IVAC P6000 Mk II Directions for Use Issue 6

English Getting Started

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Introduction... 2 Features of the IVAC® P6000 Syringe Pump... 2 Controls and Indicators... 3 Front Panel and Main Display... 3 Operating Precautions... 4 - 5 Installation... 6 Pole Clamp... 6 Replacing the Internal Fuse... 6 Loading a Syringe... 7 Starting the Pump... 8 Power ON/OFF... 9 Purge... 9 Bolus Infusions... 9 Pressure Level... 10 Volume to be Infused (VTBI)... 10 Volume Infused... 11 Drug Name... 11 Set VTBI Over Time... 12 24H Log... 13 Event Log... 13 Rate Lock... 14 Disable Rate Lock... 14 Re-Enable Rate Lock...14 Alarm Procedures... 15 - 16

Configured Options

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Drug Name Set Up... 17 General Options... 18 - 19 Clock Set... 20 Hospital Name... 21 Enable Syringe... 22

Specifications

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RS232/Nurse Call Feature... 45 Self Test Routine...47 Self Test Sequence... 48 - 50 Configuration Record... 51 Symbol Definition and Equipement Classification... 53 Specifications... 54 - 59 Routine Maintenance Procedures... 60 Disposal... 60 Cleaning and Storage... 60 Battery Operation... 62 Occlusion Pressure Limits for IVAC® 50ml Syringes... 64 Spare Parts... 65 Service Equipment... 66 Trumpet and Start-Up Curves... 67 - 69 Technical Description... 70 Service Contacts... 72 Warranty... 73 6001FAOPT73 ISS 6

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Getting Started Introduction The IVAC® P6000 is a fully featured syringe pump suitable for critical care and general infusion applications. The IVAC® P6000 functions with a range of standard, single use, disposable luer-lock syringes of various types and accepts sizes from 5ml to 100ml - see page 54 for the specification. Features of IVAC® P6000 Syringe Pump ‹ Rate range 0.1 to 1200ml/h. ‹ Large graphics format display. ‹ 24 hour logging of volume. ‹ Event logging records operation. ‹ Optional auto bolus reduction following occlusion alarm. ‹ Communications and nurse call interfaces. ‹ Configurable drug names.

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Getting Started Controls and Indicators MAIN DISPLAY - This indicates the infusion rate, volume infused, volume to be infused (VTBI) and Press PURGE/BOLUS to purge alarm prompts. the extension line during set up START Button - Press to while the pump is stopped or to start the infusion. bolus at an accelerated rate while an infusion is running. STOP Button - Press to stop the infusion. The Amber light will flash to indicate an alarm.

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

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

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

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.

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

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. Are also referred to as the rate keys.

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

Front Panel and Main Display Pump Status

Syringe Type Fitted

Time Pressure Icon

Infusion Rate

VTBI Status Volume Infused 6001FAOPT73 ISS 6

Volume Option

VTBI Option 3 / 73

Getting Started Operating Precautions This IVAC® pump has been calibrated for use with single use disposable syringes. To ensure correct and accurate operation, only use LuerLock 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 herein. 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.

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Getting Started Operating Precautions 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.) and is designed to fail safe if unreasonable levels of interference are encountered. 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 3V/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 unit emits a certain level of electromagnetic radiation which is within the levels specified by IEC60601-2-24 and IEC60601-1. If however the unit interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation. 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. 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). 6001FAOPT73 ISS 6

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Getting Started 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® P6000 Mk II 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.

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 be also secured to the base of the unit in a choice of four positions. An optional adjustable pole clamp is available, part number 6001FAOPT0H. 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.

Replacing the Mains Fuse 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 fuse has 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 the mains fuse is only replaced by a qualified service engineer. For further information regarding the replacement of the internal fuse refer to the technical service manual.

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

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. 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. 6001FAOPT73 ISS 6

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Getting Started Starting the Pump 1. Connect the pump to an AC power supply using the AC power cable. Press the ON/OFF button. 2. NEW PATIENT? - Answering NO will retain all the previous history. Answering YES will automatically reset the patient history to zero. Check the time and date displayed is correct. The question is bypassed if the AUTOSAVE is disabled; all patient history will be reset. 3. LOAD SYRINGE - Load the syringe according to the LOAD SYRINGE Procedure in the Getting Started section of this user manual. 4. 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. 5. Check the rate shown if old patient data has been retained and change the rate if necessary using the ADJUST buttons. 6. PURGE (if required) - Press the PURGE/BOLUS button then the two PURGE softkeys together until fluid flows and the purging of the syringe extension line is complete. The audible alarm will operate during use of the PURGE buttons and the volume used during purging will be shown on the display. 7. CONNECT PATIENT - Connect the extension line to the patient access device. 8. START - Press START 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/BOLUS: pressure limit alarms are temporarily increased to their maximum level, no alarms are disabled during a Bolus infusion or the use of the Purge button. 8 / 73

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Getting Started Power ON/OFF To power up the unit press the power on/off button once. To power off the unit press and hold down the power ON/OFF button for 3 seconds. The display will count down and switch the unit OFF.

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 or after changing a syringe. 1. To use the purge option stop the pump and press the PURGE button. 2. The display will change and show two purge softkeys. 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. The pump will not purge if the rate lock has been enabled.

Bolus Infusions The bolus feature can be used at the beginning of an infusion or during an infusion. If the volume of the bolus reaches the bolus volume limit the bolus will stop and the pump will automatically revert to infuse at the set rate. If the volume to be infused is reached during a bolus, the volume to be infused complete alarm will operate and the unit will revert to its previous state. Press MUTE to stop the alarm or CANCEL to acknowledge the alarm and continue at the normal infusion rate. 1. During maintenance phase infusion press the BOLUS button once to display the bolus screen. 2. Use the chevron keys to set the bolus dose required. 3. To deliver the bolus press the two BOLUS softkeys simultaneously. During the bolus the unit will display the volume being infused. 4. When the desired bolus has been delivered, release the two bolus softkeys. The bolus volume will be added to the total volume infused. 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. A bolus cannot be administered if the rate lock is enabled. 6001FAOPT73 ISS 6

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Getting Started Pressure Level 1. To check and adjust the pressure level press the PRESSURE 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 rate keys to increase or decrease the level. The new level will be indicated on the display. 3. When the pressure level has been selected press QUIT to exit the screen.

VTBI

Volume To Be Infused (VTBI)

This option allows you to set a specific volume to infuse, and rate at the end of the volume to be infused, from stop, 1ml/h, 2ml/h and continuous infusion at the set rate. 1. Press the VTBI softkey to select the VTBI option. 2. Enter the volume to be infused using the chevron keys. 3. When the volume to be infused has been entered, press the OK softkey. 4. Select the rate at the end of the VTBI using the rate selection chevrons. The default is STOP. 5. Press the OK softkey to exit the VTBI menu. 6. When the pump has delivered the set volume it will alarm. Press the CANCEL softkey to clear the alarm. 7. Press the CLEAR softkey to turn the VTBI function off, or set a new VTBI using the chevron keys.

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Getting Started Volume Infused VOLUME This option allows you to clear the volume infused.

1. Press the VOLUME softkey to select the CLEAR VOLUME option. 2. Press the YES softkey to clear the volume. Press the NO softkey to retain the volume infused data.

Drug Name Options can be accessed by using the ? button. This option allows selection of a drug name from the drug names set up in the configuration.

1. Press the ? button to access the options menu. 2. Select the DRUG NAME option using the chevron keys and press the OK softkey indicated on the screen. 3. To select a drug name press the YES softkey. 4. Select the required Drug Name from the list displayed and press the OK softkey. 5. The selected drug name will be displayed on the screen.

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Getting Started Set VTBI Over Time Options can be accessed by using the ? button. Set ‘VTBI Over Time’ must have been activated in the Configured Options. This option allows a VTBI and delivery time to be specified. The rate necessary to deliver the required volume within the required time will be calculated and displayed. Infusion must be stopped to select this option.

1. Press the ? button to access the options menu.

2. Select the SET VTBI OVER TIME option using the chevron keys and press the OK softkey indicated on the screen.

3. Adjust the volume to be infused using the chevron keys, when the volume to be infused has been entered press the OK softkey.

4. Enter the time over which the volume is to be infused. The infusion rate will automatically be calculated. Press the OK softkey to enter the value.

5. Select the rate at VTBI end and press the OK softkey. The default is STOP.

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Getting Started 24H Log Options can be accessed by using the ? button. This option allows the 24H log of volume infused to be reviewed. 1. Press the ? button to access the options menu.

2. Select the 24H LOG option using the chevron keys and press the OK softkey indicated on the screen.

3. Press the NEXT softkey indicated on the screen to access the hourly volume infused log.

4. Press the QUIT softkey indicated on the screen to exit the log.

Event Log Options can be accessed by using the ? button. This option allows the event log to be reviewed. 1. Press the ? button to access the options menu. 2. Select the EVENT LOG option using the chevron keys and press the OK softkey indicated on the screen. 3. Scroll through the log using the chevron keys. 4. Press the QUIT softkey indicated on the screen to exit the menu. 6001FAOPT73 ISS 6

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Getting Started Rate Lock The rate lock feature can be activated in the general options of the pump. When the infusion rate has been set and the infusion started the rate lock prompt will appear in the main menu. When the rate lock is enabled the rate cannot be altered if the pump is stopped, the infusion can be started and stopped in the normal way. The rate lock disables the bolus and purge operations.

1. To select the rate lock function press the YES softkey. Press the NO softkey if the rate lock is not required.

Disable Rate Lock 1. Press the ? button to access the options menu. 2. Select the UNLOCK RATE option using the chevron keys and press the OK softkey indicated on the screen.

Re-Enable Rate Lock 1. Press the ? button to access the options menu. 2. Select the RATE LOCK option using the chevron keys and press the OK softkey indicated on the screen.

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Getting Started 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 START button to resume the infusion.

Display

Description

DRIVE DISENGAGED

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

OCCLUSION

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.

SYRINGE LOCATION

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.

PLUNGER LOCATION

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

BATTERY LOW

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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.

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Getting Started Alarm Procedures Description BATTERY EMPTY - Internal battery empty. To silence the alarm switch the power switch to the OFF position and reconnect the pump to AC power. Restart operation on AC power to charge the internal battery. NEAR END OF SYRINGE WARNING (NEOI) - This is a timed event and can be set from 1 to 15 minutes. To set / change this value see the general options section in this user manual. 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. If KVO at EOI is enabled the rate will drop to the keep vein open (KVO) rate. Approximately half the remaining volume in the syringe will be delivered at the KVO rate. AC POWER SUPPLY DISCONNECTED WARNING AC Power has been disconnected and the pump is operating on battery power. Reconnect AC power or press START 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. NURSE ATTENTION WARNING - Unit left switched ON for over 2 minutes without starting operation. Press STOP or any of the control buttons to silence the alarm for a further 2 minutes. Alternatively, press and hold down STOP for 2 seconds to delay call back for 15 minutes. 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. BATTERY MAY BE LOW/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.

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Display BATTERY EMPTY

NEAR END OF SYRINGE

SYRINGE EMPTY

AC POWER FAIL

3 BEEPS

ERROR

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

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Configured Options Drug Set-up A full list of access codes can be found in the technical service manual. This option is used to set up a list of drug names. 1. Press the ON/OFF power button to the OFF position 2. Hold down the START button and press the ON/OFF button. 3. The main display will show “000”. Enter the Access Code “251” using the chevron. 4. Enter the first digit and press NEXT indicated on the screen. 5. When the complete code has been entered press OK softkey indicated on the screen. 6. Select the DRUG SETUP option using the chevron keys and press the OK softkey indicated on the screen. 7. Select the required drug and press the OK softkey. 8. To use a drug it must be enabled. Press the YES softkey indicated on the screen, to enable the selected drug. 9. To add or change a drug name use the chevron 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. When the set-up is complete, turn the pump OFF and return the pump into service, or select the next configuration option.

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Configured Options General Options 1. Press the ON/OFF power button to the OFF position 2. Hold down the START button and press the ON/OFF button. 3. The main display will show “000”. Enter the Access Code “251” using the rate selection arrows. 4. Enter the first digit and press NEXT indicated on the screen. 5. When the complete code has been entered press the OK softkey indicated on the screen. 6. Select GENERAL OPTIONS using the chevron 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.

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Configured Options General Options The general options available are as follows: Autosave -

When disabled this feature clears the patient information on power up. When enabled this feature requests confirmation to clear or use previous patient data on power up.

Backoff -

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

VTBI -

Enables or disables the VTBI function.

Volume Over Time -

If enabled allows the facility of setting a fixed volume to be delivered over a fixed period of time.

Rate Lock -

If enabled the rate can be locked to prevent idle tampering of the set infusion rate.

Quiet Mode -

If enabled then the low priority alarms and button pushes are muted.

AC Fail Alarm -

Enables or disables the AC Fail Alarm.

Rate Titration -

If enabled then the rate can be changed whilst the pump is infusing. To titrate a rate while infusing, use the rate adjust keys to select the new rate and press the START button to confirm the new rate.

NEOI Warning -

Sets the NEOI warning in time. 1 to 15 minutes.

EOI Point -

Sets the end of infusion volume as a percentage of the syringe volume. Pump runs at KVO for half this volume. 0.5% - 5%

KVO at EOI -

If enabled the pump will switch to run at the KVO rate 1.0ml/h (or the current set rate if this is lower) at the EOI point. If disabled the pump will stop at the EOI point.

Beam Alarm -

Sets up the default beam level. Select from 8 levels - 0 to 7.

Purge Rate -

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

Bolus -

Bolus enabled.

Default Bolus -

Sets the default bolus rate. 10 - 1200ml/hr.

Cap Bolus Rate -

Sets maximum permissible value for the bolus rate. 10 - 1200ml/hr.

Cap Rate -

Sets maximum permissible value for the infusion rate. 1 - 1200ml/hr.

Display Event Log -

If enabled the event log can be accessed via the options menu.

Log Last Patient -

Event log shows all patients, or just the last (since new patient selected).

Nurse Call -

Enables or disables the nursecall option.

Nurse Call Inverted -

When enabled the Nurse Call Option output function is inverted.

Comms Address -

Sets the Pumps Communications Address.

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.

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