Becton Dickinson
Alaris Volumetric Pump Series
Alaris GP Guardrails Volumetric Pump Directions for Use Issue 3
Directions for Use
44 Pages
Preview
Page 1
Alaris® GP Guardrails® Volumetric Pump
s
Directions For Use en
Contents
Page •
Introduction... 2
•
About This Manual... 2
•
Creating a Data Set... 3
•
Features of the Alaris® GP Guardrails® Volumetric Pump... 4
•
Controls and Indicators... 5
•
Symbol Definitions... 6
•
Main Display Features... 7
•
Operating Precautions... 8
•
Getting Started... 10
•
The Alaris® Safety Clamp... 12
•
Loading an Infusion Set... 13
•
Starting the Infusion... 14
•
Basic Features... 15
•
Secondary (Piggyback) Infusions... 21
•
Service Configuration Mode... 22
•
Pump Configuration available via the Guardrails® Editor Software... 23
•
Drug List available via the Guardrails® Editor Software... 24
•
Alarms...25
•
Warnings... 26
•
Prompts and Advisories... 27
•
Flow Sensor Operation (Optional)... 29
•
Infusion Sets... 30
•
Associated Products... 33
•
Maintenance... 34
•
Cleaning and Storage... 35
•
Disposal... 35
•
Specifications... 36
•
IrDA, RS232 and Nursecall Specification... 37
•
Infusion Specifications... 38
•
Trumpet & Flow Rate Curves... 39
•
Products and Spare Parts... 41
•
Service Contacts... 42
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Introduction The Alaris® GP Guardrails® Volumetric Pump (hereinafter referred to as Pump) is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates. The Guardrails® Editor software* is a medical device accessory, which allows the hospital to develop a best-practice data set of IV medication dosing guidelines for patient-specific care areas referred to as profiles. Each profile contains a specific library of drugs, as well as an appropriate pump configuration. A profile also contains Guardrails® hard limits that cannot be overridden during infusion programming. Additionally Guardrails® soft limits are available and can be overridden, based on clinical requirements. The hospital defined data set is developed and approved through pharmacy and clinical input, and then transferred into the Alaris® GP Guardrails® Volumetric Pump by qualified technical personnel. The Alaris® GP Guardrails® Volumetric Pump with a data set loaded, provides automatic alerts when a dosing limit, bolus limit, concentration limit, or weight limit has been exceeded. These safety alerts are provided without the need for the pump to be connected to a PC or network.
Intended Purpose The Alaris® GP Guardrails® Volumetric Pump is intended for use by medical staff for the purpose of controlling infusion rate and volume.
Conditions for Use The Alaris® GP Guardrails® Volumetric Pump should only be operated by medical staff competent in the use of automated volumetric pumps and in the management of infusion therapy. Medical staff should determine the suitability of the device in their care area for its intended purpose.
Indications The Alaris® GP Guardrails® Volumetric Pump is indicated for the infusion of fluids, medications, parenteral nutrition, blood and blood products through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous or irrigation of fluid spaces. The Alaris® GP Guardrails® Volumetric Pump is indicated for use on adults and paediatrics.
Contraindications The Alaris® GP Guardrails® Volumetric Pump is contraindicated for enteral or epidural therapies. * Only some parts of the Guardrails® Editor software are classified as medical device accessories.
About This Manual The user must be thoroughly familiar with the pump described in this manual prior to use. The Alaris® GP Guardrails® Volumetric Pump has minor functionality differences to the Alaris® GH/CC Guardrails® Syringe Pumps. All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump. These settings and values are for illustrative use only. The complete range of settings and values are detailed in the specifications section.
A
It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.
Conventions used in this manual BOLD
Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, VOLUME, ON/OFF button.
'Single quotes'
Used to indicate cross-references made to another section of this manual.
Italics
Used to refer to other documents or manuals and also used for emphasis.
A
Important Information: Wherever this symbol is shown an Important note is found. These notes highlight an aspect of use that is important for the user to be aware of when operating the pump.
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Creating a Data Set To create a data set for the Alaris® GP Guardrails® Volumetric Pump, first the hospital will need to develop, review, approve, upload according to the following process. Refer to the Guardrails® Editor help file for further details and operating precautions.
1. Create care area data set (Using Guardrails® Editor) Profile
A unique set of configurations and best-practice guidelines for a specific population, patient type or care area. Each profile consists of: Pump Configuration / Drug List Up to 30 profiles can be defined for each Data Set.
Pump Configuration
Pump configuration settings and units for dosing only.
Drug List
Drug names and concentrations for a data set with default value and maximum limits. Up to 100 unique drug names/drug protocol set-ups.
2. Review, approve and export data set (Using Guardrails® Editor) Review and Approve
Entire data set report to be printed, reviewed and signed as proof of approval by an authorised person, according to hospital protocol. Signed printout to be kept safe by hospital. Data set status to be set to Approved (Password is required).
Export
Export data set for use by the Data Set Transfer Tool, or to back up a data set, or to move the data set to another PC.
3. Upload data set to Alaris® GP Guardrails® Volumetric Pump (Using Data Set Transfer Tool) 4. Verify that the correct data set is loaded into the pump and accept it. 5. Switch the pump off. The pump is now ready to use. 6. Switch the pump on and verify that the software version screen displays the correct data set version.
A
Data set transfers should only be performed by qualified technical personnel.
The pump serial number and the hospital name are stored in the event log. Drug parameters have to be in accordance with local regulation and prescribed information.
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Features of the Alaris® GP Guardrails® Volumetric Pump
Alarm indicator Alaris®
GP
Door
Display Softkeys Chevrons Run Bolus
Mute
Hold Options
Pressure Battery indicator On/Off
AC power indicator
Door Lever
Handle
Release lever for rotating cam Flow sensor connector RS232/Nursecall connector (cover removed for clarity) Rotating cam to lock onto horizontal rectangular bars.
Folded pole clamp
Medical device interface (MDI)
Mains fuses cover Mains inlet IR communications port Potential Equalisation (PE) Connector
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Controls and Indicators
Controls: Symbol
Description
a b h c i d e f g
ON/OFF button - Press once to switch the pump ON. Press and hold down for approximately 3 seconds to switch the pump OFF.
RUN button - Press to start the infusion. The green LED will flash during infusion.
HOLD button - Press to put the infusion on hold. The amber LED will be lit while on hold. MUTE button - Press to silence alarm for (approximately) 2 minutes. The alarm will resound after this time. BOLUS button - Press to access BOLUS softkey. Press and hold down softkey to operate. BOLUS - fluid or drug delivered at an accelerated rate. • Pump is infusing • Infusion set is connected to patient. • Volume infused (VI) is added to the total volume infused displayed. OPTION button - Press to access optional features.
PRESSURE button - Use this button to display the pumping pressure and adjust the alarm limit.
CHEVRON keys - Double or single for faster / slower increase / decrease of values shown on display.
BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.
Indicators: Symbol
S j
Description AC POWER indicator - When illuminated the pump is connected to an AC power supply and the battery is being charged. BATTERY indicator - When illuminated the pump is running on the internal battery. When flashing the battery power is low with less than 30 minutes of use remaining.
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Symbol Definitions
Labelling Symbols: Symbol
w x
Description Attention (Consult accompanying document)
Potential Equalisation (PE) Connector
RS232/Nursecall Connector.
l
Defibrillation-proof type CF applied part. (Degree of protection against electrical shock)
IPX3
Protected against spraying water
r
Alternating Current
s T t
Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
Date of Manufacture
Manufacturer
Connector for Flow Sensor
A
Important Information
U
Not for Municipal Waste
W
Fuse rating
EC REP
Authorised representative in the European Community
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Main Display Features
Main Display - If VTBI has not been set (flow sensor must be used): Infusion Status/ Drug Name/Profile Name/Primary or Secondary (Only if secondary
ON HOLD RATE
is enabled in the data set)
Infusion Rate Volume Infused Softkey Identifiers
25.0
ON HOLD
w
a) SET RATE WITH RATE
If the rate has not been set and is showing at 0.0ml/h, RATE TOOa) LOW SET RATE WITH then message will be RATE displayed.
ml/h
VOLUME
50.0 ml
VOLUME
VTBI
ON HOLD
b)
Softkeys
SET RATE WITH RATE
If programmed rate is between 0.0ml/h and RATE TOO HIGH 0.1ml/h exclusive in drug RATE protocol, message RATE TOO LOWb) will be shown. RATE
ON HOLD ON HOLD
Clear Volume Infused Set VTBI Option
Main Display - If VTBI is set: Infusion Status/ Drug Name/Profile Name/Primary or Secondary (Only if secondary
ADRENALINE RATE
is enabled in the data set)
Infusion Rate Dose Rate Volume to be Infused Volume Infused Time Remaining Softkey Identifiers
ON HOLD RATE TOO LOW HIGH RATE ON HOLD
25.0 ml/h 16.7 µg/kg/24h
45.0 ml VOLUME 50.0 ml 1h 48m 00s VTBI
c)
ON HOLD RATE
RATE TOO HIGH
If programmed rate is greater than the Infusion Rate Max in drug protocol, message c) will be shown.
VTBI
VOLUME
Softkeys
Clear Volume Infused
Screen icon:
Set VTBI Option Time remaining display icon - Indicates time remaining before VTBI will be completed. If the time is greater than 24 hours then 24+ will be displayed. Pressure information icon - Shows the pressure from level 0 being the first bar to level 8. Alarm limits: level 2, 5 or 8.
w
? !
Indicates that a Guardrails® safety protocol is not in use. CareFusion recommends the use of Guardrails® safety limits when setting infusions as standard practice. Indicates that the value entered is outside of the soft limits. The warning can be overridden. (Indicates Guardrails® safety protocol is in use) Indicates that the value entered is outside of the hard limits. The warning can NOT be overridden. This symbol is also used to prompt the user to set the rate. (Indicates Guardrails® safety protocol is in use) 1000DF00498 Issue 3
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Operating Precautions Infusion Sets • • • •
• • • • •
To ensure correct and accurate operation, only use CareFusion single use infusion sets described in this Directions For Use. It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion Set' section. Carefully read the Directions For Use supplied with the infusion set prior to use. Use of non-specified infusion sets may impair the operation of the pump and the accuracy of the infusion. When combining several apparatus and/or instruments with infusion sets and other tubing, for example via a 3-way tap or multiple infusion, the performance of the pump may be affected and should be monitored closely. Uncontrolled flow may result if the infusion set is not properly isolated from the patient i.e. closing a tap in the set or activating an in-line clamp / roller clamp. The infusion set may be fitted with an in-line clamp, which can be used to occlude tubing in case it is required to stop fluid flow. The Alaris® GP Guardrails® Volumetric Pump is a positive pressure pump, which should use infusion sets fitted with Luer lock fittings or equivalent locking connectors. To infuse from a burette, close the roller clamp above the burette and open the clamp on the vent on top of the burette. Discard infusion set if the packaging is not intact or the protector cap is detached. Ensure sets are not kinked as this may occlude the tubing.
Using Collapsible bags, Glass Bottles & Semi Rigid containers •
It is recommended that the air vent be opened on the Alaris® GP Guardrails® Volumetric Pump set if using glass bottles or semi-rigid containers, to reduce the partial vacuum formed as the fluid is infused from the container. This action will ensure the pump can maintain volumetric accuracy whilst the container empties. The action of opening the air vent for semi-rigid containers should take place after the spiking of the container and priming of the drip chamber.
Steps for the Collapsible bags
Steps for Semi-rigid containers
Follow steps 1 to 3 as shown for the semi-rigid containers, however do not open vent as in step 4, but prime the set as per step 5. Ensure the bag outlet is fully pierced before filling the drip chamber.
2. Spike the container
3.
4.
Fill drip chamber to fill line
Open the air vent to allow pressure equalisation - ready for infusion
5.
1. Close the roller clamp
Prime the set by opening / closing the roller clamp
Operating Environment •
When using any infusion pump in conjunction with other pumps or devices requiring vascular access, extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the fluid channels of such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications.
•
The pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
•
This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.
•
The pumping pressure alarm system is not designed to provide protection against, or detection of extravasation or tissuing, complications which can occur.
•
Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating.
Operating Pressure
Alarm Conditions
Alaris®
GP
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Operating Precautions (Continued) Electromagnetic Compatibility and Interference
M
•
This pump 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 remain safe when unreasonable levels of interference are encountered.
•
Therapeutic Radiation Equipment: Do not use the pump in the vicinity of any Therapeutic Radiation Equipment. Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator, may severely affect functioning of the pump. Please consult manufacturer’s recommendations for safe distance and other precautionary requirements. For further information, please contact your local CareFusion representative.
•
Magnetic Resonance Imaging (MRI): The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices. Therefore, the pump is not considered an MRI compatible pump as such. If use of the pump within an MRI environment is unavoidable, then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the pump; or MRI image distortion. This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI). For further information, please refer to the product technical service manual (TSM). Alternatively, contact your local CareFusion representative for further guidance.
•
Accessories: Do not use any non-recommended accessory with the pump. The pump is tested and compliant with the relevant EMC claims only with the recommended accessories. Use of any accessory, transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity.
•
In some circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv; or by radio frequency radiation close to or above 10v/m. If the pump is affected by this external interference the pump will remain in a safe mode; the pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms. Should any encountered alarm condition persist even after user intervention, it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel.
•
This pump is a CISPR 11 Group 1 Class B device and uses RF energy only for its internal function in the normal product offering. Therefore, its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment. However, this pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24 and IEC/EN60601-1-2. If the pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.
•
The Alaris® GP Guardrails® Volumetric Pump is a Class I device, therefore must be earthed when connected to an AC power supply.
•
This pump also has an internal power source.
•
When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor on the AC power cable has been compromised, the pump should be disconnected from the AC power source and operated utilising the internal battery.
Alaris®
GP
Earth Conductor
d
Hazards An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources.
•
Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all servicing to qualified service personnel.
•
Do not open the RS232/Nurse Call protective covering when not in use. Electrostatic discharge (ESD) precautions are required when connecting RS232/Nurse Call. Touching the pins of the connectors may result in ESD protection failure. It is recommended that all actions must be taken by appropriately trained personnel.
•
If this pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by a qualified service engineer. When transporting or storing the pump, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the Specifications section and on the outer packaging.
•
If this pump behaves abnormally, remove from service and contact a qualified service engineer.
•
Care should be taken to ensure power leads and RS232 cables do not present a trip hazard.
•
Care should be taken in the placement of power leads and RS232 cables to prevent accidental tugging.
Al
GP aris®
B m V
•
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Getting Started
A
Before operating the pump read this Directions For Use (DFU) manual carefully.
Initial Set Up 1. 2.
3.
Check that the pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply. Items supplied are : l l l l
Alaris® GP Guardrails® Volumetric Pump Directions For Use (CD) AC Power Cable (as requested) Protective Packaging
l
Guardrails® Editor software and/or Data Set Transfer Tool - per hospital
Connect the pump to the AC power supply for at least 2½ hours to ensure that the internal battery is charged (verify that the S is lit).
A
The Guardrails® Editor software can be used to create an approved data set that can be uploaded into the pump. However, a default data set is already installed in the pump (See details below). The pump will automatically operate from its internal battery if the pump is switched on without being connected to the power supply. Should the pump fail to perform correctly, replace in its original protective packaging, where possible and contact a qualified service engineer for investigation.
Factory Default Data Set The Alaris® GP Guardrails® Volumetric Pump is supplied with the following factory default data set:
Parameter
Factory Default Setting
Default Units Enabled for Dosing Only:
AC Fail Warning
Enabled
µg/min
Alarm Volume
Medium
µg/h
Alarm Volume Adjustable
Disabled
mg/h
Occlusion Limit Default
L5
g/h
Occlusion Limit Max
L8
U/h
Rate Titration
Disabled
mmol/h
Infusion Rate Max
1200ml/h
ng/kg/min
Rate Lock
Disabled
µg/kg/min
Bolus Mode
Hands-On Only
µg/kg/h
Bolus Rate Default
500ml/h
mg/kg/min
Bolus Rate Max
1200ml/h
mg/kg/h
Bolus Volume Max
5ml
U/kg/h
Weight Default
1kg
mmol/kg/min
Weight Soft Min
1kg
mmol/kg/h
Weight Soft Max
150kg
AIL Limit
100µl
Primary VTBI Max
9999ml
Secondary Infusion
Disabled
A
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Refer to 'Display of Units' section of the DFU for configurable units. The default data set does not have Guardrails® limits. To set the limits use the Guardrails® Editor software. Care should be taken when specifying the Guardrails® limits.
Getting Started (Continued) Pole Clamp Installation A pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I.V. poles of a diameter between 15 and 40 mm. Recessed area
*
*
1.
Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.
2.
Place pump around pole and tighten screw until the clamp is secured to the pole.
A
Never mount the pump such that the infusion stand becomes top heavy or unstable.
Ensure pole clamp is folded away and stored within recessed area at the rear of the pump before connecting to a Docking Station/Workstation* or when not in use.
Docking Station/Workstation* or Equipment Rail Installation Rotating cam
Rectangular bar
Release lever (push to release)
The rotating cam can be fitted to the rectangular bar on the Docking Station/Workstation* or equipment rails measuring 10mm by 25mm. 1.
Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station/Workstation* or the equipment rail.
2.
Push the pump firmly onto the rectangular bar or equipment rail.
Alaris®
GP
Ensure that the pump 'clicks' securely into position onto the rail or bar. 3.
To release, push the release lever and pull the pump forwards.
A
It is recommended that infusion bags be located on a hanger directly above the pump with which they are being used. This minimises the potential for confusion of infusion sets when multiple volumetric pumps are used.
*Alaris® DS Docking Station and Alaris® Gateway Workstation. Pump can only be mounted on the horizontal section of the docking stations listed above.
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The Alaris® Safety Clamp
SAFETY CLAMP IN NON OCCLUDED POSITION:
Alaris® Safety Clamp**:
When a new infusion set is removed from packaging the Safety Clamp will be in this position*:
Safety Clamp Frame
Clamp in NON OCCLUDED POSITION
Safety Clamp Tab FLOW ENABLED
Safety Clamp Slider
* This is necessary to avoid tube damage during storage and to ensure correct sterilisation and allows immediate priming.
SAFETY CLAMP IN OCCLUDED POSITION:
MANUALLY OPERATING THE Safety Clamp
After infusion set is loaded into the pump, opening the door activates door hooks which will pull the Safety Clamp slider out, as shown:
To move the slider into the non occluded position manually, push up Safety Clamp Tab and push Safety Clamp Slider completely into Frame:
Clamp is in OCCLUDED POSITION
A
NO FLOW 1. Push up
2. Push
A
Æ
Ê
Pushing on the Safety Clamp Slider enables full set flow to the patient. Therefore it is recommended to always close the roller clamp as well. However, if gravity infusion is required, push up Safety Clamp Tab and push orange Safety Clamp Slider completely into Frame to enable flow. The gravity infusion can be regulated using the roller clamp on the set.
** - Hereinafter referred to as to as 'Safety Clamp'.
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Loading an Infusion Set
A
Ensure the appropriate infusion set for the fluid/drug to be infused has been selected. Follow the instructions supplied with the individual infusion set. Only use Alaris® GP Guardrails® Volumetric Pump infusion sets, (Refer to 'Infusion Sets' section of the DFU) Position the fluid container to avoid spillage onto the pump. Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any slack.
Loading an Infusion Set: Alaris® Safety Clamp in the NON OCCLUDED position - FLOW ENABLED Adaptor on infusion 1. Remove infusion set from package and close roller set (Blue) clamp. Top set retainer (Blue) Pressure sensor - UPSTREAM
Pumping mechanism
2. Insert the bag spike into the fluid container and hang appropriately. At a minimum height of 300 mm above the pump. 3. Fill the drip chamber to the fill line if shown. (Approximately half full) Refer to operating precaution section ' Using Collapsable bags, Glass Bottles & Semi-Rigid containers'.
4. Open roller clamp and prime set slowly (to prevent air bubbles) ensuring all air is removed. Pressure sensor - DOWNSTREAM
Alaris® Safety Clamp (Orange) Safety Clamp retainer (Orange) Air-in-line sensor Tubing guide
5. Close roller clamp. 6. Switch the pump on. Open door and load infusion set as follows: • Fit blue adaptor of infusion set into blue top set retainer. • Insert orange safety clamp into orange retainer. 7. Ensure infusion set is fully inserted into tubing guide. 8. Close door and open roller clamp. Ensure no drops are falling in the drip chamber. 9. Ensure all air is removed from the set. Connect the infusion set to the patient access device.
Loading an Infusion Set: Alaris® Safety Clamp in the OCCLUDED position - NO FLOW 1. Follow steps 1 to 4 as above where necessary. 2. Ensure roller clamp is closed. 3. Open door and load infusion set as follows: • Fit blue adaptor on infusion set into blue top set retainer. • Insert orange safety clamp (leaving slider extended) in the occluded position into orange retainer. Alaris® Safety Clamp (Orange) in occluded position (See previous page)
Tubing guide
A
Pushing on the Safety Clamp Slider may lead to uncontrolled flow to the patient. Therefore, always close the roller clamp before pushing on the safety clamp slider.
4. Ensure infusion set is fully inserted into tubing guide. 5. Close door and open roller clamp. Ensure no drops are falling in the drip chamber. 6. Ensure all air is removed from the set. Connect the infusion set to the patient access device.
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Starting the Infusion Prime AND LOAD the set (Refer to 'Loading an Infusion Set')
A 1. 2.
Ensure the pump is connected to an AC power supply (also operates from battery). Connect flow sensor, if required. (See 'Flow Sensor Operation' section)
3.
Press the a key. The pump will run a short self-test. Check two beeps are activated during this test. Check the displayed date and time are correct. Check display shows the data set name and version number. NOTE: The pump starts up and displays previous settings. Confirm current PROFILE a) Selecting CHANGE will display the profile selection screen, select profile using f keys and press OK softkey to confirm. Profile screen will display again, press KEEP softkey and SELECT screen will be displayed, go to step 6. b) Selecting KEEP go to step 5. NOTE: Profile screen is only shown if more than one profile is available in the data set.
4.
• No Drug Name • ml/h • Drug Name*
• Drug Protocol • Dosing Only
• Primary/Secondary • Drug Names*
CLEAR SETUP?
CLEAR SETUP? RATE 150 ml/h 1.50 mg/h CONC 0.01mg/ml VOLUME 1.4 ml
CLEAR SETUP?
RATE
300
VTBI VOLUME
46.5 ml 3.5 ml KEEP
CLEAR
5.
ml/h
KEEP
CLEAR
RATE VTBI VOLUME
300ml/h 50.0ml 0.0ml
FentanYl SECONDARY
RATE VTBI CLEAR
1.0ml/h 1.0ml
KEEP
CLEAR SETUP? - Selecting KEEP will retain all previous rate and volume settings, go to step 7. Selecting CLEAR will automatically reset the rate and volume settings to zero and the SELECT screen will be displayed (if configured).
SELECT
ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK
6.
7. 8.
Select either ml/h, DOSING ONLY or DRUGS (A-Z) and press OK to confirm. Then follow the prompts as required. (Refer to 'Basic Features -Drugs and Dosing' section) Clear VOLUME infused , if required. (Refer to 'Clear Volume Infused' section, this is recommended for a new patient or when a new infusion is set-up.) Enter VTBI (if required) by selecting VTBI softkey on main display. Set VTBI by using the BAGS option and/or f keys and press OK to confirm. (Refer to 'Setting a VTBI' or 'Setting VTBI over Time' section)
9.
Enter or adjust the RATE (if necessary) using the f keys.
10.
Press b key to start the infusion. INFUSING will be displayed. NOTE: The green run LED will flash to show that the pump is infusing.
A
If the infusion requires to be stopped immediately, the following actions may be applied: • by pressing the h key (recommended action) • by closing the roller clamp • by opening the door
* If a drug name is selected, then 'CLEAR SETUP?' will alternate with the drug name. If secondary infusions have been enabled in the data set, then 'PRIMARY' may also alternate. 1000DF00498 Issue 3
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Basic Features Drugs and Dosing The following options enable the pump to be set-up for use with a specific drug name and/or drug protocol. Drugs are pre-configured in the Guardrails® Editor to enable rapid selection of the drug name, dosing units and default rate. For increased security using a configured drug, maximum and minimum safety limits are programmable for concentration and dose rates. (Using the Guardrails® Editor software)
A
When adjusting an infusion using the dose rate, the display may not show any corresponding changes to the infusion rate in ml/h. This does not affect the accuracy of the infusion.
Selecting the INFUSION SETUP 1. Press the d button to first access the options menu. 2. Drugs and dosing set-up options are available by selecting INFUSION SETUP from the list using the f keys. 3. Select from the list of the options (ml/h, DOSING ONLY or DRUGS) as detailed below and press the OK softkey to confirm the selection.
SELECT
ml/h 1. Select ml/h from the list using the f keys (if necessary). 2. Press OK to confirm. 3. Enter the ml/h rate as prompted on the display in the next screen.
ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK
QUIT
SELECT
Dosing Only
ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK
1. Select DOSING ONLY from the list using the f keys. 2. Press OK to confirm. 3. Select the dosing units from the list using the fkeys, press OK to confirm. 4. Enter WEIGHT1 using the fkeys, press OK to confirm. 5. Use the fkeys to select the TOTAL VOLUME2, press OK to confirm. QUIT
6. Enter DRUG AMOUNT using the f keys and if units need to be changed, select UNITS which will scroll through the units available. Press OK to confirm selection. 7. A summary of the DOSING ONLY information is displayed, to CONFIRM? all details shown press OK. The BACK softkey may be used at any time to return to the previous screen. 2
SELECT
Drugs 1. Select the required DRUGS alphabetical row from the list using the f keys. 2. Press OK to confirm.
ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK
1 - Only displayed if weight based units are used. - Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container after a drug is added.
3. Select the drug from the displayed list using the fkeys, press OK to confirm. 4. Enter WEIGHT1 using the fkeys, press OK to confirm. 5. Use the fkeys to enter the TOTAL VOLUME2, press OK to confirm. QUIT
6. Enter DRUG AMOUNT using the f keys, press OK to confirm selection. 7. A summary of the DRUG information is displayed, to CONFIRM? all details shown press OK. The BACK softkey may be used at any time to return to the previous screen.
2
1 - Only displayed if weight based units are used. - Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container after a drug is added.
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Basic Features (continued)
VOLUME
Clear Volume Infused
VOLUME INFUSED
374
This option enables the volume infused to be cleared. 1. Press the VOLUME softkey on main display to show the clear VOLUME INFUSED option.
ml
2. Press the CLEAR softkey to clear the volume infused. Press the QUIT softkey to retain the volume.
QUIT
CLEAR
A
When a new drug or a new concentration has been setup and the previous volume infused has not been cleared, then the message DOSE INFUSED HAS BEEN CLEARED will be displayed.
VTBI 1500ml 1000ml 500ml 250ml 200ml 100ml 50ml 0ml
Setting a VTBI 1. Using the f keys: a) Press the VTBI softkey on main display to enter the volume to be infused screen.
(OFF)
SELECT WITH OK
b) Enter the volume to be infused using the f keys and press OK to confirm. OR 2. Using the BAGS softkey: a) Press the VTBI softkey on main display to enter the volume to be infused screen. b) Select the BAGS softkey, select the required bag volume using the f keys and press OK to confirm the selection.
BACK
c) Press OK to confirm again, or adjust the VTBI using the fkeys.
NOTE: On completion of VTBI pump will continue to infuse at KVO rate.
VTBI DONE INFUSING KVO
RATE
VTBI VOLUME CANCEL
KVO
5.0
KVO (Keep Vein Open) Rate
ml/h
0.0 ml 2.0 ml
0 h 00 m 00 s
VOLUME
At the end of VTBI, the pump will first display VTBI DONE/INFUSING KVO. Press CANCEL to display KVO screen. The pump continues to infuse at a very low (Default) rate. KVO is used to keep the patients vein open, in order to prevent blood clots and catheter occlusions. NOTE: If the KVO rate (Default 5ml/h) is greater than the set infusion parameters then the pump will continue to infuse at the set infusion rate. The KVO rate will flash on screen to indicate this is not the usual infusion rate. The pump will beep every 5 seconds while in KVO mode.
PRESSURE
Pressure
PUMPING PRESSURE
To check and adjust the pressure level, press the e button. The display will change to show the current pumping pressure level and the pressure alarm limit. The pressure alarm limit can be set via the Guardrails® Editor.
ALARM LIMIT
1. Press the f keys to increase or decrease the alarm limit (L2, L5 or L8). The new limit will be indicated on the display.
L1 L5
ADJUST WITH OK
2. Press OK to exit the screen.
The pressure alarm limit is auto adjusted and is fixed at level 8 (L8) for rates above 200ml/h. The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application. Occlusion levels for the Alaris® GP Guardrails® Volumetric Pump are configured in the Data Set Editor by profile only.
A
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Basic Features (continued)
BOLUS RATE SET WITH
VOLUME
80
Bolus Infusions Bolus - Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes. The pump should always be infusing and always attached to the patient. (Drugs given by an IV bolus could achieve immediate and high drug concentration levels.) The bolus feature can be configured via the Guardrails® Editor to: a) Bolus Mode - Disabled b) Bolus Mode - Hands-On Only
ml/h
0.0 ml
HOLD KEY BELOW QUIT BOLUS
Bolus Mode - Disabled If configured to Disabled, pressing the i button will have no effect and the pump will continue to infuse at the set rate.
A
A Bolus cannot be administered if the feature is disabled for the selected data set or specific drug. During BOLUS the pressure limit alarm is temporarily increased to the maximum level (L8).
Bolus Mode - Hands-On Only Press and hold the (flashing) Bolus softkey to deliver the required bolus. The bolus rate can be adjusted. The bolus volume is limited in the configuration via Guardrails® Editor. 1. During infusion press the i button once to display the bolus screen. 2. Use the f keys to adjust the bolus rate if required. NOTE: Rate may be restricted by the Bolus Rate Max which is configured in the Guardrails® Editor. 3. To deliver the bolus press and hold the BOLUS softkey. During the bolus, the volume being infused is displayed. When the desired bolus volume has been delivered or the bolus volume limit is reached, release the softkey. The bolus volume is added to the total volume infused displayed. NOTE:
The bolus rate will be automatically set to the current infusion rate, when the default bolus rate is lower than the current infusion rate. A bolus rate cannot be configured lower than the current infusion rate.
NOTE:
When more than one bolus is programmed without clearing the infusion setup, the bolus rate will be set to the previous bolus rate for all subsequent bolus infusions.
A
If the volume to be infused (VTBI) is reached during a bolus, the VTBI complete alarm will sound. Press c to silence the alarm or CANCEL to acknowledge the alarm. See VTBI section for more details on VTBI operation. When using infusion set 63280NY the maximum infusion rate is 150ml/h.
TITRATE
PRESS RATE
Rate Titration
TO CONFIRM
25.0 ml/h µg/kg/24h 16.7
VTBI VOLUME
45.0 ml 50.0 ml
1 h 48 m 00 s
QUIT
If Rate Titration is enabled (via the Guardrails® Editor) the infusion rate or dose rate (if available) can be adjusted while infusing. 1. Select the new rate using the f keys. The message <TITRATE PRESS b TO CONFIRM > will flash on screen and the pump continues to infuse at the original rate. 2. Press the b button to confirm the new infusion rate and start infusing at the new rate. If Rate Titration is disabled the rate can only be adjusted whilst ON HOLD: 1. Press the h button to put the pump ON HOLD. 2. Select the new rate using the f keys. 3. Press the b button to start infusing at the new rate.
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Basic Features (continued)
Rate Lock (If Enabled) If Rate Lock is enabled, when the infusion rate has been set and the infusion started (or following a bolus infusion) the rate lock prompt will appear on the main display. To select the rate lock function press the YES softkey. Press the NO softkey if the rate lock is not required. When rate lock is enabled, the following are unavailable: l Changing the infusion rate / titration l Bolus l Switching the pump off l VTBI over time infusions. l Secondary infusions (if enabled) To turn rate lock off: 1. Press the d button to access the options menu. 2. Select UNLOCK RATE and press the OK softkey. To turn rate lock on: 1. Press the d button to access the options menu. 2. Select RATE LOCK and press the OK softkey.
Adjusting Existing Dosing or Protocol Infusions - Set By ml/h / Set By Doserate To set doserate or flowrate in precise 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 f keys are used to increase/decrease the infusion rate. To set a doserate precisely the arrow must be pointing to the doserate (for example: mg/kg/h); the flowrate will be calculated from the doserate. To precisely set a flowrate the arrow must be pointing to flowrate (ml/h); the doserate will be calculated from the flowrate. Selecting the SET BY ml/h Option 1. Press the d button to access the options menu. 2. Select the SET BY ml/h option using the f keys and press the OK 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. Selecting the SET BY DOSERATE Option 1. Press the d button to access the options menu. 2. Select the SET BY DOSERATE option using the f keys and press the OK 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.
Dosing Summary To review currently selected dosing information: 1. Press the d button to first access the options menu. 2. Select DOSING SUMMARY. 3. Review the information and then press the QUIT softkey.
Infusion Setup To change the Infusion Setup, refer to 'Basic Features - Drugs and Dosing, Selecting the INFUSION SETUP' section.
Drug Name Only This feature adds a drug name to an existing infusion, when infusing using ml/h or dosing only options. 1. Press the d button to access the options menu. 2. Select DRUG NAME ONLY. 3. Press the OK softkey to confirm the drug name or press the QUIT softkey to exit the option.
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Basic Features (continued) Clear Drug Name Clearing the drug name is only available if drug name only has been selected: 1. Press hto put the pump ON HOLD. 2. Press the d button to access the options menu. 3. Select DRUG NAME ONLY using the f keys, press OK to confirm. 4. Select CLEAR DRUG NAME (displayed if a name only is selected) using the f keys. Press the OK softkey to confirm the selection.
Primary Setup If a secondary infusion has already been setup (see 'Secondary (Piggyback) Infusions' section), then access to the primary infusion setup is as follows: 1. Press hto put the pump ON HOLD. 2. Press the d button to access the options menu. 3. Select PRIMARY Setup and press the OK softkey to confirm. Make changes to the primary setup as necessary.
Setting VTBI over Time This option allows a specific VTBI and delivery time to be set. The rate necessary to deliver the required volume within the specified time is calculated and displayed. 1. Stop the infusion. Press d button to access the options menu. 2. Select the SET VTBI OVER TIME option using the fkeys and press the OK softkey. 3. Adjust the volume to be infused using the fkeys. (Or select BAGS softkey to set the VTBI) When the desired volume has been reached press the OK softkey. 4. Enter the time over which the volume is to be infused using the fkeys . The infusion rate will automatically be calculated. 5. Press OK softkey to enter the value or BACK to return to the VTBI.
Adjust Alarm Volume This option allows adjustment of the volume if enabled. 1. Press the d button to access the options menu. 2. Select ADJUST ALARM VOLUME. 3. Select HIGH, MEDIUM or LOW using the fkeys. 4. Press OK softkey to confirm or QUIT to exit screen.
Pump Details To review pump information: 1. Press the d button to access the options menu. 2. Select PUMP DETAILS. 3. Review the information and then press the QUIT softkey.
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