IVAC P6000 TCI & TIVA Directions for Use Issue 5

1PB0544C05.qxd

12-09-2003

12:06

Page 4

Basic Functions Loading a Syringe Place the pump on a stable horizontal surface or secure using the pole clamp fitted. Prepare, load and prime the single use disposable syringe and extension line using standard aseptic techniques. Important: For TCI - only use Zeneca 50ml syringes prefilled with Diprivan. 1. Squeeze the finger grips on the plunger holder and slide the mechanism to the left. Lift the syringe clamp and rotate to the left. 2. Insert the syringe into the slots on the plunger holder. Insure that the Diprifusor tag is positioned towards the display to allow the prefilled syringe tag to be read. 3. Squeeze the finger grips on the plunger holder and slide the mechanism to the right until the syringe finger flanges locates in the V slot. Important: Advance the syringe until the finger flanges touch the front of the V slot closest to the syringe clamp. This is important to prevent delay at the start of the infusion. 4. Release the finger grips. Apply gentle pressure on the plunger holder to ensure that the drive is engaged. Rotate the syringe clamp forward until it locks onto the syringe barrel. 5. Check that the syringe plunger and finger flanges are correctly located in their slots. Important: Only use a syringe of the type and size indicated on the pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion and the performance of the pump. When initially loading the syringe, allow for the volume of fluid contained in the extension line and retained in the syringe at the end of infusion as this “dead-space” will not be infused.

Power ON/OFF To power up the unit press the power

Symbol Definition

!

Attention (Consult accompanying documents) Potential Equalisation Connector RS232/Nursecall Connector (Optional) Class I Equipment Type CF Equipment (Degree of protection against electrical shock)

IPX4

Protected against splashing fluid (Degree of protection against fluid ingress)

ALARIS Medical UK Ltd (hereinafter referred to as "ALARIS Medical") warrants that: (A)

Each new instrument (pump, controller or peripheral instrument) is free from defects in material and workmanship under normal use and service for a period of one year from the date of delivery by ALARIS Medical to the first purchaser.

(B)

Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical to the first purchaser.

If any product requires service during the applicable warranty period, the purchaser should communicate directly with the local ALARIS Medical service centre to determine appropriate repair facility. Repair or replacement will be carried out at ALARIS Medical's expense, subject to the terms of this warranty. The product requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in return shipment to ALARIS Medical shall be at purchaser's risk. In no event shall ALARIS Medical be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any ALARIS Medical product. This warranty shall not apply to, and ALARIS Medical shall not be responsible for, any loss arising in connection with the purchase or use of any ALARIS Medical product which has been repaired by anyone other than an authorised ALARIS Medical service representative or altered in any way so as, in ALARIS Medical's judgement, to affect its stability or reliability, or which has been subject to misuse or negligence or accident, or which has had the serial or lot number altered, effaced or removed, or which has been used otherwise than in accordance with the instructions furnished by ALARIS Medical. This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities on ALARIS Medical's part, and ALARIS Medical neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of ALARIS Medical products. See packing inserts for international warranty. ALARIS MEDICAL DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

Alternating Current Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark. START Button - Press to start the infusion.

button once. To power off the

unit press and hold down the power button for 3 seconds. The display will count down and switch the unit OFF.

Installation Check that the pump is complete, undamaged and that the voltage rating specified on the base plate is compatible with your AC power supply. Items supplied with this ALARIS Medical Systems® syringe pump are;

IVAC TCI & TIVA. POLE CLAMP. DIRECTIONS FOR USE. DIPRIFUSOR™ GUIDE FOR ANAESTHETISTS. (Guidance on the administration of Diprivan (Propofol) by target controlled infusion).
AC POWER CABLE (AS REQUESTED).
PROTECTIVE PACKAGING. Connect the unit to the AC power supply for 24 hours to ensure that the internal battery is fully charged. Should the pump fail to perform correctly, replace it in its original protective packaging and contact a qualified service engineer for investigation.

Pole Clamp The pole clamp is supplied fitted to the rear of the unit and will provide secure fixing to standard I.V. poles of a diameter of up to 40mm. The pole clamp can also be fitted in a choice of 4 fixing positions allowing the unit to be mounted to vertical and horizontal poles, equipment rails and hospital furniture in a variety of convenient operating orientations. The pole clamp may be adjusted for use with horizontal fittings by using the existing fixings screws with the alternative fixing holes in the pole clamp. The pole clamp may also be secured to the base of the unit in a choice of four positions. Important: Do not mount the unit with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.

2/20

Warranty

STOP Button - Press to stop the infusion. The Amber light will flash to indicate an alarm. ON/OFF - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF. Use “Double Chevron” for fast increase / decrease and the “Single Chevron” for slower increase/ decrease of values shown on the display in set-up and configuration. OPTIONS button - Press the OPTIONS button to access drug name and other optional features. Press PURGE/BOLUS to purge the extension line during set up while the pump is stopped or to bolus at an accelerated rate while an infusion is running (a bolus infusion is not available in TCI mode, purging will be available in TCI mode before an infusion is started or after changing a syringe). PRESSURE button to pressure.

- Use the PRESSURE display the pumping

Use “Blank Soft Keys” in conjunction with the prompts shown on the display.

1000PB00544 Iss 5

1000PB00544 Iss 5

19/20

Getting Started - TCI Mode Starting the Pump - TCI Mode 1. 2.

3.

Connect the pump to an AC power supply using the AC power cable. Press the button. TCI MODE ? - The pump will operate in TCI Mode if the YES softkey is pressed. The pump will operate in Normal Mode or TIVA mode if the NO softkey is pressed. LOAD SYRINGE - Load the syringe according to the Load Syringe Procedure in the Getting Started section of this user manual.

4.

AGE ? - Enter the Age of the patient using the keys. Press the OK softkey when the correct value has been entered.

5.

WEIGHT ? - Enter the Weight of the patient using the keys. Press the OK softkey when the correct value has been entered. TARGET - Enter the initial target concentration value using

6.

7.

8.

9.

the keys. Press the OK softkey when the correct value has been entered. The initial infusion dose and duration will be calculated using the data entered in steps 5-6. VARIABLE INDUCTION feature - Press the MODIFY softkey to enter the Variable Induction Mode, if required. Refer to the Variable Induction Mode section. Press the CONFIRM softkey to enter the infusion data displayed. PURGE - Press the button. The display will show two purge softkeys. Press the two softkeys simultaneously until fluid flows and the purging of the syringe extension line is complete. The volume used during purging will be shown on the display. CONNECT PATIENT - Connect the extension line to the patient access device.

10. START - Press to commence operation. INFUSING will be displayed. The AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is operating. Important: The unit will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply. Each time the unit is switched ON, check that the alarm beeps twice and that all the segments of the display, the green and amber lights are illuminated during the self test routine. During PURGE/and at TCI rates >300ml/h: pressure limit alarms are temporarily increased to their maximum level, no alarms are disabled during the use of the Purge button, or at high rates.

Front Panel - TCI Mode Pump Status

Volume Infused and Mass Infused

Calculated Concentration Target Concentration

1000PB00544 Iss 5

Effect Site Concentration and Decrement Time

Purge The button allows the delivery of a limited volume of fluid in order to purge the extension line prior to being connected to a patient or after changing a syringe. 1.

To use the purge option stop the pump and press the button. 2. The display will change and show two purge soft keys. Press the two PURGE soft keys simultaneously. The purged volume is not added to the volume infused. 3. When the purging function has been completed press the QUIT softkey to exit the menu. Important: The purge feature is not available after the infusion has been started, the syringe must be reconfimed to activate the purge feature. No alarms are disabled during the operation of the purge feature.

Variable Induction Mode Variable Induction Mode allows the modification of infusion data. 1. After entering initial Target Concentration (step 6 of the Starting the Pump procedure), press the MODIFY softkey. 2.

Use the keys to adjust the Start Level concentration. Press OK to confirm.

3.

Use the keys to adjust the Final Level concentration. Press OK to confirm.

4.

Use the keys to adjust the NO. OF STEPS. Press OK to confirm. Verify concentration increment value.

5.

Use the keys to adjust the pause time. Press OK to confirm. The Pause Time refers to the time between Target concentrations. The BACK softkey may be pressed at any time to return to the previous option. When all data has been entered press CONFIRM. When operation has been started INDUCTION and a Target Site trend graph will be displayed.

6. 7.

NB. When running in Variable Induction Mode, pressing the key will confirm current phase target concentration and continue infusing. Manually titrating rate will always terminate the Variable Induction feature. Variable Induction Profile Final Target Level

Final Step

Current Target Level

Target Site Concentration

Start Level

Effect Site Concentration

Pause Time Step 1

7.5ml 22.5mg

Step 2

Trend Graph

3/20

Getting Started - TCI Mode Infusion Graph

Pressure Level

The graph displayed on the screen shows the concentration over time. To change the graph scale scroll through the time option softkey. In Variable Induction Mode the graph always scales to the final level. The upper line shows the Diprifusor™ calculated Target Site Concentration. The shaded area shows the Diprifusor™ calculated Effect Site Concentration. Target Concentration 4.0 mg/ml

1.

To check and adjust the pressure level press the button. The display will change and a bar graph will show the pressure alarm level and current pressure level.

2.

To adjust the alarm level press the keys to increase or decrease the level. The new level will be indicated on the display. When the pressure level has been selected press QUIT to exit the screen.

3.

End of Operation

37.0ml/h

Effect Site Concentration

Changing a target concentration during infusion To titrate the target concentration without stopping the infusion, use the chevron keys to set a new target. Press the new target.

to confirm

1.

Use the keys to select the titrated target. The display will indicate that the target is being titrated with the text TITRATE shown. The target will flash to indicate that although being adjusted the target selected has not been confirmed.

2.

Press the button to confirm the new target. When the target has been confirmed the pump will automatically switch to the new target. If the target is titrated on the display but not confirmed by pressing the button within 10 seconds a warning beep will sound. If the new concentration is not confirmed within 2 minutes the titrated target will revert to the actual infusion target, no target change will occur.

To halt the infusion press the button. The option END OPERATION will be displayed. Answer YES to end the operation in TCI Mode. The pump will revert to the start - up screen without powering down the unit. Answering NO will leave the pump in the ON HOLD state, with a target concentration of 0, the result of which is a decreasing calculated concentration. Variable Induction will also be terminated. Pressing the RESUME key will leave the pump in the ON HOLD state but with the same target concentration. Calculated concentration will decrease until the infusion is restarted. To restart the infusion press the button and titrate the target concentration to the required value. Important: Diprifusor™ uses a phamacokinetic model of the distribution and elimination of Propofol in the body to calculate plasma concentrations in µg/ml. If the phamacokinetic model is stopped and reset the TCI operation cannot be restarted. The model will be stopped in TCI mode if the END OPERATION is confirmed or if the pump is powered down. Important: The pre-filled Propofol syringes are for single use in one patient only. Any portion of the contents remaining after use MUST be discarded.

Effect Site Icon

High Target

Display of the Diprifusor™ calculated effect site concentration for Propofol.

Targets above the normal maximum (10.0µg/ml) and below the absolute maximum(15.0µg/ml) will cause the display to warn the user of use of a high target.

Decrement Time Icon Optional display of the time estimated to reach Decrement Concentration can be set in the options. This feature can be used to estimate time to reach a concentration lower than the calculated value, if the infusion is stopped or target set to 0.0mg/ml. This feature may be disabled in the Configured Options. The user has the option to adjust the default lower concentration value, see the TCI Options.

Event Log This option allows the event log to be reviewed. 1.

Press the

2.

Select the EVENT LOG option using the press the OK softkey indicated on the screen.

3. 4.

Scroll through the log using the keys. Press the QUIT softkey indicated on the screen to exit the menu.

4/20

button to access the options menu. keys and

TCI Options The following options can be viewed using the button: Drug Name The TCI model drug in use. Cannot be modified from the options button. Duration The duration of the operation since the pump was first started. Cannot be modified from the options button. Decrement Conc. Press the MODIFY softkey to amend the concentration used in the Decrement Time Calculation estimate, when the revised value has been entered press the OK softkey. Age The TCI model patient age. Cannot be modified from the options button. Weight The TCI model patient weight. Cannot be modified from the options button. Event Log Follow event log instructions.

1000PB00544 Iss 5

Getting Started - TIVA Mode Starting the Pump - TIVA Mode

Purge

Configuration allows the user to define drug names, and typical defaults for the information entered in the start sequence below. If there have been no drugs configured these steps will not appear. 1. Connect the pump to an AC power supply using the AC 2. 3. 4. 5.

6.

power cable. Press the button. Press the NO softkey to select the TIVA mode. CLEAR SETUP - If you wish to reset the setup information press the YES softkey. If you want to use the previous setup information press the NO softkey. SELECT DRUG - Select a drug from the list displayed. If there are no drugs programmed refer to the configured options to set up the drug protocols. CONC - Enter the syringe concentration, for example in mg/ml between the limits set in the drug protocol. Press the OK softkey to enter. If the drug default concentration, minimum concentration and the maximum concentration are equal step 5 is bypassed. WEIGHT (if required for dosing) - Enter the patient weight using the

keys. Press the OK softkey to enter.

7.

INDUCTION - Using the keys, enter the induction dose amount per kg (if required for dosing) of patient weight. Press the OK softkey to enter. The Induction feature may be disabled. Refer to Drug Set-Up to disable/enable induction feature. 8. TIME - Enter the induction time in seconds over which the induction dose will be delivered. Press the OK softkey to enter. 9. MAINTENANCE - Set the maintenance dose rate in the drug protocol units. Press the OK softkey to enter. 10. CONFIRM - Confirm the induction and maintenance rates are set up correctly. 11. LOAD SYRINGE - Load the syringe according to the LOAD SYRINGE Procedure in the Getting Started section of this user manual. 12. CONFIRM SYRINGE - Check that the syringe type and size being used matches the display. If required, the type of syringe can be changed by pressing the TYPE button. Press CONFIRM when the correct type and size are shown. Purge extension line if necessary. 13. CONNECT PATIENT - Connect the extension line to the patient access device. 14. START - Press to commence operation. INDUCTION will be displayed. The AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is operating. Important: Each time the unit is switched ON, check that the alarm beeps twice and that all the segments of the display and the green and amber lights are illuminated during the self test routine. The unit will automatically operate from its own internal battery if the pump is switched ON without being connected to the AC power supply.

Main Display - TIVA Mode Syringe Type or Drug Name

Pump Status

Time

IVAC ® TIVA

Flowrate Doserate

INFUSING 100 ml/h 10.0 mg/ml/h + ADJUST -

Volume Infused

1000PB00544 Iss 5

SYRINGE TYPE VOLUME

0.0ml

12:00 INDUCTION

10s

0.0ng

?

Review Information

The button allows the delivery of a limited volume of fluid in order to purge the extension line prior to being connected to a patient. 1.

To use the purge option stop the pump and press the button. 2. The display will change and show two purge soft keys. Press the two PURGE softkeys simultaneously. The purged volume is not added to the volume infused. 3. When the purging function has been completed press the QUIT softkey to exit the menu. Important: No alarms are disabled during the operation of the purge feature.

Bolus Infusion This option is enabled/disabled within the General Options. It is not possible to deliver a bolus during an induction or if bolus is disabled. 1.

During the maintenance phase infusion press the button once. This displays the bolus screen. 2. If necessary, press the RATE softkey to select the bolus delivery rate. 3. Press and hold the BOLUS softkey to deliver a bolus dose. 4. Release the BOLUS softkey once the required dose has been delivered. Important: Alarms are not disabled during the operation of the bolus feature. The pressure alarms are temporarily increased to their maximum levels during the operation of the bolus feature.

Bolus Infusion - Hands Free During induction it is not possible to deliver a bolus. This option is enabled/disabled within General Options. 1.

During maintenance phase infusion press the This will display the bolus screen.

2.

Use the keys to set the bolus dose required. If necessary press the RATE softkey to select the bolus delivery rate. Press the BOLUS button once to begin the delivery of the bolus dose. The display will revert to the main display showing the bolus being delivered, counting up on the review section of the screen. On completion of the bolus the instrument will automatically revert to the maintenance rate. To exit the bolus feature press the QUIT softkey. To terminate a bolus being delivered either press the STOP

3.

4. 5.

button.

button and restart the infusion, or press the button and press the STOP softkey. This will stop the bolus and continue infusing at the maintenance rate. Important: Alarms are not disabled during the operation of the bolus feature. The pressure alarms are temporarily increased to their maximum levels during the operation of the bolus feature.

REVIEW

Review Option

5/20

Getting Started - TIVA Mode Changing a rate during infusion

Repeat Operation

The infusion rate can be changed by stopping the infusion, setting a new rate and restarting the pump.

This option will only appear in the options menu when the infusion has been stopped.

1.

1.

Use the keys to select the titrated rate. The display will indicate that the rate is being titrated with the text TITRATE shown. The target will flash to indicate that although being adjusted, the rate selected has not been confirmed.

2.

Press the button to confirm the new target. When the rate has been confirmed the pump will automatically switch to the new rate. If the rate is titrated on the display but not confirmed

by pressing the button within 10 seconds a warning beep will sound. If the rate is not confirmed within 2 minutes the titrated rate will revert to the actual infusion rate, no rate change will occur. Important: This method suspends the infusion for a few seconds while the new rate is being set. This may be considered a disadvantage.

Pressure Level 1.

To check and adjust the pressure level press the button. The display will change and a bar graph will show the pressure alarm level and current pressure level.

2.

To adjust the alarm level press the keys to increase or decrease the level. The new level will be indicated on the display. When the pressure level has been selected press QUIT to exit the screen.

3.

Clear Volume 1.

Press the

2.

Select the CLEAR VOLUME option using the keys and press the OK softkey indicated on the screen. The volume infused will be displayed. Press the YES softkey to clear the volume infused displayed.

3. 4.

button to access the options menu.

Time Before Syringe Empty Icon

1. 2. 3. 4.

To review the protocol data press the REVIEW softkey. The protocol data will be displayed in the main display. Press the REVIEW key to display the next protocol data set. Repeat until the protocol data required is displayed in the main display.

Clear Induction To clear the induction, press the button. The CLEAR INDUCTION prompt is shown. To clear the induction press the YES softkey. Answering NO to the CLEAR INDUCTION prompt will leave the pump in the ON HOLD state; the induction can be restarted by pressing the

6/20

button.

button to access the options menu.

2.

Select the REPEAT OPERATION option using the keys. 3. Press the OK softkey indicated on the screen. This will revert the pump to the initial programming WEIGHT step (if the drug protocol is weight dependant), without powering down the pump. When WEIGHT is confirmed the other initial induction parameters will be recalled.

Set by Doserate / Set by ml/h To set rates accurately in doserate or flowrate increments it may be necessary to switch between the rate adjust options SET BY DOSERATE and SET BY ml/h. An arrow to the left of the rate display shows the rate changed when the keys are used to increase/decrease the infusion rate. To set a doserate precisely the arrow must be pointing to the doserate (mg/kg/h); the flowrate will be calculated from the doserate. To accurately set a flowrate the arrow must be pointing to flowrate (ml/h); the doserate will be calculated from the flowrate. Selecting the Set By Doserate Option 1.

Whilst the pump is infusing, press the the options menu.

button to access

2.

Select the SET BY DOSERATE option using the keys and press the MODIFY softkey indicated on the screen. This will select the set by doserate option, the arrow on the display will automatically select the doserate, the doserate can be adjusted if necessary. Selecting the Set By ml/h Option 1.

Whilst the pump is infusing, press the the options menu.

2.

Select the SET BY ml/h option using the keys and press the MODIFY softkey indicated on the screen. This will select the set by flowrate option, the arrow on the display will automatically select the flowrate, the flowrate can be adjusted if necessary.

The time to syringe empty is displayed in the display, the icon indicates the time remaining before the syringe empty alarm is activated. For example 0:33:46 indicates that running at the current rate approximately 33 minutes and 46 seconds remain before the syringe empty alarm will occur.

Review

Press the

button to access

Event Log 1.

Press the

button to access the options menu.

2. 3. 4.

Select the EVENT LOG option using the keys. Press the OK softkey indicated on the screen. Press the QUIT softkey indicated on the screen to exit the menu.

End Of Operation This option will only appear in the options menu when the infusion has been stopped. 1.

Press the

button to access the options menu.

2.

Select the END OF OPERATION option using the keys. 3. Press the OK softkey indicated on the screen. This will revert the pump to the the initial start up screen, without powering down the pump. 1000PB00544 Iss 5

Getting Started - Normal Mode Starting the Pump - Normal Mode

Purge

If TCI mode is not confirmed and NO DRUG is selected the configuration steps will not appear. When a drug is selected the pump enters TIVA Mode - see Starting the Pump - TIVA Mode.

The PURGE button allows the delivery of a limited volume of fluid in order to purge the extension line prior to being connected to a patient.

1.

1.

Connect the pump to an AC power supply using the AC power cable. Press the

button.

2.

Press the NO softkey to select the TIVA mode.

3.

CLEAR SETUP - If you wish to reset the setup information press the YES softkey. If you want to use the previous setup information press the NO softkey.

4.

SELECT NO DRUG - Select the no drug option from the list displayed. If there are no drugs programmed refer to the configured options to set up the drug protocols required.

5.

LOAD SYRINGE - Load the syringe according to the LOAD SYRINGE Procedure in the Getting Started section of this user manual.

6.

CONFIRM SYRINGE - Check that the syringe type and size being used matches the display. If required, the type of syringe can be changed by pressing the TYPE button. Press CONFIRM when the correct type and size are shown. Purge extension line if necessary.

7.

CONNECT PATIENT - Connect the extension line to the patient access device.

8.

START - Press to commence operation. INFUSION will be displayed. The AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is operating.

Important: Each time the unit is switched ON, check that the alarm beeps twice and that all the segments of the display and the green and amber lights are illuminated during the self test routine. The unit will automatically operate from its own internal battery if the pump is switched ON without being connected to the AC power supply.

To use the purge option stop the pump and press the button. 2. The display will change and show two purge soft keys. Press the two PURGE softkeys simultaneously. The purged volume is not added to the volume infused. 3. When the purging function has been completed press the QUIT softkey to exit the menu. Important: No alarms are disabled during the operation of the purge feature.

Bolus Infusions This option is enabled/disabled within the General Options. It is not possible to deliver a bolus during an induction or if bolus is disabled. 1.

During the maintenance phase infusion press the button once. This displays the bolus screen. 2. If necessary, press the RATE softkey to select the bolus delivery rate. 3. Press and hold the BOLUS softkey to deliver a bolus dose. 4. Release the BOLUS softkey once the required dose has been delivered. Important: Alarms are not disabled during the operation of the bolus feature. The pressure alarms are temporarily increased to their maximum levels during the operation of the bolus feature.

Bolus Infusions - Hands Free During induction it is not possible to deliver a bolus. This option is enabled/disabled within General Options.

Main Display - Normal Mode Syringe Type

Pump Status Flowrate

INFUSING 100 ml/h

SYRINGE TYPE

Volume Infused

During maintenance phase infusion press the This will display the bolus screen.

2.

Use the keys to set the bolus dose required. If necessary press the RATE softkey to select the bolus delivery rate. Press the BOLUS button once to begin the delivery of the bolus dose. The display will revert to the main display showing the bolus being delivered, counting up on the review section of the screen. On completion of the bolus the instrument will automatically revert to the maintenance rate. To exit the bolus feature press the QUIT softkey. To terminate a bolus being delivered either press the STOP

Time 12:00

VOLUME

0.0ml

0:33:46

+ ADJUST -

1.

REVIEW

3.

? Review Information Review Option

4. 5.

button.

button and restart the infusion, or press the button and press the STOP softkey. This will stop the bolus and continue infusing at the maintenance rate. Important: Alarms are not disabled during the operation of the bolus feature. The pressure alarms are temporarily increased to their maximum levels during the operation of the bolus feature.

1000PB00544 Iss 5

7/20

Alarm Procedures Alarms are indicated by a combination of an audible alarm, flashing amber STOP light and a descriptive message in the display. 1. A continuous audible alarm indicates that the infusion has stopped. First press MUTE to silence the alarm for a maximum of 2 minutes. Then check the display for a alarm message. Press CANCEL to cancel the alarm message. 2.

When the cause of the alarm has been rectified, press the

button to resume the infusion.

?

WARNING ALARM MESSAGE MUTE

CANCEL

Description

Display

PUMP DRIVE DISENGAGED - The drive system has been disengaged during the infusion. Check the finger grip and the position of the syringe.

DRIVE DECLUTCHED

EXCESSIVE DRIVE PRESSURE - Pumping pressure has reached the alarm limit. Following an occlusion the drive will backoff (if enabled - see general options) to reduce excess pressure; alternatively squeeze finger grips on the plunger holder to release the drive mechanism and relieve any excessive pressure in the syringe and patient line. Identify and remove the cause of the blockage in the administration system before restarting the infusion.

OCCLUSION

SYRINGE CLAMP LOCATION - Incorrect size of syringe has been fitted, the syringe clamp has not been positioned correctly, or the syringe has been disturbed during operation. Check syringe location, position of syringe clamp, and syringe.

SYRINGE LOCATION

PLUNGER NOT DETECTED -The syringe plunger is not correctly fitted in the plunger holder. Check the syringe plunger location.

PLUNGER LOCATION

BATTERY CHARGE LOW WARNING - Battery charge low with up to 30 minutes operation remaining. Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted. Reconnect to AC power to continue operation and charge the internal battery.

BATTERY LOW

BATTERY EMPTY - Internal battery empty. To silence the alarm switch the pump OFF and reconnect the pump to AC power. Restart operation on AC power to charge the internal battery.

BATTERY EMPTY

NEAR END OF SYRINGE WARNING (NEOI) - This is a timed event and can be set from 2% - 10%. To set / change this value see the general options section in this user manual.

NEAR END OF SYRINGE

SYRINGE EMPTY - END OF INFUSION (EOI) - The pump has reached the end of the infusion. About 1% (can be set in configuration) of the syringe volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set.

SYRINGE EMPTY

AC POWER SUPPLY DISCONNECTED WARNING AC Power has been disconnected and the

AC POWER FAIL

pump is operating on battery power. Reconnect AC power or press to silence the alarm and continue battery operation. The display will flash AC POWER FAIL. The alarm will automatically cancel if the AC power is reconnected. INTERNAL MALFUNCTION - The alarm system has detected an internal malfunction. Note the malfunction code. Remove the unit from service for examination by a qualified service engineer.

ERROR

BATTERY MAY BE LOW OR EMPTY - When the pump was last turned off the battery was low. If the pump has not been charged since then operate on AC power only.

BATTERY WAS LOW AT LAST POWER OFF. HAS PUMP BEEN RECHARGED?

INTERNAL MALFUNCTION IN TCI MODE - The alarm system has detected an internal malfunction. TCI mode has been disabled until the pump is serviced. TIVA mode can be used THIS PUMP HAS REPORTED A in the event of emergency. Remove pump from service for examination by a qualified service MALFUNCTION. TCI MODE NOT AVAILABLE. PUMP REQUIRES engineer. SERVICING. TIVA MODE AVAILABLE FOR EMERGENCY USE ONLY.

Alarm Procedures - Alarms without screen prompts CALL BACK WARNING - Unit left switched ON for over 2 minutes without starting operation. Press

or any of the control buttons to silence the alarm for a further 2 minutes. Alternatively,

“3 BEEPS”

press and hold down for 2 seconds to delay call back for 15 minutes. After a TIVA/TCI setup has been entered the CALL BACK WARNING alarm will be set to call back after 60 minutes. 8/20

1000PB00544 Iss 5

Configured Options This menu comprises a list of options which are configurable by the user. 1. Turn pump OFF. 2. 3.

Whilst holding down the button turn the pump ON. The main display will show 000. Enter the Access Code “xxx”

4. 5.

using the keys. (For technician access codes please refer to the Technical Service Manual.) Press NEXT to move through the digits. When the complete code has been entered press OK to enter.

Drug Set-up 1. 2. 3. 4.

5.

Select the DRUG SETUP option using the keys and press the OK softkey indicated on the screen. Select the required drug and press the OK softkey. To use a drug it must be enabled. Press the YES softkey indicated on the screen, to enable the selected drug. To add or change a drug name use the keys to toggle through the alphabet. To select a letter press the NEXT softkey. On completion press the OK softkey indicated on the screen.

6.

Select the Concentration Units using the keys, press the OK softkey to select the concentration units. Select the Default Concentration of the drug selected, use the

7.

keys to increase/decrease the default concentration shown on the screen. When the default concentration has been selected press the OK softkey. Select the Minimum Concentration of the drug selected. Use

8.

the keys to increase/decrease the minimum concentration shown on the screen. When the minimum concentration has been selected press the OK softkey. It is possible to select OFF by continuously pressing . Select the Maximum Concentration of the drug selected. Use

the keys to increase/decrease the maximum concentration shown on the screen. When the maximum concentration has been selected press the OK softkey. It is possible to select OFF by continuously pressing . Important: If the default concentration, the minimum concentration and the maximum concentration are equal, the CONCENTRATION prompt will be bypassed during the TIVA start up sequence. 9. Select the Dose Units required for maintenance doses, use

Clock Set Clock Set is used to set the pumps internal clock. 1.

Select CLOCK SET using the softkey indicated on the screen.

2. 3.

To adjust the value displayed use the keys. When the displayed value is correct press the NEXT softkey to access the next field. Repeat the process until the correct time and date is displayed. Press the OK softkey to store the values.

4.

keys and press the OK

Enable Syringes Enable syringes is used to pre-configure the type and size of syringe allowed for use by an operator. Select all the syringes which may be used with the pump. Disable any syringes which will not be used. 1.

Select ENABLE SYRINGES using the the OK softkey indicated on the screen.

2.

Use the keys to toggle up and down the list of available syringe types and sizes. Press the MODIFY softkey to enable/disable the syringe. Press the OK softkey to store the syringes enabled. When the set-up is complete, turn the pump OFF and return the pump into service, or select the next configuration option.

3. 4.

keys and press

Hospital Name The hospital name allows the user to programme in the name of the hospital, ward or department to appear during the power up display sequence. 1.

Select HOSPITAL NAME using the the OK softkey indicated on the screen.

2. 3.

To adjust the character displayed use the keys. When the displayed character is correct press the NEXT softkey to access the next field. Repeat the process until the correct Hospital Name is displayed. Press the OK softkey to store the values.

4.

keys and press

the keys to select the dose units required. When the dose units required have been selected press the OK softkey. 10. Select the Induction Dose (per kg selected in dose units) required, use the keys to increase / decrease the induction displayed. When the induction has been selected press the OK softkey. If the setting is less than 0.01 the INDUCTION prompt will not appear in the TIVA mode start-up sequence. 11. Select the Induction time required, use the keys to increase/decrease the time over which the induction is to take place. When the time has been selected press the OK softkey. 12. Select the Maintenance Rate required, use the keys to increase/decrease the maintenance rate. When the rate has been selected press the OK softkey. 13. Select the Bolus Dose (per kg selected in dose units) required. Use the keys to increase / decrease the bolus dose. When the dose has been selected press the OK softkey. If the setting is less than 0.01 the Bolus setting is turned off. The Bolus feature is disabled in TIVA mode. 14. Review the drug setup data, press the OK softkey to confirm the data displayed. This will return the pump to the drug setup menu. 1000PB00544 Iss 5

9/20

Configured Options General Options 1.

Turn pump OFF.

2.

Whilst holding down the

3.

The general options available are as follows:

AC Fail Alarm -

Enables or disables the AC Fail Alarm.

NEOI Warning -

Sets the NEOI warning from 2.0% to 10.0%.

EOI Point -

Sets the end of infusion volume as a percentage of the syringe volume from 0.5% to 2.0%.

Beam Alarm -

Sets up the default beam level.

Weight -

Sets up default patient weight, for normal mode only.

Purge Rate -

Sets the purge rate. The upper limit prevents excessive loss of fluid whilst purging.

Hands Free Bolus -

Enables Hands Free bolus to be delivered.

Default Bolus -

Sets the default bolus amount, for normal mode only.

Nurse Call -

Enables or disables the nursecall option.

Nurse Call Inverted -

When enabled the Nurse Call Option output function is inverted.

The main display will show 000. Enter the Access Code “xxx”

4.

Press NEXT to move through the digits.

5.

When the complete code has been entered press OK to enter.

6.

Select GENERAL OPTIONS using the the OK softkey indicated on the screen.

7.

Select the option you wish to enable/disable or adjust and press the MODIFY softkey indicated on the screen.

9.

If the backoff feature is enabled it causes the motor to reverse to relieve line pressure when an occlusion condition occurs. (Does not apply when the pump is in TCI mode.)

button turn the pump ON.

using the keys. (For technician access codes please refer to the Technical Service Manual.)

8.

Backoff -

keys and press

When all the options that you require to enable/disable or adjust have been selected press the OK softkey indicated on the screen. When the set-up is complete, turn the pump OFF and return the pump into service, or select the next configuration option.

Comms Pump Address - Sets the Address.

Pumps

Communications

Comms Monitor Only - If not enabled, allows remote control of the unit from the comms links. Monitor is always possible. * Comms Odd Parity -

If enabled, communication parity is odd.

* Comms ASCII -

If enabled, communications protocol is in ASCII.

TCI -

If enabled, the TCI option is activated (TCI hardware must be fitted).

Display TCI Decrement Time -

If enabled, the display shows the TCI Decrement Time Icon (TCI hardware must be fitted).

* Please note that users are unable to adjust these options.

10/20

1000PB00544 Iss 5

Self Test Routine The self test routine is designed to allow confirmation of many of the pump functions, defaults and calibrations without requiring internal inspection. It does not represent a full calibration check. 1.

Press the

button OFF.

2.

Hold down the

button and press the

button ON.

3. The main display will show “000”. Enter the Access Code “123” using the keys. 4. Enter the first digit and press NEXT indicated on the screen. 5. When the complete code has been entered press OK indicated on the screen. 6. The pump will now proceed through a series of tests. Press the NEXT button to move to the next test. Important: Should the pump fail the test sequence, it should be taken out of service and inspected by a qualified service engineer.

Self Test Sequence Display

Test Description

SOFTWARE REVIEW

SOFTWARE / SET UP AND REVIEW: Including software version, program crc and language.

SYRINGE REVIEW

REVIEW SET UP OF CALIBRATION DATA: Including syringe, beam and linear calibration.

_.__V

INTERNAL PSU VOLTAGE: On battery typically : 5.50V - 6.50V mains powered : 6.50V - 7.50V.S

AUDIO: ALARM

AUDIBLE ALARM TEST: Check loud alarm sound beeps.

AUDIO:WATCHDOG

AUDIBLE ALARM TEST: Check loud alarm sounds continuously.

AUDIO: KEYPAD

AUDIBLE ALARM TEST: Check soft alarm sounds continuously.

DISPLAY TEST

DISPLAY TEST: Check that the display is operating. You should see the display show an even graduated grey tone.

BACKLIGHT FULL / DIM / OFF

BACKLIGHT TEST: The display will begin the test on full backlight, dim and then turn off. At the end of the test it will turn back on to full.

LEDs FLASHING

INDICATOR LED TEST: Check that the STOP, START and BATTERY LED’S are flashing. Note: the AC LED will not flash.

Press 01

TOUCH PANEL SWITCH TEST: Press buttons in turn from S1 to S13 from START to PURGE.

DECLUTCH: 1

DECLUTCH SWITCH TEST: Squeeze plunger holder finger grips and check that the display alternates between 1 (engaged) and 0 (disengaged - finger grips squeezed together).

SYRINGE PLUNGER: 1

PLUNGER DETECTOR TEST: Press plunger plate button. Check display switches from 0 (No syringe fitted) to 1 (Syringe plunger fitted).

MOTOR / ENCODER : 1

MOTOR ENCODER TEST: Motor is pulsed while encoders are tested. Motor moves forwards and backwards as encoders pass.

LINEAR POT : _ . _ _

LINEAR POT TEST: Declutch the transmission and slide plunger holder to the far left, check the value displayed (approx. 00.19V). Declutch and slide the plunger holder to the far right and check the value displayed (approx. 03.00V).

SYRINGE POT :_ . _ _ V

SYRINGE SIZE DETECTION SYSTEM: Lift the syringe clamp and check that the values displayed increase within the normal range (approx. 0.05V and 3.00V).

BEAM FORCE :_ . _ _ V

PUMPING PRESSURE DETECTION TEST: Remove the syringe and confirm that the value displayed is within normal range (± 0.05V). Gently press back on the plunger holder watch the value increase.

NURSECALL: ON

NURSECALL: During this test you should be able to hear audible clicks of the relay (refer to service manual for more detailed testing).

COMMS

COMMS: Self Test, transmit/receive link back check. (checks a pass with pins 2 & 3 wired together)

DONE - SWITCH OFF

Final screen displays “TESTS DONE”. If the unit passed all the tests it can be powered OFF and put back into service.

1000PB00544 Iss 5

11/20

Routine Maintenance, Disposal, Cleaning & Storage and Battery Operation Routine Maintenance Procedures To ensure that this instrument remains in good operating condition, it is important to keep it clean and carry out the routine maintenance procedures described below. All servicing should only be performed by a qualified service engineer with reference to the technical service manual (TSM) for this product (Service Manual reference: 6000PB00001). Technical service features are available using a three digit access code. Refer to the Technical Service Manual for a list of access codes. Important: If the pump is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of service for examination by a qualified service engineer. Interval

Routine Maintenance Procedures

As Required

Thoroughly clean external surfaces of the pump before and after prolonged period of storage.

12 Monthly

1. 2. 3. 4. 5. 6.

Inspect AC power supply plug and cable for damage. Perform functional OPERATIONAL AND ALARM TEST. See TSM. Perform the SELF TEST ROUTINE. Perform rate accuracy verification test. See TSM. Perform pressure calibration verification test. See TSM. Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging.

Disposal The pump should be disposed of taking environmental factors into consideration. To ensure no risk or hazard remove the internal rechargeable battery and the nicad battery (component B1) from the control board and dispose of as outlined by the local country regulations. Do not send back to manufacturer. All other components can be safely disposed of in the normal manner.

Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use, clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution. The syringe and extension line are disposable single use items and should be discarded after use according to their manufacturers instructions. If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packaging for protection. Once every 3 months during storage, carry out functional tests as described in the OPERATIONAL AND ALARM TEST in the technical service manual and SELF TEST ROUTINE and ensure that the internal battery is fully charged. Important: Before cleaning always switch OFF and disconnect from the AC power supply. Never allow liquid to enter the casing and avoid excess fluid build up on the pump. Do not use aggressive cleaning agents as these may damage the exterior surface of the pump. Do not steam autoclave, ethylene oxide sterilise or immerse this pump in any fluid.

Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable, for example during patient transfer or AC power failure. A fully charged battery will provide over 6 hours operation at typical infusion rates. From the battery low alarm it will take about 24 hours to fully recharge when reconnected to the AC power supply, whether the unit is in use or not. The battery is automatically charged during AC operation and whenever the unit is connected to the AC power supply and the AC power indicator is illuminated. It is good practice to periodically operate the unit on battery power until the battery low alarm then charge the battery to confirm battery operation and charging. When not in use, connect the unit to the AC power supply in order to maintain the battery in the fully charged state. The battery is a maintenance free, sealed lead acid type and requires no routine servicing. However, to achieve optimum operation, ensure that the battery is fully recharged after full discharge, before storage, and at regular 3 month intervals during storage. The internal rechargeable battery will retain charge if utilised as described above on a regular basis. Charge retention will eventually degrade. Where retention is critical the internal battery should be replaced every 3 years.

Replacing the AC Fuses If the pump continually illuminates the battery symbol and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON, suspect that either, the power supply fuse in the AC power plug, or, the internal AC fuses have blown. First check the power supply fuse in the AC mains plug. If the AC power indicator light does not illuminate remove the pump from service. It is recommended that only a qualified service engineer replaces the AC fuses. For further information regarding the replacement of the internal AC fuses refer to the technical service manual.

12/20

1000PB00544 Iss 5

Trumpet and Start Up Curves In this instrument, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause shortterm fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the accuracy of fluid delivery over various time periods is measured (trumpet curves), and 2) the delay in onset of fluid flow when infusion commences (start-up curves).

Trumpet Curves Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or 'observation windows', not continuous data versus operating time. Over long observation windows, short term fluctuations have little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have greater effects as represented by the "mouth" of the trumpet. Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short term fluctuations in rate accuracy may have clinical impact depending on the half-life of the drug being infused and the degree of inter vascular integration, the clinical effect cannot be determined from the trumpet curves alone.

Start-up Curves In this instrument, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the delay in onset of fluid flow when infusion commences (startup curves), and 2) the accuracy of fluid delivery over various time periods is measured (trumpet curves). The start-up curves represent continuous flow versus operating time from the start of the infusion. They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed per IEC60601-2-24 standard. Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or 'observation windows', not continuous data versus operating time. Over long observation windows, short term fluctuations have little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have greater effects as represented by the "mouth" of the trumpet. Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short term fluctuations in rate accuracy may have clinical impact depending on the half-life of the drug being infused, therefore the clinical effect cannot be determined from the trumpet curves alone. Important: Start-up and trumpet curves may not be indicative of operation under negative pressure. Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented. Additional curves for compatible syringes are available upon written request. For applications where flow uniformity is a concern, rates of 1.0ml/hr or above are recommended. Start-up Trend. BD Plastipak 50ml @ 0.1ml/h

Trumpet Curve. BD Plastipak 50ml @ 0.1ml/h (Initial Period) 86.39

90.0 70.0 50.0

0.3

Error (%)

Rate (ml/h)

0.5

0.1 -0.1 -0.3

44.41

30.0

13.82

4.70

2.43

-7.91

-5.76

-10.0 -30.0

-11.45

-36.94-24.31

-50.0

-64.15

-70.0

-0.5

9.32

10.0

-90.0

0

10

20

30

40

50

60

70

80

90

100 110 120

0

5

10

15

20

25

30

Observation Window (mins)

Start-up Trend. BD Plastipak 50ml @ 1.0ml/h

Trumpet Curve. BD Plastipak 50ml @ 1.0ml/h (Initial Period)

35

Error (%)

Rate (ml/h)

Time (mins)

Observation Window (mins)

Start-up Trend. BD Plastipak 50ml @ 5.0ml/h

Trumpet Curve. BD Plastipak 50ml @ 5.0ml/h (Initial Period)

Error (%)

Rate (ml/h)

Time (mins)

Time (mins)

1000PB00544 Iss 5

Observation Window (mins)

13/20

Specifications RS232/Nursecall Feature The RS232 / Nursecall feature fitted to this IVAC “P” Series Syringe Pump allows the pump to be monitored remotely and/or controlled via a suitable central monitoring or computer system. When the pump is started by a command from the serial interface, communication must take place over the serial interface, a communication must take place every 15 seconds or the pump will alarm, display communications failure and stop infusing. This failure protects against failure of the communications, including the removal of the RS232 cable. Important: The nursecall interface provides a remote backup to the internal audible alarm. It should not be relied upon to replace monitoring of internal alarm. Refer to the technical service manual for further information regarding the RS232 interface. Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient, responsibility for the control of the pump is vested in the software run on the computer control system. The assessment for the suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment. This software should include detection of the disconnection or other failure of the RS232 cable. The protocol is detailed in the technical service manual and is for general information only. This relates to IVAC “P” Series Syringe pumps fitted with the RS232 communication interface. Any connected analogue and digital components are required to meet EN60950 for data processing and EN60601 for medical devices. Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard EN60601-1-1.

RS232/Nursecall Specification Connector

D Type - 9 Pin

TXD/RXD

EIA RS232-C Standard .

TXD Output Voltage

Minimum: -5V (mark), +5V (space). Typical:-7V (mark), +7V (space) with 3K load to ground.

RXD Input Voltage

-30V - +30V max.

RXD Input Thresholds Low: 0.6V minimum / High: 3.0V maximum. RXD Input Resistance 3 K minimum Enable Active Low:

7V to -12V Active, High:+7V to +12V, powers up the isolated RS232 circuitry.

Inactive:

Floating/open circuit, allows isolated RS232 circuitry to power down.

Isolation Socket/Pump 4 KV (dc, or ac peak) Start Bits

1 Start Bit

Data Bits

8 Data Bits

Parity

Odd Parity / No Parity

Stop Bits

1 stop bit

Nurse Call

Pins 1, 6 + 9, 30V dc, 1A rating

Typical Connection Data Description 1. Nursecall Normally Closed 2. Received data (RXD) Input 3. Transmit data (TXD) Output 4. Not used 5. Ground (GND) 6. Nurse Call Normally Open 7. Request to send (RTS) Input 8. Clear to send (CTS) Output 9. Nursecall Common Important: The IBM connector pins grouped in pairs above should be linked at the connector.

14/20

IBM Compatible (9 Pin)

IVAC ‘P’ Series Syringe Pump

IBM Compatible (25 Pin)

PIN 3 (TXD) PIN 2 (RXD) PIN 5 (GND) PIN 7 (RTS) PIN 8 (CTS) PIN 4 (DTR) PIN 6 (DSR)

PIN 2 (RXD) PIN 3 (TXD) PIN 5 (GND) PIN 8 (CTS) PIN 7 (RTS)

PIN 2 (TXD) PIN 3 (RXD) PIN 7 (GND) PIN 4 (RTS) PIN 5 (CTS) PIN 20 (DTR) PIN 6 (DSR)

1000PB00544 Iss 5

Specifications Syringe Types

Bolus Limit -

The unit is calibrated and labelled for use with single use disposable luer-lock syringes. Only use the size and type of syringe specified on the pump display.

25.0ml

Options include :-

100ml/h-500ml/h Limited to maximum rate for syringe.

Purge -

IVAC

50ml, 100ml

Purge Limit

BD Plastipak

5ml, 10ml, 20ml, 30ml, 50ml

2.0ml.

Terumo

10ml, 20ml, 30ml, 50ml

B Braun Omnifix

5ml, 10ml, 20ml, 30ml, 50ml

Volume Infused

Sherwood Monoject

5ml, 10ml, 20ml, 30ml, 50ml

Nipro

5ml, 20ml, 30ml, 50ml

Near End Of Infusion (NEOI) Alarm -

Once

50ml

2.0% - 10.0% of syringe volume

Fresenius

50ml

End Of Infusion (EOI) Alarm -

Zeneca

50ml

0.5% - 5% of syringe volume

B Braun Perfusor

20ml, 50ml

Critical Volume -

JMS

100ml

BD Perfusion

50ml

The maximum-over infusion which can occur in the event of a single fault condition is 0.5ml.

BD Precise

50ml

Maximum Pumping Pressure Limit -

BD Precise

20ml

280mmHg - nominal at L-3: Factory Preset, 650mmHg - nominal at L-7: highest alarm level. Occlusion levels L-0 to L-7.

Compatible Extension Lines and Syringes The unit uses a standard, single use, disposable extension line and syringes with luer-lock connectors. Of type designed for use on syringe pumps. 30602N

IVAC 50/60ml Luer-Lock syringe

30120

IVAC 100/120ml Luer-Lock syringe

G40015

Standard Syringe Extension Set - 150cm

G40020B

Standard Syringe Extension Set - 200cm

G40615

Low Sorbing Syringe Extension Set - 150cm

G40620

Low Sorbing Syringe Extension Set - 200cm

G40215

Opaque Syringe Extension Set - 150cm

G40320

Opaque Syringe Extension Set - 200cm

It is recommended that the extension sets are changed according to the hospital protocols. Infusion Rate Maximum infusion rate can be set as part of the configuration. 0.1 ml/h - 150 ml/h

5 ml syringes

0.1 ml/h - 300 ml/h

10 ml syringes

0.1 ml/h - 600 ml/h

20 ml syringes

0.1 ml/h - 900 ml/h

30 ml syringes

0.1 ml/h - 1200 ml/h

50 ml + 100ml syringes

0.1 ml/h steps (0.1 - 99.9) 1 ml/h steps (100 - 999)

0.0ml/h - 9990ml

System Accuracy Drive Linearity

+/- 1%

Volumetric Mean +/- 2% (nominal) Important: (System accuracy is +/-2% typical by volume as measured using the trumpet curve test method defined in IEC60601-2-24 at rates of 1.0ml/h and above when the instrument is used with the recommended syringes. Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves.) also see trumpet curves section. Battery Type Rechargeable Sealed Lead Acid. Automatically charges when the pump is connected to AC power.) Battery Life 4 h @ 5.0ml/h (20 ºC). Battery Charging 10 hours from discharge to 80% charge and 24 hours to 100% charge. Memory Retention The electronic memory of the unit will be retained for more than 6 months when not powered up. AC Power Supply 115-230VAC, 50/60Hz, 20VA (nominal).

10 ml/h (1000 - 1200) Bolus Rate Maximum Bolus rates can be set as part of the configuration. Bolus rates are user adjustable. 10 ml/h - 150 ml/h

5 ml syringes

10 ml/h - 300 ml/h

10 ml syringes

10 ml/h - 600 ml/h

20 ml syringes

10 ml/h - 900 ml/h

30 ml syringes

10 ml/h - 1200 ml/h

50 ml + 100 ml syringes

1000PB00544 Iss 5

B D is a trademark of Becton-Dickinson, Inc. MONOJECT is a trademark of TYCO/ Healthcare Kendall - Monoject INJECTOMAT is a trademark of Fresenius A.G. PERFUSOR is a trademark of B Braun Melsungen A.G.

15/20

Specifications Equipment Classification

Case Material Noryl (with fire retardant to UL94V-0) Dimensions 400 mm (w) x 115 mm (h) x 180mm (d). Weight: 3.5kg (excluding pole clamp and power cable). Manufacturers Patent Notice This instrument is designed and manufactured in the U.K. by ALARIS Medical UK Ltd. under patent GB222444. ALARIS Medical UK Ltd. reserves the right to alter product specifications without notice. Alarm Conditions Occlusion Drive Disengaged Infusion Complete Purge / Bolus Activated Nurse Attention VTBI Complete Near End of Infusion

AC Power Disconnected Low Battery Warning Battery Exhausted Syringe Location Plunger Location Internal Malfunction

Electrical/Mechanical Safety Complies with IEC601-1 1988 (EN60601-1: 1993) EMC Complies with BS EN 60601-1-2 Classification Continuous Mode Operation, Transportable, Electrical Class I / Internally Powered, Type CF, Fluid protection for IPX4. Not to be used in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.

Environmental Temperature Relative Humidity Atmospheric Pressure

Operating +5°C - +40°C 30% - 90% 700 - 1060hPa

Temperature Relative Humidity Atmospheric Pressure

Transport/Storage -20°C - +50°C 5% - 95% 600 - 1060hPa

Conversion factor Dosing conversion factors: 1.0µg = 1000ng

1.0mg/h = 24.0mg/24h

1.0mg/min) = 60.0mg/h

1.0mg = 1000µg

Volume/unit time = dose rate/concentration 1.0ml/h = 1.0mg/h / 1.0mg/ml The formula is: VOL / RATE = (...µg/kg/min)) x (...kg) x (60 min)/h) = µg/h = ml/h concentration in / mg/ml x 1000µg/mg Drug units available:

16/20

µg/ml

ng/min), ng/kg/min), ml/h µg/min), µg/kg/min), µg/h, µg/kg/h, µg/24h, µg/kg/24h mg/min), mg/kg/min), mg/h, mg/kg/h, mg/24h, mg/kg/24h U/kg/min), U/h, U/kg/h, U/24h, kU/24, mmol/h

1000PB00544 Iss 5

Specifications Occlusion Pressure Limits for IVAC 50ml Syringes The following tables show the worst case values for line pressure, time to alarm and bolus volume that can be expected in the event of an occlusion when the IVAC 50ml syringe is selected, G40020 administration set. Alarm Level

Rate (ml/h)

Nominal Occlusion Alarm Pressure (mmHg) 0 +50 / -50 90 +50 / -90 190 +50 / -150 280 +100 / -100 370 +100 / -100 460 +100 / -100 560 +100 / -100 650 +100 / -100

Maximum Bolus Volume (ml)

1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0

Maximum Time to occlusion alarm (h:min) 0:02 0:09 0:22 0:34 0:56 1:10 1:30 1:45

*0 *1 *2 3 4 5 6 7 *0 *1 *2 3 4 5 6 7

5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0

0:01 0:02 0:06 0:08 0:12 0:14 0:17 0:19

0 +50 / -50 90 +50 / -90 190 + 50 /-150 280 +100 / -100 370 +100 / -100 460 +100 / -100 560 +100 / -100 650 +100 / -100

0.1 0.2 0.4 0.6 0.8 1.0 1.2 1.4

0.1 0.2 0.3 0.5 0.7 0.9 1.0 1.3

* Tests at these levels may alarm immediately - the force at these levels is commonly less than the friction in the syringe (with no additional fluid pressure). The result is that the pressure relating to the low forces will be less than the nominal quoted occlusion pressure. Bolus volume following occlusion will be minimised by the back off feature if enabled. The back off will reduce the line pressure by removing the volume stored in the occluded line and deducting this volume from volume infused.

Technical Description MONITORING OF THE SYSTEM CLOCK FREQUENCY / WATCHDOG The system clock, which is used to control the rate of the pump is derived from the microprocessor crystal oscillator. A watchdog circuit is implemented in the pump to monitor the correct time period. The watchdog circuit requires the microprocessor to send a reset pulse every 10mS to stop the counter from timing out and triggering the watchdog alarm. The reset signal has to be in a time ' window' of between 8 to 12mS. If it is either too fast or too slow the watchdog hardware will detect this and generate a alarm and disable the motor drive. Additionally, on power up the watchdog is allowed to time-out and the period is measured and tested to be within a set tolerance. This then confirms that both the microprocessor crystal and the watchdog crystal frequencies are correct. DETECTION OF LINEAR MOVEMENT A linear potentiometer is incorporated in the unit to detect the movement of the pumping mechanism. This movement is monitored in the electronics and software of the system. If it is detected that the mechanism is either moving too fast, too slow, or not moving at all then an error code will be displayed, the motor drive will be disabled and the pump will stop. CONTROL OF LINEAR SPEED / INFUSION RATE The pump mechanism is driven using a d.c. motor; feedback for the control system is provided by two opto switches. To enable the motor drive there are three transistors which need to be turned on. The correct operation of these transistors is tested on power up. The control system monitors the feedback from the opto encoders and adjusts the motor on time to maintain the required speed. If there are no encoder signals feedback, indicating that an opto has failed or the transmission has jammed, an error code will be displayed and the pump will fail-safe. If there are too many encoders detected by the encoder feedback indicating that a transistor has gone short circuit an error code will be displayed and the pump will fail-safe. The pump calculates the appropriate motor control rate from the set infusion rate and syringe constant data stored within the pump software. The syringe constant data converts ml’s to mm’s of movement for each syringe type and size.

1000PB00544 Iss 5

17/20

Operating Precautions This IVAC pump has been calibrated for use with single use disposable syringes. To ensure correct and accurate operation, only use Luer-Lock versions of the syringe make specified on the pump or described in the directions for use. Use of non-specified syringes or administration sets may impair the operation of the pump and the accuracy of the infusion. Uncontrolled flow or syphoning may result if the syringe is located on the pump without its finger grips and plunger correctly located in the slots provided, or if it is removed from the pump before the extension line is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp. When combining several apparatus and/or instruments with administration sets and other tubing, for example via a 3 way tap, the performance of the pump may be impacted and should be monitored closely. Do not mount the pump in a vertical position with the AC power inlet or the syringe pointing upwards as this could affect electrical safety, in the event of a fluid spill over the unit or lead to an infusion of air which may be in the syringe. To protect against the introduction of air the user should regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified in the purge procedure in Getting Started. This is a positive pressure device designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system. The pumping pressure alarm system is not designed to provide protection against, or detection of, infiltration conditions which can occur at low pressures. Several alarm conditions detected by this pump will stop the infusion and generate audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating. This instrument is Class 1 electrical equipment, if there is any doubt about the integrity of the external protective earth conductor, the equipment shall be operated from its internal battery.

This instrument is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) In some circumstances the unit may be affected by an electrostatic discharge of above 8kV. At test levels lower than these values the unit will operate normally. In rare circumstances the unit may be affected by radio frequency radiation above a level of 10V/m. If the unit is affected by this external interference the unit will fail safe or reset, (a call back alarm will occur after 2 minutes). Should false alarm conditions be encountered either, remove the source of the interference, or regulate the infusion by another appropriate means. If this instrument is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by a qualified service engineer. An explosion hazard exists if the instrument is used in the presence of flammable anaesthetics. Exercise care to locate the unit away from any such hazardous sources. An electrical shock hazard exists if the units casing is opened or removed. Refer all servicing to qualified service personnel. Diprifusor™ uses a pharmacokinetic model of the distribution and elimination of Propofol in the body to calculate plasma concentrations in µg/ml. If the pharmacokinetic model is stopped and reset the TCI operation cannot be restarted. The model will be stopped in TCI mode if the END OPERATION is confirmed or if the pump is powered down. TCI infusion must not be started on a patient that has received a Diprivan or other Propofol injection or infusion within the previous 4 hours. A comprehensive service manual containing circuit descriptions, servicing and testing information is available for this unit. It can be ordered from your ALARIS Medical Systems® authorised distributor (Technical Service 6000PB00001).

18/20

Manual

Part

Number

1000PB00544 Iss 5

1PB0544C05.qxd

12-09-2003

12:06

Page 4

Basic Functions Loading a Syringe Place the pump on a stable horizontal surface or secure using the pole clamp fitted. Prepare, load and prime the single use disposable syringe and extension line using standard aseptic techniques. Important: For TCI - only use Zeneca 50ml syringes prefilled with Diprivan. 1. Squeeze the finger grips on the plunger holder and slide the mechanism to the left. Lift the syringe clamp and rotate to the left. 2. Insert the syringe into the slots on the plunger holder. Insure that the Diprifusor tag is positioned towards the display to allow the prefilled syringe tag to be read. 3. Squeeze the finger grips on the plunger holder and slide the mechanism to the right until the syringe finger flanges locates in the V slot. Important: Advance the syringe until the finger flanges touch the front of the V slot closest to the syringe clamp. This is important to prevent delay at the start of the infusion. 4. Release the finger grips. Apply gentle pressure on the plunger holder to ensure that the drive is engaged. Rotate the syringe clamp forward until it locks onto the syringe barrel. 5. Check that the syringe plunger and finger flanges are correctly located in their slots. Important: Only use a syringe of the type and size indicated on the pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion and the performance of the pump. When initially loading the syringe, allow for the volume of fluid contained in the extension line and retained in the syringe at the end of infusion as this “dead-space” will not be infused.

Power ON/OFF To power up the unit press the power

Symbol Definition

!

Attention (Consult accompanying documents) Potential Equalisation Connector RS232/Nursecall Connector (Optional) Class I Equipment Type CF Equipment (Degree of protection against electrical shock)

IPX4

Protected against splashing fluid (Degree of protection against fluid ingress)

ALARIS Medical UK Ltd (hereinafter referred to as "ALARIS Medical") warrants that: (A)

Each new instrument (pump, controller or peripheral instrument) is free from defects in material and workmanship under normal use and service for a period of one year from the date of delivery by ALARIS Medical to the first purchaser.

(B)

Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical to the first purchaser.

If any product requires service during the applicable warranty period, the purchaser should communicate directly with the local ALARIS Medical service centre to determine appropriate repair facility. Repair or replacement will be carried out at ALARIS Medical's expense, subject to the terms of this warranty. The product requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in return shipment to ALARIS Medical shall be at purchaser's risk. In no event shall ALARIS Medical be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any ALARIS Medical product. This warranty shall not apply to, and ALARIS Medical shall not be responsible for, any loss arising in connection with the purchase or use of any ALARIS Medical product which has been repaired by anyone other than an authorised ALARIS Medical service representative or altered in any way so as, in ALARIS Medical's judgement, to affect its stability or reliability, or which has been subject to misuse or negligence or accident, or which has had the serial or lot number altered, effaced or removed, or which has been used otherwise than in accordance with the instructions furnished by ALARIS Medical. This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities on ALARIS Medical's part, and ALARIS Medical neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of ALARIS Medical products. See packing inserts for international warranty. ALARIS MEDICAL DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

Alternating Current Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark. START Button - Press to start the infusion.

button once. To power off the

unit press and hold down the power button for 3 seconds. The display will count down and switch the unit OFF.

Installation Check that the pump is complete, undamaged and that the voltage rating specified on the base plate is compatible with your AC power supply. Items supplied with this ALARIS Medical Systems® syringe pump are;

IVAC TCI & TIVA. POLE CLAMP. DIRECTIONS FOR USE. DIPRIFUSOR™ GUIDE FOR ANAESTHETISTS. (Guidance on the administration of Diprivan (Propofol) by target controlled infusion).
AC POWER CABLE (AS REQUESTED).
PROTECTIVE PACKAGING. Connect the unit to the AC power supply for 24 hours to ensure that the internal battery is fully charged. Should the pump fail to perform correctly, replace it in its original protective packaging and contact a qualified service engineer for investigation.

Pole Clamp The pole clamp is supplied fitted to the rear of the unit and will provide secure fixing to standard I.V. poles of a diameter of up to 40mm. The pole clamp can also be fitted in a choice of 4 fixing positions allowing the unit to be mounted to vertical and horizontal poles, equipment rails and hospital furniture in a variety of convenient operating orientations. The pole clamp may be adjusted for use with horizontal fittings by using the existing fixings screws with the alternative fixing holes in the pole clamp. The pole clamp may also be secured to the base of the unit in a choice of four positions. Important: Do not mount the unit with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.

2/20

Warranty

STOP Button - Press to stop the infusion. The Amber light will flash to indicate an alarm. ON/OFF - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF. Use “Double Chevron” for fast increase / decrease and the “Single Chevron” for slower increase/ decrease of values shown on the display in set-up and configuration. OPTIONS button - Press the OPTIONS button to access drug name and other optional features. Press PURGE/BOLUS to purge the extension line during set up while the pump is stopped or to bolus at an accelerated rate while an infusion is running (a bolus infusion is not available in TCI mode, purging will be available in TCI mode before an infusion is started or after changing a syringe). PRESSURE button to pressure.

- Use the PRESSURE display the pumping

Use “Blank Soft Keys” in conjunction with the prompts shown on the display.

1000PB00544 Iss 5

1000PB00544 Iss 5

19/20

1PB0544C05.qxd

12-09-2003

12:06

Page 2

Spare Parts A comprehensive list of spare parts for this pump is included within the Technical Service Manual (6000PB00001). This can be ordered from your local ALARIS® Affiliate Office or authorised distributor, refer to Service Contact addresses listed below.

Service Equipment The IVAC TCI & TIVA has been designed to allow simple and low cost servicing. For further information on general servicing refer to the Technical Service Manual (6000PB00001).

Directions For Use - English

Service Contacts For service contact your local ALARIS Medical Systems® Affiliate Office or Distributor. ALARIS Medical Systems® Service Centre Addresses:

SYRINGE TAG - Locate tag next to the detector to allow TCI control.

AE

DE

HU

NZ

ALARIS Medical Systems Middle East Office, PO Box 5527, Dubai, United Arab Emirates. Tel: (971) 4 28 22 842 Fax: (971) 4 28 22 914

ALARIS Medical Deutschland, GmbH, Pascalstr. 2, 52499 Baesweiler, Deutschland. Tel: (49) 2401 604 0 Fax: (49) 2401 604 121

ALARIS Medical Hungary Döbrentei tér 1, H-1013 Budapest, Magyar. Tel: (36) 14 88 0232 Fax: (36) 12 01 5987

ALARIS Medical NZ Ltd, Unit 14, 13 Highbrook Drive, East Tamaki, Auckland, New Zealand. Tel: (64) 9 273 3901 Fax: (64) 9 273 3098

IT

SE

BATTERY When illuminated the pump is running on the internal battery. When flashing the battery power is low, less than 30 minutes of use remains.

ES

ALARIS Medical Italia S.P.A. Via Ticino 4, 50019 Sesto Fiorentino, Firenze, Italia. Tél: (39) 055 34 00 23 Fax: (39) 055 34 00 24

ALARIS Medical Nordic, AB Hammarbacken 4B, 191 46 Sollentuna, Sverige. Tel: (46) 8 544 43 200 Fax: (46) 8 544 43 225

AC POWER - When illuminated the unit is connected to AC power and the internal battery is being charged.

NL

US

ALARIS Medical Holland, B.V., Kantorenpand “Hoefse Wing”, Printerweg 5, 3821 AP Amersfoort, Nederland. Tel: (31) 33 455 51 00 Fax: (31) 33 455 51 01

ALARIS Medical Systems, Inc. 10221 Wateridge Circle, San Diego, CA 92121, USA. Tel: (1) 800 854 7128 Fax: (1) 858 458 6179

NO

ALARIS Medical S.A. (Pty) Ltd, Unit 2 Oude Molen Business Park, Oude Molen Road, Ndabeni, Cape Town 7405, South Africa. Tel: (27) 0860 597 572 Fax: (27) 21 5107567

AU ALARIS Medical Australia Pty Ltd, 8/167 Prospect Highway, Seven Hills, NSW 2147, Australia. Tel: (61) 2 9838 0255 Fax: (61) 2 9674 4444

BE ALARIS Medical Belgium B.V., Otto De Mentockplein 19, 1853 Strombeek - Bever, Belgium. Tel: (32) 2 267 38 99 Fax: (32) 2 267 99 21

CA ALARIS Medical Canada, Ltd,5975 Whittle Road, Suite #120, Mississauga, Ontario L4Z 3N1, Canada. Tel: (1) 905-507-1131 Fax: (1) 905-507-6664

CN ALARIS Medical Systems Office, Suite 401 No. 88 Chang Su Road, Shanghai PC 200040, China. Tel: (56) 8621-62488591 Fax: (56) 8621-62482567

ALARIS Medical España, S.L., Avenida Valdeparra 27, Edificio Alcor, 28108 - Alcobendas, Madrid, España. Tel: (34) 91 657 20 31 Fax: (34) 91 657 20 42

FR ALARIS Medical France, S.A., 95, rue Péreire, 78105 St Germain en Laye Cedex. France. Tél: (33) 1 39 10 50 11 Fax: (33) 1 30 61 22 23

GB - Manufacturer’s Address: ALARIS Medical UK Ltd, The Crescent, Jays Close, Basingstoke, Hampshire, RG22 4BS, United Kingdom. Tel: (44) 0800 389 6972 Fax: (44) 1256 388 411

ALARIS Medical Norway A/S Solbråveien 10 A, 1383 ASKER, Norge. Tel: (47) 66 98 76 00 Fax: (47) 66 98 76 01

ZA

Website

Contents Introduction Features of IVAC TCI & TIVA Basic Functions Installation Getting Started TCI Mode Getting Started TIVA Mode Getting Started Normal Mode Alarm Procedures Configured Options Self Test Routine Routine Maintenance Trumpet and Start Up Curves Specifications Technical Description Operating Precautions Warranty Spare Parts Service Equipment Service Contacts

Visit our website: www.alarismed.com

CO Number

Date

Description of Change/Changed By:

1 2 3 4 5

1624 1624/1675 3963 4087 4449

03/99 05/99 08/02 10/02 09/03

Production Release. Nicky Morgan Prodcution Release. Nicky Morgan Various modifications Emma Hill Software Upgrade. Sian Dorey Administrative changes. Ian Tyler

20/20

Introduction 1 1 2 2 3-4 5-6 7 8 9 - 10 11 12 13 14 - 17 17 18 19 20 20 20

Features of the IVAC TCI & TIVA

Document History Revision

MAIN DISPLAY - For screen information see Starting the Pump in TCI mode, TIVA mode or in Normal mode.

1000PB00544 Iss 5

Three modes of operation - TCI Mode, TIVA Mode and Normal Mode. Delivery of Target Controlled Infusion (TCI) of ‘Dipvrivan’ (propofol) using Diprifusor™. Rate range 0.1 to 1200ml/h. Large graphics format display. Drug Protocols for anaesthesia environment. Event logging records operation. Communications and nurse call interfaces. Variable Induction Mode. Effect Site Concentration trend. Induction and Bolus can be turned off. Hands Free bolus.

1000PB00544 Iss 5

The IVAC TCI & TIVA is a fully featured syringe pump which provides the anaesthetist with an instrument which has been designed to work in the way drugs are delivered in the operating theatre, including dose based calculations of induction and maintenance rates. The IVAC TCI & TIVA can operate in three modes of operation: TCI mode, TIVA mode and Normal mode. The IVAC TCI & TIVA is compatible with a wide range of standard single use disposable luer-lock syringes of various types. The IVAC TCI & TIVA accepts sizes from 5ml - 100ml. See page 15 for the specification. In TCI mode, Diprifusor™ TCI software (copyright of The University of Glasgow), controls the infusion rate. This software consists of infusion rate control algorithms linked to a pharmacokinetic simulation program. The current model requires the patient age and weight to be entered together with the desired target blood concentration of Propofol. Electronically tagged pre-filled syringes of Diprivan 1% or 2% are required for the operation of the pump in TCI mode. Before using TCI the user should be thoroughly familiar with the Diprivan prescribing information and the concepts of anaesthesia by TCI (Target Controlled Infusion), as described in the Diprifusor™ Guide for Anaesthetists supplied by Zeneca. Diprivan (propofol) and Diprifusor are manufactured by Zeneca Pharmaceuticals. The TCI & TIVA syringe pump incorporates Diprifusor under license from Zeneca. If the Diprifusor Guide for Anaesthetists is missing or new copies are required contact your local Zeneca Pharmaceuticals office. Contact Zeneca Pharmaceuticals for prescribing information for Diprivan. Diprivan and Diprifusor are trademarks owned by Zeneca.

1/20