Medtronic 30526 Operator's Manual

HMS Plus

Hemostasis Management System

Operator’s Manual

Caution: Federal law (USA) restricts this device to sale by or on

the order of a physician.

Explanation of symbols on package and device labeling

Conformité Européenne (European Conformity). This symbol means that the device fully complies with the
European Council Directive 98/79/EC (27 October 1998, on in vitro diagnostic medical devices).

Attention, See Instructions for Use

Consult Instructions for Use

In Vitro Diagnostic Device

Biological Hazards

Fuse

On

Off

Alternating Current

Humidity Limitation

Temperature Limitation

Date of Manufacture

Catalog Number

Lot Number

Serial Number

Quantity

For US Audiences Only

Keep Dry

Fragile, Handle with Care

This Way Up

Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with
IEC 61010-1:2001, 2nd Edition, and CSA C22.2 No. 61010-1 - Edition 2.

Do not dispose of this product in unsorted municipal waste stream. Dispose of this product according to
local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.

Manufacturer

i

ii

HMS Plus 0
Hemostasis Management System 0

Operator's Manual

Multichannel Clot Timing
Instrument with
Automated Pipetting

NOTE:

This Operator’s Manual is to be used with HMS Plus system software Version 4.X.X and 5.X.X. The
software version can be found on the opening screen after power-on.

PROPRIETARY INFORMATION

The entire contents of this manual are copyrighted and the property of Medtronic, Inc. No part of this book
may be used or reproduced in any form or by any means, or stored in a database or retrieval system, without
the prior written authorization of Medtronic, Inc.

Medtronic

®

and HEPtrac® are registered trademarks of Medtronic, Inc.

iv

Table of Contents

Product Description: Application and Use 1-1

Product Description 1-2

Application 1-4

Use 1-4

Warnings and Operational Precautions 2-1

Warnings 2-2

Operational Precautions 2-4

Installation and Setup 3-1

Electrical Requirements 3-2

Unpacking 3-2

Power On and Instrument Checkout 3-3

User Interface 3-4

Use Locations and Results Displayed 3-5

Main Menu Screen 3-6

Select Patient Screen 3-7

Default Operating Parameters 3-9

Setting the Operating Parameters 3-10

Entering Cartridge Lot Numbers and Expiration Dates 3-19

Entering Control Lot Numbers and Expiration Dates 3-22

Entering Parameters Determined by the Quality Control Manager 3-26

Adjusting the Temperature Display 3-30

Principles of Operation and Calculations 4-1

Cartridge Design 4-2

Types of Test Cartridges 4-3

Actuator/Dispenser 4-4

User Interface Operating Principles 4-6

Instrument Back Panel 4-9

Calculations 4-10

Operating Instructions 5-1

General Operation 5-2

Recommended Protocol 5-11

Test Results Calculated 5-12

Running a Heparin Dose Response (HDR) 5-13

Running a Heparin Assay (HPT) 5-20

Running an HR-ACT 5-28

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens 5-31

Differential Diagnosis of Postsurgical Bleeding 5-35

View Current Test Results 5-36

Test History Menu 5-37

v

Specifications 6-1

Instrument Specifications 6-2

Maintenance and Quality Control 7-1

Quality Control Menu Screen 7-2

Running Liquid Quality Control Tests 7-2

Verification of Dispenser Volume Delivery 7-7

Adjustment of Heat Block Temperature Display 7-9

Installing Printer Paper 7-10

Routine Cleaning 7-11

Fuse Replacement 7-12

End of Life Disposition 7-12

Quality Control Test History 7-12

Service and Troubleshooting 8-1

Instrument Service 8-2

Instrument Return 8-3

Troubleshooting 8-3

Screen Messages 8-4

Equipment Limited Warranties 8-10

References 9-1

Appendix A-1

Introduction A-2

Parts of the Scanner A-2

Scanning in Hand-Held Mode A-2

Setting Bar Code Format Options A-3

Troubleshooting A-4

vi

Product Description: Application and Use

Product Description 1-2

Application 1-4

Use 1-4

1

1

HMS Plus Operator’s Manual 1-1

Chapter 1

Product Description

Product Description

6

8

7

1

2

5

3

4

1. Sample Dispenser/Syringe 5. Main Keypad

2. Start/Stop Key 6. LCD Screen and Variable Function Keys

3. Carry Handle (s) 7. Heat Block and Cartridge Receiver

4. Printer 8. Protective Shield

Figure 1-1. Front View, HMS Plus

The HMS Plus instrument is a microprocessor based, multichannel clot timing system
with automated syringe handling for pipetting blood into single use cartridges. It
performs in vitro heparin sensitivity evaluations, heparin assays, and activated
clotting times. The HMS Plus instrument can store and recall parameters on up to five
patients.

Information provided to the user by the HMS Plus instrument includes the following:

■

In vitro indication of heparin response using Heparin Dose Response
(HDR) cartridges.

■

Heparin calculation based on dosing protocol, patient blood volume, and
extracorporeal circuit parameters.

■

Simultaneous quantitative and functional evaluation of heparin using the Heparin
Assay (HPT) and Activated Clotting Time (HR-ACT) cartridges.

■

Calculation of additional heparin required to maintain the patient at a
predetermined heparin concentration.

■

Protamine dose needed to reverse heparin.

1-2 HMS Plus Operator’s Manual

Product Description: Application and Use

1

2

3

4

5

Product Description

1. Main Power Switch (On/Off) 4. Fuse (s)

2. Ventilation Slots 5. Serial Connector (RS-232)

3. Power Inlet Module

Figure 1-2. Rear View, HMS Plus

HMS Plus Operator’s Manual 1-3

Chapter 1

Application

Application

Hemostasis control is an important aspect of patient care in any application requiring
heparin management. The versatility of the HMS Plus instrument allows convenient
hemostasis management for a variety of applications. Such areas of application
include, but are not necessarily limited to, the following:

■

Cardiopulmonary Bypass Surgery

■

Cardiac Catheterization Laboratory

■

Intensive Care Unit/Critical Care Unit/Clinical Laboratory

The HMS Plus instrument allows convenient selection of the location for its use.
Patient and protocol parameters are entered into the system and these parameters
are used in computing test results.

In all these locations, there may be a need to monitor several patients at a time. The
HMS Plus instrument can accommodate these needs by permitting storage of patient
and protocol parameters on up to five patients. System operation remains the same
as for single patient use except that the appropriate patient is selected before or after
each test.

Use

Key features of the HMS Plus instrument are ease of use and rapid turnaround of test
results with minimal operator interface. An optional bar code scanner may be used to
simplify data entry (see Appendix A). All necessary reagents are contained within the
single use cartridges. An optical code on each cartridge instructs the system as to the
type of test being performed, the parameters which need to be accounted for in
calculations, and the sample volume required for the test. The operator inserts the
appropriate cartridge and a sample filled syringe into the system and starts the test.
The HMS Plus instrument will fill the cartridge and perform the test as instructed by
the optical code on the cartridge.

Test results include clotting time data, which are presented on the LCD screen of the
HMS Plus instrument. The most pertinent results for each test type are automatically
displayed at the completion of the test. Secondary calculations and clotting times can
be displayed, if desired. Test results can be printed automatically at test completion
with the internal HMS Plus printer or, at user option, manually by pressing the
Print key.

The HMS Plus instrument also provides long-term data storage and retrieval,
enabling access to previous test information for both patient and quality control tests.
Test results are stored in the order in which they are performed and may be printed
by user-selected sort criteria. The versatility of the system is also enhanced by the
ability to externally transfer test history data (for patient and quality control tests) out
the RS-232 serial port to a peripheral device (such as a PC running the HMS Plus
External Data Manager software).

1-4 HMS Plus Operator’s Manual

Warnings and Operational Precautions

Warnings 2-2

Operational Precautions 2-4

2

2

HMS Plus Operator’s Manual 2-1

Chapter 2

Warnings

This section contains important warnings and operational precautions for proper use
of the HMS Plus instrument.

A list of screen messages that may appear during instrument use is provided in
Section 8: “Service and Troubleshooting”.

Warnings

Proper Instrument and Cartridge Use

The HMS Plus instrument and cartridges must only be used in the manner and for the
purpose for which they are intended. Instructions for proper use are included in this
manual and in the cartridge package inserts.

Read all Warnings, Precautions and Instructions for Use carefully prior to use. Failure

to read and follow all instructions, or failure to observe all stated warnings,
could cause serious injury or death to the patient.

No Unapproved Instrument Use

Do not use the HMS Plus instrument in any manner not specified in the operator’s
manual or other applicable labeling. The HMS Plus instrument must be used in
accordance with all the instructions and labeling provided by Medtronic. Any other use
may adversely affect the safe and effective use of the instrument.

Explosive Anesthetics

An explosion hazard exists if the HMS Plus instrument is used in the presence of
flammable anesthetics.

Main Power Off and Disconnect Access

Do not locate the HMS Plus instrument in a place that restricts quick and easy access
to the main-power switch or the power cord. The main-power switch (on/off) at the
rear of the instrument, and the power cord must be accessible at all times, because
they are the means to turn off or disconnect the instrument from its power source.

Electric Shock

Electric shock hazard exists, do not remove the instrument cover. Refer all servicing
to Medtronic Technical Service or other authorized service representative.

Proper Maintenance and Calibration

It is important that the HMS Plus be maintained in good working order and calibrated
on a regular basis by a Medtronic-qualified service technician. Otherwise, a reduction
in the accuracy of a measuring function may occur.

No User Serviceable Parts Inside Case

Internal servicing must be done only by Medtronic Technical Service or other
authorized service representative.

2-2 HMS Plus Operator’s Manual

Sterilizing and Cleaning

Do not steam, autoclave, or immerse the HMS Plus instrument. Periodically clean the
exterior surfaces per the instructions provided in “Routine Cleaning” on page 7-12.

Plastic materials used in the HMS Plus and its disposable kits may be sensitive to
chemicals (such as solvents and certain detergents). Under certain adverse
conditions, exposure to these chemicals (including vapors) may cause the plastics to
fail or malfunction.

Handling of Blood

All blood samples, controls, blood filled cartridges, syringes, and needles should be
considered potentially hazardous and handled with universal precautions to protect
against blood-borne pathogens. Dispose of all blood samples and these products in
accordance with the guidelines established for the specific institution. The user must
wear protective gloves when handling potentially infectious substances.

Use of Cartridges and Controls

Please refer to the specific cartridge and control package inserts for additional
detailed warnings and precautions regarding use. Treat all blood samples as
potentially infectious.

Warnings and Operational Precautions

Warnings

Dispensing

To avoid possible injury, fingers must be kept out of the dispenser area while
dispensing is in progress. The operator should be aware that even small, rapidly
rotating parts have enough dynamic energy to cause severe injury if clothing, jewelry,
or other objects are caught in the rotating parts.

HMS Plus Operator’s Manual 2-3

Chapter 2

Operational Precautions

Operational Precautions

The following precautions and limitations apply to the use of the HMS Plus instrument
and the related disposable test cartridges.

General Precautions

1. The HMS Plus instrument is intended for in vitro diagnostic use only.

2. The instrument must be set up with appropriate operating parameters to obtain
valid results.

3. The screen and printout values shown in this manual are intended for illustration
only. These illustrated values are not intended to match actual results obtained
during instrument use.

4. Formulas used to calculate male and female blood volumes were derived for
adult patients weighing 45 kg (99 lb) or more and measuring 142 cm (4 ft 8 in) or
taller. The pediatric blood volume formula is used for any patient whose weight
or height is less than these values.

5. The calculated blood volume and other measurements made by the HMS Plus
instrument may be affected by factors discussed in this manual. All of these
factors must be taken into consideration when using the system to monitor
patient hemostasis.

6. Adequate sample quantity must be drawn into the syringe and the needle primed
to fill all cartridge channels needed for the test. Refer to the individual cartridge
package inserts for details.

7. Syringe insertion is very important to the success of a test. If the syringe is not
properly installed in the syringe holder, nonuniform sample dispensing may
occur. Inaccuracy in blood volume delivered will have a direct effect on the test
result. When inserting the syringe into the syringe holder, the syringe body must
be oriented to allow capture by the drive system. The lock switch groove
captures a syringe plunger crossmember when it is locked. This prevents the
syringe from moving out of the drive wheel during sample delivery. (refer to
Figure 5-5 on page 5-8).

8. The syringe and cartridge should not be interfered with during test dispensing
and processing, as inaccurate test results can occur.

9. It is suggested that the instrument’s protective shield should be closed during
operation.

10. The HMS Plus instrument is intended to be used while positioned on a flat
surface. Dropping, soaking, or otherwise misusing the instrument may prevent it
from functioning properly.

Precautions Regarding Blood Volume Calculations

The blood volume calculation is an approximation based on general (normal) patient
populations. Computed blood volume may differ from actual blood volume in several
disease states including, but not limited to the following patients: those with poor
mitral valves, heart transplants, kidney disease, and/or amputated limbs.

When the patient gender, height, or weight value has been modified, a new blood
volume, corresponding to that patient, will be recalculated and displayed.

Precautions for Use of Cartridges and Controls

Note: Please refer to the specific cartridge and control package inserts for additional

detailed precautions regarding use.

1. Treat all blood samples as potentially infectious.

2-4 HMS Plus Operator’s Manual

Warnings and Operational Precautions

Operational Precautions

2. Samples should be run as soon as possible after being drawn and be free of
tissue thromboplastin.

3. Samples should not be taken from heparinized indwelling catheters or other
anticoagulated lines without thoroughly flushing the line and pulling back an
adequate void volume.

4. Cartridges are expiration dated on the box only and should remain in the box
until used. Cartridges are for single use only.

5. Ensure that the proper cartridge type is selected. Inspect the cartridge for proper
reagent fill prior to performing any tests.

6. Most cartridges should be prewarmed to 37°C ± 0.5°C before use. A monthly
verification of the heat block temperature should be performed. For more details,
refer to Section 7: “Maintenance and Quality Control” and the specific cartridge
package inserts.

7. The resolution of the Heparin Assay cartridge is such that most controls can clot
in either Channel 3 or 4 of a four-channel cartridge, or 5 or 6 of a six-channel
cartridge. The exceptions are the Red/Yellow control in the Red cartridge, and
the Tan/Silver control in the Tan Cartridge. (For more details, see specific
package inserts.) This is due in part to the USP

1

tolerances for protamine sulfate

and heparin, which limit the accuracy of the test.

8. If the heparin concentration is measured at Channel 1 (Channel 1 clot detect) in
a Heparin Assay cartridge that does not have a zero (protamine) in Channel 1,
the actual heparin may be lower than the measured value. Similarly, if it is
measured in Channel 4 of a four-channel cartridge, or Channel 6 of a
six-channel cartridge, the actual heparin value may be higher than the measured
value. In these cases, another test with a different cartridge (lower or higher as
needed) should be run to confirm the test result.

9. System functionality and dispensing volumes should be verified by periodic
testing using liquid controls, the HEPtrac electronic control and a monthly test of
dispenser volume delivery accuracy. For further details, refer to Section 7:
“Maintenance and Quality Control”.

Precautions Regarding Parameter Entry

All computed test results are based on user-entered parameters. Incorrectly entered
protocol and patient parameters can result in inaccurate test calculations. The
HMS Plus instrument is programmed to alert the user if certain key parameters are
out of range:

1. If a Protamine-Heparin Ratio of less than 0.3 or greater than 3.0 is entered, the
screen’s Status Message area will indicate the out-of-range condition (“Value out
of range. Enter 0.3 – 3.0.”).

2. Medtronic manufactures cartridges to monitor heparin up to 6.0 mg/kg (600 u/kg
or 8.2 u/mL); however, protocol heparin concentration values (Protocol Hep
Conc) can be entered up to 7.3 mg/kg (730 u/kg or 9.9 u/mL). If a protocol
heparin concentration greater than 7.3 mg/kg (730 u/kg or 9.9 u/mL) or less
than 0.1 mg/kg (10 u/kg or 0.1 u/mL) is entered, the screen’s Status Message
area will indicate the out-of-range condition (“Value out of range.
Enter 0.1 – 7.3.”). No heparin bolus dose information will be computed until a
valid value is entered.

3. If the computed patient blood volume is less than 100 mL or greater than
19,999 mL, the screen’s Status Message area will indicate the out of range
condition (“Patient Blood Volume < 100 ml” or “Patient Blood Volume
> 19999 ml”). Check that appropriate height and weight parameter values have
been entered.

1

United States Pharmacopeia

HMS Plus Operator’s Manual 2-5

Chapter 2

Operational Precautions

Precautions Regarding Heparin Concentration

For a variety of reasons, heparin concentration may vary significantly following
administration of the initial heparin dose.

Factors that may contribute to a HIGHER than calculated circulating heparin
concentration include the following:

1. Patient's actual blood volume is less than the calculated blood volume.

2. Heparin activity is greater than expected (USP-grade heparin activity may vary
from published values).

3. Heparin is inadequately mixed with patient-prime fluid.

4. Metabolic rate and blood temperature may influence the half-life of heparin.

Factors that may contribute to a LOWER than calculated circulating heparin
concentration include the following:

1. Patient's actual blood volume is greater than the calculated blood volume.

2. Heparin activity is less than expected.

3. If a heparin dose that is smaller than required is added to the prime, there will be
an abrupt decline in heparin concentration upon initiating cardiopulmonary
bypass.

4. Metabolic rate and blood temperature may influence the half-life of heparin.

5. Sequestering of heparin in the extravascular space.

Precautions Regarding Heparin Dose Response

The Heparin Dose Response (HDR) is an in vitro test for heparin response and,
therefore, cannot measure all in vivo variables.

If the amount of heparin given to the patient has been calculated using a fixed amount
of heparin in the pump (Pump Heparin), the prebypass HR-ACT may be higher or
lower than the time projected by the HDR test. This can occur because the heparin
requirements are calculated for the total or combined pump and patient volumes.
Thus, if a protocol pump heparin is used and the concentration of heparin in the pump
is not equal to the reference heparin concentration used in calculating a bolus value,
the patient requirement will include the amount to make the pump concentration
correct. The total heparin amount is the same as if the bolus were distributed
proportionally between the pump and patient volumes. To avoid this, allow the
HMS Plus instrument to calculate the pump heparin requirement by setting the
instrument Location parameter to [CPB-Pump Calc].

At the end of an HDR test, the patient’s protocol heparin concentration that was
entered will be replaced with the concentration calculated from the HDR data
(displayed as “Projected Heparin Conc”). If the projected value is not the desired
value, it can be changed from the HDR RESULTS screen.

Warning: To avoid running a procedure with the wrong heparin concentration value,
verify the value after running an HDR test.

The HMS Plus instrument cannot measure heparin concentrations greater
than 6.0 mg/kg (600 u/kg or 8.2 u/mL). If a “Protocol Hep Conc” value exceeds

7.3 mg/kg (730 u/kg or 9.9 u/mL), the screen’s Status Message area will indicate the
out of range condition. If the “Projected Heparin Conc” from the HDR RESULTS
screen exceeds 7.3 mg/kg (730 u/kg or 9.9 u/mL), the screen’s Status Message area
will indicate the out of range condition (“HDR Proj Hep Conc > 7.3 mg/kg”), no results
will be computed for “Heparin Bolus”, and dashes are displayed on the screen.

2-6 HMS Plus Operator’s Manual

Installation and Setup

Electrical Requirements 3-2

Unpacking 3-2

Power On and Instrument Checkout 3-3

User Interface 3-4

Use Locations and Results Displayed 3-5

Main Menu Screen 3-6

Select Patient Screen 3-7

3

3

Default Operating Parameters 3-9

Setting the Operating Parameters 3-10

Entering Cartridge Lot Numbers and Expiration Dates 3-19

Entering Control Lot Numbers and Expiration Dates 3-22

Entering Parameters Determined by the Quality Control Manager 3-26

Adjusting the Temperature Display 3-30

HMS Plus Operator’s Manual 3-1

Chapter 3

Electrical Requirements

To ensure proper operation of the HMS Plus instrument, the appropriate installation,
check out, and setup procedures should be followed.

Electrical Requirements

Refer to “Instrument Specifications” on page 6-2 for requirements.

Unpacking

The HMS Plus instrument, manual, and accessories are shipped in a corrugated
container with foam cushioning.

1. Inspect the shipping container for signs of mishandling.

2. Open the top of the container, remove the accessory tray, and lift the instrument
from the container using the handles of the corrugated and foam cradle. Place
the cradle (with instrument) on a level surface, lower the sides, and remove the
instrument from cradle.

3. Place the instrument on a level surface and remove the plastic bag covering the
instrument, the foam protecting the actuator assembly, and the protective sheet
covering the instrument’s protective shield.

Note: The HMS Plus instrument cart has been designed for use with the HMS Plus
instrument as an accessory component (refer to Figure 3-1).

4. Inspect the instrument for any dents or scratches. If the instrument appears
damaged, contact Medtronic Service or an authorized service representative
before proceeding (refer to “Instrument Service” on page 8-2).

3-2 HMS Plus Operator’s Manual

Figure 3-1. HMS Plus Cart

Power On and Instrument Checkout

Attach the power cord and plug it into a grounded, hospital-grade main power outlet.
If desired, attach and program the optional bar code scanner (see Appendix A).

Turn on the HMS Plus instrument using the main power switch located on the back.
The instrument will perform the following self-tests:

1. The HMS Plus software will initiate a series of power-on diagnostic tests to
ensure instrument functionality.

2. The dispenser will cycle and return to the “park” position.

3. Three audio beeps will occur and the STARTUP screen will be displayed with the
message “Self Test in Progress.” A brief message follows indicating “Self Test
Pass” and then an automatic transition occurs to the instrument’s MAIN MENU
screen (refer to “Main Menu Screen” on page 3-6).

Note: The instrument’s software version number appears on the STARTUP screen.

4. The temperature will be automatically displayed until the heat block reaches the
appropriate temperature for testing (36.5°C – 37.5°C), unless a higher-priority
message is processed.

Note: Allow up to 25 minutes of warm-up time for the heat block to reach the desired
temperature prior to performing any tests. The actual warmup time depends on the
instrument’s ambient temperature.

Installation and Setup

Power On and Instrument Checkout

Note: If any of the instrument self-tests fail or are not completed, the software will
attempt to display the message “Self Test: FAIL XXX,” where XXX is a three-digit
number indicating a system error code. Write down the error code (if displayed) and
notify Medtronic Technical Service or an authorized representative before continuing
(refer to “Instrument Service” on page 8-2).

Once successfully powered on, the HMS Plus instrument will perform continuous
self-diagnostics to ensure proper function. Many error or precautionary conditions are
self-diagnosed by the HMS Plus instrument and presented on the screen’s Status
Message area. Refer to Section 8: “Service and Troubleshooting” for a list of screen
messages.

HMS Plus Operator’s Manual 3-3

Chapter 3

Variable

Function

Keys

Variable
Function Keys

HMS PLUS

Clear

Main

Menu

Select

Patient

Cancel

Enter

Paper

Advance

Print

Start

Stop

User Interface

User Interface

The User Interface components are identified in Figure 3-2. The User Interface
includes the LCD screen and all keys for instrument control (ie, entering data, screen
navigation, starting and stopping tests, and printing).

Note: For details on operating the HMS Plus instrument with the interface
components, refer to “User Interface Operating Principles” on page 4-6.

3-4 HMS Plus Operator’s Manual

Figure 3-2. User Interface Components

Use Locations and Results Displayed

Use Locations

For flexibility in performing tests in different clinical settings, the HMS Plus instrument
can be set for five (5) different locations of instrument use. Changing the location of
instrument use is described in the section “Entering Instrument Parameters” on
page 3-11. The following location choices are available:

■

CPB-Pump Enter – Cardiopulmonary Bypass where the quantity of heparin that
is to be added to the extracorporeal prime is entered by the operator.

■

CPB-Pump Calc – Cardiopulmonary Bypass where the HMS Plus instrument
calculates the quantity of heparin that is to be added to the extracorporeal prime
(based on patient needs and data entered).

■

Cath Lab – Catheterization Laboratory where no pump data is entered (ie, Pump
Heparin and Pump Volume).

■

ICU/CCU/Lab – Intensive Care Unit/Critical Care Unit/Clinical Laboratory where
no pump data is entered (ie, Pump Heparin and Pump Volume).

■

Test Only – Test Only location where tests are run without patient data.

If a test was run with the wrong Location parameter setting, test results appropriate
for a different location can be displayed by changing the instrument’s Location
parameter. Additional patient/protocol parameters may need to be entered for the new
location.

Installation and Setup

Use Locations and Results Displayed

Results Displayed

Depending on the selected location of instrument use, the information presented
on your screens may differ from the screens shown in this manual. Also, the

location selected determines the information that can be entered, the calculations that
are performed, and the test results displayed. Refer to Table 3-1 “Patient/Protocol
Parameters Entered for Each Location” on page 3-10 and Table 5-1 “Test Results
Calculated for Each Location” on page 5-12 for additional information.

Note: This manual will use the convention to show all screens with the instrument
Location parameter set as [CPB-Pump Enter] as it provides a comprehensive
representation of the instrument’s features.

Refer to “Screen Layout” on page 4-8 for additional information on the screen
appearance.

HMS Plus Operator’s Manual 3-5

Chapter 3

1 PID: 34567

Temp: 37.1

°C

MAIN MENU

Patient/Protocol
Parameters

Instrument
Parameters

Quality Control

View Current

Test Results

Output Patient

Results

Cartridge

Lot/Exp Date

Main Menu Screen

Main Menu Screen

The MAIN MENU screen appears after instrument power up and self-testing (refer to
Figure 3-3). This screen shows the current patient number and ID, the instrument
heat block temperature, and text for six (6) variable function keys to access one of the
screens described below.

Note: The MAIN MENU screen can be accessed at any time by pressing the

Main Menu key (except when a test is in process or data input is active). The
MAIN MENU screen provides access to all other HMS Plus instrument screens
and will be used often.

Figure 3-3. Main Menu Screen

Patient/Protocol Parameters – Pressing this variable function key displays the

PATIENT/PROTOCOL PARAMETERS screen. From this screen, the current patient
and protocol values that have been entered can be viewed and/or changed for each
patient (refer to “Entering Patient and Protocol Parameters” on page 5-2).

Instrument Parameters – Pressing this variable function key displays the first of four
INSTRUMENT PARAMETERS screens. From these screens, the current instrument
values that have been entered can be viewed and/or changed (refer to “Entering
Instrument Parameters” on page 3-11).

Quality Control – Pressing this variable function key displays the QUALITY
CONTROL MENU screen and the quality control (QC) functions of the HMS Plus
instrument. These functions include the following: performing QC tests, changing the
QC setup (including entering control lot information), verifying the dispenser volume
delivery, adjusting the heat block temperature display, viewing the QC due status, and
outputting QC test history (refer to “Quality Control Menu Screen” on page 7-2).

View Current Test Results – Pressing this variable function key displays the results
screen of the last test performed with the HMS Plus instrument (refer to “View Current
Test Results” on page 5-36).

Output Patient Results – Pressing this variable function key displays the TEST
HISTORY MENU screen. From this screen, test histories for all the HMS Plus
instrument’s supported tests can be printed by the following sort criteria: Sort by Total
Days, Sort by Test Type, and Sort by Patient ID (refer to“Test History Menu” on
page 5-37).

3-6 HMS Plus Operator’s Manual

Cartridge Lot/Expiration Date – Pressing this variable function key displays the

1

2345

SELECT PATIENT 1

Back to Previous
Patient

Go to Next

Patient

Exit Select

Patient

Calculate Last
Test—New Patient

PID: 34567
Sex: Male
Height: 170 cm
Weight: 70 kg

BV: 5000 mL
BSA: 1.7 sq meters
Bolus: 14600 units
UID: 1234567

CARTRIDGE LOT/EXP DATE screen. From this screen, cartridge lot numbers and
expiration dates can be entered, viewed, and/or changed (refer to “Entering Cartridge
Lot Numbers and Expiration Dates” on page 3-19). In addition, the active lot number
currently being used for tests can be changed (refer to the description for the “Toggle
Active” key on page 3-23).

Select Patient Screen

The SELECT PATIENT screen appears when the Select Patient key is pressed. This
screen allows a new patient to be selected and test results of the last test run to be
recalculated. Tests can also be started from this screen.

Note: Patient parameters cannot be entered from the SELECT PATIENT screen; they
must be entered from the PATIENT PARAMETERS screen. To access this screen,

press the Main Menu key followed by the Patient/Protocol Parameters and Set
Patient Parameters variable function keys.

The SELECT PATIENT screen shows the current patient parameters and the
calculated values for Blood Volume (BV), Body Surface Area (BSA), and Bolus dose
of heparin (Bolus). The current patient number (1-5) is highlighted on the screen.

Installation and Setup

Select Patient Screen

Figure 3-4. Select Patient Screen

Note: UID is an abbreviation for User Identification number, and PID is an

abbreviation for Patient Identification number.

The SELECT PATIENT screen can be accessed at any time by pressing the Select
Patient key (except when a test is in process or data input is active). If patient
parameters have not been entered for the selected patient, no values will be
displayed. If the Location selected for instrument use is set to [Test Only], the
patient ID only will appear on the SELECT PATIENT screen.

When the SELECT PATIENT screen is displayed, the patient and protocol parameters
for the current patient may be printed by pressing the Print key.

HMS Plus Operator’s Manual 3-7

Chapter 3

Select Patient Screen

Multiple Patient Operation

The HMS Plus instrument provides for storage and retrieval of parameters on up to
five patients. Operation is identical to single patient operation; the only additional step
is that the desired patient (1–5) must be selected each time a test is run or parameters
are changed.

Patient selection

With the SELECT PATIENT screen displayed, select a new patient by the following
method:

■

Press either the Go to Next Patient or Back to Previous Patient variable
function key.

The selected patient (1–5) will be highlighted and the screen will show the entered
and calculated values for that patient. A patient can be selected before or after a test
is completed. To exit the SELECT PATIENT screen, press either the Main Menu key
to go to the instrument’s MAIN MENU screen, or the Exit Select Patient variable
function key to return to the screen that was displayed at the time the SELECT
PATIENT screen was entered.

Warning: When the Exit Select Patient variable function key is pressed, the
instrument returns to the screen displayed before the SELECT PATIENT screen was
accessed. If this was a RESULTS screen, the results are automatically recalculated
for the newly selected patient. If the results were from an HDR test, this could result
in an unintended change in the projected heparin concentration for that patient. To
avoid this, it is recommended that the test on the newly selected patient be started
directly from the SELECT PATIENT screen by pressing the Start/Stop key after the
new patient is selected.

Calculating last test results for a different patient

The SELECT PATIENT screen allows results from the last test run to be recalculated
with new patient parameters. This feature is useful if a test was run before the correct
patient was selected or updated.

To recalculate the last test results for a different patient or the same patient with
updated parameters, access the SELECT PATIENT screen after test completion and,
with the applicable patient selected, do the following:

■

Press the Calculate Last Test – New Patient variable function key. All test data
will now be recalculated for the selected patient.

Print

Test results can be printed during multiple patient use with the Print key (refer to
“Printer function keys” on page 4-7). To print setup conditions for the current patient,
refer to “Patient/Protocol Parameters Printout” on page 5-5.

Note: Each patient must first be selected prior to printing.

Running cartridges

All cartridges are run as described in Section 5: “Operating Instructions” of this
manual, however, the appropriate patient must be selected before or after each
cartridge is run.

3-8 HMS Plus Operator’s Manual

Default Operating Parameters

The HMS Plus instrument comes from the factory with most parameters having preset
default values (values can be preset for five patient protocols). Once a default value
is changed, it is saved as the new parameter value with each power off/on cycling. To
enter new operating parameters, refer to “Setting the Operating Parameters” on
page 3-10. To change patient protocol parameters, refer to “Entering Patient and
Protocol Parameters” on page 5-2.

Patient/Protocol Parameters

a

PID

Sex No default

Height No default

Weight No default

UID No default

Protocol Hep Conc [3.0 mg/kg]

Pump Heparin [0 units]

Pump Volume [0 ml]

ACT Target Time [0 sec]

a

PID: Patient Identification Number

Installation and Setup

Default Operating Parameters

No default

Instrument Parameters

Heparin Conc Unit [mg/kg]

Heparin Type [IU]

Protamine-Heparin Ratio [1.1:1]

Protamine Units [mg]

Confirm Patient [On]

Print Mode [Manual]

Audio Tone [On]

All Ch Detect [Off]

Dispenser [On]

Date - yyyy-mm-dd Preset in manufacturing

Time - hh:mm Preset in manufacturing

Language Preset in manufacturing

Location Preset in manufacturing

QC Manager Parameters

User Lockout [Off]

Permanent Record [None]

QC Lockout [Off]

QC Interval — Liquid [None]

HMS Plus Operator’s Manual 3-9

Chapter 3

Setting the Operating Parameters

QC Interval — EQC/HEPtrac [None]

Cartridges Enabled All

Setting the Operating Parameters

Before using the HMS Plus instrument, the operating parameters (instrument,
QC Manager, patient, and protocol) must be set and verified to your clinical needs and
institutional protocol. Some parameters are set infrequently while others are set with
each instrument use or for each individual patient.

This section describes the HMS Plus instrument parameters and the procedure for
entering appropriate values.

Notes:

■

Up to five different sets of patient protocol parameters can be preset and held in
the memory of the HMS Plus instrument. Refer to “Entering Patient and Protocol
Parameters” on page 5-2 for details on setting up these parameters.

■

Prior to setting parameter values, refer to “User Interface Operating Principles” on
page 4-6 for an explanation of the User Interface and the operating principles of
the HMS Plus instrument.

■

The parameter values that can be entered are dependent on the Location
selected for instrument use (refer to Table 3-1). Also, depending on the selected
location of instrument use, the information presented on your screens may

differ from the screens shown in this manual.

■

Numeric parameter values cannot be entered out of the parameter’s accepted
range. Out-of-range entries will result in a screen message indicating this
condition. Refer to Section 8: “Service and Troubleshooting” for additional
information on screen messages.

■

The PATIENT PROTOCOL and INSTRUMENT PARAMETER screens can be
accessed from the Main Menu screen (refer to “Main Menu Screen” on page 3-6).

Patient and protocol parameters entered for each location

The table below shows the patient and protocol parameter values for each location
(X = parameter can be entered). Instrument parameters apply to all locations.

Parameter

PID X X X X X

Sex X X X X

Height X X X X

Weight X X X X

Protocol Hep Conc X X X X

Pump Heparin X

Pump Volume X X

ACT Target Time X X X X X

3-10 HMS Plus Operator’s Manual

Table 3-1. Patient/Protocol Parameters Entered for Each Location

Selected Location

CPB-Pump

Enter

CPB-Pump

Calc

Cath Lab ICU/CCU/Lab Test Only

Entering Instrument Parameters

Heparin Conc Unit
[mg/kg]

Heparin Type
[IU]

Protamine-Heparin
Ratio [1.1:1]

Protamine Units

[mg]

Confirm Patient

[On]

Go to

Page2of4

INSTRUMENT PARAMETERS

(Page1of4)

CPB-Pump Enter

To set the instrument parameters, do the following:

1. From the MAIN MENU screen, press the Instrument Parameters variable
function key to display the first INSTRUMENT PARAMETERS screen (refer to
Figure 3-5).

2. There are four (4) instrument parameter screens. Screens 1 through 3 are
labeled INSTRUMENT PARAMETERS. The fourth screen is labeled DEFAULT
PROTOCOL PARAMETERS.

Note: Instrument parameters are the same for all patients and tests run; they are
not specific to a particular patient.

3. Follow the instructions below for each parameter value to be set.

Installation and Setup

Setting the Operating Parameters

Figure 3-5. Instrument Parameters Screen (Page 1)

Set Instrument Parameters

1. Heparin Conc Unit – The choices of heparin units of measure are mg/kg
(milligrams/kilogram), u/kg (units/kilogram), or u/mL (units/milliliter).

a. Press the Heparin Conc Unit variable function key to select the parameter.

b. If needed, press the Heparin Conc Unit variable function key again to toggle

until the desired units are displayed.

c. Press the Enter key to accept the parameter.

2. Heparin Type – The heparin type is International Units “IU”.

a. Press the Heparin Type variable function key to select the parameter.

b. If needed, press the Heparin Type variable function key again to toggle until

the desired heparin type is displayed.

c. Press the Enter key to accept the parameter.

3. Protamine-Heparin Ratio – The protamine-heparin ratio is used for calculation
of the protamine dose for heparin neutralization; it does not apply for the “Test
Only” instrument location. The acceptable range for the protamine-heparin ratio
is 0.3 – 3.0 with a resolution of 0.1. (The value that will be entered is X.X:1,
where X.X is the desired protamine value.)

a. Press the Protamine-Heparin Ratio variable function key to select the

parameter.

HMS Plus Operator’s Manual 3-11

Chapter 3

Output Mode
[Auto-Transmit]

Audio Tone
[On]

Back to
Page1of4

All Ch Detect

[Off]

Dispenser

[On]

Go to

Page3of4

INSTRUMENT PARAMETERS

(Page2of4)

CPB-Pump Enter

Setting the Operating Parameters

b. Enter an appropriate “Protamine-Heparin Ratio” value.

c. Press the Enter key to accept the value.

4. Protamine Units – The choices for protamine units of measure are mg
(milligrams) or units; it does not apply for the [Test Only] instrument location.

a. Press the Protamine Units variable function key to select the parameter.

b. If needed, press the Protamine Units variable function key again to toggle

until the desired protamine units are displayed.

c. Press the Enter key to accept the value.

5. Confirm Patient – The confirm patient parameter can be set to [On] or [Off] to
control whether the CONFIRM PATIENT screen appears at the start of a test. If
the confirm patient parameter is set to [On], the CONFIRM PATIENT screen is
displayed when the Start/Stop key is pressed to start a test. This allows for
verification of the patient and cartridge selection prior to starting a test (refer to
“Confirm Patient Screen” on page 5-9).

Note: Even if the confirm patient selection has been set to [Off], the CONFIRM
PATIENT screen will appear for 10 seconds after each power on and the first
time a test is run after any parameter has been modified. If unconfirmed, the

screen will disappear and the test will commence after 10 seconds. (If the
confirm patient selection has been set to [On], it will pause indefinitely
awaiting an explicit confirmation and will not time out after 10 seconds.)

a. Press the Confirm Patient variable function key to select the parameter.

b. If needed, press the Confirm Patient variable function key again to toggle to

the desired setting (On or Off).

c. Press the Enter key to accept the value.

6. Output Mode – The output mode parameter can be set to [Manual], [Auto Print],
[Auto-Transmit], or [Auto Both], to control whether a test result is automatically
sent to the HMS Plus instrument’s internal printer (Auto Print), RS-232 serial port
(Auto-Transmit), or both (Auto Both), or printed only when the Print key is
pressed (Manual).

a. Press the Output Mode variable function key to select the parameter.

b. If needed, press the Output Mode variable function key again to toggle to the

desired setting (Auto Print, Auto-Transmit, Auto Both, or Manual).

3-12 HMS Plus Operator’s Manual

c. Press the Enter key to accept the value.

Figure 3-6. Instrument Parameters Screen (Page 2)

Installation and Setup

Date - yyyy-mm-dd
[2011-02-15]

Time - hh:mm
[09:30]

Back to
Page2of4

Language

[English]

Location

[CPB-Pump Enter]

Go to

Page4of4

INSTRUMENT PARAMETERS

(Page3of4)

CPB-Pump Enter

Setting the Operating Parameters

7. Audio Tone – The audio tone parameter can be set to [On] or [Off]. When the
audio tone is set to [On], an audio tone will sound for the instrument’s defined
audio indicators (refer to “Audio types” on page 4-8). Audio tone set to [Off]
disables all audio tones except for those associated with alarms.

a. Press the Audio Tone variable function key to select the parameter.

b. If needed, press the Audio Tone variable function key again to toggle to the

desired setting (On or Off).

c. Press the Enter key to accept the value.

8. All Channel Detect – The all channel detect parameter can be set to [On] or
[Off] for use with Heparin Assay (HPT) tests. When set to [On], the instrument
continues HPT tests until all channels in the cartridge detect (clot) or until the
test is stopped. When set to [Off], the test stops after the first channel in the
HPT cartridge detects. It has no influence on other tests performed with the
HMS Plus instrument.

a. Press the All Ch Detect variable function key to select the parameter.

b. If needed, press the All Ch Detect variable function key again to toggle to the

desired setting (On or Off).

c. Press the Enter key to accept the value.

9. Dispenser – The dispenser can be set to [On] or [Off] (enabled or disabled) to
control sample dispensing when the Start/Stop key is pressed. If the dispenser is
[Off], an alternative method must be used to deliver samples into the cartridges.

a. Press the Dispenser variable function key to select the parameter.

b. If needed, press the Dispenser variable function key again to toggle to the

desired setting (On or Off).

c. Press the Enter key to accept the value.

Figure 3-7. Instrument Parameters Screen (Page 3)

10. Date–yyyy-mm-dd– The date is entered where yyyy = year (accepted range
1998 to 2097), mm = month (accepted range 01 to 12), and dd = days (accepted
range 01 to 31).

a. Press the Date - yyyy-mm-dd variable function key to select the parameter.

b. Enter appropriate values for yyyy-mm-dd.

c. Press the Enter key to accept the values entered.

HMS Plus Operator’s Manual 3-13

Chapter 3

Setting the Operating Parameters

11. Time–hh:mm– The time is entered based on a 24-hour clock where
hh = hours (accepted range 00 to 23) and mm = minutes (accepted range
00 to 59).

a. Press the Time - hh:mm variable function key to select the parameter.

b. Enter appropriate values for hh:mm.

c. Press the Enter key to accept the values entered.

12. Language – The HMS Plus screens can be set for English, French (Français),
Italian (Italiano), German (Deutsch), or Spanish (Español).

a. Press the Language variable function key to select the parameter.

b. If needed, press the Language variable function key to toggle until the desired

language is displayed.

c. Press the Enter key to accept the value.

13. Location – The HMS Plus instrument has five (5) choices available for the
location where the instrument will be used:

■

CPB-Pump Enter – Cardiopulmonary Bypass where the quantity of heparin
that is to be added to the extracorporeal prime is entered by the operator.

■

CPB-Pump Calc – Cardiopulmonary Bypass where the HMS Plus instrument
calculates the quantity of heparin that is to be added to the extracorporeal
prime (based on patient needs and data entered).

■

Cath Lab – Catheterization Laboratory where no pump data is entered (ie,
Pump Heparin and Pump Volume).

■

ICU/CCU/Lab – Intensive Care Unit/Critical Care Unit/Clinical Laboratory
where no pump data is entered (ie, Pump Heparin and Pump Volume).

■

Test Only – Test Only location where tests are run without patient data.

Note: The location selected determines the information that can be entered, the
calculations that are performed, and the information displayed on the screen.
Refer to “Use Locations and Results Displayed” on page 3-5 for further
information.

a. Press the Location variable function key to select the parameter.

b. If needed, press the Location variable function key to toggle until the desired

location choice is displayed.

c. Press the Enter key to accept the value.

3-14 HMS Plus Operator’s Manual

Installation and Setup

1

234 5

Back to
Page3of4

Exit to

Main Menu

DEFAULT PROTOCOL PARAMETERS

(Page 4 of 4)

CPB-Pump Enter

Set Default
Parameters

Go to Next

Patient

Protocol Hep Conc
Pump Heparin
Pump Volume
ACT Target Time

: 3.0 mg/kg
: 0 units
: 0 ml
: 0 secs

Patient 4

Protocol Hep Conc
[3.0 mg/kg]

Pump Heparin
[10,000 units]

Pump Volume
[1000 ml]

ACT Target Time

[480 secs]

Exit to Default

Protocol Params

PATI ENT 1

DEFAULT PROTOCOL PARAMETERS

CPB-Pump Enter

Patient: 1

Setting the Operating Parameters

Figure 3-8. Default Protocol Parameters Setup Screen (Instrument Parameters Page 4 of 4).

14. Set Default Protocol Parameters – Up to five different default protocol
parameters can be preset and held in the memory of the HMS Plus instrument.
These parameters are identified as patients 1 through 5 on the DEFAULT
PROTOCOL PARAMETERS setup screen (INSTRUMENT PARAMETERS
Page4of4).

Entering Default Protocol Parameters

The DEFAULT PROTOCOL PARAMETERS SETUP screen appears as shown in
Figure 3-8.

Set Default Protocol Parameters

The DEFAULT PROTOCOL PARAMETERS entry screen appears as shown in
Figure 3-9. This screen can be accessed from the DEFAULT PROTOCOL
PARAMETERS screen by pressing the Set Default Parameters key.

Figure 3-9. Default Protocol Parameters Entry Screen

HMS Plus Operator’s Manual 3-15

Chapter 3

Setting the Operating Parameters

1. Protocol Hep Conc – The protocol heparin concentration is the desired heparin
concentration to be maintained throughout the procedure for heparin dosing and
maintenance. This parameter is displayed in units/milliliter, units/kilogram, or
milligrams/kilogram (u/mL, u/kg, mg/kg). These units are set in the
INSTRUMENT PARAMETERS screen (refer to “Entering Instrument
Parameters” on page 3-11). Acceptable ranges for the protocol heparin
concentration are: 0.1 – 9.9 u/mL, 10 – 730 u/kg, and 0.1 – 7.3 mg/kg.

a. Press the Protocol Hep Conc variable function key to select the parameter.

b. Enter an appropriate “Protocol Hep Conc” value.

c. Press the Enter key to accept the value.

Note: At the completion of an HDR test, the calculated projected heparin
concentration “Projected Heparin Conc” will replace the “Protocol Hep Conc”
parameter that was entered. Refer to “Confirm Patient Screen” on page 5-9 for
more information.

2. Pump Heparin – The pump heparin is the quantity of heparin (in units) to be
added to the extracorporeal prime. It is only applicable when the location of
instrument use is set to [CPB-Pump Enter]. If the location parameter is set to
[CPB-Pump Calc], the message (“Pump Heparin preset by instrument”) appears
when the Pump Heparin variable function key is pressed; no value can be
entered in this instance as the value is calculated by the HMS Plus instrument.
The acceptable range for pump heparin is 0 – 99999 units.

a. Press the Pump Heparin variable function key to select the parameter.

b. Enter an appropriate “Pump Heparin” value.

c. Press the Enter key to accept the value.

3. Pump Volume – The pump volume is the volume (in mL) of the extracorporeal
prime. It is only applicable when the location of instrument use is set to
[CPB-Pump Enter] or [CPB-Pump Calc]. The acceptable range for pump volume
is 0–9999mL.

a. Press the Pump Volume variable function key to select the parameter.

b. Enter an appropriate “Pump Volume” value.

c. Press the Enter key to accept the value.

4. Activated Clotting Time (ACT) Target Time – The ACT target time is the
desired reference time (in seconds) for Heparin Dose Response (HDR) tests.
This reference is the shortest heparinized HR-ACT that would be acceptable
after the bolus dose of heparin is given. The acceptable range for ACT Target
Time is 0 – 999 seconds (sec).

a. Press the ACT Target Time variable function key to select the parameter.

b. Enter an appropriate “ACT Target Time” value.

c. Press the Enter key to accept the value.

If no modifications are made to the default protocol parameters, the instrument default
parameters are applied.

Instrument Parameters Printout

All settings for the instrument parameters may be verified by a printout. Once the
values are entered, simply press the Print key. The format of the printout is shown in
Figure 3-10.

Note: The printout can be obtained from any of the first three (3) Instrument
Parameter screens discussed in this section and all parameter information will
appear on the printout.

3-16 HMS Plus Operator’s Manual

Installation and Setup

HMS PLUS S/ N 1234567

CPB-Pump Enter

INSTRUMENT PARAMETERS

2011-02-15
Block Temp:

Time: 14:49

37.0 Deg C

Hep Conc Units:
Hep Type:
Prot-Hep Ratio:
Protamine Units:
Confirm Pat:
Output Mode:
Audio Tone:
All Ch Detect:
Dispenser:
Language:
Location:

mg/kg

[IU]

1.1:1
mg

On

Auto

On
Off
On

English

CPB-Pump Enter

Setting the Operating Parameters

Figure 3-10. Instrument Parameters Printout

Default Protocol Parameters Printout

To print the five sets of default protocol parameters, press the Print key when either
the DEFAULT PROTOCOL PARAMETERS setup screen or the DEFAULT
PROTOCOL PARAMETERS entry screen appears on the HMS Plus instrument.

The format of the printout is shown in Figure 3-11.

HMS Plus Operator’s Manual 3-17

Chapter 3

CPB-Pump Enter

DEFAULT PROTOCOL PARAMS

2011-02-15
Block Temp:

Time: 14:49

37.0 Deg C

Pat Number: 1
Protocol
Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:

Pat Number: 2
Protocol
Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:

Pat Number: 3
Protocol
Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:

Pat Number: 4
Protocol
Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:

Pat Number: 5
Protocol
Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:

3.0 mg/kg

10000 units

1000 ml

480 secs

3.0 mg/kg

10000 units

1000 ml

480 secs

3.0 mg/kg

10000 units

1000 ml

480 secs

3.0 mg/kg

10000 units

1000 ml

480 secs

3.0 mg/kg

10000 units

1000 ml

480 secs

Setting the Operating Parameters

HMS PLUS S/N 1234567

Figure 3-11. Default Protocol Parameters Printout

3-18 HMS Plus Operator’s Manual

Entering Cartridge Lot Numbers and Expiration Dates

1 PID: 34567

CARTRIDGE LOT/EXP DATE

Page1of6

Scroll

Exit to

Main Menu

ACT
Black
Blue
Gold

Entering Cartridge Lot Numbers and Expiration Dates

Set Cartridge Lot Numbers and Expiration Dates

The CARTRIDGE LOT/EXP DATE screen appears as shown in Figure 3-12. This
screen can be accessed from the MAIN MENU screen by pressing the Cartridge

Lot/Exp Date key.

Installation and Setup

Figure 3-12. Cartridge Lot/Exp Date Screen

Note: The names of cartridges disabled by the Quality Control Manager (refer to

“Enable/Disable Cartridges” on page 3-30) will not appear in the CARTRIDGE
LOT/EXP DATE and CONTROL SETUP screen lists. Select the cartridges to be used
before entering lot information.

Using the Bar Code Scanner

When there is no or one lot number for a cartridge type:

1. Scan the bar code on the cartridge box. The lot number and expiration date will
automatically populate their respective fields.

2. To return to the MAIN MENU, select Exit to Main Menu.

When two lot numbers exist for a cartridge type:

1. Select Remove Lot.

2. To remove one of the lot numbers, toggle to the appropriate lot number by using
the Up/Down keys to highlight the number of the lot to be removed.

3. To delete the selected cartridge lot number, select Remove Selected Lot.

4. Scan the bar code on the cartridge box. The lot number and expiration date will
automatically populate their respective fields.

5. To return to the MAIN MENU, select Exit to Main Menu.

Note: For some cartridge types (ie, Heparin Dose Response [HDR] and Heparin
Assay [HPT]), after scanning, the HMS Plus instrument will prompt for the storage
method (refrigerated or room temperature) to determine the proper expiration date.

HMS Plus Operator’s Manual 3-19

Chapter 3

Entering Cartridge Lot Numbers and Expiration Dates

Manual Data Entry

1. Up/Down Keys – These keys provide navigation within the list of cartridges.
When the keys are solid triangles, the cartridge list changes by page. When the
keys are arrows, the highlighted cartridge changes line by line.

a. Press the Up/Down keys to arrive at the desired point in the cartridge list.

b. Use the Scroll variable function key (described below) to change the

navigation mode.

2. Scroll – Use this key to toggle between the two navigation modes for the
Up/Down Keys.

a. Press the Scroll variable function key to change the navigation mode. See

Up/Down Keys above for a description of the navigation modes.

b. Use the Up/Down keys to arrive at the desired point in the cartridge list.

c. Press the Scroll key again to change the navigation mode if desired.

3. Toggle Active – This key is used to select the current active lot of cartridges to
be used for tests.

Note: This key only appears on the screen when there are two lot numbers.

a. Use the Up/Down and Scroll variable function keys to highlight the cartridge

for changing the active lot.

b. Press the Toggle Active variable function key to select the active lot.

c. An asterisk (*) will appear next to the current active lot.

4. Edit Cartridge – When this key is pressed, a set of key options appears on the
screen to provide for editing, adding, or removing cartridge lots. The screen then
appears as shown in Figure 3-13. See below for those key functions.

a. Use the Scroll variable function key to change the arrow type.

b. Use the Up/Down keys to highlight the cartridge to be edited.

c. Press the Edit Cartridge variable function key to edit the cartridge.

d. If no cartridge lots have been entered, press the Add Lot Number and Add

Exp Date variable function keys to add cartridge lot information. If one
cartridge lot has been entered already, use the Edit Lot, Remove Lot, and
Add Cartridge Lot variable function keys to add or edit lot information. If two
cartridge lots have been entered, use the Edit Cartridge and Toggle Active
variable function keys to edit cartridge lot information or to change the active
lot.

e. Press the Exit to Cart Selection variable function key to return to the cartridge

list.

Note: When the Edit Cartridge key is pressed, the CARTRIDGE LOT/EXP DATE
screen appears as shown in Figure 3-13.

3-20 HMS Plus Operator’s Manual

Installation and Setup

ACT
Black
Blue

Gold

1 PID: 34567

CARTRIDGE LOT/EXP DATE

Page1of6

Edit Lot

Exit to Cart

Selection

Remove Lot

Add Cartridge

Lot

*0304000116

Entering Cartridge Lot Numbers and Expiration Dates

↑

Figure 3-13. Cartridge Lot/Exp Date Screen after Edit Cartridge is pressed

Note: Toggle Active appears in place of Add Cart. Lot when two lots have

already been entered.

5. Edit Lot – When this key is pressed, a set of key options appears on the screen
to provide for editing the lot number and/or expiration date of the selected
cartridge. The screen then appears as shown in Figure 3-13. See below for
those key functions.

a. Press the Edit Lot variable function key to display the lot edit keys.

b. Use the Up/Down and Scroll variable function keys to highlight the lot to be

edited if necessary.

c. Use the Edit Lot Number and Edit Exp Date variable function keys to edit the

lot.

d. Press the Exit to Cart Selection variable function key to return to the cartridge

list.

6. Edit Lot Number – This key is used to change an existing lot number.

a. Press the Edit Lot Number variable function key to select the parameter.

b. Enter the cartridge lot number.

Notes:

■

Some HEPtrac EQC cartridges contain the letters “HEP” in the serial number.
When entering a HEPtrac serial number in this location, press the decimal
(“.”) key to enter “HEP” in the Lot Number field.

■

Entry of “Exp Date” is not needed for the EQC/HEPtrac.

c. Press the Enter key to accept the number.

7. Edit Exp Date – This key provides for changing an existing expiration date.

a. Press the Edit Exp Date variable function key to select the parameter.

b. Enter the cartridge expiration date in the format shown. Enter the last two digits

of the year (eg, 11), and it will be printed as four digits (eg, 2011).

c. Press the Enter key to accept the expiration date.

8. Remove Lot – This key is used to completely remove a lot from the list.

a. Press the Remove Lot variable function key to select the parameter.

b. Use the Up/Down keys to highlight the number of the lot to be removed.

c. Press the Remove Selected Lot variable function key to remove the lot.

↓

HMS Plus Operator’s Manual 3-21

Chapter 3

CONTROL SETUP

PAG E 1 OF 3

Scroll

Exit to

QC Setup

ACT Abnormal 1234567890 *1234567891
ACT Normal
Blue/Gold
Green/White

*2345678901

Entering Control Lot Numbers and Expiration Dates

d. Press the Exit to Cart Selection variable function key to return to the cartridge

list.

9. Add Cartridge Lot – This key appears instead of Toggle Active when one lot
has been entered already. When this key is pressed, a set of key options
appears on the screen to provide for editing the lot number and/or expiration
date of the selected cartridge. The screen then appears as shown in
Figure 3-13. See below for those key functions.

a. Press the Add Cartridge Lot variable function key to display the Add Lot keys.

b. Use the Add Lot Number, and Add Exp Date variable function keys to add lot

information.

c. Press the Exit to Cart Selection variable function key to return to the cartridge

list.

Entering Control Lot Numbers and Expiration Dates

Set Control Lot Numbers and Expiration Dates

The CONTROL SETUP screen appears as shown in Figure 3-14. This screen can be
accessed from the QUALITY CONTROL SETUP screen by pressing the Control

Lot/Exp variable function key.

Using the Bar Code Scanner

When there is no or one lot number for a control type:

1. Scan the bar code on the control box. The lot number and expiration date will

3-22 HMS Plus Operator’s Manual

automatically populate their respective fields.

2. The upper- and lower-range limits for the control lot must be entered before
running an HR-ACT QC test.

Note: The Set Range key shows on the screen only when editing
“ACT Abnormal” or “ACT Normal” controls. HPT controls have a preset range.

a. Press the Set Range variable function key to select the parameter.

Figure 3-14. Control Setup Screen

Installation and Setup

Entering Control Lot Numbers and Expiration Dates

b. Press the Low Range variable function key, then enter the low-range number.

Press the Enter key to accept the range.

c. Press the High Range variable function key, then enter the high-range

number. Press the Enter key to accept the range.

d. Press the Exit to Control Selection variable function key to return to the

control list.

3. To return to the QUALITY CONTROL MENU screen, select Exit to Quality
Control Menu.

When two lot numbers exist for a control type:

1. To remove one of the lot numbers, select Remove Lot.

2. To delete the selected control lot number, toggle to the appropriate lot number by
using the Up/Down keys to highlight the number of the lot to be removed.

3. To delete the selected control lot number, select Remove Selected Lot.

4. To enter the new lot number, scan the bar code on the control box. The lot
number and expiration date will automatically populate their respective fields.

5. To enter the range for the control, select Set Range.

a. Use the Up/Down keys to highlight the number of the lot to have the range set.

b. Press the Low Range variable function key, then enter the low-range number.

Press the Enter key to accept the range.

c. Press the High Range variable function key, then enter the high-range

number. Press the Enter key to accept the range.

6. To return to the QUALITY CONTROL MENU screen, select Exit to Quality

Control Menu.

Note: The names of cartridges disabled by the Quality Control Manager (refer to

“Enable/Disable Cartridges” on page 3-30) will not appear in the CARTRIDGE
LOT/EXP DATE and CONTROL SETUP screen lists. Select the cartridges to be
used before entering lot information.

Manual Data Entry

1. Up/Down Keys – These keys are used to navigate within the list of controls.
When the keys appear as solid triangles, the control list changes by page. When
the keys appear as arrows, the highlighted control changes by line.

a. Press the Up/Down keys to arrive at the desired point in the control list.

b. Use the Scroll variable function key (described below in 2a.) to change the

navigation mode.

2. Scroll – Use this key to toggle between the two navigation modes for the
Up/Down keys.

a. Press the Scroll variable function key to change the navigation mode. See

Up/Down Keys (explained above in 1.) for a description of the navigation
modes.

b. Use the Up/Down keys to arrive at the desired point in the control list.

c. Press the Scroll key again to change the navigation mode if desired.

3. Toggle Active – This key appears only when two lot numbers have been
entered already. It is used to select the current active lot of controls to be used
for tests.

a. Use the Up/Down and Scroll variable function keys to highlight the control for

changing the active lot.

b. Press the Toggle Active variable function key to select the active lot.

HMS Plus Operator’s Manual 3-23

Chapter 3

CONTROL SETUP

PAG E 2 OF 3

Set Range

Exit to Control

Selection

Remove Lot

Add Lot/Exp
Date

ACT Abnormal 1234567890 *1234567891
ACT Normal
Blue/Gold
Green/White

*2345678901

Entering Control Lot Numbers and Expiration Dates

c. An asterisk (*) will appear next to the current active lot.

4. Edit Control – When this key is pressed, a set of key options appears on the
screen that provide for adding, removing, or setting the range of control lots. The
screen then appears as shown in Figure 3-15. See below for those key
functions.

a. Use the Up/Down and Scroll variable function keys to highlight the control to

be edited.

b. Press the Edit Control variable function key to select the control to be edited.

c. Use the Add Lot/Exp Date, Set Range, and Remove Lot variable function

keys to edit the control.

d. Press the Exit to Control Selection variable function key to return to the

control list.

When the Edit Control key is pressed, the CONTROL SETUP screen appears as
shown in Figure 3-15.

Figure 3-15. Control Lot/Exp Date Screen after Edit Control is pressed

5. Add Lot/Exp Date – When this key is pressed, a set of key options appears on
the screen that are used to edit the lot number and/or expiration date of the
selected control. The screen then appears as shown in Figure 3-16. See below
for those key functions.

a. Press the Add Lot/Exp Date variable function key to display the Lot Edit keys.

b. Use the Up/Down and Scroll variable function keys to highlight the lot to be

edited if necessary.

c. Use the Add Lot Number, Add Exp Date, and Toggle Active variable

function keys to edit the lot.

d. Press the Exit to Control Selection variable function key to return to the

control list.

When the Add Lot/Exp Date key is pressed, the CONTROL SETUP screen appears
as shown in Figure 3-16.

3-24 HMS Plus Operator’s Manual

Installation and Setup

CONTROL SETUP

PAG E 3 OF 3

Add Exp Date

Exit to Control

Selection

Add Lot Number
[]

Set Range

ACT Abnormal 1234567890 *1234567891
ACT Normal
Blue/Gold
Green/White

*2345678901

Entering Control Lot Numbers and Expiration Dates

Figure 3-16. Control Lot/Exp Date Screen after Lot/Exp Date is pressed

6. Add Lot Number – This key is used to change an existing lot number.

a. Press the Add Lot Number variable function key to select the parameter.

b. Enter the control lot number.

c. Press the Enter key to accept the number.

7. Add Exp Date – This key is used to change an existing expiration date.

a. Press the Add Exp Date variable function key to select the parameter.

b. Enter the control expiration date in the format shown.

c. Press the Enter key to accept the expiration date.

8. Set Range – This key is used to enter the range of an ACTcontrol.

Notes:

■

The upper- and lower-range limits for the control lot must be entered before
running an HR-ACT QC test.

■

The Set Range key shows on the screen only when editing ACT Abnormal or
ACT Normal controls. HPT controls have a preset range.

a. Press the Set Range variable function key to select the parameter.

b. Use the Up/Down keys to highlight the number of the lot to be removed.

c. Press the Low Range variable function key, then enter the low-range number.

Press the Enter key to accept the range.

d. Press the High Range variable function key, then enter the high-range

number. Press the Enter key to accept the range.

e. Press the Exit to Control Selection variable function key to return to the

control list.

9. Remove Lot – This key is used to completely remove a lot from the list.

a. Press the Remove Lot variable function key to select the parameter.

b. Use the Up/Down keys to highlight the number of the lot to be removed.

c. Press the Remove Selected Lot variable function key to remove the lot.

d. Press the Exit to Control Selection variable function key to return to the

control list.

HMS Plus Operator’s Manual 3-25

Chapter 3

Te mp : 3 7. 1° C

QUALITY CONTROL MENU

QC Setup

Verify Dispenser
Volume Delivery

Temperature
Adjustment

QC Due Status

Output QC Results

Exit to

Main Menu

To Begin a QC Test, Press START

QUALITY CONTROL SETUP

Control Lot/Exp

Exit to Quality

Control Menu

QC Manager

Setup

Entering Parameters Determined by the Quality Control Manager

Entering Parameters Determined by the Quality Control Manager

Quality Control Manager Setup

The QUALITY CONTROL MENU screen appears as shown in Figure 3-17. This
screen can be accessed from the MAIN MENU screen by pressing the Quality
Control Menu variable function key. Refer to Section 7: “Maintenance and Quality
Control” for explanation of additional functions performed by the daily user from this
screen.

Note: If the User Lockout function is activated, the ENTER USER ID screen will be
displayed first when the Quality Control Menu variable function key is pressed. This
function is explained in the section below.

The QUALITY CONTROL SETUP screen appears as shown in Figure 3-18. This
screen can be accessed from the QUALITY CONTROL MENU screen by pressing the

QC Setup variable function key.

Figure 3-17. Quality Control Menu Screen

Figure 3-18. Quality Control Setup Screen

3-26 HMS Plus Operator’s Manual

Installation and Setup

QC MANAGER SETUP

(Page1of2)

User ID Setup

Cartridge
[Enable Setup]

QC Lockout
[Off]

QC Interval

Setup

Exit to QC

Setup

Go to

Page2of2

--->>> QC MANAGER <<<---

QC MANAGER SETUP

(Page2of2)

Bar Code Update

Back to
Page1of2

Perm Record

[None]

Purge Records

Exit to

QC Setup

--->>> QC MANAGER <<<---

Entering Parameters Determined by the Quality Control Manager

1. QC Manager Setup – Parameters for controlling instrument access and test
documentation are accessed from the QC MANAGER SETUP screens
(Figure 3-19). Access is protected by a password. Use the following sequence to
access this screen.

a. Press the Quality Control variable function key on the MAIN MENU screen.

b. Enter or scan your User ID if necessary. This will be required if the User

Lockout function is activated.

c. Press the QC Setup variable function key on the QUALITY CONTROL MENU

screen.

d. Press the QC Manager Setup variable function key on the QUALITY

CONTROL SETUP screen.

e. Enter the “QC Manager Password”.

f. The QC MANAGER SETUP screen will now be displayed.

Figure 3-19. Quality Control Manager Setup Screens

HMS Plus Operator’s Manual 3-27

Chapter 3

USER ID SETUP

Add/Delete
User IDs

User Lockout
[Off]

QC Manager Password

Exit to QC

Manager Setup

--->>> QC MANAGER <<<---

Entering Parameters Determined by the Quality Control Manager

2. User ID Setup – When the User ID Setup variable function key is pressed in the
QC MANAGER SETUP screen, the USER ID SETUP screen appears as shown
in Figure 3-20. Functions for controlling user access by identification are
available in this screen.

3. Add/Delete User IDs – When the Add/Delete User IDs variable function key is
pressed in the USER ID SETUP screen, the ADD/DELETE USER IDs screen
appears. The list of authorized users is maintained in this screen.

a. Press the Add variable function key to add a new user. Enter or scan the new

User ID number. Press the Enter key to accept the User ID number.

Note: Use the A..Z and Z..A variable function keys along with the decimal (“.”)
key to enter alpha characters. To enter an alpha character, press the “.” key,
then navigate to the desired letter using the A..Z and Z..A keys.

b. Press the Delete key to remove a user from the list. If necessary, press the

Up/Down keys to arrive at the desired point in the user list. Press the Delete
Selection key to confirm deletion once the User ID has been selected.

4. User Lockout – If enabled, this function requires entry of an authorized User ID
number in order to run a test.

Note: If User Lockout is turned on, you must enter a valid user identification
number (UID) to gain access to the QUALITY CONTROL MENU screen from the
MAIN MENU screen. Valid UIDs are those displayed on the ADD/DELETE
USER IDs screen, described above.

a. Press the User Lockout variable function key to toggle between [On] and [Off].

b. Press the Enter key to accept the parameter.

5. QC Manager Password – This function allows the QC Manager to change the
password that provides entry into the QC Manager screens.

a. Press the QC Manager Password variable function key to select the

parameter.

b. Enter the new password and press the Enter key.

c. Enter the new password and press the Enter key again to confirm and accept

the new password.

Note: BE CERTAIN TO REMEMBER THE PASSWORD. IT IS REQUIRED IN
ORDER TO ACCESS THE QC MANAGER FUNCTIONS.

Figure 3-20. User ID Setup Screen

3-28 HMS Plus Operator’s Manual

Installation and Setup

QC INTERVAL SETUP

Liquid Interval
[None]

EQC/HEPtrac Interval
[None]

Exit to QC

Manager Setup

--->>> QC MANAGER <<<---

Entering Parameters Determined by the Quality Control Manager

6. Perm Record – The HMS Plus instrument can track either printed or electronic
records to monitor output status. The Perm Record (Permanent Record) key is
used to select the record type that will be tracked by the HMS Plus instrument for
output status. When space remains for 20 test records, the display will show a
warning. This indicates that non-outputted records should be sent to avoid
overwriting old test records with new ones.

a. From the QC MANAGER SETUP screen, press the Perm Record variable

function key to toggle between [None], [Printed], and [Electronic].

b. Press the Enter key to accept the parameter.

Note: If using the optional HMS Plus External Data Manager, it is recommended
that the Perm Record setting be [Electronic].

7. Purge Records – Select this option if you wish to erase all patient and QC test
records from the device (eg, to protect patient privacy before service).

Note: The HMS Plus instrument will prompt you for a confirmation that you are
sure you wish to permanently delete these records. It will also tell you if your Perm
Record setting is set to [Electronic] or [Printed], and some records have yet to be
exported.

8. Bar Code Update – On occasion, Medtronic may offer updates to the HMS Plus
system to support new cartridges and controls. If instructed to do so by a
Medtronic representative, simply activate the BAR CODE ENTRY screen and
scan the new bar code that is delivered to you.

9. QC Lockout – The HMS Plus instrument can either warn or prevent the user
from running patient tests, based on QC status. When this parameter is set to
[On], patient tests cannot be run if their quality control is overdue or has failed.
When set to [Warning], a message will appear on the display and print out to
indicate an overdue quality control.

Note: If the QC interval expires while running patient tests, and “QC Lockout” is
set to [On], the user is permitted to continue running tests on the same patient.

a. From the QC MANAGER SETUP screen, press the QC Lockout variable

function key to toggle between [Off], [On], and [Warning].

b. Press the Enter key to accept the parameter.

Figure 3-21. Quality Control Interval Setup Screen

HMS Plus Operator’s Manual 3-29

Chapter 3

CARTRIDGE ENABLE/DISABLE

PAG E 1 OF 3

Scroll

Exit to

Manager Setup

ACT [On]
EQC/HEPtrac [On]
HDR [On]
HPT Black [On]

--->>> QC MANAGER <<<---

Adjusting the Temperature Display

10. QC Interval Setup – When the QC Interval Setup variable function key is
pressed in the QC MANAGER SETUP screen, the QC INTERVAL SETUP
screen appears as shown in Figure 3-21. Liquid and Electronic QC intervals can
be set in this screen.

a. Press the Liquid Interval variable function key to set the liquid QC interval.

Press the Liquid Interval key again to toggle between [None], [8 Hours], and
[7 days]. Press the Enter key to accept the liquid QC interval.

b. Press the EQC/HEPtrac Interval variable function key to set the electronic

QC interval. Press the EQC/HEPtrac Interval key again to toggle between
[None] and [8 Hours]. Press the Enter key to accept the electronic QC interval.

Figure 3-22. Cartridge Enable/Disable Screen

11. Enable/Disable Cartridges – When the Cartridge Enable Setup variable
function key is pressed in the QC MANAGER SETUP screen, the CARTRIDGE
ENABLE/DISABLE screen appears as shown in Figure 3-22. The list of
authorized cartridges is maintained in this screen.

a. Use the Up/Down and Scroll variable function keys to highlight the cartridge

to be enabled or disabled.

b. The cartridge name will appear in the lower left variable function key location.

Press this key to toggle between [On] and [Off].

c. Press the Enter key to accept the cartridge status.

12. Exit to QC Setup – When this key is pressed in the QC MANAGER SETUP
screen, the user leaves the password-protected QC Manager screens and
returns to the QUALITY CONTROL SETUP screen.

Adjusting the Temperature Display

Refer to Section 7: “Maintenance and Quality Control” for instructions on verifying and
adjusting the instrument’s displayed heat block temperature.

3-30 HMS Plus Operator’s Manual

Principles of Operation and Calculations

Cartridge Design 4-2

Types of Test Cartridges 4-3

Actuator/Dispenser 4-4

User Interface Operating Principles 4-6

Instrument Back Panel 4-9

Calculations 4-10

4

4

HMS Plus Operator’s Manual 4-1

Chapter 4

Cartridge Design

The HMS Plus instrument is an integrated system consisting of a component for
tracking clot detection and computing results, a component for sample delivery, and
the single-use test cartridges for actual performance of the tests. The cartridge
instructs the system, through an optical code, as to the type of test or tests being
performed, the calculations and format required for results, and the volume of sample
needed for each channel.

The detection process uses the plunger assembly within the cartridge. This assembly
is lifted and dropped through the sample/reagent mixture by a lifting mechanism in the
HMS Plus actuator. As the sample clots, a fibrin web forms around the daisy, located
on the bottom of the plunger assembly, and impedes the rate of descent of the
assembly. This change in fall rate is detected by a photo-optical system located in the
actuator assembly of the instrument. The end point of the test is the time at which clot
formation is detected; from these clotting times, derived results are calculated for all
tests.

Cartridge Design

All of the test cartridges consist of the following functional components (refer to
Figure 4-1):

Reagent Chamber – The reagent chamber is sealed below by the bottom plug and
above by the plunger assembly. This chamber contains the liquid reagents.

Reaction Chamber – The reaction chamber is located above the reagent chamber
and contains the plunger assembly. The sample is added to this chamber. Upon test
initiation, reagent from the reagent chamber is delivered into the reaction chamber
where it is mixed with the sample by the plunger assembly. The chamber may contain
reagents that are dispensed and dried during the manufacturing process.

Plunger Assembly – Each plunger assembly consists of a plastic flag with a daisy
shaped disc on the bottom. The plunger assembly mixes the sample and reagent and
provides the mechanism for measurement of clot formation.

Optical Code – The optical code is located on the back of each cartridge label. This
bar code identifies to the instrument the type of test and the sample volume required.

4-2 HMS Plus Operator’s Manual

Principles of Operation and Calculations

Optical Code

Plunger Assembly

Reaction Chamber

Reagent Chamber

Figure 4-1. Cartridge Design

Types of Test Cartridges

Types of Test Cartridges

A brief description of the types of test cartridges that are available for use with the
HMS Plus instrument follows.

Note: Refer to the cartridge package inserts for detailed information on each
cartridge before running any tests.

Heparin Dose Response (HDR)

The HDR is a modified HR-ACT, which measures the in vitro anticoagulant response
to a known concentration of heparin. This response can be used to evaluate a
patient’s resistance or sensitivity to heparin. It can also be used to estimate a
minimum heparin dose required to achieve the desired target clotting time
(ACT Target Time).

The HDR is a six-channel cartridge. All six channels contain the same kaolin reagent
used in the HR-ACT cartridge. Channels 1 and 2 contain USP porcine heparin to
reach a sample heparin concentration of 2.84 u/mL. Channels 3 and 4 contain
USP porcine heparin to reach a sample heparin concentration of 1.70 u/mL.
Channels 5 and 6 do not contain heparin and are used to obtain a baseline clotting
time.

A completed HDR calculates the projected heparin concentration to reach the target
activated clotting time entered into the system.

The HDR test also provides the Baseline ACT, individual channel clotting time results,
the calculated slope response to heparin, and the required bolus dose of heparin to
achieve the calculated heparin concentration using the entered patient and protocol
parameters.

HMS Plus Operator’s Manual 4-3

Chapter 4

Actuator/Dispenser

Heparin Assay (HPT)

The Heparin Assay test uses the principle of heparin/protamine titration to
quantitatively determine the concentration of heparin in the sample. Each channel of
the cartridge contains a different amount of protamine with a constant amount of
thromboplastin for activation of the test. The channel that most closely neutralizes the
heparin in the sample will be the first to clot.

The heparin concentration determined by the HPT test is used by the HMS Plus
instrument to calculate any additional heparin required to maintain the patient at the
protocol heparin concentration entered into the system. The system can determine
the heparin requirement for the patient, pump, or the total circuit volume. The heparin
concentration is also used to calculate the protamine dose required for neutralization.

The Heparin Assay is available as either a four- or six-channel test. The four-channel
test allows performance of a simultaneous HR-ACT. The six-channel test provides a
wider range of heparin concentrations to be titrated.

Activated Clotting Time (HR-ACT)

The HR-ACT is a functional evaluation of the intrinsic coagulation system. It evaluates
heparin anticoagulation as well as numerous factors affecting intrinsic clotting (eg,
platelet function, hemodilution and hypothermia).

The HR-ACT is a two-channel cartridge and is performed in Channels 5 and 6 of the
HMS Plus instrument. The test is activated by kaolin suspended in a HEPES buffer
containing calcium. The use of standardized kaolin minimizes lot-to-lot variation.

Actuator/Dispenser

The actuator assembly consists of a heat block, an actuator cover and a sample
dispenser.

Heat Block – The heat block maintains a stable temperature of 37°C ± 0.5°C to
provide optimal testing conditions. Within the heat block are infrared light beams used
for detection. An infrared beam is projected from the front of the heat block through to
the back of the cartridge body. As the plunger assemblies are raised and lowered, the
light beam is broken. The heat block also contains infrared sensors used for cartridge
code reading to identify the cartridge inserted. The dispenser delivers the sample
according to the instructions of the cartridge optical code.

Actuator Cover – The actuator cover assembly contains the plunger lifting assembly
and the infrared light source for cartridge reading. When the Start/Stop key is
pressed, the HMS Plus actuator cover will cycle and the sensors in the heat block will
read the cartridge code to determine the type of tests being performed and the volume
of sample required for each cartridge channel. Once the sample has been pipetted,
the flags will be lifted and then dropped preparing for reagent delivery from the bottom
chamber. After the reagent is delivered, the instrument begins the test by cycling the
plunger up and down.

4-4 HMS Plus Operator’s Manual

Principles of Operation and Calculations

Drive Wheel

Idler Wheel

Lock Switch

(shown locked)

Keyhole Slot

Holder Foot

Needle Hub

Lock Switch Disk

Idler Wheel

Lock Switch Disk

Lock Switch Groove

Drive Wheel

Syringe Plunger
Crossmember

Top V i ew

Syringe Plunger

Crossmember

Actuator/Dispenser

Sample Dispenser – The sample dispenser is used to pipette the blood into the
disposable cartridges (refer to Figure 4-2). The system uses 3-mL Monoject™

1

syringe and 19-gauge blunt needles provided with the cartridges. Additional syringes
and needles can be ordered from Medtronic. The dispenser is normally “parked” to
the right of the actuator block. The syringe is placed in the holding device and locked
in using the lock switch. The lock switch groove captures a syringe plunger
crossmember when it is locked. This prevents the syringe from moving out of the drive
wheel during sample delivery. Upon test initiation, the crossmember of the syringe
plunger is clamped against a roller assembly to enable delivery of the sample. The
dispenser delivers the sample according to the instructions of the cartridge optical
code (refer to Table 4-1 “Cartridge Channel Sample Fill Volumes”).

Tab le 4- 1. Cartridge Channel Sample Fill Volumes

Cartridge Type Cartridge Channel Fill Volume

Heparin Dose Response (HDR) 350 µL*

Heparin Assay (HPT) 240 µL

Activated Clotting Time (HR-ACT) 400 µL

*Milliliter (mL) conversion from microliters (µL): mL = µL/1000

When the sample has been pipetted, the dispenser returns to the parked position.

1

Figure 4-2. HMS Plus Syringe Holder with Syringe

Monoject™ is a trademark of Coridien AG

HMS Plus Operator’s Manual 4-5

Chapter 4

Variable

Function

Keys

Variable
Function
Keys

Main

Menu

Select

Patient

User Interface Operating Principles

User Interface Operating Principles

User Interface Components

The user interface of the HMS Plus instrument contains the LCD screen, the printer,
and all keys for operating the instrument. The HMS Plus instrument also has unique
audio tones to provide notification of instrument operating conditions (eg, key
presses, channel clot detects).

LCD screen, Variable Function keys, Main Menu and Select Patient keys

Refer to Figure 4-3.

The variable function keys on the sides of the LCD screen are used for screen
navigation and to select and change parameter values that appear on the screen.
Refer to “Screen Layout” on page 4-8 for further information on screen layout and the
screen’s Status Message area.

The keys labeled Main Menu and Select Patient provide access to the MAIN MENU
and SELECT PATIENT screens. Refer to Section 3: “Installation and Setup” for a
complete description of these screens.

Figure 4-3. LCD Screen, Variable Function Keys, Main Menu, and Select Patient Keys

Main Keypad

The HMS Plus instrument’s main keypad is shown in Figure 4-4. A description of each
key is provided below. The main keypad is used to enter data and set parameter
values on the HMS Plus screen. The main keypad also contains the Paper Advance
and Print keys, which control operation of the internal printer. The keys described
below, except the Paper Advance and Print keys, are only active once a parameter is
selected. Selecting a value simply means that the value is active and changes can be
made.

To select a value and enter parameters, follow the procedure below.

1. Press the appropriate screen variable function key next to the parameter to be
changed. Once selected, the parameter’s value flashes in inverse video (light
text on dark background). The values for each parameter appear on the screen
within brackets (eg, [mg/kg]).

2. Parameter values are either entered as numeric digits (eg, ID [1492]), or the
value is selected by toggling the parameter’s variable function key until the
desired value appears (eg, Sex [Male] or [Female]).

4-6 HMS Plus Operator’s Manual

Principles of Operation and Calculations

HMS PLUS

Clear

Cancel

Enter

Paper

Advance

Print

User Interface Operating Principles

3. All values selected must either be accepted by pressing the Enter key or

deselected by pressing the Cancel key to retain the old value.

Figure 4-4. Main Keypad

Numeric keys and decimal point – The Numeric keys and Decimal Point are used

for entering numeric digits for screen parameters. A numeric value is entered in a
fixed amount of space allocated for each parameter. As new digits are entered, the
numbers are shifted left as the value is entered. Key presses exceeding the allocated
space for the parameter are ignored and indicated by an audio tone. The decimal
point must be entered by the user in the appropriate place.

Note: The decimal-point key is also used in certain screens to enter alpha characters
into cartridge lot numbers, Patient IDs, and User IDs. Refer to the appropriate
sections for details.

Clear key – The Clear key is used to clear the digits in a selected numeric value.
Once the digit field is cleared, the value remains selected allowing parameter entry to
continue.

Cancel key – The Cancel key deselects the current value during parameter entry and
restores the parameter to its previous value prior to selection.

Enter key – The Enter key is used to accept a selected value. After a value has been
selected and changed, the Enter key must be pressed for the new value to be
accepted. If a value has been selected but not changed, pressing the Enter key
retains the existing value.

Note: When the Enter key is pressed on a selected numeric parameter, the
HMS Plus instrument will check that the value entered is in the accepted range
for that parameter. If the value is in the accepted range, it will be accepted. If not,
a message appears in the screen’s Status Message area indicating the out of
range entry. Refer to “Screen Messages” on page 8-4 for a listing of instrument
messages.

Printer function keys

Print – The Print key is used to print test results for both patient and quality control

tests. Either the last test run or stored tests (Test History feature) may be printed. The
Print key is also used to obtain a printout of the current user-set operating parameters
(patient/protocol, or instrument).

Note: The screen displayed determines what is printed when the Print key
is pressed. Refer to the individual operating parameter and test printout sections

of this manual for the output and format of the printouts.

Paper Advance – The Paper Advance key advances paper through the instrument’s
printer approximately 1.5 in (3.8 cm) for each key press (refer to “Installing Printer
Paper” on page 7-10).

HMS Plus Operator’s Manual 4-7

Chapter 4

Start

Stop

Var iable

SCREEN TITLE

Variable Function Key Text

and

Information Display Area

(PN) PID xxxxxxxxxxxx

Status Message Area

User Interface Operating Principles

Start/Stop key

The Start/Stop key, located above the printer, activates the dispenser mechanism and
is used to start and stop tests. Once a test is started, pressing this key stops the test.
The Start/Stop key also is used to stop the HMS Plus printer.

Bar Code Scanner (Optional)

The optional Bar Code Scanner connects via the RS-232 serial connector and may
be used to scan in patient and user IDs, and cartridge and control lot and expiration
dates (see Appendix A).

Audio types

The HMS Plus instrument supports six (6) unique audio indicators. Audio can be
selected to [On] or [Off] as described in “Entering Instrument Parameters” on
page 3-11. With the Audio Tone parameter set to [On], an audible tone will sound for
the following events: key presses, clot detects in cartridge channels, completion of a
test, invalid key presses, alerts, and system alarms.

Figure 4-5. Start/Stop Key

Screen Layout

Alert audio is presented as a three-beep audio tone. System alarms have a single,
long audio tone. Refer to Section 8: “Service and Troubleshooting” for a description
of alerts, system alarms, and screen messages.

Note: Audio Tone is always active for system alarms.

The layout of the HMS Plus instrument’s screen is shown below, identifying areas on
the screen where information is presented.

Note: Not all items appear on all screens.

4-8 HMS Plus Operator’s Manual

Figure 4-6. Screen Layout

PN – Display area showing the current patient number (1 – 5).

PID – Display area showing the user-entered ID number for the current patient.

Status Message Area – This area provides informational and alert messages during

instrument operation. Messages are highlighted in inverse video (light text on dark
background) and displayed in a priority structure in the event of simultaneous events
occurring. Refer to “Screen Messages” on page 8-4 for a list of screen messages.

Variable – Display area showing either the current heat block temperature or the
selected instrument location. This information does not appear on all screens.

Screen Title – Provides the name (title) of the screen that is displayed (eg, MAIN
MENU, HDR IN PROGRESS, HDR RESULTS).

Variable Function Key Text/Information Display Area – This area is where the
variable function key text is located identifying the menu options for variable function
key presses (eg, View Current Test Results). It is also the main information display
area for all functions of the instrument such as running tests and viewing the results.
Arrows on the screen point to the variable function key for the parameter or navigation
text displayed.

Instrument Back Panel

Principles of Operation and Calculations

Instrument Back Panel

The back panel of the HMS Plus instrument contains the items described below and
shown in Figure 4-7.

1. Main Power Switch — Switches AC power on and off.

2. Ventilation Slots — Provide air cooling for the internal components of the
HMS Plus instrument.

3. Power Inlet Module — IEC 320 power inlet for attachment of power cord, mains
voltage selection and fuses.

4. Fuse — Provides access to the replaceable fuse(s).

5. Serial Connector — RS-232 connector permits installation of a cable for serial
transmission of data and/or bar code scanning (see Appendix A).

HMS Plus Operator’s Manual 4-9

Chapter 4

Calculations

1

2

Calculations

Unit Conversions

3

4

5

Figure 4-7. HMS Plus Rear Panel

The HMS Plus instrument performs numerous calculations based on clotting time
results and patient and protocol parameters.

Note: Due to rounding of internal computations, values calculated by the HMS Plus
instrument may differ slightly from hand-calculations.

The HMS Plus instrument calculates and displays parameters in the units of measure
described below.

Heparin

■

Milligram/kilogram (mg/kg)

■

Units/kilogram (u/kg)

■

Units/milliliter (u/mL)

Protamine

■

Milligram or units (mg or u)

4-10 HMS Plus Operator’s Manual

Patient Parameters

Heparin

(mg/kg) = (u/mL) / 1.36
(u/kg) = (mg/kg) x 100
(u/mL) = (u/kg) x 1.36/100

Protamine

(mg) = 100 units

Patient Parameters

(in) = cm x .3931
(ft) = cm x .0328
(lb) = kg x 2.2

Blood Volume (mL) = aH3+bW+c

H = Height in centimeters (cm)
W = Weight in kilograms (kg)

Blood Volume (mL) = W x ( a - bH )

H = Height in centimeters (cm)
W = Weight in kilograms (kg)

■

Feet/inches (ft/in) or centimeters (cm)

■

Pounds (lb) or kilograms (kg)

Blood Volume Calculations

The HMS Plus instrument uses either an adult or pediatric algorithm to compute blood
volume. These calculations require patient height, weight, and sex entries.

Principles of Operation and Calculations

Calculations

Adult Equation

The adult algorithm is used if the height is greater than or equal to 142 cm (4 ft 8 in)
and/or the weight is greater than or equal to 45 kg (99 lb). This equation was
described by Allen TH, et al.

Male:

a = 0.000417 mL/cm

3

b=45.0mL/kg
c=-30mL

Female:

a = 0.000414 mL/cm

3

b=32.8mL/kg
c=-30mL

Pediatric Equation

The pediatric algorithm is used if the height is less than 142 cm (4 ft 8 in) and/or the
weight is less than 45 kg (99 lb). This algorithm was derived from data published in
Geigy Pharmaceuticals Scientific Tables, 7th edition.

HMS Plus Operator’s Manual 4-11

Chapter 4

BSA (Meters2) = 71.84 x 10-4 x H0.725 x W0.425

H = Patient height in centimeters (cm)
W = Weight in kilograms (kg)

Slope = 1/2 ( Slope1+ Slope2)x0.88

Slope

1

= ; Slope2=

Slope is given in (seconds/unit of heparin/mL)

A = Avg clotting time of Channels 5 & 6 (sec)
B = Avg clotting time of Channels 3 & 4 (sec)
C = Avg clotting time of Channels 1 & 2 (sec)
H=1.5u/mL (heparin Chan3&4–heparin Chan5&6)
I = 1.0 u/mL = (heparin Chan 1 & 2 – heparin Chan 3 & 4)

I

C-B

H

B-A

Projected Heparin Conc = (u/mL)

A = Avg clotting time of Channels 5 & 6
T = ACT Target Time (sec)
S = Slope (seconds/unit of heparin/mL)

T – A

S

350 - 250 sec

1.0 u/mL

Calculations

The constants are independent of patient sex:

a = 92.5 mL/kg
b = 0.129 mL/(kg x cm)

Body Surface Area Calculation

The body surface area (BSA) is calculated using the DuBois equation.

Heparin Dose Response Calculations

The clotting times in an HDR test are used to calculate the patient’s slope response
to heparin.

Slope Calculation(s)

Projected Heparin Concentration

Using the slope, the projected heparin concentration is calculated.

Example:

A = 100 sec
B = 250 sec
C = 350 sec
T = 480 sec

Slope

= = 100 sec/u/mL

1

4-12 HMS Plus Operator’s Manual

Principles of Operation and Calculations

250 - 100 sec

1.5 u/mL

(480 - 100) sec
100 sec u/mL

(u/mL) = 1.36 x (mg/kg)

(u/kg) = 100 x (mg/kg)

(mg/kg) = (u/mL) / 1.36

Patient Bolus Dose (units) = [RH ( V + PV ) ] - PH

RH = Protocol Hep Conc (u/mL)
V = Patient Blood Volume (mL)
PV = Pump Volume (mL)
PH = Pump Heparin (units)

■

Total Bolus Dose (units) = Patient Bolus + Pump Heparin
(units)

Slope2==100sec/u/mL

Slope = 1/2 (100 + 100) sec/u/mL

= 100 sec/u/mL

Projected Heparin Conc

=

=3.8u/mL
=2.8mg/kg
=280u/kg

Unit Conversions for Projected Heparin Concentration

Calculations

Heparin Bolus Dose Calculations

The “Heparin Bolus” results will be calculated based on the values of the heparin
concentration and the pump and the patient volumes. The heparin concentration will
be either the entered “Protocol Hep Conc” or the calculated “Projected Heparin Conc”
from an HDR test. The calculations performed are dependent on the instrument
location selected. If the pump heparin is entered by the user for the [CPB-Pump Enter]
Location, the instrument will calculate the patient and total heparin bolus.
Alternatively, the HMS Plus instrument will calculate the patient, pump, and total
heparin bolus for the [CPB-Pump Calc] Location.

“CPB-Pump Enter” Heparin Calculations

When the pump heparin is entered by the user, the HMS Plus instrument uses this
heparin value to compute the bolus needs for the patient.

Example:

RH = 4.1 u/mL
V = 6000 mL
PV = 2000 mL
PH = 10000 units

Patient Bolus Dose = [4.1 (6000 + 2000)] - 10000 units = 22800 units

HMS Plus Operator’s Manual 4-13

Chapter 4

Total Bolus Dose (units) = RH (V + PV)
Patient Bolus Dose (units) = RH x V
Pump Heparin (units) = RH x PV

RH = Protocol Hep Conc (u/mL)
V = Patient Blood Volume (mL)
PV = Pump Volume (mL)

Heparin Required (units) = V x ( RH - MH )

RH = Protocol Hep Conc (u/mL)
MH = Measured heparin (u/mL)
V = Volume (patient, pump, or total) (mL)

Calculations

Total Bolus Dose = 22800 + 10000 units = 32800 units

“CPB-Pump Calc” Heparin Calculations

For this selection, the pump heparin cannot be entered by the user; the HMS Plus
instrument will compute heparin for the patient and pump. It partitions the final
required heparin so the concentration in the patient and pump are both equal to the
desired heparin concentration.

Example:

RH = 4.1 u/mL
V = 6000 mL
PV = 2000 mL

Total Bolus Dose = 4.1 x (6000 + 2000) units = 32800 units

Patient Bolus Dose = 4.1 x 6000 units = 24600 units

Pump Heparin = 4.1 x 2000 units = 8200 units

Heparin Assay Calculations

Heparin Required

Heparin Assay results include calculation of required heparin and protamine for the
patient, pump or total volume.

Example:

RH = 4.1 u/mL
MH = 3.4 u/mL
V = 6000 mL

Heparin Required = 6000 (4.1 - 3.4) units = 4200 units

4-14 HMS Plus Operator’s Manual

Protamine Dose

Protamine Dose (units) = ( MH x V ) x P : H

MH = Measured heparin (u/mL)
V = Volume (patient, pump, or total) (mL)
P : H = Protamine – Heparin Ratio

Pair Spread = |ChX - ChY|/ (Avg. of ChX and ChY)

ChX and ChY are a channel pair

HDR: (X=1, Y=2), (X=3, Y=4), (X=5, Y=6)
ACT: X=5, Y=6

Example:

Protamine Dose = (3.4 x 6000) x 1.1 units = 22440 units (224 mg)

Protamine Dose is given in units or milligrams (mg) based on user selection of the
Protamine Units parameter.

Pair Spread Calculations

At the completion of an HDR and HR-ACT test, the HMS Plus instrument will
calculate the pair spread as described in the calculation below. If the pair spread is
greater than ± 12% for the HDR or greater than 12% for the HR-ACT, an alert
message appears. This calculation is done to determine whether an inaccuracy exists
with paired data.

Principles of Operation and Calculations

Calculations

MH = 3.4 u/mL
V = 6000 mL
P:H=1.1

HMS Plus Operator’s Manual 4-15

Chapter 4

Calculations

4-16 HMS Plus Operator’s Manual

Operating Instructions

General Operation 5-2

Recommended Protocol 5-11

Test Results Calculated 5-12

Running a Heparin Dose Response (HDR) 5-13

Running a Heparin Assay (HPT) 5-20

Running an HR-ACT 5-28

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens 5-31

5

5

Differential Diagnosis of Postsurgical Bleeding 5-35

View Current Test Results 5-36

Test History Menu 5-37

HMS Plus Operator’s Manual 5-1

Chapter 5

1

2345

PATIENT/PROTOCOL PARAMETERS

Set Patient
Parameters

Go to Next

Patient

Exit to

Main Menu

Set Protocol
Parameters

PID: 34567
Sex: Male
Height: 170 cm
Weight: 70 kg

BV: 5000 ml
BSA: 1.7 sq meters
Bolus: 14600 units
UID: 1234567

1 PID: 34567

General Operation

To provide the best possible heparin management, Medtronic recommends that the
protocol described in this section be used before, during and after cardiopulmonary
bypass surgery. Specific instructions on how to use the cartridges are also given in
the individual cartridge package inserts.

Refer to Section 2: “Warnings and Operational Precautions” before performing any
tests.

Instructions for multiple patient operation can be found in the section titled “Multiple
Patient Operation” on page 3-8.

The HMS Plus system is intended for operation only by a trained and qualified
medical professional.

The screen and printout values shown in this manual are intended for illustration only.
These illustrated values are not intended to match actual results obtained during
instrument use.

General Operation

Maintenance and Quality Control

Refer to Section 7: “Maintenance and Quality Control” and the individual cartridge
and control package inserts.

Operating Parameters

Patient, protocol, and instrument operating parameters appropriate to your clinical
needs are entered into the HMS Plus system prior to performing the tests described
in this section. Setting these parameters is described in Section 3: “Installation and
Setup”.

Entering Patient and Protocol Parameters

The PATIENT/PROTOCOL PARAMETERS screen appears as shown in Figure 5-1.

5-2 HMS Plus Operator’s Manual

To set the patient and protocol parameters, do the following:

Figure 5-1. Patient/Protocol Parameters Screen

Operating Instructions

1 PID: 34567

PATI E N T 1 PA R AMETERS

PID
[34567]

Sex
[Male]

Weight
[70 kg]

UID

[1234567]

Exit to Patient

Protocol Params

BV: 5000 ml BSA: 1.7 sq meters

Bolus: 14600 units

Height
[170 cm]

General Operation

1. From the MAIN MENU screen, press the Patient/Protocol Parameters variable
function key to display the PATIENT/PROTOCOL PARAMETERS screen.

2. Press the Go to Next Patient variable function key until the desired patient is
selected. The Enter key does not have to be pressed to select the new patient.

Note: A patient can be selected using the SELECT PATIENT screen; however,
parameters cannot be changed from this screen.

3. Press either the Set Patient Parameters or Set Protocol Parameters variable
function key to access the PATIENT PARAMETERS or PROTOCOL
PARAMETERS screen(s).

4. Follow the instructions below for each parameter value to be set.

Set Patient Parameters

The PATIENT PARAMETERS screen appears as shown in Figure 5-2.

1. PID – The PID (patient Identification) is a unique identifier that is entered for
each patient. The instrument stores data for up to five patients. The acceptable
values for the patient ID are numeric digits 0 – 9. The maximum number of digits
that can be entered is 12.

a. Press the PID variable function key to select the parameter.

b. Scan or enter an appropriate “PID” using the numeric keypad.

c. Press the Enter key to accept the value.

2. Sex – Male or Female can be entered.

a. Press the Sex variable function key to select the parameter.

b. If needed, press the Sex variable function key again to toggle the value to

desired setting.

c. Press the Enter key to accept the value.

3. Height – Patient height can be entered in centimeters (cm) or feet-inches
(ft – in). The acceptable range for centimeters is 0 – 302 cm. The acceptable
range for feet is 0–9ft. The acceptable range for inches is dependent on the
setting for feet. If feet is entered as 0, the inches range is 0 – 99. If feet is
entered > 0, the inches range is 0 – 11. When entering inches only, a zero must
first be entered for the feet value.

a. Press the Height variable function key to select the parameter.

Figure 5-2. Patient Parameters Screen

HMS Plus Operator’s Manual 5-3

Chapter 5

1 PID: 34567

PATIENT 1

PROTOCOL PARAMETERS

Protocol Hep Conc
[3.0 mg/kg]

Pump Heparin
[10000 units]

ACT Target Time

[480 secs]

Go to Patient

Parameters

Exit to Patient

Protocol Params

Pump Volume
[1000 ml]

General Operation

b. If needed, press the Height variable function key again to toggle the units

(ft – in / cm).

c. Enter an appropriate “Height” value.

If the selected units are ft – in, the first value entered is the feet “ft” value and
the second and third values entered will be the inches “in” values.

d. Press the Enter key to accept the value.

4. Weight – Patient weight can be entered in kilograms (kg) or pounds (lb). The
acceptable range for kg units is 0.0 – 454.1 kg. The acceptable range for lb units
is 0 – 999 lb.

a. Press the Weight variable function key to select the parameter.

b. If needed, press the Weight variable function key again to toggle the units

(kg or lb).

c. Enter an appropriate “Weight” value.

d. Press the Enter key to accept the value.

5. User ID – If the user lock out is on, “User ID” must be entered or scanned to
save patient information.

Set Protocol Parameters

The PROTOCOL PARAMETERS screen appears as shown in Figure 5-3. This
screen can be accessed from either the PATIENT PARAMETERS screen or the
SELECT PATIENT screen.

Up to five different sets of patient protocol parameters can be preset and held in the
memory of the HMS Plus instrument. Refer to “Entering Patient and Protocol
Parameters” on page 5-2 for details on setting up these default parameters.

6. Protocol Hep Conc – The protocol heparin concentration is the desired heparin
concentration to be maintained throughout the procedure for heparin dosing and
maintenance. This parameter is displayed in units/milliliter (u/mL),
units/kilogram (u/kg), or milligrams/kilogram (mg/kg). These units are set in the
INSTRUMENT PARAMETERS screen (refer to “Entering Instrument
Parameters” on page 3-11). Acceptable ranges for the protocol heparin
concentration are 0.1 – 9.9 u/mL, 10 – 730 u/kg, and 0.1 – 7.3 mg/kg.

a. Press the Protocol Hep Conc variable function key to select the parameter.

Figure 5-3. Protocol Parameters Screen

5-4 HMS Plus Operator’s Manual

Operating Instructions

General Operation

b. Enter an appropriate “Protocol Hep Conc” value.

c. Press the Enter key to accept the value.

Note: At the completion of an HDR test, the calculated projected heparin
concentration “Projected Heparin Conc” will replace the “Protocol Hep Conc”
parameter that was entered. Refer to “Projected Heparin Conc” on page 5-15 for
more information.

7. Pump Heparin – The pump heparin is the quantity of heparin (in units) to be
added to the extracorporeal prime. It is only applicable when the location of
instrument use is set to [CPB-Pump Enter.] If the location parameter is set to
[CPB-Pump Calc], the message (“Pump Heparin preset by instrument”) appears
when the Pump Heparin variable function key is pressed; no value can be
entered in this instance, as the value is calculated by the HMS Plus instrument.
The acceptable range for pump heparin is 0 – 99999 units.

a. Press the Pump Heparin variable function key to select the parameter.

b. Enter an appropriate “Pump Heparin” value.

c. Press the Enter key to accept the value.

8. Pump Volume – The pump volume is the volume (in mL) of the extracorporeal
prime. It is only applicable when the location of instrument use is set to
[CPB-Pump Enter] or [CPB-Pump Calc]. The acceptable range for pump volume
is 0–9999mL.

a. Press the Pump Volume variable function key to select the parameter.

b. Enter an appropriate “Pump Volume” value.

c. Press the Enter key to accept the value.

9. ACT Target Time – The ACT target time is the desired reference time (in
seconds) for Heparin Dose Response (HDR) tests. This reference is the shortest
heparinized High Range (HR)-ACT that would be acceptable after the bolus
dose of heparin is given. The acceptable range for ACT Target Time is
0 – 999 seconds (sec).

a. Press the ACT Target Time variable function key to select the parameter.

b. Enter an appropriate “ACT Target Time” value.

c. Press the Enter key to accept the value.

Printing

To print individual test results, press the Print key on the front panel. Results of the
last test run are printed using the HMS Plus instrument’s internal printer. All tests run
on the HMS Plus instrument (patient and quality control tests) can have the results
printed at test completion. The HMS Plus instrument can automatically print results
following each test [Auto Print] or [Auto Both] (Output Mode) or print only on request
when the Print key is pressed [Manual] (Output Mode). Refer to “Entering Instrument
Parameters” on page 3-11 to change the print options.

Notes:

■

Printouts show only the information pertaining to the screens and test results
displayed.

■

HEPtrac tests automatically print at test completion even if the Output Mode
is set to [Manual].

Patient/Protocol Parameters Printout

All settings for the patient and protocol parameters may be verified by a printout. Once
the values are entered, simply press the Print key. The format of the printout is shown
in Figure 5-4.

HMS Plus Operator’s Manual 5-5

Chapter 5

HMS PLUS S/N 1234567

CPB-Pump Enter

PATIENT PROTOCOL PARAMS

2011-02-15
Block Temp:

Time: 14:49

37.0 Deg C

Pat Number: 1
PID: 34567
Sex:
Height:

Weight:

Pat Blood Vol:
BSA:
Bolus:

Protocol
Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:

Male

170 cm

5'7"

70.0 kg
154 lbs

5000 ml

1.7 sq meters
14600 units

3.0 mg/kg

10000 units

1000 ml

480 secs

General Operation

Note: The printout can be obtained for the selected patient from any of the
three (3) screens discussed in this section (PATIENT, PROTOCOL, or
PATIENT/PROTOCOL screens) and all parameter information will appear on the
printout. Alternatively, a printout of patient and protocol parameters may be
obtained from the SELECT PATIENT screen (refer to “Select Patient Screen” on
page 3-7).

Test History printing

Test results for the patient and quality control tests are stored in memory and can be
printed using the HMS Plus instrument’s internal printer. Alternatively, stored test
results may be routed to the instrument’s RS-232 serial port for data transfer to an
external computer (ie, for use with the optional HMS Plus External Data Manager
software). Refer to “Test History Menu” on page 5-37 for detailed information on
patient test history or “Quality Control Test History” on page 7-12 for detailed
information on quality control test history output.

Editing Test Results

In some tests, an average of paired channel clot times is used to calculate the test
results. If there is a valid reason for excluding one of the paired values from the
calculation, the EDIT function may be used to remove the invalid value. The
remaining value is then used in the calculation instead of the pair average.

Paired data that can be edited are found in the HDR and HR-ACT tests. One valid
reason for removing a value is the occurrence of an abnormally short clot time (false
detect). Another may be an incorrect sample volume in a cartridge channel; this can
be determined by inspection of the cartridge after the test completes. To avoid these
problems, always use a 3-mL syringe completely full when running an HDR test and
at least a 2.5-mL blood sample when running a combined Heparin Assay and
HR-ACT test. Avoid touching or bumping flags during testing.

An invalid clotting time can be deleted from the calculations by using the Edit
Channel variable function key on the applicable test’s RESULTS or TEST
INFORMATION screen.

Figure 5-4. Patient/Protocol Parameters Printout

5-6 HMS Plus Operator’s Manual

Test Preparation

Operating Instructions

General Operation

Note: If there is no reason identified for an inappropriate clot detection in a
cartridge channel, the test should be repeated instead of editing a channel.

Editing of channel data — for tests that support the editing feature — is described in
the sections that follow for each test type.

■

For edited channels, the edit symbol (X) will appear in place of the channel’s
clotting time and the results will be recalculated.

■

To recover edited values, press the Undo Edit variable function key presented in
the applicable test’s EDIT screen. The edit symbol (X) will disappear and the data
will be recalculated to again include the edited value.

■

On the printout, edited clotting times will be designated as such by an “X” next to
the channel’s clotting time and “X = Edited Channel” is printed after the clotting
time results.

■

Only one clot detection in each pair of HDR and HR-ACT clotting times can be
edited. Heparin Assay test results cannot be edited.

To use the HMS Plus instrument, 3-mL syringes, and 19-gauge 1 7/16-inch blunt
needles will be needed in addition to the test cartridges. These supplies accompany
the cartridges or can be obtained from Medtronic.

Note: Due to the accuracy required for dispensing, other types of syringes and
needles are not recommended.

Verify that the heat block of the HMS Plus instrument is at 37°C ± 0.5°C.
Approximately 20 to 25 minutes are required to reach this temperature from room
temperature. Heat block temperature will be displayed until the appropriate
temperature range is reached. If the instrument temperature does not stabilize
between 36.5°C and 37.5°C, refer to Section 7.

General Test Requirements

Many error or precautionary conditions are self-diagnosed by the HMS Plus
instrument and presented on the screen’s Status Message area. Refer to Section 8:
“Service and Troubleshooting” for a list of screen messages that may appear during
instrument use.

■

Patient tests can be run from most screens at any desired time. Exceptions are
when data input is active, printing is in progress, or the instrument is in Quality
Control mode. After running a QC test, return to the MAIN MENU screen before
running a patient test.

■

Verify that the correct patient and protocol parameters have been entered as
discussed in “Setting the Operating Parameters” on page 3-10.

■

The HMS Plus instrument automatically reads the cartridge code to determine the
test type.

■

A syringe must be properly loaded, locked in place, and the Dispenser parameter
must be set to [On] for dispensing to occur.

■

During test sample dispensing and processing, the instrument will ignore all key
presses except for the Start/Stop key.

■

When a test is in process and the Start/Stop key is pressed, the test is terminated
and the results screen displayed. Dashes are displayed for results not yet
obtained at the time the test was stopped.

■

If any test results cannot be calculated because of insufficient patient data,
dashes are displayed on the results screen.

HMS Plus Operator’s Manual 5-7

Chapter 5

Drive Wheel

Idler Wheel

Lock Switch

(shown locked)

Keyhole Slot

Holder Foot

Needle Hub

Lock Switch Disk

Idler Wheel

Lock Switch Disk

Lock Switch Groove

Drive Wheel

Syringe Plunger
Crossmember

Top V i e w

Syringe Plunger Crossmember

General Operation

Syringe Insertion

Note: Patient data can be entered or changed on the same patient after a test

completes and the current test results recalculated with the new information by
accessing the MAIN MENU screen and then pressing the View Current Test
Results variable function key (refer to “View Current Test Results” on page 5-36).

■

Test results on the last test run can be recalculated for a different patient. To
recalculate the last test results with a new patient, refer to “Calculating last test
results for a different patient” on page 3-8.

■

If a test was run in the wrong location, test results appropriate for a new location
can be displayed by changing the instrument’s Location parameter. Additional
patient/protocol parameters may need to be entered for the new location.

■

When a test completes, the test results are automatically stored. These stored
results can be retrieved via the instrument’s TEST HISTORY MENU screen (refer
to “Test History Menu” on page 5-37).

Warning: Syringe insertion is very important to the success of a test. If the syringe is
not properly installed in the syringe holder, non-uniform sample dispensing may
occur. Inaccuracy in blood volume delivered will have a direct effect on the test result.
When inserting the syringe into the syringe holder, the syringe body must be oriented
to allow capture by the drive system. The lock switch (when locked) engages the drive
wheel during pipetting (refer to Figure 5-5).

5-8 HMS Plus Operator’s Manual

Figure 5-5. Syringe Insertion

1. Draw the appropriate amount of sample into the syringe, then attach and prime
the needle.

2. Push the lock switch to retract the idler wheel for syringe insertion.

3. Insert the sample filled syringe into the dispenser by sliding the needle through
the keyhole slot so the hub of the needle is down on the syringe holder foot.

4. Rotate the syringe until a crossmember of the syringe plunger is parallel to the
face of the syringe holder.

5. Press the syringe body into the syringe holder ensuring that the crossmember is
positioned between the drive and the idler wheels.

6. Push the lock switch to clamp the syringe plunger’s crossmember between the
drive and idler wheels.

7. Upon completion or termination of the test, push the lock switch to release the
syringe; remove the syringe, then the cartridge, and dispose of them in an
appropriate hazardous waste container.

Confirm Patient and Test Dispense Screens

When the Start/Stop key is pressed to initiate a test and the Confirm Patient
parameter has been set to [On], the CONFIRM PATIENT screen appears. If this
parameter has been set to [Off], the test will immediately start and the TEST
DISPENSE screen will appear.

Operating Instructions

General Operation

Note: Even if the confirm patient selection has been set to [Off], the CONFIRM
PATIENT screen will appear after each power on and the first time a test is run after
any parameter has been changed.

Confirm Patient Screen

This screen allows you to verify that the test will be run with the desired patient,
protocol parameters, cartridge type, and cartridge lot. A new patient can be selected
by pressing the Select Patient key. To change protocol or cartridge lot information, exit
to the MAIN MENU screen. The CONFIRM PATIENT screen displays the current
patient number, the patient ID, the current protocol parameters, the cartridge type
installed, and the cartridge lot. Figure 5-6 shows a CONFIRM PATIENT screen for an
HDR test. The format of the CONFIRM PATIENT INFORMATION screen will be
based upon previously selected instrument parameters, specifically the location of the
HMS Plus instrument.

Note: Even if the confirm patient selection has been set to [Off], the CONFIRM
PATIENT screen will appear for 10 seconds after each power on and the first time a
test is run after any parameter has been modified. If unconfirmed, the screen will

disappear and the test will commence after 10 seconds. (If confirm patient
selection has been set to [On], it will pause indefinitely awaiting an explicit
confirmation and will not time out after 10 seconds.

Note: A valid cartridge lot must be active when running a patient test. If no valid lot is

active, an error message will appear when the Start/Stop key is pressed. Exit to the
MAIN MENU screen, then press the Cartridge Lot/Exp Date variable function key to
access the CARTRIDGE LOT/EXP DATE screen (refer to “Entering Cartridge Lot
Numbers and Expiration Dates” on page 3-19).

If the Dispenser parameter is set to [Off], the Status Message area will provide a
message indicating this condition.

HMS Plus Operator’s Manual 5-9

Chapter 5

CONFIRM PATIENT INFORMATION

Protocol Hep Conc:
Pump Heparin:
Pump Volume:
ACT Target Time:
Cartridge: 1234567890

3.0 mg/kg
10000 units
1000 ml
480 secs
2002-05-05

1 PID: 34567

HDR Cartridge Loaded

Press START to continue

Press SELECT PATIENT to change patient

Press MAIN MENU to exit

CPB-Pump Enter

HDR IN PROGRESS

1 PID: 34567

Press STOP to terminate test

Dispensing Sample

General Operation

Figure 5-6. Confirm Patient Screen

Once the patient and cartridge type are confirmed, press the Start/Stop key to initiate
the test.

Test Dispense Screen

The TEST DISPENSE screen appears after a test has been started and remains
during sample dispensing. The text “Dispensing Sample” flashes in inverse video
while the dispense cycle is in process. Figure 5-7 shows a dispensing screen for an
HDR test. The format of this screen is the same for all tests, except the cartridge type
shown (eg, HDR IN PROGRESS) will be for the specific test run.

Figure 5-7. Test Dispense Screen

5-10 HMS Plus Operator’s Manual

Recommended Protocol

Cardiopulmonary bypass procedures require the use of heparin to maintain
anticoagulation throughout bypass. A standard dose of heparin is often sufficient in
many patients but some form of monitoring is needed to guarantee a safe degree of
anticoagulation for all patients. Individuals vary considerably in their hemostatic
response to heparin and a standard dose can give a wide range of clotting times due
to this individual variability. There is also considerable variability in individual rates of
heparin metabolism, therefore, a standard dose of heparin can remain effective for
varying lengths of time in different patients. If the heparin concentration during bypass
is inadequate, clotting factors can be consumed by subclinical coagulation and
precipitate a postsurgical bleeding problem. This situation can be missed due to a
falsely “adequate” HR-ACT, prolonged by the depleted factors rather than heparin.
These problems can be controlled by effective monitoring of anticoagulation during
cardiopulmonary bypass.

There are currently two methods used to monitor the state of anticoagulation during
bypass procedures. One method evaluates the effect of heparin by means of an
HR-ACT test. This test measures the overall state of anticoagulation but cannot
necessarily be correlated to heparin concentration because the test is also sensitive
to many factors including temperature, hemodilution, platelet function, and drugs. The
second method consists of measuring the concentration of circulating heparin via the
Heparin Assay. This test can be used to confirm if anticoagulation is the result of
heparin and to calculate the dose of protamine required for neutralization. The
HMS Plus instrument can provide both measurements simultaneously for effective
anticoagulation monitoring.

Operating Instructions

Recommended Protocol

The Heparin Dose Response (HDR) cartridge provides additional information
regarding the patient's in vitro response to heparin. Use of this test aids in identifying
patients who do not respond typically to a standard dose of heparin. The HDR
determines the alterations needed in dosing to adequately anticoagulate these
problem patients.

Medtronic recommends the use of the protocol described below.

Cardiopulmonary bypass surgery protocol

1. Verify that the correct patient and protocol parameters have been entered.

2. Run an HDR cartridge to determine the patient’s individual response to heparin.

3. Read the projected heparin concentration “Projected Heparin Conc” from the
HDR RESULTS screen; the heparin concentration may be changed if desired.

Note: Performing an HDR will change the previously entered protocol heparin,
referred to as the “Protocol Hep Conc” parameter.

4. Determine the initial heparin bolus from the HDR RESULTS screen.

5. After the heparin has circulated for 3 to 5 minutes, verify anticoagulation by
running a Heparin Assay (HPT) and HR-ACT test. If the HR-ACT is not
adequately extended, give additional heparin and repeat this test.

6. Verify heparin concentration and anticoagulation by running a Heparin Assay
and HR-ACT every 20 to 30 minutes while on bypass. Give additional heparin as
required.

7. Just prior to coming off bypass, perform a Heparin Assay and HR-ACT to
determine the required protamine dose.

8. After protamine has been slowly administered and allowed to circulate for
10 minutes, verify neutralization by running an appropriate Heparin Assay
cartridge and HR-ACT.

HMS Plus Operator’s Manual 5-11

Chapter 5

Test Results Calculated

Note: If a patient has been on heparin before surgery, it is necessary to run a Heparin
Assay cartridge in addition to an HDR cartridge. The heparin concentration as
projected by the HDR should be added to the heparin concentration already in the
patient to determine the heparin concentration needed for bypass.

Use in locations other than cardiopulmonary bypass surgery

The HMS Plus instrument and cartridges can be used in other situations where
coagulation monitoring is required.

The HDR cartridge is a good tool for screening patients for heparin resistance before
they are anticoagulated with heparin, for example in the cardiac catheterization lab.

Heparin Assay cartridges provide a quantitative measure of heparin in a patient’s
blood and can be used whenever such an assay is needed. These can be used to
estimate a required dose of heparin, or of protamine for reversal, if patient parameters
are entered (Cath Lab or ICU/Clinical Lab modes). They may also be used with no
patient parameters in [Test Only] mode to obtain a single measure of heparin
concentration. All levels of Heparin Assay cartridges are available in formulations for
use with fresh whole blood.

9. If postoperative bleeding occurs, HMS Plus cartridges can be used for
differential diagnosis (refer to “Differential Diagnosis of Postsurgical Bleeding” on
page 5-35).

Test Results Calculated

The results calculated for each test depend on the HMS Plus instrument’s Location
parameter setting. Table 5-1 shows the results calculated for each test based on the
5 instrument location choices (X = result is calculated).

Test Type Result CPB-Pump

HDR Clot Times x x x x x

Channel Pair
Averages

Slope x x x x x

Projected Heparin
Conc

Bolus

Table 5-1. Test Results Calculated for Each Location

Selected Location

CPB-Pump

Enter

xxx x x

xxx x x

Patient x x x x

Pump x x

To ta l x x

Calc

Cath Lab ICU/CCU/Lab Test Only

Baseline ACT x x x x x

HPT (Measured)

Heparin Conc

Clot Times x x x x x

5-12 HMS Plus Operator’s Manual

xxx x x

Operating Instructions

Running a Heparin Dose Response (HDR)

Tab le 5- 1. Test Results Calculated for Each Location

Selected Location

Test Type Result CPB-Pump

Enter

Heparin Required

Patient x x x x

Pump x x

To ta l x x

Protamine Dose

Patient x x x x

Pump x x

To ta l x x

HR-ACT Clot Times x x x x x

Average ACT x x x x x

CPB-Pump

Calc

Cath Lab ICU/CCU/Lab Test Only

Running a Heparin Dose Response (HDR)

HDR cartridges should be run on unheparinized samples obtained prior to vein or
artery harvesting, or any other invasive procedures. Refer to the HDR cartridge

package insert for additional information prior to running an HDR test.

HDR Test Setup

Error or precautionary conditions associated with the HDR test can be self-diagnosed
by the HMS Plus instrument. If any such conditions occur, a message will appear on
the screen’s Status Message area prior to calculation of results. Error and
precautionary messages are discussed in Section 8: “Service and Troubleshooting”.

Tests can be run from most screens at any desired time. Exceptions are when data
input is active or printing is in progress.

1. Gently shake or tap the cartridge and then place into the heat block and allow to
prewarm for at least 3 minutes prior to drawing the sample.

2. Draw a full 3.0 mL of sample into the syringe and attach the needle. Fill (prime)
the needle with sample.

3. Insert the syringe and needle into the dispenser of the HMS Plus instrument and
press the Start/Stop key to initiate the test (refer to Figure 5-5 on page 5-8).

Note: If the “Confirm Patient” parameter has been set to [On], the CONFIRM
PATIENT screen appears. Even if the confirm patient selection has been set to
[Off], the CONFIRM PATIENT screen will appear after each power on and the first
time a test is run after any parameter has been changed. Press the Start/Stop key
again and the TEST DISPENSE screen will appear.

HMS Plus Operator’s Manual 5-13

Chapter 5

Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6

HDR IN PROGRESS

Elapsed Time: 230 seconds

1 PID: 34567

u/ml

secs

2.5

2.5

1.5

220

110

105

0

0

1.5

Running a Heparin Dose Response (HDR)

HDR In Progress Screen

Once dispensing is complete, the HDR IN PROGRESS screen will appear (refer to
Figure 5-8). This screen shows the reagent heparin concentration — framed in a
box — for each of the six (6) channels of the HDR cartridge.

As the HDR test proceeds, the “Elapsed Time” is displayed to indicate the test’s run
time. When a clot occurs, the reagent concentration of the channel detected will be
highlighted in inverse video and the channel’s clotting time appears (in seconds). If
the Audio Tone parameter is set to [On], an audible tone will sound for each channel
clot detect. The end point of the test is detection of clot formation in each cartridge
channel or 999 seconds of elapsed test time. At test completion, the HDR RESULTS
screen appears.

HDR Results Screen

The HDR RESULTS screen appears as shown in Figure 5-9. Additional test
information (channel clotting times, the HDR Slope, and the screen for editing
channel clotting times) can be accessed from this screen by pressing the More Test
Information variable function key (refer to “HDR Test Information Screen” on
page 5-16).

Note: Figure 5-9 shows the instrument Location parameter was set to either
[CPB-Pump Enter] or [CPB-Pump Calc].

Figure 5-8. HDR In Progress Screen

5-14 HMS Plus Operator’s Manual

Projected Heparin Conc

HDR RESULTS

1 PID: 34567

Projected

Heparin Conc.

Heparin Bolus

1.5 mg/kg

Baseline ACT: 107 secs

More Test

Information

Change Heparin
Conc.

Patient: 20000 units

Pump: 10000 units

Total: 30000 units

Operating Instructions

Running a Heparin Dose Response (HDR)

Figure 5-9. HDR Results Screen

This is the patient’s projected heparin level calculated to reach the minimum desired
clotting time (ACT Target Time). The results for projected heparin concentration are
displayed in the units selected for the “Heparin Conc Unit” parameter (mg/kg, u/kg,
u/mL).

The “Projected Heparin Conc” value on the HDR RESULTS screen is displayed in the
ranges of 0.1mg/kg–7.3mg/kg (10u/kg–730u/kg, or 0.1u/mL–9.9u/mL). Out of
range values result in a screen message indicating the condition and no results will
be computed for “Heparin Bolus” (dashes are displayed). Refer to Section 8: “Service
and Troubleshooting” for additional information on screen messages.

At the completion of an HDR test, the calculated projected heparin concentration
“Projected Heparin Conc” will replace the “Protocol Hep Conc” parameter that was
entered. The screen’s Status Message area will provide a message indicating this
condition at HDR test completion; however, this message will not be seen if a higher
priority message is displayed.

Warning: To avoid running a procedure with the wrong heparin concentration, verify
this value after running an HDR test. This may be done with a printout or by confirming
that the value displayed on the screen is appropriate.

If desired, the calculated HDR result “Projected Heparin Conc” can be changed by the
following procedure.

1. Press the Change Heparin Conc variable function key to select the parameter.

2. Enter desired value.

3. Press the Enter key to accept the value.

If the heparin concentration has been changed according to the procedure above, the
“Projected Heparin Conc” screen text will change to “Heparin Conc” to indicate the
value has been modified. No edits can be performed once the value has been
modified. The entered heparin concentration will appear on the printout below the
“HDR Proj Hep Conc” (refer to Figure 5-12 on page 5-19).

HMS Plus Operator’s Manual 5-15

Chapter 5

Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6

343 223 107

105110226220340346

HDR TEST INFORMATION

1 PID: 34567

u/ml

secs

Slope: 100 secs/unit/ml

Edit HDR Channel

Exit to

HDR Results

2.5

2.5 1.5

0

0

1.5

Running a Heparin Dose Response (HDR)

Heparin Bolus

The “Heparin Bolus” results will be calculated based on the values of the heparin
concentration and the pump and the patient volumes. The heparin concentration will
be either the entered “Protocol Hep Conc” or the calculated “Projected Heparin Conc”
from an HDR test. The HMS Plus instrument can calculate a “Heparin Bolus” for the
patient, pump, and total bolus.

■

If a Pump Heparin value has been entered in the system — for location set to
[CPB-Pump Enter] — the HMS Plus instrument will take this heparin into account
when computing the patient dose to ensure adequate heparinization on bypass.

■

If a Pump Heparin has not been entered in the system — for location set to
[CPB-Pump Calc] — the HMS Plus instrument will determine the heparin dose
needed for both the patient and the pump.

■

The [Cath Lab] and [ICU/CCU/LAB] instrument locations will show a heparin
bolus for the patient only. The [Test Only] location does not provide a heparin
bolus calculation.

Baseline ACT

The calculated “Baseline ACT” is the clotting time average of Channels 5 and 6 of the
HDR cartridge. These channels contain no heparin.

More Test Information

The HDR TEST INFORMATION screen is the second screen of information available
for an HDR test. It is accessed from the HDR RESULTS screen by pressing the More

Test Information variable function key.

HDR Test Information Screen

The HDR TEST INFORMATION screen appears as shown in Figure 5-10. Channel
clotting times, channel pair clotting time averages, and the HDR slope are presented.

Channel Clotting Times

The individual channel clotting times and the paired channel clotting time averages

5-16 HMS Plus Operator’s Manual

are presented.

Figure 5-10. HDR Test Information Screen

Operating Instructions

Running a Heparin Dose Response (HDR)

Notes:

■

If the difference in clotting times between a channel pair is greater than ± 12%,
the screen’s Status Message area will provide a message indicating this
condition.

■

If one or more channel pairs in the HDR test fail to detect, a screen message
appears indicating this condition and dashes are displayed in place of HDR result
values.

■

If the HDR test time exceeds 999 seconds, dashes are displayed in place of
HDR results and the printout shows “> 999.”

Slope

The in vitro heparin response slope is calculated from the different HDR channel
clotting times. Refer to “Heparin Dose Response Calculations” on page 4-12 for the
slope calculation. The test responds linearly to increasing heparin concentrations in
the cartridge channels. The calculated slope can be used to determine a patient’s
response to heparin and help identify potentially sensitive or resistant patients.

If the calculated HDR slope is negative or zero (0), a message will appear on the
screen’s Status Message area indicating this condition and dashes are displayed in
place of the HDR results (refer to “Screen Messages” on page 8-4).

Edit HDR Channel

HDR data calculations can be affected by incorrect sample volume or inappropriate
detections. Channel clotting times can be edited and the results recalculated following
the removal of the edited channel’s clotting time from the calculation. Press the Edit

HDR Channel variable function key to access the EDIT HDR CHANNEL screen.

Edit HDR Channel Screen

The EDIT HDR CHANNEL screen appears as shown in Figure 5-11 on page 5-18
(Channel 1 is shown edited). General information on editing test data is discussed in
“Editing Test Results” on page 5-6.

Notes:

■

Only one clotting time from each channel pair can be edited.

■

If only one channel in a pair detects, it cannot be edited.

■

If the “Projected Heparin Conc” value from the HDR RESULTS screen has been
changed, no edits are allowed.

HMS Plus Operator’s Manual 5-17

Chapter 5

Ch 2 Ch 3 Ch 4 Ch 5 Ch 6

340 223 107

105110220226340X

Ch 1

EDIT HDR CHANNEL

1 PID: 34567

u/ml

secs

Undo Edit

Exit to

HDR Results

Edit Channel

Go to

Next Channel

2.5

2.5

1.5

0

0

1.5

Running a Heparin Dose Response (HDR)

To edit a channel, follow the procedure below.

1. Select the channel to be edited by pressing the Go to Next Channel variable
function key until the desired channel is selected (highlighted in inverse video).

Figure 5-11. Edit HDR Channel Screen

HDR Test Printout

2. Press the Edit Channel variable function key. An “X” appears to replace the
channel’s clotting time; the average for the channel pair is now the remaining
clotting time.

3. To restore the edited channel, simply select the edited channel and press the
Undo Edit variable function key.

HDR test results can be printed manually by pressing the Print key, or automatically
if the Output Mode is set to [Auto Print] or [Auto Both]. Refer to Figure 5-12 for a
sample printout.

5-18 HMS Plus Operator’s Manual

(1)

HMS PLUS S/N 1234567

CPB-Pump Enter

2011-02-15
Block Temp:

Time: 14:49

37.0 Deg C

Patient: 1
PID: 34567
Sex:
Height:

Weight:

Pat Blood Vol:
Pump Vol:
Total Vol:

Male

170 cm

5'7"

70.0 kg
154 lbs

5000 ml
1000 ml
6000 ml

HEPARIN DOSE RESPONSE

Cartridge Lot:
Cartridge Exp:

HDR Proj Hep Conc
Entered Hep Conc

Baseline ACT:

Heparin Bolus
Patient:
Pump:
To ta l :

ACT Target Time:
Slope:
Clotting Times:

Averages
Ch 1&2:
Ch 3&4:
Ch 5&6:

Ch 1:
Ch 2:
Ch 3:
Ch 4:
Ch 5:
Ch 6:
X = Edited Channel

1234567890

2011-03-15

3.0 mg/kg

3.0 mg/kg

120 secs

20000 units
10000 units
30000 units

480 secs

86 secs/unit/ml

330 secs
253 secs
120 secs

340 secs X

330 secs
253 secs
253 secs
120 secs
120 secs

(2)

Operating Instructions

Running a Heparin Dose Response (HDR)

HDR Printout Error Messages

■

Error messages pertaining to patient blood volume out of range are located on the
printout where indicated by “(1).”

■

Other error messages (eg, HDR projected heparin concentration out of range, not
enough HDR data, HDR slope ≤ 0, Target ACT < Baseline ACT, etc.) are located
on the printout where indicated by “(2).”

■

Error messages pertaining to channel pairs differing by more than ± 12% are
located on the printout where indicated by “(3).”

(3)

Figure 5-12. HDR Test Printout

HMS Plus Operator’s Manual 5-19

Chapter 5

Running a Heparin Assay (HPT)

Running a Heparin Assay (HPT)

The Heparin Assay (HPT) is performed in a four- or six-channel cartridge. The
procedure for running a Heparin Assay with the six-channel cartridge is identical to
the four-channel cartridge except two additional channels of clotting time data will be
presented.

The Heparin Assay may be run alone or a combined Heparin Assay/Activated Clotting
Time (HR-ACT) test may be run using a four-channel Heparin Assay cartridge with
the two-channel HR-ACT cartridge (refer to “Running an HR-ACT” on page 5-28).

Note: This section shows the screens displayed for a Heparin Assay alone. The
screens displayed for a combined Heparin Assay/Activated Clotting Time test are
shown in “Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens” on
page 5-31.

Refer to the appropriate cartridge package inserts for additional information prior to
running a Heparin Assay or HR-ACT test.

Cartridge Selection

Refer to Table 5-2 “Heparin Assay Cartridge Selection”.

Heparin Assay cartridges are selected based on the desired protocol. The family of
HMS Plus Heparin Assay cartridges titrate heparin levels from 0 to 6.0 mg/kg
(0 to 8.2 u/mL, 0 to 600 u/kg). The desired heparin concentration to maintain for the
patient — set as the “Protocol Hep Conc” parameter — should correspond to
Channels 3 or 4 of the four-channel Heparin Assay cartridges or Channels 4, 5, or 6
of the six-channel Heparin Assay cartridges.

The 0.0 - 0.9 mg/kg (Red), 0.0 - 1.5 mg/kg (Yellow), and 0.0 - 2.5 mg/kg (Orange)
cartridges are designed to verify protamine neutralization and evaluate postsurgical
bleeding (refer to “Differential Diagnosis of Postsurgical Bleeding” on page 5-35).
These ranges are also useful for catheterization lab, critical care, and vascular
surgery applications.

5-20 HMS Plus Operator’s Manual

Operating Instructions

Running a Heparin Assay (HPT)

Table 5-2. Heparin Assay Cartridge Selection

Reference Concentration Cartridge Range Color

4-Channel Cartridges

0.6 - 0.9 mg/kg 0.0 - 0.9 mg/kg Red*

1.0-1.5mg/kg 0.0-1.5mg/kg Yellow*

2.5-3.0mg/kg 1.5-3.0mg/kg Tan

3.0-3.5mg/kg 2.0-3.5mg/kg Silver

3.5-4.0mg/kg 2.5-4.0mg/kg Blue

4.5-5.0mg/kg 3.5-5.0mg/kg Green

5.5-6.0mg/kg 4.5-6.0mg/kg Purple

6-Channel Cartridges

1.5 - 2.5 mg/kg 0.0 - 2.5 mg/kg Orange*

3.0-4.0mg/kg 1.5-4.0mg/kg Gold

4.0-5.0mg/kg 2.5-5.0mg/kg White

5.0-6.0mg/kg 3.5-6.0mg/kg Black

HPT Test Setup

* Designed to verify protamine neutralization and evaluate postsurgical bleeding.

Error or precautionary conditions associated with Heparin Assay (HPT) and HR-ACT
tests can be self-diagnosed by the HMS Plus instrument. If any such conditions occur,
a message will appear on the screen’s Status Message area prior to calculation of
results. Error and precautionary messages are discussed in Section 8: “Service and
Troubleshooting”.

Patient tests can be run from most screens at any desired time. Exceptions are when
data input is active, printing is in progress, or the instrument is in Quality Control
mode. After running a QC test, return to the MAIN MENU screen before running a
patient test.

1. Gently shake or tap the cartridge and then place into the heat block. If an
HR-ACT is also being run, allow both to prewarm for at least three (3) minutes
prior to drawing the sample. If ONLY Heparin Assay tests are being performed,
the prewarming can be omitted.

Note: The two-channel HR-ACT cartridge is placed in the right side of the heat
block (Channels 5 and 6).

To ensure that a cartridge is always ready, the next cartridge(s) to be run can be
placed into the heat block upon completion of the current test.

2. Draw approximately 3.0 mL of sample into the syringe and attach the needle. Fill
(prime) the needle with sample.

The minimum sample needed for a four-channel Heparin Assay is 1.5 mL;
six-channel Heparin Assay cartridges require 2 mL. At least 2.5 mL of sample is
needed for a combined Heparin Assay (HPT) and HR-ACT test.

3. Insert the syringe and needle into the dispenser of the HMS Plus instrument and
press the Start/Stop key to initiate the test (refer to Figure 5-5 on page 5-8).

HMS Plus Operator’s Manual 5-21

Chapter 5

Ch 1 Ch 2 Ch 3 Ch 4

60

HPT IN PROGRESS

Elapsed Time: 60 seconds

Silver Cartridge

1 PID: 34567

mg/kg

secs

2.0

3.0

3.5

2.5

Running a Heparin Assay (HPT)

Note: If the Confirm Patient parameter has been set to [On], the CONFIRM
PATIENT screen appears. Even if the confirm patient selection has been set to
[Off], the CONFIRM PATIENT screen will appear after each power on and the first
time a test is run after any parameter has been changed. Press the Start/Stop key
again and the TEST DISPENSE screen will appear.

HPT In Progress Screen

Once dispensing is complete, the HPT IN PROGRESS screen will appear (refer to
Figure 5-13). This screen shows the type of cartridge loaded and the heparin
concentration — framed in a box — for each of the cartridge channels. The heparin
concentration is displayed according to the “Heparin Conc Unit” parameter selected
(mg/kg, u/kg, u/mL).

Note: If an HR-ACT is being run with a four-channel Heparin Assay cartridge,
Channels 5 and 6 of the screen will show the ACT channels (refer to Figure 5-23
on page 5-32).

As the HPT test proceeds, the “Elapsed Time” is displayed to indicate the test’s run
time. When a clot occurs, the reagent concentration of the channel detected will be
highlighted in inverse video and the channel’s clotting time appears (in seconds). If
the Audio Tone parameter is set to [On], an audible tone will sound for each channel
clot. If more than one detect occurs at the same time, the result indicated is the
channel with the lower concentration. The end point of the test is clot detection in one
(or all) of the channels of the HPT cartridge, or the elapsed test time exceeding the
limit allowed by the instrument (refer to “All Channel Detect parameter” below).

Note: If an HR-ACT is being run, the test continues until clot detects occur for this
cartridge, or the ACT elapsed test time has exceeded the limit allowed by the
instrument. The ACT test typically has a longer test time than the HPT test.

All Channel Detect parameter

The All Ch Detect parameter setting determines whether a Heparin Assay test stops
on the first channel to detect or continues until all channels in the HPT cartridge detect
(clot). The All Ch Detect parameter set to [Off] results in the HPT test stopping as
soon as the first channel detect occurs. Typically, this parameter is set to [Off].

The maximum test run time is 999 seconds.

5-22 HMS Plus Operator’s Manual

Figure 5-13. HPT In Progress Screen

If All Ch Detect is set to [On], the test will run until all channels have detected or until

HPT RESULTS

1 PID: 34567

Heparin Conc. Heparin Required

2.5 mg/kg
Patient: 20000 units

Pump: 10000 units

Total: 30000 units

More Test

Information

Protamine Dose

Channel 2:

60 secs

the test is stopped, either by pressing the Start/Stop key or at 999 seconds. At test
completion, the HPT RESULTS screen appears.

HPT Results Screen

The HPT RESULTS screen appears as shown in Figure 5-14. Additional test
information (PROTAMINE DOSE and HPT TEST INFORMATION screens) can be
accessed from this screen by pressing the Protamine Dose or More Test

Information variable function keys.

Operating Instructions

Running a Heparin Assay (HPT)

Note: If the time when the first Heparin Assay channel detects is greater than
249 seconds, the test may not be considered valid. The screen’s Status Message
area will indicate “HPT Test Time >249 sec.” Refer to “HPT Printout Error
Messages” on page 5-27 and the Heparin Assay cartridge package inserts for
more information.

Note: Figure 5-14 shows the instrument Location parameter set to either
[CPB-Pump Enter] or [CPB-Pump Calc].

Heparin Conc

The “Heparin Conc” result is the measured heparin concentration (quantity of heparin
titrated). The cartridge channel titrated is identified with the clotting time. The results
for heparin concentration are displayed in the units selected for the “Heparin Conc”
Unit parameter (mg/kg, u/kg, u/mL).

Heparin Required

The “Heparin Required” result shows the additional heparin required for the patient,
pump, or total volume to achieve (or maintain) the desired heparin level (Protocol Hep
Conc) for the patient.

Notes:

■

Heparin Assay (HPT) and HR-ACT results should be interpreted based on the
current stage of the procedure (ie, prebypass or during bypass).

■

If the Location parameter is set to [Cath Lab] or [ICU/CCU/Lab], only patient
results are displayed for the “Heparin Required”.

Figure 5-14. HPT Results Screen

HMS Plus Operator’s Manual 5-23

Chapter 5

Running a Heparin Assay (HPT)

■

If the Location parameter is set to [Test Only], no Heparin Required results will be
displayed.

If an HR-ACT is also run, the average clotting time “Average ACT” result will also be
displayed (refer to Figure 5-25 on page 5-33). If the HR-ACT result is not extended
beyond the ACT Target Time, additional heparin should be administered and the
Heparin Assay and HR-ACT repeated.

Cautions:

■

If sufficient heparin is not added to the prime, there will be an abrupt decline in
heparin concentration upon initiating bypass which will require adjustment with
additional heparin.

■

The HR-ACT during bypass may be much longer than the prebypass HR-ACT
due to hemodilution, hypothermia, reduced platelet count and poor platelet
function.

■

Patients with varying metabolic rates may require more frequent testing,
accompanied by heparin additions, to maintain safe anticoagulation.

■

Diuresis or additional fluids can influence heparin concentration.

■

When a clot is detected in Channel 1 of an HPT cartridge that does not have a
zero value in Channel 1, the alert message “Hep Conc may be < indicated value”
appears, indicating that the heparin concentration may be less than the
Channel 1 cartridge value. When a clot is detected in the last channel of the
HPT cartridge (Channel 4 or 6), the alert message “Hep Conc may be > indicated
value” appears, indicating that the heparin concentration may be higher than the
measured value.

Note: In these cases, run another test with a different cartridge — lower or higher
as needed — to confirm the test result (refer toTable 5-2 on page page 5-21).

Protamine Dose

To view the protamine dose calculations for neutralizing the heparin concentration,
press the Protamine Dose variable function key to access the PROTAMINE DOSE
screen (refer to Figure 5-15). If the Location parameter is set to [Test Only], the

Protamine Dose variable function key text will not appear.

More Test Information

Additional test information is available by pressing the More Test Information
variable function key (refer to “HPT Test Information Screen” on page 5-26).

Protamine Dose Screen

The PROTAMINE DOSE screen appears as shown in Figure 5-15.

The protamine results displayed varies based on the instrument Location and
Protamine Units parameters selected. Pump volume protamine dose results will only
appear for the instrument Location set to either [CPB-Pump Enter] or [CPB-Pump
Calc].

Warning: The pump volume protamine represents additional protamine required if
the pump volume is to be given to the patient. It is not intended to indicate that
protamine should be added to the pump, since this would result in clotting.

5-24 HMS Plus Operator’s Manual

Change Pump Volume

PROTAMINE DOSE

1 PID: 34567

For Patient :

Exit to

HPT Results

Change Pump Volume

For Pump Volume

to Patient :

To ta l :

265 mg

88 mg

353 mg

PROTAMINE DOSE

1 PID: 34567

For Patient :

For Pump Volume

to Patient :

To ta l :

265 mg

88 mg

353 mg

Pump Volume :

1000

ml

Operating Instructions

Running a Heparin Assay (HPT)

Figure 5-15. Protamine Dose Screen

If desired, the protamine dose results can be recalculated with a different pump
volume. To change the pump volume, press the Change Pump Volume variable
function key to access the CHANGE PUMP VOLUME screen (refer to Figure 5-16).

Figure 5-16. HPT Change Pump Volume Screen

The “Pump Volume” value will be flashing to indicate it is active and can be changed.
A new “Pump Volume” value can be entered by the normal procedure for entering
parameter values; the acceptable range for the “Pump Volume” is 0 - 9999 mL.

When the Enter key is pressed to accept the change, the protamine dose results are
recalculated, and the PROTAMINE DOSE screen appears, displaying the
recalculated values.

Warning: If the “Pump Volume” is changed as described above, the “Pump Volume”
parameter entered during protocol parameter entry will also be changed for the
current patient.

HMS Plus Operator’s Manual 5-25

Chapter 5

Ch 1 Ch 2 Ch 3 Ch 4

60

HPT TEST INFORMATION

1 PID: 34567

mg/kg

secs

Exit to

HPT Results

Protocol Heparin Conc.: 3.0 mg/kg

2.0

3.0

3.5

2.5

Running a Heparin Assay (HPT)

HPT Test Information Screen

The HPT TEST INFORMATION screen appears as shown in Figure 5-17. Channel
clotting times and the preset “Protocol Heparin Conc” parameter value are displayed.

HPT Test Printout

Figure 5-17. HPT Test Information Screen

If the All Ch Detect parameter is set to [On], clotting times for each channel will be
displayed. The “Protocol Heparin Conc” value is displayed in the units set for the
“Heparin Conc Unit” parameter.

If an HR-ACT is run with the “Heparin Assay”, the “HR-ACT” values will be displayed
(refer to Figure 5-26 on page 5-33).

HPT test results can be printed manually by pressing the Print key, or automatically if
the Output Mode is set to [Auto Print] or [Auto Both]. Refer to Figure 5-18 for a sample
printout with the “All Ch Detect” parameter set to [Off].

5-26 HMS Plus Operator’s Manual

Operating Instructions

(1)

HMS PLUS S/N 1234567

CPB-Pump Enter

2011-02-15
Block Temp:

Time: 14:49

37.0 Deg C

Patient: 1
PID: 34567
Sex:
Height:

Weight:

Pat Blood Vol:
Pump Vol:
Total Vol:

Male

170 cm

5'7"

70.0 kg
154 lbs

5000 ml
1000 ml
6000 ml

Verif y AC T Tim es

HPT

Cartridge Lot:
Cartridge Exp:

Cartridge:
Test Range:

Hep Test Conc:
Ch 2:

Protocol
Hep Conc:

Heparin Required
Patient:
Pump:
To ta l :

Protamine Dose
Patient:
Pump:
To ta l :

1234567890

2011-03-15

Silver

2.0 - 3.5 mg/kg

2.5 mg/kg
60 secs

3.0 mg/kg

20000 units
10000 units
30000 units

265 mg

88 mg

353 mg

Running a Heparin Assay (HPT)

HPT Printout Error Messages

■

Error messages are located on the HPT printout where indicated by “(1).”

Figure 5-18. HPT Test Printout

HMS Plus Operator’s Manual 5-27

Chapter 5

Running an HR-ACT

Running an HR-ACT

The two-channel HR-ACT can be run with a Heparin Assay, as discussed, or can be
run by itself. The HR-ACT must be run in Channels 5 and 6. The HMS Plus
instrument will recognize the presence of the two-channel cartridge and dispense
sample into Channels 5 and 6 only. Refer to the HR-ACT cartridge package insert for

additional information prior to running an HR-ACT test.

HR-ACT Test Setup

Error or precautionary conditions associated with HR-ACT tests can be
self-diagnosed by the HMS Plus instrument. If any such conditions occur, a message
will appear on the screen’s Status Message area prior to calculation of results. Error
and precautionary messages are discussed in Section 8: “Service and
Troubleshooting”.

Patient tests can be run from most screens at any desired time. Exceptions are when
data input is active, printing is in progress, or the instrument is in Quality Control
mode. After running a QC test, return to the MAIN MENU screen before running a
patient test.

1. Gently shake or tap the cartridge and then place into the heat block and allow to
prewarm for at least 3 minutes prior to drawing the sample.

2. Draw approximately 3.0 mL of sample into the syringe and attach the needle. Fill
(prime) the needle with sample. The minimum sample needed for an HR-ACT
is 1.5 mL.

3. Insert the syringe and needle into the dispenser of the HMS Plus instrument and
press the Start/Stop key to initiate the test (refer to Figure 5-5 on page 5-8).

Note: If the Confirm Patient parameter has been set to [On], the CONFIRM
PATIENT screen appears. Even if the confirm patient selection has been set to
[Off], the CONFIRM PATIENT screen will appear after each power on and the first
time a test is run after any parameter has been changed. Press the Start/Stop key
again and the TEST DISPENSE screen will appear.

HR-ACT In Progress Screen

Once dispensing is complete, the HR-ACT IN PROGRESS screen will appear (refer
to Figure 5-19). This screen shows cartridge Channels 5 and 6. As the HR-ACT test
proceeds, the “Elapsed Time” is displayed to indicate the test run time. When a clot
occurs, the channel detected will be highlighted in inverse video and the channel’s
clotting time appears (in seconds). If the Audio Tone parameter is set to [On], an
audible tone will sound for each channel clot detect.

The end point of the test is detection of clot formation in each cartridge channel or
> 999 seconds of elapsed test time. If the HR-ACT run time exceeds 999 seconds
before both channels detect, the test will be stopped and the screen’s Status Message
area will indicate “ACT Test Time > 999 seconds.” The printout will indicate the
channel(s) exceeding the allowed test time. At test completion, the HR-ACT
RESULTS screen appears.

5-28 HMS Plus Operator’s Manual

HR-ACT Results Screen

Ch 5 Ch 6

420

ACT IN PROGRESS

Elapsed Time: 425 seconds

1 PID: 34567

secs

ACT

ACT

Ch 5 Ch 6

420 460

ACT RESULTS

1 PID: 34567

secs

Edit ACT Channel

Average ACT: 440 secs

ACT

ACT

Operating Instructions

Running an HR-ACT

Figure 5-19. HR-ACT In Progress Screen

The HR-ACT RESULTS screen appears as shown in Figure 5-20. The
“Average ACT” of the two channels is presented. If only one channel detected, the
result will be the clotting time of the channel to detect. If neither channel detected, the
screen will display “Average ACT > 999” for the result.

If the difference in clotting times between the channel pair is greater than 12%, an
audible alert sounds and the screen’s Status Message area will indicate this condition.

Figure 5-20. HR-ACT Results Screen

Inappropriate channel clotting times can be edited and the results recalculated by
pressing the Edit ACT Channel variable function key. The EDIT HR-ACT CHANNEL
screen appears.

HMS Plus Operator’s Manual 5-29

Chapter 5

Ch 6

X 460

Ch 5

EDIT ACT CHANNEL

1 PID: 34567

secs

Undo Edit

Exit to

ACT Results

Edit Channel

Go to

Next Channel

ACT

ACT

Running an HR-ACT

Edit HR-ACT Channel Screen

The EDIT HR-ACT CHANNEL screen appears as shown in Figure 5-21 (Channel 5 is
edited). General information on editing test data is discussed in “Editing Test Results”
on page 5-6.

Note: Only one clotting time from the channel pair can be edited.

To edit a channel, follow the procedure below.

1. Select the channel to be edited by pressing the Go to Next Channel variable

2. Press the Edit Channel variable function key. An “X” appears to replace the

3. To restore the edited channel, simply select the edited channel and press the

HR-ACT Test Printout

HR-ACT test results can be printed manually by pressing the Print key, or
automatically if the Output Mode is set to [Auto Print] or [Auto Both]. Refer to
Figure 5-22 for a sample printout.

Figure 5-21. Edit HR-ACT Channel Screen

function key until the desired channel is selected (highlighted in inverse video).

channel’s clotting time; the average for the channel pair is now the remaining
clotting time.

Undo Edit variable function key.

5-30 HMS Plus Operator’s Manual

Operating Instructions

(1)

HMS PLUS S/N 1234567

ACTIVATED CLOTTING TIME

2011-02-15
Block Temp:

Patient: 1
PID: 34567

Time: 14:4 9

37.0 Deg C

Cartridge Lot:
Cartridge Exp:

Average:

Ch 5:
Ch 6:

1234567890

2011-03-15

122 secs

120 secs
124 secs

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens

Figure 5-22. HR-ACT Test Printout

HR-ACT Printout Error Messages

■

Error messages pertaining to the channels differing by more than 12% are located
on the printout where indicated by “(1).”

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens

A combined Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) test may be run
using a four-channel Heparin Assay cartridge with the two-channel HR-ACT
cartridge. The test procedure and screens displayed when running a combined
HPT/HR-ACT are nearly identical to the individual HPT and HR-ACT tests except the
screens displayed combine the information from each individual test.

This section presents the combined HPT/HR-ACT screens and a sample printout for
reference information. Refer to the individual sections on running the Heparin
Assay (HPT) and Activated Clotting Time (HR-ACT) test for the actual test procedure.

Note: During a combined HPT/HR-ACT test where a clot detection has
occurred for the HPT test and the HR-ACT test is still running, a temporary
results screen is displayed prior to the final results screen (refer to Figure 5-24
and Figure 5-25). This temporary screen is similar to the final results screen
except the test run time “ACT Elapsed Time” for each channel of the HR-ACT
cartridge is shown instead of the “Average ACT” and the patient’s calculated
“Protamine Dose (Patient)” is displayed. This allows the HPT results to be
displayed while the HR-ACT test is still in process.

Following test completion, the final HPT/HR-ACT RESULTS screen appears (refer to
Figure 5-25). This screen can be used to access the PROTAMINE DOSE and TEST
INFORMATION screens.

HMS Plus Operator’s Manual 5-31

Chapter 5

Ch 1 Ch 2 Ch 3 Ch 4 Ch 5 Ch 6

60 420

HPT/ACT IN PROGRESS

Elapsed Time: 425 seconds

Silver HPT/ACT Cartridges

1 PID: 34567

mg/kg

secs

secs

2.0

3.0

3.5

2.5

ACT

ACT

HPT/ACT IN PROGRESS

1 PID: 34567

Heparin Conc. Heparin Required

2.5 mg/kg
Patient: 20000 units

Pump: 10000 units

Total: 30000 units

Channel 2:

60 secs

Protamine Dose (Patient): 265 mg

ACT Elapsed Time: 420 450 secs

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens

HPT/HR-ACT In Progress Screen

Figure 5-23. HPT/HR-ACT In Progress Screen

HPT Results/HR-ACT In Progress Screen

Figure 5-24. HPT Results/HR-ACT In Progress Screen

5-32 HMS Plus Operator’s Manual

HPT/HR-ACT Results Screen

HPT/ACT RESULTS

1 PID: 34567

Heparin Conc. Heparin Required

2.5 mg/kg

Patient: 20000 units

Pump: 10000 units

Total: 30000 units

More Test

Information

Protamine Dose

Channel 2:

60 secs

Average ACT: 440 secs

Ch 1 Ch 2 Ch 3 Ch 4

60

Ch 5 Ch 6

420 460

440

HPT/ACT TEST INFORMATION

1 PID: 34567

mg/kg

secs

Exit to

HPT/ACT Results

Protocol Heparin Conc.: 3.0 mg/kg

secs

Edit ACT Channel

2.0

3.0

3.5

2.5

ACT

ACT

Operating Instructions

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens

Figure 5-25. HPT/HR-ACT Results Screen

HPT/HR-ACT Test Information Screen

HPT/HR-ACT Test Printout

Figure 5-26. HPT/HR-ACT Test Information Screen

The HPT/HR-ACT test results can be printed manually by pressing the Print key, or
automatically if the Output Mode is set to [Auto Print] or [Auto Both]. Refer to
Figure 5-27 for a sample printout with the “All Ch Detect” parameter set to [Off].

HMS Plus Operator’s Manual 5-33

Chapter 5

HMS PLUS S/N 1234567

CPB-Pump Enter

2011-02-15
Block Temp:

Time: 1 4:49

37.0 Deg C

Patient: 1
PID: 34567
Sex:
Height:

Weight:

Pat Blood Vol:
Pump Vol:
Total Vol:

Male

170 cm

5'7"

70.0 kg
154 lbs

5000 ml
1000 ml
6000 ml

Verif y ACT Times

HPT

Cartridge Lot:
Cartridge Exp:

Cartridge:
Test Range:

Hep Test Conc:
Ch 2:

Protocol
Hep Conc:

Heparin Required
Patient:
Pump:
To ta l :

Protamine Dose
Patient:
Pump:
To ta l :

1234567890

2011-03-15

Silver

2.0 - 3.5 mg/kg

2.5 mg/kg
60 secs

3.0 mg/kg

20000 units
10000 units
30000 units

265 mg

88 mg

353 mg

ACTIVATED CLOTTING TIME

Average:

Ch 5:
Ch 6:

508 secs

508 secs
508 secs

Heparin Assay (HPT)/Activated Clotting Time (HR-ACT) Screens

HPT/HR-ACT Printout Error Messages

■

Figure 5-27. HPT/HR-ACT Test Printout

Error messages on a combined HPT/HR-ACT test printout appear in the same
locations as the individual HPT and HR-ACT test printouts.

5-34 HMS Plus Operator’s Manual

Differential Diagnosis of Postsurgical Bleeding

Is Bleeding Heparin

Related?

Run HPT

(Heparin Assay) and ACT

(Activated Clotting Time)

to determine if

heparin is present

NO

0.0 circulating heparin

YES

heparin present

Evaluate Platelet Function

to determine if

platelet related

Platelet Function

abnormal

Platelet Function

normal

Administer appropriate

platelet therapy

Verif y A CT

previously run

Give additional

protamine as

determined by HPT

Run HPT to

confirm reversal

NO

0.0 circulating heparin

YES

heparin present

ACT returned

to baseline

ACT elevated

above baseline

Is Patient

Bleeding?

YES NO

Look for mechanical

bleeding sites or test

for fibrinolysis

Is Patient

Bleeding?

YES NO

Perform more specific laboratory

test to determine etiology of
bleeding problem (eg, depleted
coagulation factors, fibrinolysis)

Differential Diagnosis of Postsurgical Bleeding

Perform a low-range Heparin Assay and an HR-ACT (refer to “Cartridge Selection” on
page 5-20). The diagram below shows indications based on the results of these two
tests.

Operating Instructions

Figure 5-28. Differential Diagnosis of Postsurgical Bleeding

HMS Plus Operator’s Manual 5-35

Chapter 5

1 PID: 34567

MAIN MENU

Patient/Protocol
Parameters

Instrument
Parameters

View Current

Test Results

Output Patient

Results

Cartridge

Lot/Exp Date

Quality Control

Te mp : 3 7. 1° C

View Current Test Results

View Current Test Results

The results screen of the last test performed with the HMS Plus instrument can be
displayed by accessing the MAIN MENU screen and then pressing the View Current
Test Results variable function key. If no tests have been run since the instrument’s
power has been cycled Off/On, the screen’s Status Message area will indicate this
condition with a display message.

Figure 5-29. View Current Test Results Variable Function Key

When the View Current Test Results variable function key is pressed, the most
recent tests results are displayed for the current patient using this patient’s parameter
settings.

Notes:

■

If patient or protocol parameters have been entered or changed on the same
patient after a test completes, the current test results will be recalculated with the

new information and appear when the View Current Test Results variable
function key is pressed.

■

If the patient has been changed and then the View Current Test Results variable
function key is pressed, results from the most recent test will be recalculated for
the new patient.

5-36 HMS Plus Operator’s Manual