ARGUSmedDB – Instruction for Use

Medication Database Version 1.1X

DOSE ERROR REDUCTION SYSTEM

for CODAN Argus Infusion Pumps
Copyright © 2011 CODAN ARGUS A

Content
General ..................................................................................................................................................... 2
System Requirements .............................................................................................................................. 4
Parameters for Recording a Drug .............................................................................................................. 5
Use of the Integrated Demo Library....................................................................................................... 11
Creating a New Drug Library .................................................................................................................. 12
Saving a Drug Library .............................................................................................................................. 15
Combine Drug Libraries .......................................................................................................................... 15
Printing a Drug Library............................................................................................................................ 16
Define a Drug List for Downloading ....................................................................................................... 18
Check a Downloaded Drug List on the Device ........................................................................................ 20
Setup a Download File for the Technical Service ................................................................................... 21
Upload a Drug Library from the Device .................................................................................................. 22
Password Protection .............................................................................................................................. 22
Change a Password................................................................................................................................. 23
DB Options (Database Options) ............................................................................................................. 23
Further Options ...................................................................................................................................... 24

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General

ARGUSmedDB is a database solution for recording drugs. The precisely defined drug specifications, with
the option of defining restrictions for the user, allow for safe and efficient infusion with the
ARGUS 606 S syringe pump and the ARGUS A717 V / 718 V volumetric pumps.
Centralised or decentralised database management is possible. The department-specific drug
specifications can be recorded, managed and loaded onto the devices as separate files.
The database allows for the recording of drugs for various areas of application (anaesthesia, intensive
care unit etc.). Thanks to graduated safety settings and basic function control for each drug, the user
only has access to the functions on the device which comply with the hospital’s general regulations or
standards. The aim is to reduce application errors.

Caution: All of the drugs specified in the database are activated once they have been downloaded onto
the devices, as soon as the user selects a drug.

The management of the contents of the database and the correctness of the recorded drugs are the
exclusive responsibility of the qualified, specialist medical staff.
The drug data should only be downloaded onto the devices by qualified, specialist technical staff who
are authorised by CODAN ARGUS.

CODAN ARGUS AG accepts no liability for the contents of the data.

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System Requirements

Hardware requirements (PC)

Intel® Pentium® III or faster CPU recommended

1 GB RAM or more recommended

XGA (1024 x 768) or higher video adapter and monitor

300 MB available hard disk space

RS 232 or USB 2.0 required

Software requirements – supported operating systems (PC)

Windows XP Home /Professional/Media Centre Edition Service Pack 2 and 3 (32 bit)

Windows Vista Ultimate/Enterprise/Business/Home Premium/Home Basic Edition (32 & 64 bit) Service
Pack 1

Windows 7 Ultimate/Professional/Home Premium/Home Basic Edition (32 & 64 bit)

.NET 2.0 (download under http://www.microsoft.com/net/)

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Parameters for Recording a Drug

Below you will find a description of all of the parameters which can be defined in the database for a
particular drug.

The database specifications are paramount, and take precedence over the configuration of the device.

1. NAME

Enter the name of the drug here as it should be displayed on the device (restrictions: 1 character must
be a letter, the name must contain a minimum of three characters and a maximum of fifteen
characters).

2. ARGUSrails

Various definition and safety levels are available; the safety threshold for subsequent entries is prepared
by clicking on the relevant button.

a) Drug Name Only

This is used to record the names of drugs which are not specified any further and which contain no dose
specifications. The name can be selected in the device by the user and it then appears on the device
display.

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b) SOFT rails only

These describe a certain range which can be used by the user. If the limit is exceeded, a warning will
appear on the device. The user can override this warning and activate the application by entering a
confirmation.

c) HARD rails only

These define a certain application range which cannot be exceeded by the user. Entries which exceed
the limit are blocked.

d) SOFT and HARD rails

These permit the setting of two-stage limits with the respective properties.

2. CONCENTRATION

The units and the active ingredient content are specified in this part of the database.

a) Units / Mode (Einheiten / Modus)

Specify the units of the active ingredient here.

The concentration is predefined with a fixed value as a default (= Concentration Fix) and this can
therefore not be changed on the device by the user.

If no concentration is defined, all subsequent entries are restricted to ml and ml/h.

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b) Level (active ingredient quantity):

Specify the content for the defined unit.

3. RATE UNIT

Here you define both the dose unit and the speed with which the drug should be administered.

If the calculated result exceeds or falls below the technical limits, the next smaller unit must be selected.

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4. KVO ON / OFF

For certain drugs, a KVO rate (Keep Vein Open) is often not wanted. In this case, set the button to ‘KVO
off’ (see picture above).

This specification takes priority, regardless of whether or not the device configuration allows for a KVO
rate.

5. DOSE CALCUALTION

a) In the ‘Rate’ field, specify a default value for the dose rate; this specification is displayed on the device
as soon as the drug has been selected. It can be modified by the user (within the limits) prior to the start
of the infusion.

The value in the database can also be 0 and is also displayed as a 0 value on the device.
In this case, the user must enter the rate (within the limits) on the device.

b) Is the field Volume’ (VTBI volume) activated, a total infusion volume can also be specified (with or
without rails). The pre-setting „Volume” (VTBI) = 0 prompts the user to enter a volume on the device
before starting the infusion.
Caution: making a volume specification results in a restriction of the infusion time, depending on the
selected rate.

6. BOLUS

The Bolus field offers many different setting options. In case that the administration of a bolus is
desired, you need to activate the ‘Bolus’ checkbox. If this is not activated, the bolus function will not be
available on the device.

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The default setting for the bolus (once it has been activated) is for administration at the highest possible
rate (in accordance with the device configuration). Deactivate this default setting and define other
specifications.

By deactivating the checkbox “Use highest possible bolus rate”, other pre-settings are made available.

a) Bolus volume
The entry of the volume restricts the maximum permitted quantity of the drug which can be
administered per bolus, regardless of whether it is a manual or an automatic bolus.

b) Bolus time
The speed for the bolus administration is defined in ml/h .

c) Bolus fix / variable

If you do not want it to be possible for the user to modify the bolus volume on the device, set the ‘Fix’
button.

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d) Bolus action

Define the administration method by selecting either ‘Manual’ or ‘Automatic’.

This definition is binding and cannot subsequently be changed by the user on the device.

Caution: An automatic bolus always requires a bolus volume!

7. TIVA (Total Intravenous Anaesthesia)

This application always includes the specification of an induction and a maintenance rate. To activate
the application, tick the ‘TIVA’ checkbox.

a) Induction

The induction is defined by means of a specified volume. The administration speed is specified as a time
unit (in seconds).
The change from induction to maintenance rate can be controlled by means of the “Behavior” button;
“Auto Start” means that, once the induction has been administered, the device starts the maintenance
rate directly. “Manual” means that the user starts the maintenance rate manually at the specified time.

The “Limit” button is only activated when the application allows for HARD rails. If the “Limit” button is
set to OFF, the induction dose can be modified without any restrictions (subject to the technical limits)
prior to starting. If the ‘Limit’ button is set to ON, an upper limit can be set in the database which cannot
be exceeded by the user.

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b) Maintenance

The maintenance rate can be specified with a default value; if no HARD rails are defined, this rate can be
modified on the device by the user as required (subject to the technical limits).

Use of the Integrated Demo Library

Your software contains a library model. It will be made available after installation and the first software
start. To open it, you must click the button „Demo Database“. Read and confirm the usage instructions.

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Safe the library and assign a name and a version number. This library may then be modified for your
own applications.

Creating a New Drug Library

In the task bar, select ‘New DB’ and enter a name and the desired version number. The text field can be
used to enter an additional description.

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Record a ward

Several wards can be recorded in a drug database and loaded onto a device. Take care when entering
names, in order to ensure that access for the user on the device is unambiguous.

Specify drugs
Drugs can be recorded and specified in various ways:

 Drug name only

no further parameters are recorded and only the name is displayed on the device

 Drugs with specified concentration, dose units and, if desired, with limits

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Display of drug details by department::

Modifying data (protection against accidental change)

In order to protect existing entries in the database against accidental change, a modification can only
ever be made after clicking on the Edit button. The modification is completed by clicking on ‘End edit’.

Caution: If the concentration of a drug is subsequently modified, all of the parameters previously
defined are reset for safety reasons.

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Saving a Drug Library

When a drug library is saved, an .amdb file is created. This format is also used for loading the recorded
drugs onto the device.

Combine Drug Libraries

You may bring together various libraries into one file:

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Printing a Drug Library

You can display and print out the recorded drugs as a report. The software automatically creates a PDF
file as soon as “Print Preview” or “Print” is activated.

Drugs of an entire ward or an individual drug can be displayed as detailed overview.

Select “All drugs”:

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Or select “Drug list”:

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Define a Drug List for Downloading

Open the respective library (.amd file) and click on the view „Download Selection.

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Click on the „Add“ button and enter a name for the download list.

Make sure that all check boxes from those drugs are activated which shall be downloaded onto the
device. Safe your download list for later applications and for documentation purposes.

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Check a Downloaded Drug List on the Device

It is strongly recommended that the recorded drug data is verified on the device.

Click in the task bar on „Download“ and choose the correct COM Port.

The device must be in the configuration mode and connected with the interface cable.

By clicking on the download button, the drug list is sent to the device.

The Download list can then be sent in form of a hex file to the technical department. The technician is
able to equip the respective devices with the drug library by means of the ARGUSservice tool

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Setup a Download File for the Technical Service

Click on the „Save“ button; the „Device“ window is popped up.

Activate the required device type. Following this, „Directory“ window is shown, where the desired
location can be selected.

Two types of files are automatically produced: a .gmdb and a.hex file.

The file name is composed of the name of the download list and of its version number as well as from
the device type.

Example: „DEMO MedDB 16_11_2011_V0.11_ARGUS 606 S.hex“

Downloading a drug list is the responsibility of the technical service.

Before bringing the device into operation, the loaded data must be checked for correctness and
completeness.

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Upload a Drug Library from the Device

Proceed as described in the previous chapter. By clicking on the “Upload” Button the drug library of the
device will be uploaded and shown in the database. You may print and save this library or download it
onto another device. It is not possible to make changes on the uploaded data.

Password Protection

Protect your files by restricting the read and write permission by means of a password:

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Change a Password

Use the button “Password”. Enter the old and the new password. The new password must be entered a
second time for verification purposes.

DB Options (Database Options)

Click on “File” in the task list. This function allows modifications of the name and version of a drug
library.

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Further Options

33

Various settings may be adjusted here:

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