data Port Baud Rate:

Data Formats:

9600

Dip switch 4 = UP

2400

Dip switch 4 = DN

7 Data + Even Parity + 1 Stop Bit

Dip switch 5 = DN Dip switch 6 = DN

7 Data + Odd Parity + 1 Stop Bit

Dip switch 5 = UP Dip switch 6 = DN

8 Data + No Parity + 1 Stop Bit

Dip switch 5 = DN Dip switch 6 = UP

8 Data + Odd Parity + 1 Stop Bit

Dip switch 5 = UP Dip switch 6 = UP

Accessories Pipettors Several pipettors are offered by Medtronic Perfusion Systems. Auxiliary Heat Block and Heater The Auxiliary Heat Block and Heater holds six cartridges. Its use can facilitate test processing by removing the necessity of warming the cartridges in the heat block of the instrument. Contact the Medtronic Order Entry Department or your local representative for ordering information.

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