Model 500 and Micro 505 Infusion Pump Technical User Manual March 2002

Published by Graseby Medical Limited. All possible care has been taken in the preparation of this publication, but Graseby Medical Limited accepts no liability for any inaccuracies that may be found. Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes. Copyright © 2002 Graseby Medical Limited No part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Graseby Medical Limited. GRASEBY MEDICAL LIMITED Colonial Way, Watford, Hertfordshire, United Kingdom, WD24 4LG Telephone: Facsimile:

+44 (0)1923 246434 +44 (0)1923 231595

http://www.graseby.co.uk Registered in England. Company number 995550

Trademarks and acknowledgements: Graseby and Smiths are registered trademarks of the Smiths Group plc. All other trademarks are acknowledged as the property of their respective owners.

Warnings and Cautions

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Wa r n i n g s Warnings tell you about dangerous conditions, that could lead to death or serious injury to the user or patient, that can occur if you do not obey all of the instructions in this manual. 1.

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WARNING: You should ensure that the performance offered by the pump is fit for the intended purpose. Failure to do so may result in compromised function of the product, patient injury or user injury. WARNING: Do not use a faulty pump. If the pump detects a fault when it is first turned on, or if it develops a fault during operation then a continuous system alarm sounds. The pump must be referred to a suitably qualified technician or returned to Graseby Medical in order to have the fault rectified. WARNING: Before using the pump, it should be inspected for physical damage. The pump should not be used if damage is evident, and should be returned to service personnel for repair before being returned to use. Failure to do so may result in compromised function of the product, patient injury or user injury. WARNING: Do not use the pump if you detect any cracks, chips and loose or bent parts, or if the buttons do not move in and out freely when they are pressed. Failure to do so could cause inadvertent disconnection of the pumps. WARNING: Do not push or pull on the pumps, or the IV pole may tip over or the pumps fall to the floor. Do not try to remove modular connected pumps from the IV pole whilst they are joined together. Either of these could cause the administration set to separate from the fluid container thus spilling the medication, or the pumps themselves could be damaged. WARNING: Correct entry of data is essential in order to ensure that the intended infusion is performed. Before confirming any displayed data when setting up an infusion, you should ensure that it is correct. Failure to do so may result in compromised function of the product, patient injury or user injury. WARNING: Dose-rate calculation requires care in entering data. Refer to specific product drug labelling for information on appropriate administration techniques and dosages. Entering incorrect data may result in patient injury or death.

Volumetric Infusion Pumps

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WARNING: When delivering drugs in the epidural space, use only those medications specifically indicated for epidural use. Epidural administration of other drugs could result in serious patient injury or death. 9. WARNING: The use of administration sets incorporating injection sites could lead to an improper or inappropriate infusion resulting in serious patient injury or death. 10. WARNING: Failure to clearly identify the pump and administration sets could lead to an improper or inappropriate infusion resulting in serious patient injury or death. 11. WARNING: Remove any air to prevent air embolism. The presence of air within the infusion can result in complications resulting in patient injury or death. 12. WARNING: To avoid over infusion, do not prime the infusion line when the administration set is connected to the patient. Over infusion can result in patient injury or death. 13. WARNING: The Occlusion alarm level must be checked before starting an infusion to ensure that it is appropriate for the infusion. Failure to do so may result in an unacceptably slow time to Occlusion alarm, resulting in patient injury or death. 14. WARNING: Prior to starting an infusion, inspect the fluid path for kinks, a closed clamp or other obstructions. Failure to do so may result in the infusion not being delivered correctly, resulting in patient injury or death. 15. WARNING: If using a blood pressure cuff above the patient’s venipuncture site take extra care in setting the Occlusion alarm pressures. Failure to do so may result in unnecessary Occlusion alarms, resulting in patient injury or death. 16. WARNING: The Occlusion detection system measures downline pressure in the administration set, but does not detect infiltration. In accordance with local protocol, you must periodically inspect the patient’s infusion site for signs of infiltration. Failure to do so may result in an unacceptably slow time to Occlusion resulting in patient injury or death. 17. WARNING: If an Occlusion alarm occurs, immediately clamp the line to the patient. Then inspect the fluid pathway to determine what has caused the obstruction. An unintentional bolus of medication can result in patient injury or death.

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Warnings and Cautions

18. WARNING: Do not run parallel infusion lines below the pump. Delivering a Secondary infusion means running a second line above the pump. Failure to do so may result in an inaccurate delivery of medication, resulting in patient injury or death. 19. WARNING: Check the Secondary set carefully, since an occlusion above the pump on the Secondary line could cause the Primary fluid to be delivered instead of the Secondary infusion. Administering the wrong medication may cause serious patient injury or death. 20. WARNING: The Secondary volume to be infused must match the amount of fluid in the secondary container. Primary flow resumes when the secondary container is empty. If the volumes do not correspond, the wrong infusion may be delivered which could cause serious patient injury or death. 21. WARNING: Correct management of battery charging, as described in this documentation is essential to ensure that the pump can operate on battery for the time specified. Failure to do so may result in compromised function of the product or patient injury. 22. WARNING: If a backup alarm sounds, the pump should be immediately removed from the patient and sent to be repaired by a Graseby Medical qualified technician. Failure to do so may cause patient injury or death. 23. WARNING: Failure to use the power cord retainer means that the pump may be accidentally or erroneously disconnected from

the mains. Although there is a battery backup in case this happens, the battery may not be charged sufficiently. Consequently, there is a risk of the pump not functioning which could lead to patient injury or death. 24. WARNING: Do not open the pump housing. Refer all service faults only to qualified technical personnel. Opening the pump housing may cause electric shock leading to patient or user injury or death. 25. WARNING: When the pump is carrying out an infusion, to ensure that electrical safety is maintained, only items of equipment that conform to EN60950 are to be connected to the RS232 connector situated at the back of the pump, otherwise patient safety may be compromised. 26. WARNING: While Graseby Medical Limited have taken all reasonable steps to ensure that the pump operates correctly while under remote control, it is the responsibility of the person who designs and implements the controlling device to ensure that the resulting system (pump and controlling device) is fit for its intended purpose. Failure to do so may result in compromised function of the product, patient injury or user injury. 27. WARNING: Use only Graseby Medical administration sets with this product. Failure to do so may result in compromised system accuracy leading to complications resulting in patient injury or death.

Cautions Cautions tell you about dangerous conditions that can occur and cause damage to the pump if you do not obey all of the instructions in this manual. 1.

2.

3.

CAUTION: Refer all service, repair and calibrations only to qualified technical personnel. Unauthorised modifications to the pump must not be carried out. CAUTION: Do not autoclave, steam sterilize, ETO sterilise or subject the pump to temperatures in excess of 55° C (131° F). Excessive temperatures may cause damage to the pump. CAUTION: To prevent serious damage to the pump it must not be immersed in any liquids or exposed to strong organic solvents. Wipe off spills immediately. Do not allow fluid or residues to remain on the pump. Additionally,

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the pump is not designed to allow it to be sterilised. Failure to observe these cautions may cause internal damage to the pump. CAUTION: Carry out periodic cleaning following the detailed instructions in the Volumetric Infusion Pumps Service Manual. Do not use unapproved cleaning agents. CAUTION: When turning the pump on, if screens similar to those illustrated are not displayed, do not use the pump, and send the pump to authorised service personnel. CAUTION: Only carry the pump by the handle. Failure to do so may result in damage to the pump, or the pump may be dropped which could cause internal damage to the pump. CAUTION: The backlight has a limited life and may, if used constantly, cause the light to dim. Eventually the message display may then need to be replaced. To preserve the life of the message display, you should only turn on the Message Display Light as described here if it is specifically required. Misuse of this feature could lead to both battery and LCD depletion.

Volumetric Infusion Pumps

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Contents

Contents Who should read this manual ... 1

Introduction ... 1 Contents of the box ... 2 Checking labels and serial number ... 3 Functional inspections and tests ... 4 Setting up ... 8 Regular testing ... 9 Requirements ... 9

Menus ... 10 Technician menu ... 11 Technician parameters ... 12 Using Technician parameters ... 13

Biomedical menu ... 16 Biomedical menu parameters ... 17

Service Functions menu ... 19 Service Functions menu parameters ... 20 Sensors screen ... 21

Specifications ... S - 1 Standards ... S - 9 Trumpet curves ... S - 10 Index ... I - 1

V o l u m e t r i c Te c h n i c a l U s e r G u i d e

i

Te c h n i c a l U s e r M a n u a l

Graseby Medical Ltd.

Introduction This Technical User Guide accompanies pump software version 0.71 and above. The information in this guide supplements the Volumetric Infusion Pump Instruction Manual which is intended for anyone using the pump on a day-to-day basis. Technical issues, such as acceptance testing, configuring the pump and looking at technical information are not needed by most users, so they are separated into this stand-alone manual.

Apart from acting as a reference for use of the configuration menus, and providing technical details and a pump specification, this manual contains a summary of the initial setting up and acceptance testing of the pump. For more detailed information, see the Volumetric Infusion Pump Service Manual, available on request from Graseby Medical Limited.

Who should read this manual You should be familiar with the use of the Volumetric Infusion Pump before reading this manual in order to understand the effect of changes you should make with the configuration menus described in this manual.

• a member of a Biomedical Engineering / Medical Physics department who is configuring the pump for use in a particular environment;

As well as training in the use of the pump, this manual also assumes that you have appropriate experience of technical aspects of Volumetric pumps.

• a member of a team setting up protocols for the use of a pump in a particular environment;

In order to understand the significance of the functions and features described in this manual, you should have read the Volumetric Infusion Pump Instruction Manual. You may also need to refer to it when using this manual.

• a Technician servicing a pump;

• a Clinician deciding how a pump should be configured for specialised use; • a trainer who is setting up the pump.

You should read this manual if you fall into one of the following groups of people who need to configure the pump rather than using it to run infusions:

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Contents of the box The box should contain the following items shown in the diagram below. • two manuals: an Instruction Manual and this Technical User Manual • the Volumetric Infusion Pump • an AC power cord fitted to the pump with a power cord retainer and screw. We suggest you keep the box in case you have to return the pump for servicing.

When you have unpacked the pump When you have unpacked the items, do the following: • Carry out the Visual checks described on page 4 to ensure that no damage has occurred during transit • Set up, test and configure the pump as described on page 4.

The pump should not be used if damage is evident. Contact your Graseby Medical Service Department

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Checking labels and serial number The pump has a number of labels which should be kept clean and legible. As shown in the diagram below, the instructions label on the right side of the pump can be used to identify the revision of the pump for ordering replacement parts.

Volumetric Infusion Pump

Optional Labels To help users to differentiate the pump and IV set being used for epidural delivery from those being used for other routes of administration, a yellow Epidural Label Set for the Volumetric Infusion Pump (part number TPF-00306) is available from Graseby Medical.

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Functional inspections and tests Perform the following tasks when you have taken the pump out of the packaging or when following the regular testing described on page 9. As you remove the parts from the packaging, check that the parts match the description on page 2.

Visual check Check for damage: • check for marks on the pump or other signs of mechanical damage; • check the appearance of the LCD screen for damage, when the pump is switched off; • check the serial number and the label as described on page 3. If you are carrying out routine functional checking, repair or replace any parts that are damaged. Additionally, check for: • chipping or cracking of the housing and the modular connector system; • proper movement of the mechanical parts; • damage to the sleeve or plug on the AC power cord; • check that the AC power cord retainer is fitted to prevent the cord from being pulled out of the IEC socket. WARNING: Failure to use the power cord retainer means that the pump may be accidentally or erroneously disconnected from the mains. Although there is a battery backup in case this happens, the battery may not be charged sufficiently. Consequently, there is a risk of the pump not functioning which could lead to patient injury or death.

4

Power up and self test Test that the pump is functioning correctly. Switch on the pump and watch the screen and listen to the sounds made by the pump. You should observe the following: Note: If the pump is switched off and connnected to AC power and the saftey keypad lockout feature is active, the pump cannot be switched on via the keypad. See Instruction Manual, Safety keypad lockout, page 2-22.

1. When the pump is connected to the AC mains supply, the green Mains LED lights up.

2. When you press the On/Off key on the keypad, you hear a click to indicate that you have pressed the key. The pump then performs a self test. 3. The LEDs on the Primary, Secondary/Bolus, Run and Hold keys light. The Battery LED also lights.

4. When the self test is complete, the LCD Message Display shows:

Verify that the backlight is on. 5. Unplug the pump and verify that the mains LED goes out and that the battery LED lights. 6. Connect the pump to the AC mains supply again and, with the pump switched off, open the door. Verify that the pump turns on automatically, and that it does so with the LED on the Primary key lit.

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Te c h n i c a l U s e r M a n u a l

7. Leave the door open for at least six seconds and verify that the pump does not sound the alarm. If it does, there is a fault.

• if the LCD message screen is not clearly visible;

8. Press the Secondary key and verify that the LED lights and the Primary key LED goes out.

If there is a fault during a routine service check, repair or replace the faulty parts.

Use the following checklist for errors that might occur in the above steps. If any of the following faults occur with a new pump, contact your Graseby Medical Service Department. • if any LEDs do not light in steps 1, 3 or 5; • if no sound is heard in step 2; • if no display appears in step 4; • if the backlight does not come on in step 4.

LCD and LED tests Run this test with the AC power cord connected to the AC mains supply. Test the LCD and the LED ambient light sensor as follows. With the pump switched on, you should observe the following: 1. When you view the pump from the front at an angle of about 20 degrees, the LCD message screen should be clearly readable and have a minimum contrast. 2. Cover the ambient light sensor (which is just below the Secondary/ Bolus key) and verify that the LED display intensity decreases. When you uncover it the display should return to the original intensity. If any of the following faults occur with a new pump, contact your Graseby Medical Service Department. Volumetric Infusion Pump

• if the ambient light sensor does not respond.

Load an administration set Prepare a container of solution and prime a ‘Standard Adult Set, 8C-820’ (non-checkvalve 20 drop/mL) administration set Product Code 21-0346-25 for the following tests. Ensure that a suitable drain is provided for the expended solution. Prime the administration set using the instructions in its accompanying leaflet. Verify that the administration set can be loaded into the pump correctly.

Running checks 1. Press the Rate key and enter 12.3 mL/h. Verify that the correct rate appears in the rate display. 2. Press the Volume to be Infused key and enter 4567mL on the Model 500 or 456.7mL on the Micro 505. Verify that the correct volume appears in the Volume display. 3. Press the Occlusion Alarm Setting key and verify that the message display shows the occlusion alarm setting. If the pump is new it will display a Medium setting. 4. Press the Rate key and enter 890mL/h for a Model 500 pump or 89.0mL/h for a Micro 505. Press the Volume to be Infused key and enter 88.8mL. Ensure that the lower roller clamp is still closed and press the Run key. Verify that the

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following message is displayed and an insistent alarm sounds:

5. Silence the alarm and open the lower roller clamp.

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9. With pump on hold, press the Total Volume key and verify that the message display shows a volume and time like the following:

6. Press the Run key and then press the Options key. Verify that the message display shows the time remaining with a value like the following:

If you have a new pump and it does not behave as described here, contact your Graseby Medical Service Department.

7. Close the upper tubing clamp or pinch the tubing above the pump and verify that the message display shows:

Lockout and safety checks

and the pump alarms. Silence the alarm and open the upper tubing clamp, or release the tubing. 8. Press the Run key. Tip the administration set drip chamber to introduce air into the line. When the air reaches the upper cassette chamber, verify that the pump alarms and the message display shows:

Silence the alarm and clear the air as follows: Close the lower roller clamp and open the door . Wait for the cassette to fill and then slowly close the door. The air should be expelled up the tube. If necessary repeat the process to clear the remaining air.

6

If there is a fault during a routine service check, repair the pump as described in the Service Manual. 1. Press the Run key and then press the Keypad lock/unlock button on the lower right of the panel at the rear of the pump so that the screen momentarily shows

2. Press each key, including the On/Off key, to verify that all keys are inactive and the above message appears when you press a key. 3. Press the Keypad lock/unlock button to enable the keypad again and press the Hold key and verify that the pump stops. 4. Press the Run key and then open the door. When the pump alarms and this message appears, silence the alarm.

5. Pull the safety clip from the slot and then, holding the tubing, pull the clip towards you so that the clip can be slid down the tubing. Volumetric Infusion Pump

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Slide it down so that it is clear of the pump. Ensure that the cassette is firmly home on the pins and close the door. When this message appears, silence the alarm and open the door:

6. Slide the safety clip up the tubing and push it into its slot. Close the clamp above the cassette. Then close the door and silence the alarm when this message appears:

7. Open the roller clamp, open the door and close it again. 8. When the message disappears, press the Run key and verify that the pump is running. Then press the Hold key. If the pump does not behave as in the description above, contact your Graseby Medical Service Department.

Audio alarm check This test uses the Biomedical menu. Full details of this menu are given on page 17. 1. Switch the pump off. Then, while simultaneously holding the Options key, switch the pump on. 2. When the ID screen is displayed, enter the number 3031, and then enter the password 7867. If the Passwords screen does not come up, switch off and start again. 3. Press the Options key 9 times to display the alarm test screen:

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Te c h n i c a l U s e r M a n u a l

4. Press 1 to test the non-insistent

alarm, 2 to test the insistent alarm and 3 to test the continuous backup alarm. Press the alarm Silence key to stop each one.

5. Switch off the pump. If you have a new pump and it does not behave as described here, contact your Graseby Medical Service Department. If there is a fault during a routine service check, repair the pump as described in the Service Manual.

Further testing The above tests are basic tests and are a subset of the acceptance tests described in the Service Manual. Carry out further tests as required by your internal acceptance protocol.

Instrument Care Periodic cleaning of the pump housing and inside surface of the door is recommended. Unplug the power cord and use a sponge or cloth lightly dampened with a solution of warm water and a mild, non-staining disinfectant/cleaner. Do not use cleaning agents which could damage the outer pump housing. The Service Manual contains information on which cleaning agents may or may not be used, and how to perform cleaning. CAUTION: Carry out periodic cleaning following the detailed instructions in the Volumetric Infusion Pumps Service Manual. Do not use unapproved cleaning agents.

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Setting up Battery charging

Enabling limits

Before using the pump for clinical use, connect the power cord to the AC mains supply and charge for at least 10 hours.

When enabling limits, and deciding on the protocol to be used, you should be aware of the following:

Pump configuration

• Primary limits can be enabled independently of Secondary limits; this is because rates for Secondary/ Bolus infusions may need to be higher than Primary limits;

With version 0.71 of the pump software, additional features can be configured. The complete list of parameters is shown in the table on page 12. The features which are enabled when the pump leaves the factory are the same as the ones enabled on previous versions of the pump. This allows you to run the pump as if it had been delivered from the factory as a previous version, without having to configure it. When you have carried out the tests on pages 4 to 7, if you decide to use additional features, the pump must be configured. See the description of the Technician menu on page 12 for details of how to enable and disable features as required. You may also need to set the date and time using the Service Functions menu as described on page 20.

Deciding on the configuration In most cases, your hospital’s protocol will have been agreed for the configuration settings for the use of the pump in particular locations. When deciding on features to enable, bear in mind that to have too many features enabled may confuse the user and also that with more parameters enabled, it may take longer to reach the one required when pressing the Options key.

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• if limits are enabled, you should ensure that the clinical protocol includes checking and/or amending the values for the minimum and maximum rate and maximum VTBI limits using the Options key; • if limits are enabled, the limits remain at the pump default values as described in the Specification unless the operator has set limits using the Options key; • if limits are not enabled, then the pump VTBI/rate limits are as described in the Specification; the operator cannot alter them; • only Primary limits are displayed during power up, even if both primary and secondary limits are enabled; You cannot disable the ability to give a Secondary infusion, although you can disable the Bolus feature. However, if Secondary infusions are not used in a particular environment, you could enable the Secondary limits on the Technician Menu and then set the Secondary max rate limit to 1mL/h. You cannot set a maximum of zero, but setting the lowest possible maximum can reduce the risk of a Secondary infusion being given.

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Graseby Medical Ltd.

Te c h n i c a l U s e r M a n u a l

Regular testing In addition to the regular testing requirements listed below, Graseby Medical recommends that a qualified technician should carry out annual functional and accuracy checks on each pump as described in the Service Manual.

Requirements After checking the following, you should decide whether the pump is fit for use. 1. The safety information and operating instructions on the side of the pump must be legible. 2. The mechanical conditions of the pump must allow safe operation. 3. The pump must be clean. 4. The safety fuses must be of the specified type and rating.

6. Ground impedance between the protective contact in the pump inlet and the potential equalisation terminal must be less than or equal to 0.1 Ohm. 7. The leakage current must meet the specification described on page S-3. 8. The functional inspections and tests described on page 4 are satisfactorily completed.

5. Ground impedance between the protective contact in the AC mains plug and the potential equalisation terminal must be £ 0.2 Ohm.

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Menus There are several menus on the pump, some of which have an overlap of features. This is to keep backwards compatibility with pump software versions before version 0.71. Users familiar with previous versions of the pump software can continue to use a familiar menu to set up the features of pump that existed before version 0.71.

Which version of software is in the pump?

The Biomedical menu This menu is the one that also exists in versions of the pump before version 0.71. In previous documentation it has also been called the “Biomedical Special Functions”. As well as enabling or disabling features, it also displays data for fault finding and calibration.

Parameters on two menus The common parameters on both the Technician and Biomedical menus are:

You know that a pump has version 0.71 software (or later), if:

• Rate Taper • Volume Over Time • Dose Rate Calculation.

• the Secondary infusion key appears as:

Which menu should you use?

• the label on the right hand side of the pump, as shown on page 4, lists more than eight options; • the Biomedical menu (menu item number 9) shows V0.71, for example:

For the parameters that are on both Technician and Biomedical menus, you can use either menu. In most instances, however, you will: • use the Technician menu, where parameters for all the features appear, to configure the pump for the user; • use the Biomedical menu only when you are servicing the pump.

The Service Functions menu The Technician menu This menu is only present on pumps with version 0.71 software and later. You use the Technician menu to enable the features of the pump that have been introduced with version 0.71 software, as well as the features that existed in earlier versions. These features and their defaults are described on page 13.

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This menu contains a number of functions for servicing the pump. It is also where you set the time in the pump.

The Special Functions menu This menu is used to initialise the pump when it is upgraded. A description of its use is included in the Service Manual and the Instruction Worksheet for the 500/3000 Volumetric Infusion Pump Software Upgrade Kit.

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Te c h n i c a l U s e r M a n u a l

Te c h n i c i a n m e n u This menu allows you to define how the pump behaves by setting values or by disabling or enabling parameters. To enter this menu, first switch off the pump if it is switched on.

You cannot move back through the menu. If you make a mistake, then you can continue to move through the list by continuing to press the Options key and the first item appears again when you reach the end. You may find it faster to switch off and start again.

Then press the Total Volume key while simultaneously pressing the On/Off key. When you take your fingers off the keys, the pump switches on and you are asked to enter the Technician menu ID.

To move through the list quickly, and avoid going past the item you want, you may also find it faster to count the number of times you press the Options key. The table on the next page has been numbered to help you do this.

Enter the numbers 0002.

Leaving the Technician menu

As you enter the digits, asterisks (*) are displayed for security protection. If you make a mistake, you must switch the pump off to enter the correct ID. When prompted:

To exit from the menu, switch off the pump.

Entering the Technician menu

Enter the password 2020. The Technician menu ID is always 0002 and the password is always 2020. These cannot be changed.

Using the Technician menu When you enter the Technician menu, the first parameter is the one to enable or disable the display of the Pump Identifier. Move down the list by pressing the Options key. Use the * key to toggle a parameter. Thus if you see a screen like the following:

then the feature is disabled and you must press the * key to enable it.

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Graseby Medical Ltd.

Technician parameters The numbers on the left of this table show the number of Options key presses to reach the parameter. The default settings are the factory settings. Configuration Parameter

Operation

Pump Identifier

Enable or Disable

Disabled

1

Drug List

Enable or Disable

Disabled

2

Primary rate limits

Enable or Disable

Disabled

3

Primary Max VTBI

Enable or Disable

Disabled

4

Secondary/Bolus rate limits

Enable or Disable

Disabled

5

Sec / Bolus Max VTBI

Enable or Disable

Disabled

6

KVO rate entry

Enable or Disable

Disabled

7

Occlusion Default

High, Medium or Low

Medium

8

Secondary Stop

Enable or Disable

Disabled

9

Bolus

Enable or Disable

Disabled

10 Quick Rate

Enable or Disable

Enabled

11 Rate Taper

Enable or Disable

Enabled

12 Volume over Time

Enable or Disable

Enabled

13 Dose Rate Calculation (DRC) Enable or Disable

Enabled

14 DRC Recovery

Enable or Disable

Disabled

15 Backlight

Enable or Disable

Enabled

16 Autolock Keypad

Enable or Disable

Disabled

17 GMT Timestamp

Enable or Disable

Enabled

18 Service Date

Review or Date Entry

00/00/00 (disabled)

19 Micrograms

Selection 1 (µg) or 2 (mcg)

12

Default

2

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Using Technician parameters Most parameters enable or disable features that appear when the Options key is pressed. All only affect one feature, but for some you may need to think about making another setting at the same time. For example, if you enable Primary rate limits, you might also enable Primary Max VTBI. See also page 8 for guidance on creating protocols for setting parameters.

can be infused for a Primary infusion.

Minimum and maximum secondary/ bolus rate Enabling this parameter allows the user to define a range to limit the Secondary rate or Bolus rate.

Pump Identifier If you enable this parameter, when you press the Options key to move to the next parameter you can edit the identifier text. When the pump leaves the factory, the identifier is set to the serial number of the pump. You can change the identifier character by character by using the up and down keys (1 and 3) to cycle through alphanumeric values. Press the * key to move to the next character. Press the Options key when you are finished.

Drug list Enabling this parameter gives the user the ability to change the displayed Drug label. If it is disabled, then the label is not displayed.

Minimum and maximum primary rate Enabling this parameter allows the user to define a range to limit the Primary rate.

Maximum primary VTBI Enabling this parameter allows the user to set the maximum volume that Volumetric Infusion Pump

Maximum secondary/bolus VTBI Enabling this parameter allows the user to set the maximum volume that can be infused for a Secondary or Bolus infusion.

KVO rate entry If this is enabled, then the user can set their own KVO rate. If it is disabled, the default KVO rate is used. KVO rate ranges and KVO default rates are in the Specification, see page S-7.

Occlusion default setting Use this option to set the occlusion default setting that should be applied when the pump is switched on. Press * to change the default. The user can press the Occlusion Alarm Setting key to change the occlusion level for a particular infusion regardless of this default parameter setting. However the default setting is reapplied when the pump is switched off and on again. 13

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Secondary stop With this parameter enabled, the pump stops when a Secondary infusion is completed. It sounds an insistent alarm and displays a message to say that the secondary infusion is complete:

If Secondary Stop is disabled, when a secondary infusion is complete, the pump sounds a non-insistent alarm twice and then automatically restarts the infusion at the primary rate. This parameter is independent of the setting of the Bolus parameter and only affects a Secondary infusion; at the end of a Bolus infusion the pump always reverts to the previously programmed Primary rate.

Bolus When this parameter is enabled, the user is given a choice of whether a Secondary or a bolus infusion is to be run when they press the Secondary/ Bolus key. If Bolus is chosen, the volume infused is deducted from the Primary VTBI. If Secondary is chosen, the Secondary volume infused is kept as a separate total and does not affect the Primary VTBI. If Bolus is disabled, the user is not given a choice when they press the Secondary/Bolus key: they can only make settings for a Secondary infusion.

Quick Rate The Quick Rate Change parameter was always enabled in software versions before version 0.71. From version 0.71, the parameter may be enabled or disabled on the Technician Menu.

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Graseby Medical Ltd.

Enabling this feature allows users to use the Options key to put the pump into a mode in which they can change the rate quickly while the pump is running or on hold.

Rate Taper Enabling this parameter allows the user to taper the infusion rate, either up or down, for the administration of Total Parenteral Nutrition (TPN), Total Parenteral Admixture (Three-in-One) or other applicable therapies.

Volume Over Time Enabling this parameter allows the user to set up an infusion using the volume to be infused and the total time, with the pump automatically calculating the infusion rate. This can be done with either Primary or Secondary infusions.

Dose-Rate Calculation Enabling this parameter allows the user to set the dosing rate, patient weight, the drug amount in the fluid bag and the volume in the container, from which the pump then calculates the infusion rate. Note: If you enable Dose-Rate Calculation, the Micrograms unit should also be set (using the Micrograms parameter on this menu) according to your protocol.

DRC Recovery Enabling this feature allows a DoseRate Calculation mode infusion to be accessed quickly when the pump is switched on.

Volumetric Infusion Pump

Graseby Medical Ltd.

Backlight This parameter sets the default for how the backlight behaves when the pump is switched on. With the parameter disabled, the backlight will go off after a minute of keypad inactivity. If the parameter is enabled, the user can use the Options key to control whether the Message Display Light is permanently on or behaves as described above when the option is disabled.

Autolock Keypad With this parameter enabled, the keypad will automatically lock one minute after a key was pressed. The user can unlock the keypad by pressing twice on the Keypad lock/ unlock button on the back of the pump.

GMT Timestamp Enabling this parameter displays the message ‘GMT’ to the right of a time display.

Service Date

Te c h n i c a l U s e r M a n u a l

When the pump is in use, if the date set is reached or exceeded, then the following message is displayed with an insistent alarm when the pump is switched on:

The alarm must be silenced for the pump to work, as a reminder to the user that the pump should be serviced.

Micrograms Use this feature to determine the units to be displayed as µg or mcg for the Dose-Rate Calculation. If you are not enabling Dose rate calculation, you can ignore this item. Note: Since the pump does not confirm the chosen unit display, test that the display is set correctly. Switch the pump on normally and press the Options key until the Message Display asks you to set the Dose-Rate calculation. Then press * to examine the next screen.

This parameter is used to set the service due date that is displayed during power up when the pump is switched on. You can set or clear the service date when this screen is displayed with the date flashing on the Technician Menu:

Enter the new date in the format MM/DD/YY, or to disable the Service Date feature, set the month, day and year to zeroes.

Volumetric Infusion Pump

CAUTION: The backlight has a limited life and may, if used constantly, cause the light to dim. Eventually the message display may then need to be replaced. To preserve the life of the message display, you should only allow the Message Display Light to be turned on as described here if it is specifically required. Misuse of this feature could lead to both battery and LCD depletion.

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