Cardinal IVAC 598 User manual

IVAC®598 Volumetric Pump
Directions For Use - English
s
Contents
Page
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Features of the IVAC® 598 Volumetric Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Loading an Infusion Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Starting the Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Basic Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Alarm and Display Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Flow Sensor Operation (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Infusion Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Trumpet and Flow Rate Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Products and Spare Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Service Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
1000DF00161 Issue 1 1/24
Introduction
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 USE:
The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use (DFU) including general wards, critical and intensive care, operating rooms and accident and emergency rooms.
This pump is suitable for use by appropriately trained clinicians or nurses. This pump can be used for Intravenous modes, supporting fluid therapy, drug therapy, blood transfusions and parenteral nutrition.
About this Manual
The user must be thoroughly familiar with the pump described in this manual prior to use. 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.
1000DF00161 Issue 1 2/24
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 IVAC® 598 Volumetric 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
Flow Sensor Connector
Fuse Holders
1000DF00161 Issue 1 3/24
Controls:
Symbol Description
Controls and Indicators
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.
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 (KVO) 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 VTBI 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.
1000DF00161 Issue 1 4/24
Labelling Symbols:
Symbol Description
w
x
Symbol Definitions
Attention (Consult accompanying document)
Potential Equalisation (PE) Connector
Type CF applied part. (Degree of protection against electrical shock)
IPX1
s T
t
A
U
W
Protected against vertically falling drops of water
Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark.
Date of Manufacture
Manufacturer
Important Information
Not for Municipal Waste
Fuse rating
1000DF00161 Issue 1 5/24
Operating Precautions
Infusion Sets
To ensure correct and accurate operation, only use Cardinal Health 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.
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.
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.
Carefully read the Directions For Use supplied with the infusion set prior to use.
Using Collapsible bags, Glass Bottles & Semi Rigid containers
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 all establishments, other than 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.
Operating Pressure
The pumping pressure alarm system is not designed to provide protection against, or detection of, extravasation or tissuing complications which can occur.
1000DF00161 Issue 1 6/24
M
Operating Precautions (Continued)
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.
Electromagnetic Compatibility and Interference
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.
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 p ump is a CISPR 11 Group 1 Class A device and uses RF e nergy only for its internal f unction 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.
B
Earth Conductor
The IVAC® 598 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.
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.
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.
Latex Content
The IVAC® 598 Volumetric Pump does not contain any latex.
1000DF00161 Issue 1 7/24
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