IVAC P6000 TIVA Directions for Use Issue 5

Page 2

Basic Functions

Specifications Alarm Conditions -

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.

5.

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. 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

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.

Equipment Classification 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 II / Internally Powered, Type CF, IPX4. Not to be used in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.

IPX4

Protected against splashing fluid (Degree of protection against fluid ingress). Alternating Current Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark.

RS232/Nursecall Specification -

9

4. Not used

NC

3. Transmit data (TXD) Output 5. Ground (GND)

8. Clear to send (CTS) Output

TXD Output Voltage

Minimum: -5V (mark), +5V (space).

9. Nursecall Common

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

Important: The IBM connector pins grouped in pairs above should be linked at the connector.

RXD Input Voltage

-30V - +30V max.

RXD Input Thresholds

Low: 0.6V minimum / High: 3.0V maximum.

RXD Input Resistance

3 K minimum.

Inactive:

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

1000PB00537 Iss 5

2. Received data (RXD) Input

7. Request to send (RTS) Input

STOP Button - Press to stop the infusion. The Amber light will flash to indicate an alarm.

PRESSURE - Use the PRESSURE button to display the pumping pressure.

1. Nursecall Normally Closed

EIA RS232-C Standard.

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

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.

Description

TXD/RXD

Active Low:

OPTIONS button - Press the OPTIONS button to access drug name and other optional features.

Typical Connection Data

6. Nurse Call Normally Open

Enable

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.

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

D Type - 9 Pin.

START Button - Press to start the infusion.

ON/OFF - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF.

Nurse Call

Connector

Functional Earth

Use “Blank Soft Keys” in conjunction with the prompts shown on the display. 2/16

Temperature Relative Humidity Atmospheric Pressure

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

1 stop bit

8

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.

Stop Bits

CTS

3.

Type CF Equipment (Degree of protection against electrical shock).

Odd Parity / No Parity

7

Insert the syringe into the slots on the plunger holder.

Temperature Relative Humidity Atmospheric Pressure

8 Data Bits

Parity

RTS

2.

Class II Equipment

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

Data Bits

6

Squeeze the finger grips on the plunger holder and slide the mechanism to the left. Lift the syringe clamp and rotate to the left.

Environmental -

1 Start Bit

NC

1.

RS232/Nursecall Connector (Optional)

Start Bits

NC

Important: Only use a syringe of the type stated on the pump labelling.

4 KV (dc, or ac peak)

1

Potential Equalisation Connector

Isolation Socket/Pump

2

Prepare, load and prime the single use disposable syringe and extension line using standard aseptic techniques.

Attention (Consult accompanying documents)

RS232/Nursecall Specification AC Power Disconnected Low Battery Warning Battery Exhausted Syringe Location Plunger Location Internal Malfunction

RXD

!

Occlusion Drive Disengaged Infusion Complete Purge / Bolus Activated Nurse Attention VTBI Complete Near End of Infusion

3

Place the pump on a stable horizontal surface or secure using the pole clamp fitted.

Symbol Definition

TXD

Loading a Syringe

4

14:11

5

12-09-2003

GND

1PB0537C05.qxd

IBM Compatible (9 Pin) PIN 3 (TXD) PIN 2 (RXD) PIN 5 (GND) PIN 7 (RTS) PIN 8 (CTS) PIN 4 (DTR) PIN 6 (DSR)

IVAC ‘P’ Series Syringe Pump

IBM Compatible (25 Pin)

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)

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)

*0 *1 *2 3 4 5 6 7

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

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) 0.1 0.2 0.3 0.5 0.7 0.9 1.0 1.3

*0 5.0 0:01 0 +50 / -50 0.1 *1 5.0 0:02 90 +50 / -90 0.2 *2 5.0 0:06 190 + 50 /-150 0.4 3 5.0 0:08 280 +100 / -100 0.6 4 5.0 0:12 370 +100 / -100 0.8 5 5.0 0:14 460 +100 / -100 1.0 6 5.0 0:17 560 +100 / -100 1.2 7 5.0 0:19 650 +100 / -100 1.4 * 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.

1000PB00537 Iss 5

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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 power

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.

2.

3.

4.

5.

cable. Press the button. 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 4 is bypassed. WEIGHT (if required for dosing) - Enter the patient weight using the

keys. Press the OK softkey to enter.

6.

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. 7. TIME - Enter the induction time in seconds over which the induction dose will be delivered. Press the OK softkey to enter. 8. MAINTENANCE - Set the maintenance dose rate in the drug protocol units. Press the OK softkey to enter. 9. CONFIRM - Confirm the induction and maintenance rates are set up correctly. 10. LOAD SYRINGE - Load the syringe according to the LOAD SYRINGE Procedure in the Getting Started section of this user manual. 11. 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. 12. CONNECT PATIENT - Connect the extension line to the patient access device. 13. 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 Pump Status IVAC fi TCI & TIVA

Flowrate

INFUSING

100 ml/h 10.0 mg/ml/h

Doserate

+ ADJUST -

Volume Infused

1000PB00537 Iss 5

SYRINGE

12:00

VOLUME

INDUCTION

0.0ml

10s

0.0ng

REVIEW

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: The purge feature is not available after the infusion has been started, the syringe must be reconfirmed to activate the purge feature. No alarms are disabled during the operation of the purge feature.

Bolus Infusion Bolus feature is enabled in Drug Set Up, refer to Drug Set Up section. It is not possible to deliver a bolus during an induction or if bolus is disabled. To use this feature ensure that the hands free bolus option is disabled. Refer to the GENERAL OPTIONS section of this user manual. 1.

During the maintenance phase infusion press the button once. This displays the bolus screen. 2. The bolus delivery rate can be adjusted using the RATE softkey. 3. To deliver the bolus press the BOLUS softkey. The unit will display the volume being delivered. 4. When the desired bolus has been delivered, release the BOLUS softkey. The bolus volume will be added to the total volume infused. To exit the bolus feature press the QUIT softkey. 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 the general options. 1. 2.

3.

4 5. Time

Syringe Type or Drug Name

1.

?

During maintenance phase infusion press the button. This will display the bolus screen. Use the chevron keys to set the bolus dose required. If necessary press the RATE softkey to select the bolus delivery rate. Press the BOLUS softkey once to begin the delivery of the bolus dose. The display will revert to the main display showing the bolus being delivered, counting down 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 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.

Review Information

Review Option

3/16

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 method suspends the infusion for a few seconds while the new rate is being set, this can be a disadvantage.

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

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.

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.

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

1.

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.

3. 4.

Time Before Syringe Empty Icon 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.

Press the

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.

Press the

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.

4/16

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.

button to access the options 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. The pump will display the CLEAR SETUP prompt, and will not be powered down. If you wish to reset the information press the YES softkey. If you wish to use the previous information press NO.

Event Log

Review 1. 2. 3. 4.

button to access the options menu.

2.

button.

Press the button to access the options menu. Select the CLEAR VOLUME option using the chevron 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.

button to access the options menu.

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.

Clear Volume 1. 2.

Press the

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.

1000PB00537 Iss 5

Getting Started - Normal Mode Starting the Pump - Normal Mode

Bolus Infusions

When a drug is selected the pump enters TIVA Mode - see Starting the Pump - TIVA Mode. 1. Connect the pump to an AC power supply using the AC

To use this feature ensure that the hands free bolus option is disabled. Refer to the GENERAL OPTIONS section of this user manual.

2.

3.

4.

5.

6. 7.

power cable. Press the button. 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 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. LOAD SYRINGE - Load the syringe according to the LOAD SYRINGE Procedure in the Getting Started section of this user manual. 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. CONNECT PATIENT - Connect the extension line to the patient access device. 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.

Main Display - Normal Mode Syringe Type

Pump Status

Time

IVAC fi TCI & TIVA

INFUSING

Flowrate

SYRINGE TYPE

12:00

VOLUME

100 ml/h

0.0ml 0:33:46

+ ADJUST -

REVIEW

Volume Infused

? Review Information

Review Option

1. 2. 3. 4.

During the maintenance phase infusion press the button once. This displays the bolus screen. The bolus delivery rate can be adjusted using the RATE softkey. To deliver the bolus press the BOLUS softkey. The unit will display the volume being delivered. When the desired bolus has been delivered, release the BOLUS softkey. The bolus volume will be added to the total volume infused. To exit the bolus feature press the QUIT softkey.

Bolus Infusions - Hands Free 1.

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

2.

4

Use the keys to set the bolus dose required. If necessary press the RATE softkey to select the bolus delivery rate. Press the BOLUS softkey once to begin the delivery of the bolus dose. The display will revert to the main display showing the bolus being delivered, counting down 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.

5.

To terminate a bolus being delivered either press the

3.

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.

Purge 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.

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.

1000PB00537 Iss 5

5/16

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. 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.

DRIVE DECLUTCHED

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. Between 0.5% and 2.0% (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 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.

AC POWER FAIL

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

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,

press and hold down

for 2 seconds to delay call back for 15 minutes.

3 BEEPS

After a TIVA setup has been entered the CALL BACK WARNING alarm will be set to call back after 60 minutes.

6/16

1000PB00537 Iss 5

Configured Options Drug Set-up 1.

Press the

2. 3.

Hold down the button and press the button ON. The main display will show “000”. Enter the Access Code “xxx”

4. 5. 6. 7. 8. 9.

button OFF.

using the keys. (For technician access codes please refer to the Technical Service Manual.) Enter the first digit and press NEXT indicated on the screen. When the complete code has been entered press OK softkey indicated on the screen. 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.

10. Select the Concentration Units using the keys, press the OK softkey to select the concentration units. 11. Select the Default Concentration of the drug selected, use the keys to increase/decrease the default concentration shown on the screen. When the default concentration has been selected press the OK softkey. 12. Select the Minimum Concentration of the drug selected. Use the keys to increase/decrease the minimum concentration shown on the screen. When the minimum concentration has been selected press the OK softkey. 13. 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. Important: If the default concentration, the minimum concentration and the maximum concentration are equal the start-up sequence will bypass the concentration request. 14. Select the Dose Units required for maintenance doses, use the keys to select the dose units required. When the dose units required have been selected press the OK softkey. 15. 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 then it turns the Induction setting off. It will disable the Induction Set-Up in TIVA mode. 16. 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.

General Options 1.

Press the

2. 3.

Hold down the button and press the button ON. The main display will show “000”. Enter the Access Code

4. 5.

button OFF.

“xxx” using the keys. (For technician access codes please refer to the Technical Service Manual.) Enter the first digit and press NEXT indicated on the screen. When the complete code has been entered press OK softkey indicated on the screen.

6.

Select GENERAL OPTIONS using the keys and press 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. 8. When all the options that you require to enable/disable or adjust have been selected press the OK softkey indicated on the screen. 9. When the set-up is complete, turn the pump OFF and return the pump into service, or select the next configuration option. The general options available are as follows: Backoff -

If the backoff feature is enabled it causes the motor to reverse to relieve line pressure when an occlusion condition occurs.

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 between 0 and 7.

Weight -

Sets up default patient weight (0.1kg to 150kg), for normal mode only.

Purge Rate -

Sets the purge rate between 100 and 500 ml/hr. 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 between 0.1ml and 25ml, 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.

17. Select the Maintenance Rate required, use the keys to increase/decrease the maintenance rate. When the rate has been selected press the OK softkey. 18. Select the Bolus Dose (per kg selected in dose units) required.

Comms Pump Address - Sets the Address.

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 then it turns the Bolus setting off. It will disable the Bolus feature in TIVA mode. 19. Review the drug setup data, press the OK softkey to confirm the data displayed. This will return the pump to the drug setup menu.

Comms Odd Parity -

If enabled, communication parity is odd.

Comms ASCII -

If enabled, communications protocol is in ASCII.

1000PB00537 Iss 5

Pumps

Communications

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

7/16

Configured Options and RS232 / Nursecall Hospital Name

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

Press the

2. 3.

Hold down the button and press the button ON. The main display will show “000”. Enter the Access Code

4. 5.

button OFF.

“xxx” using the keys. (For technician access codes please refer to the Technical Service Manual.) Enter the first digit and press NEXT indicated on the screen. When the complete code has been entered press OK softkey indicated on the screen.

6.

Select CLOCK SET using the softkey indicated on the screen.

7. 8.

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.

9.

keys and press the OK

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.

Press the

2. 3.

Hold down the button and press the button ON. The main display will show “000”. Enter the Access Code

4. 5.

button OFF.

“xxx” using the keys. (For technician access codes please refer to the Technical Service Manual.) Enter the first digit and press NEXT indicated on the screen. When the complete code has been entered press OK softkey indicated on the screen.

6.

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

7. 8.

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.

9.

keys and press the

Enable Syringes

RS232/Nursecall Feature

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.

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.

1.

Press the

2. 3.

Hold down the button and press the button ON. The main display will show “000”. Enter the Access Code

4. 5.

button OFF.

“xxx” using the keys. (For technician access codes please refer to the Technical Service Manual.) Enter the first digit and press NEXT indicated on the screen. When the complete code has been entered press OK softkey indicated on the screen.

6.

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

7.

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.

8. 9.

8/16

keys and press

1000PB00537 Iss 5

Operating Precautions / Installation Operating Precautions 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.

This IVAC® pump has been calibrated for use with single use disposable syringes. To ensure correct and accurate operation, use only 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.

This unit emits a certain level of electromagnetic radiation which is within the levels specified by IEC60601-2-24 and IEC60601-1-2. If however the unit interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.

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.

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.)

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.

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.

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.

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 Manual Part Number 6000PB00001).

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.

Installation Installation

Functional Earth

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;

It should be noted that the PSU fitted to this pump is functionally earthed. The functional earth feature has been designed to prevent electrical interference to other medical or electrical equipment. The AC power supply applied to this pump must have an earth conductor. Important: This provides a functional earth, not a protective earth.

‹ ‹ ‹ ‹ ‹

IVAC ® TIVA POLE CLAMP DIRECTIONS FOR USE 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.

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.

1000PB00537 Iss 5

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. An optional adjustable pole clamp is available, part number 6002FAOPT0H. 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.

9/16

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.

Spare Parts / Service Equipment Spare Parts

Service Equipment

A comprehensive list of spare parts for IVAC® Syringe pumps is

These IVAC® “P” Series Syringe pumps have been designed to allow simple and low cost servicing. Standard components are employed where possible so that no special test, calibration or tools are required. However, the following items may be useful for general servicing.

included within the service manual. This can be ordered from ALARIS Medical Systems®, or authorised distributor. For part number please refer to summary parts list below: Part Number

Description

6002FAOPT71

Directions For Use IVAC® TIVA

6000PB00001 0000EL00004

Part Number

Description

Technical Service Manual

0000TG00020

Occlusion Test Gear

Internal Battery - 6V NP2.6 - 6 Rechargeable

0000TG00002

Linear Accuracy Test Gear

1000EL00043

Ribbon Cable Extension

1001FAOPT91

AC Power Lead - U.K

0000JG00004

Cradle Support

1001FAOPT92

AC Power Lead - European

0000TG00010

50ml Syringe Sizing Test Gear

1001FAOPT93

AC Power Lead - Unterminated

0000TG00011

100ml Syringe Sizing Test Gear

0000ME00026

Foot - Self adhesive

1000SP01015

Pole Clamp Assembly

6000LB00009

Label Front Panel TIVA

6000LB00016

Label Set P6000/TIVA/P7000

10/16

1000PB00537 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.

1000PB00537 Iss 5

11/16

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, use access code “xxx”, refer to the technical service manual. 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.

12/16

1000PB00537 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 0.5

70.0 50.0

Error (%)

Rate (ml/h)

0.3 0.1 -0.1

44.41

30.0

13.82

9.32

10.0

4.70

2.43

-7.91

-5.76

-10.0 -11.45

-30.0

-36.94-24.31

-50.0

-0.3

-64.15

-70.0 -0.5

-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)

1000PB00537 Iss 5

Observation Window (mins)

13/16

Specifications Syringe Types

Critical Volume -

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.

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

Options include :IVAC® BD Plastipak Terumo B Braun Omnifix Sherwood Monoject Nipro Once Fresenius Zeneca B Braun Perfusor JMS BD Perfusion BD Precise

30ml, 50ml, 100ml 5ml, 10ml, 20ml, 30ml, 50ml 10ml, 20ml, 30ml, 50ml 5ml, 10ml, 20ml, 30ml, 50ml 5ml, 10ml, 20ml, 30ml, 50ml 5ml, 20ml, 30ml, 50ml 50ml 50ml 50ml 20ml, 50ml 100ml 50ml 20ml, 50ml

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 30120 G40015 G40020B G40615 G40620 G40215 G40320

IVAC 50/60ml Luer-Lock syringe IVAC 100/120ml Luer-Lock syringe Standard Syringe Extension Set - 150cm Standard Syringe Extension Set - 200cm Low Sorbing Syringe Extension Set - 150cm Low Sorbing Syringe Extension Set - 200cm Opaque Syringe Extension Set - 150cm Opaque Syringe Extension Set - 200cm

It is recommended that the extension sets are changed according to the hospital protocols.

Maximum Pumping Pressure Limit 465mmHg - nominal at L-5: Factory Preset, 650mmHg - nominal at L-7: highest alarm level. Occlusion levels L-0 to L-7 System Accuracy Drive Linearity +/- 1% Volumetric Mean +/- 2% 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 6 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.

Infusion Rate -

AC Power Supply -

Maximum infusion rate can be set as part of the configuration.

115-230VAC, 50/60Hz, 20VA (nominal).

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) 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 10 ml/h - 300 ml/h 10 ml/h - 600 ml/h 10 ml/h - 900 ml/h 10 ml/h - 1200 ml/h

5 ml syringes 10 ml syringes 20 ml syringes 30 ml syringes 50 ml + 100 ml syringes

Bolus Limit -

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. Conversion factor Dosing conversion factors 1.0µg = 1000ng 1.0mg/h = 24.0mg/24h 1.0mg/m = 60.0mg/h 1.0mg = 1000µg Volume/unit time = dose rate/concentration 1.0ml/h = 1.0mg/h / 1.0mg/ml

25.0ml Purge -

The formula is:

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

VOL / RATE = (...µg/kg/min) x (...kg) x (60 min/h) = µg/h = ml/h

Purge Limit 2.0ml. Volume Infused 0.0ml/h - 9990ml Near End Of Infusion (NEOI) Alarm 2.0% - 10.0% of syringe volume End Of Infusion (EOI) Alarm -

concentration in / mg/ml x 1000µg/mg µg/ml Drug units available: 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

0.5% - 5% of syringe volume

14/16

1000PB00537 Iss 5

Page 2

Basic Functions

Specifications Alarm Conditions -

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.

5.

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. 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

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.

Equipment Classification 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 II / Internally Powered, Type CF, IPX4. Not to be used in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.

IPX4

Protected against splashing fluid (Degree of protection against fluid ingress). Alternating Current Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark.

RS232/Nursecall Specification -

9

4. Not used

NC

3. Transmit data (TXD) Output 5. Ground (GND)

8. Clear to send (CTS) Output

TXD Output Voltage

Minimum: -5V (mark), +5V (space).

9. Nursecall Common

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

Important: The IBM connector pins grouped in pairs above should be linked at the connector.

RXD Input Voltage

-30V - +30V max.

RXD Input Thresholds

Low: 0.6V minimum / High: 3.0V maximum.

RXD Input Resistance

3 K minimum.

Inactive:

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

1000PB00537 Iss 5

2. Received data (RXD) Input

7. Request to send (RTS) Input

STOP Button - Press to stop the infusion. The Amber light will flash to indicate an alarm.

PRESSURE - Use the PRESSURE button to display the pumping pressure.

1. Nursecall Normally Closed

EIA RS232-C Standard.

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

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.

Description

TXD/RXD

Active Low:

OPTIONS button - Press the OPTIONS button to access drug name and other optional features.

Typical Connection Data

6. Nurse Call Normally Open

Enable

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.

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

D Type - 9 Pin.

START Button - Press to start the infusion.

ON/OFF - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF.

Nurse Call

Connector

Functional Earth

Use “Blank Soft Keys” in conjunction with the prompts shown on the display. 2/16

Temperature Relative Humidity Atmospheric Pressure

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

1 stop bit

8

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.

Stop Bits

CTS

3.

Type CF Equipment (Degree of protection against electrical shock).

Odd Parity / No Parity

7

Insert the syringe into the slots on the plunger holder.

Temperature Relative Humidity Atmospheric Pressure

8 Data Bits

Parity

RTS

2.

Class II Equipment

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

Data Bits

6

Squeeze the finger grips on the plunger holder and slide the mechanism to the left. Lift the syringe clamp and rotate to the left.

Environmental -

1 Start Bit

NC

1.

RS232/Nursecall Connector (Optional)

Start Bits

NC

Important: Only use a syringe of the type stated on the pump labelling.

4 KV (dc, or ac peak)

1

Potential Equalisation Connector

Isolation Socket/Pump

2

Prepare, load and prime the single use disposable syringe and extension line using standard aseptic techniques.

Attention (Consult accompanying documents)

RS232/Nursecall Specification AC Power Disconnected Low Battery Warning Battery Exhausted Syringe Location Plunger Location Internal Malfunction

RXD

!

Occlusion Drive Disengaged Infusion Complete Purge / Bolus Activated Nurse Attention VTBI Complete Near End of Infusion

3

Place the pump on a stable horizontal surface or secure using the pole clamp fitted.

Symbol Definition

TXD

Loading a Syringe

4

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5

12-09-2003

GND

1PB0537C05.qxd

IBM Compatible (9 Pin) PIN 3 (TXD) PIN 2 (RXD) PIN 5 (GND) PIN 7 (RTS) PIN 8 (CTS) PIN 4 (DTR) PIN 6 (DSR)

IVAC ‘P’ Series Syringe Pump

IBM Compatible (25 Pin)

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)

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)

*0 *1 *2 3 4 5 6 7

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

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) 0.1 0.2 0.3 0.5 0.7 0.9 1.0 1.3

*0 5.0 0:01 0 +50 / -50 0.1 *1 5.0 0:02 90 +50 / -90 0.2 *2 5.0 0:06 190 + 50 /-150 0.4 3 5.0 0:08 280 +100 / -100 0.6 4 5.0 0:12 370 +100 / -100 0.8 5 5.0 0:14 460 +100 / -100 1.0 6 5.0 0:17 560 +100 / -100 1.2 7 5.0 0:19 650 +100 / -100 1.4 * 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.

1000PB00537 Iss 5

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Warranty ALARIS Medical Systems® (here in after referred to as “ALARIS”) 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 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 to the first purchaser. If any product requires service during the applicable warranty period, the purchaser should communicate directly with the local ALARIS service centre to determine appropriate repair facility. Repair or replacement will be carried out at ALARIS'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 shall be at purchaser's risk. In no event shall ALARIS be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any ALARIS product. This warranty shall not apply to, and ALARIS shall not be responsible for, any loss arising in connection with the purchase or use of any ALARIS product which has been repaired by anyone other than an authorised ALARIS service representative or altered in any way so as, in ALARIS'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. This warranty is in lieu of all other warranties, express or implied, and of all other obligations of liabilities on ALARIS's part, and ALARIS neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of ALARIS products. See packing inserts for international warranty. ALARIS disclaims all other warranties, express or implied, including any warranty of merchantability for function of fitness for a particular purpose or application.

Directions For Use - English MAIN DISPLAY - For screen information see Starting the Pump in Normal mode or in TIVA mode.

Service Contacts For service contact your local ALARIS® Affiliate Office or Distributor. ALARIS® Service Centre Addresses: IT DE AE

SG

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

ALARIS Medical Systems Office, 65 Chulia Street, #40-04 OCBC Centre, Singapore 049513. Tel: (65) 5345351 Fax: (65) 5345516

AU

ES

NL

US

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

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

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. 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. Tel: (27) 0860 597 572 Fax: (27) 21 5107567

FR BE ALARIS Medical Belgium B.V., Otto De Mentockplein 19, 1853 Strombeek - Bever. Tel: (32) 2 263 09 75 Fax: (32) 2 267 99 21

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

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

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

ZA

ALARIS Medical Hungary Döbrentei tér 1. ALARIS Medical Systems Office, Suite 401 No. 88 Chang Su Road, H-1013 Budapest Hungary Shanghai PC 200040, Tel: (36) 14 88 0232 China. Fax: (36) 12 01 5987 Tel: (56) 8621-62488591 Fax: (56) 8621-62482567 B D is a trademark of Becton-Dickinson, Inc. MONOJECT is a trademark of Tyco/Healthcare Kendall-Monoject

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

Contents

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

SE

HU CN

ALARIS Medical Norway A/S Hamang Terrasse 55, PO Box 248, N-1301 Sandvika Tel: (47) 67 57 58 50 Fax: (47) 67 57 58 60

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.

ALARIS Medical Nordic, AB Hammarbacken 4B, 191 46 Sollentuna Sverige. Tel: (46) 8 544 43 200 Fax: (46) 8 544 43 225 INJECTOMAT is a trademark of Fresenius A.G. PERFUSOR is a trademark of B Braun Melsungen A.G.

Document History

Introduction Features of

Introduction 1

the IVAC ® TIVA

1

Basic Functions

2

Getting Started - TIVA Mode

2-4

Getting Started - Normal Mode

5

Alarm Procedures

6

Configured Options

7-8

RS232/Nursecall Feature

8

Operating Precautions

9

Installation

9

Technical Description

10

Spare Parts & Service Equipment

10

Self Test Routine

11

Routine Maintenance Trumpet & Start-Up Curves Specification

Rate range 0.1 to 1200ml/h.

Large graphics format display.

Drug Protocols for anaesthesia environment.

12

Event logging records operation.

13

Option of hands-on or hands free bolus delivery.

Communications and nurse call interfaces.

14-15

Date

Description of Change/Changed By:

Warranty

16

1 2 3 4 5

1624 1624/1675 4060 4087 4449

03/99 05/99 09/02 11/02 09/03

Production Release. Des Miles Production Release. Nicky Morgan CE Mark, Registered Mark and Service Centres updated. Start-Up Curve, Spec Updates. Claire Nash-Williams Administrative changes. Ian Tyler

Service Contacts

16

1000PB00537 Iss 5

Features of the IVAC ® TIVA Two modes of operation - Normal Mode and TIVA Mode.

CO Number

1000PB00537 Iss 5

The IVAC® TIVA can operate in two modes of operation: Normal mode and TIVA mode.

Revision

16/16

The IVAC® 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.

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