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IVAC 598

CareFusion IVAC 598 Directions For Use Manual

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IVAC®598 Volumetric Pump
Directions For Use
en
Contents
Introduction
About This Manual
Features of the Pump
Controls and Indicators
Symbol Definitions
Operating Precautions
Getting Started
Loading an Infusion Set
Starting the Infusion
Basic Features
Alarms and Display Messages
Flow Sensor Operation (Optional)
Specifications
Maintenance
CareFusion Dedicated Infusion Sets
Trumpet and Flow Rate Curves
Spare Parts
Service Contacts
Document History
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Introduction
Introduction
This Directions For Use applies to the IVAC® 598 Volumetric Pump.
The IVAC® 598 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 IVAC® 598 Volumetric Pump automatically regulates the infusion rate of intravenous solutions. The microprocessor-based pump uses a linear peristaltic, volume displacement mechanism to regulate fluid flow at the desired rate. The pump's many features include:
Easy setup and operation:• Advisory prompts to assist in setup and operation.• Quick start mode.• Diagnostic alarm messages to simplify operation and troubleshooting.• Easy viewing of rate and Volume To Be Infused (VTBI) settings.• Wide range of infusion rates: 1 to 999 ml/h in 1 ml/h increments.• Volumetric rate entry.• Volume To Be Infused capability with automatic switchover to the Keep Vein Open (KVO) rate.• Integral ultrasonic air in line detection.• Detection of upstream/downstream occlusions.• Low occlusion pressures (nominal 6 to 8 psi).• Lightweight and portable with self-contained rechargeable battery.• Automatic flow shutoff with activation of audible and visible alarms.• Audible and visible low battery alert about one hour before battery alarm.• Optional flow sensor (Model 192).• Optional remote computer monitoring capability.•
Intended Purpose
The IVAC® 598 infusion pump is intended for use by medical staff for purposes of controlling infusion rate and volume.
Conditions of Use
The Pump should only be operated by a clinician competent in use of automated infusion pumps and post-placement management of intravenous catheters. Only CareFusion dedicated infusion sets should be used.
Indications
The IVAC® 598 infusion pump is indicated for infusion of therapeutics including:
analgesics • antimicrobials • blood products• chemotherapy• nutrition•
Contraindications
The IVAC® 598 Infusion Pump is contraindicated for enteral feeding, extracorporeal circulation of blood and for diagnostic uses including:
angiography• urodynamics• cavernosometry• cavernosongraphy•
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About This Manual
About This Manual
Users are advised to read, to understand this manual and to be thoroughly familiar with the Pump prior to operating.
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 infusion rates, settings and values are shown in the 'Specifications' section.
Conventions used in this manual
BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for
example, AC Power Indicator, HOLD, ON/OFF switch.
'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.
Important Information: Wherever this symbol is shown an Important note is found. These notes highlight
A
an aspect of use that is important for the user to be aware of when operating the Pump.
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Features of the Pump
VOL TO BE INF
READ VOL
CLEAR VOL
VOL
ml
RATEKVO
VTBI
ON / OFF
RUN/ HOLD
ml/hr
Model 598
Volumetric Pump
Display Indicators
Keyboard
Features of the Pump
Main Display
Door
CAM Follower Assembly
AC power
Indicator
Pole Clamp
CAM Follower Assembly Latch
Air-In-Line Sensor
PE Connector
Test Connector Cover
AC Power Connector
Fuse Holders
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Flow Sensor Connector
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Controls and Indicators
Controls:
Symbol Description
ON/OFF switch - Press once to switch the pump ON. Press and hold down for approximately 3 seconds
to switch the pump OFF.
RUN/HOLD switch - Starts and stops pump infusions. Silences/cancels alarms.
VOLUME TO BE INFUSED switch - Sets value of Volume To Be Infused (VTBI).
CLEAR VOLUME switch - Resets volume infused value to zero.
READ VOLUME switch - Displays volume infused value.
CHEVRON switches - Double chevrons/single chevrons for faster/slower increase or decrease of infusion
rate and volume values.
Controls and Indicators
Indicators:
Symbol Description
AC POWER indicator - When illuminated the pump is connected to an AC power supply and the battery
is being charged.
VTBI The value displayed is the Volume To Be Infused.
KVO The pump is infusing at the Keep Vein Open rate of 5ml/h (or current rate, whichever is less).
VOL The value displayed is the volume infused.
RATE The value displayed is the current infusion rate.
ml (Millilitres) The value displayed is the Volume To Be Infused or volume infused value.
ml/hr (Millilitres / hour) The value displayed is the infusion rate.
Infusion indicator. Three horizontal bars in the left-hand display position flash sequentially when the pump is infusing.
Infusion indicator with Flow Sensor in use. Upper two horizontal bars convert to a square when a drop is detected by the flow sensor in the drip chamber.
Flashing Display When the pump is operating on battery power, the Display flashes on/off.
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Symbol Definitions
Labelling Symbols:
Symbol Description
Symbol Definitions
w
x
k
IPX1
r
s
T
t
U
W
Attention (Consult accompanying documents)
Potential Equalisation (PE) Connector
Type CF applied part. (Degree of protection against electrical shock)
Protected against vertically falling drops of water
Alternating Current
Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
Date of Manufacture
Manufacturer
Not for Municipal Waste
Fuse Rating
EC REP
Authorised Representative in the European Community
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Operating Precautions
Disposable Infusion Sets
To ensure correct and accurate operation, only use CareFusion dedicated 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 IVAC® 598 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 and Semi Rigid Containers
It is recommended that the air vent be opened on the IVAC® 598 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.
Operating Precautions
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
1.
Close the roller clamp
3.
Fill drip chamber to fill line
Open the air vent to allow pressure equalisation - ready for infusion
5.
Prime the set by opening / closing the roller clamp
4.
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 hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that supplies buildings used for domestic purposes. However, it may be used in domestic establishments under the supervision of medical professionals with additional necessary appropriate measures. (Consult Technical Service Manual, appropriately trained technical personnel or CareFusion for further information). Mains power quality should be that of a typical commercial or hospital environment.
The Pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.
Operating Pressure
The pumping pressure alarm system is not designed to provide protection against, or detection of, extravasation or tissuing complications which can occur.
Alarm Conditions
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.
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B A
d
M
Operating Precautions
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.
The IVAC® 598 Volumetric Pump is a Class I device, therefore must be earthed when connected to an AC power supply.
The 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 in the installation or its arrangement is in doubt, the Pump should be operated from the battery.
If the 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.
Electromagnetic Compatibility and Interference
The 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 abnormally high 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. 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.
This Pump is a CISPR 11 Group 1 Class A 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, the Pump emits a certain level of electromagnetic radiation which is within the levels specified by 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.
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.
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