Alaris IVAC PCAM User manual
IVAC®PCAM® Syringe Pump
Directions For Use - English
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Contents
Page
Introduction ....................................................................................................................................... 2
About This Manual ............................................................................................................................ 2
Features of the Pump ........................................................................................................................ 3
Controls & Indicators ......................................................................................................................... 4
Symbol Definitions ............................................................................................................................ 5
Main Display Features ....................................................................................................................... 6
Operating Precautions ...................................................................................................................... 7
Getting Started .................................................................................................................................. 9
Basic Features .................................................................................................................................... 12
Alarms ................................................................................................................................................. 16
Configured Options ........................................................................................................................... 17
Drugs and Protocol Record ............................................................................................................... 21
Specifications ..................................................................................................................................... 22
Occlusion Pressure Limits ................................................................................................................ 23
Compatible Syringes ........................................................................................................................ 23
Compatible Extension Sets .............................................................................................................. 24
Maintenance ...................................................................................................................................... 26
RS232 and Nurse call Specification .................................................................................................. 28
Trumpet Curves & Start-up Curves .................................................................................................. 29
Service Contacts ............................................................................................................................... 30
Document History ............................................................................................................................. 30
Spare Parts ......................................................................................................................................... 31
Warranty ............................................................................................................................................ 31
Index ................................................................................................................................................... 32
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Introduction
The IVAC® PCAM® Syringe Pump (herein after referred to as "pump") system allows a patient to maintain a consistent level of pain relief by
providing self administration of a clinician-prescribed dose of analgesic as and when it is required.
When the hand set is operated and the demand is within the parameters set by the clinician, the pump will automatically administer a
precise bolus dose of analgesic.
For enhanced monitoring and management of post operative acute pain within the hospital, the pump provides convenient Patient
Controlled Analgesia ( PCA) and detailed information at the bed-side about the patients use of PCA.
Central to an effective pain service, the pump promotes improved pain management, more effective use of nursing resources, provides
patient comfort and can contribute towards a quicker recovery.
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, neonatal, operating rooms and accident and emergency rooms.
This pump is suitable for use by appropriately trained clinicians or nurses. The pump is suitable to deliver fluids and medications via
intravenous and epidural routes. Supporting fluid therapy, blood transfusions and parenteral feeding.
The pump is compatible with a wide range of standard, single-use, disposable Luer-lock syringes. It accepts syringe sizes from 20 ml to
100 ml. See the 'Compatible Syringes' section for a full list of compatible syringes.
User configured PCA protocols.
Comprehensive history.
Large graphics format display.
Two key positions providing separation of nursing and programming procedures.
10 pre-set hospital PCA protocols.
Unique electronic hand set with status indicator.
Communications and nurse call interfaces.
About This Manual
The user must be thoroughly familiar with the IVAC® PCAM® Syringe 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. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an
intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the
Specifications section.
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LOCK 2
(on side of case)
COVER
START
Features of the Pump
Display
PURGE
LOCK 1
STOP
PLUS/MINUS
ARROW
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HISTORY
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Handset
Connector
RS232 Connector
Controls:
Controls & Indicators
Symbol
H
X
W
J
V
R Q
S
Description
START button - Press to start the infusion. The green LED will flash during infusion.
STOP button - Press to put the infusion on hold. The amber LED will be lit while on
hold.
PURGE button - Press and hold both buttons to purge the extension set during set
up. See 'Basic Features' for further information.
HISTORY button - Press to display PCA demands and drug infused history graphs, 24
hour review and event log.
PRINT button - Press to print patient history. Note: A suitable printer must be
connected to the pump.
PLUS/MINUS buttons - Use to move cursor and to increase or decrease values
shown on main display.
ARROW buttons - Use as softkeys in conjunction with the prompts shown on the
display.
LOCK 1 -
OFF
SET
RUN
Indicators:
Symbol Description
j
S
Insert key into LOCK 1 keyswitch and turn key to switch between OFF, SET and
RUN positions.
OFF - Turns the power off.
SET - Use to select or modify protocols and to access configuration and test
routines.
RUN - Use to start the infusion.
Note: Switching from RUN mode to SET mode without first pressing the STOP
button automatically stops the infusion.
LOCK 2 - Insert key into LOCK 2 and turn key clockwise to open the syringe cover.
(This key lock is located on the left side of the pump)
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.
AC POWER indicator - When illuminated the pump is connected to an AC power
supply and the battery is being charged.
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Labelling Symbols:
Symbol Description
Attention (Consult accompanying documents)
w
Potential Equalisation (PE) Connector
x
RS232/Nurse call Connector (Optional)
y
Class II Equipment
Type CF applied part (Degree of protection against electrical shock)
Symbol Definitions
P
r
s
T
t
U
A
Protected against splashing fluid (degree of protection against fluid ingress)
Alternating Current
Device complies with the requirements of the EC Directive 93/42/EEC. Registered
with the CE Mark.
Date of Manufacture
Manufacturer
Not for Municipal Waste
Important information
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Main Display
Main Display Features
Current Protocol
PCA Demand
Status
IVAC
50 ml
Syringe Type/Infusion Rate
Protocol Summary Screen
MORPHINE
1.0 mg/ml
LOADING
0
μg
Pump Status
PCA AVAILABLE
DEMANDS
TOTAL
GOOD
PROTOCOL
PCA DOSE
1.0 mg
DOSE LIMIT
50.0 mg IN 4 h
Volume Infused
( Mass/ Volume)
1
1
LOCKOUT
2 min
DRUG INFUSED
1.0 μg
0.1 ml
PROTOCOL
View Protocol Summary
CONTINUOUS
μg/h
0
DOSE RATE
STAT
QUIT
Time
13:07
Pumping
Pressure Icon*
Maximum
Dose Icon*
* These icons are not displayed when disabled.
Screen Icons:
Symbol Description
PUMPING PRESSURE icon - When enabled, this icon is shown on the Display. It provides a visual indicator of
current pumping pressure and pressure level at which the alarm will operate.
MAXIMUM DOSE icon - When enabled, this icon is shown on the Display. It provides a visual indication of the
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amount of drug administered during the limit period (as shown to the left of the icon). If the dose limit reaches the
alarm level, the bottle icon will appear full, the pump will stop infusing and the message Max Dose Limit is displayed
and the icon will flash until the dosing is less than the maximum dose limit. Clinician over-ride is always available.
BACK icon - Indicates the softkey to press to go back to previous screen.
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m
n
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Operating Precautions
Disposable Syringes and Extension Sets
• This pump has been calibrated for use with single-use disposable syringes. To ensure correct and accurate
operation, only use 3 piece Luer-Lock versions of the syringe make specified on the pump or described in
this manual. Use of non-specified syringes or extension 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 incorrectly in the pump, or if it is
removed from the pump before the extension set is properly isolated from the patient. Isolation may
include closing a tap in the extension set or activating a flow stop clamp.
• When combining several apparatus and/or instruments with extension sets and other tubing, for example
via a 3-way tap, the performance of the pump may be impacted and should be monitored closely.
Mounting the Pump
• Do not mount the pump in a vertical position with the syringe pointing upwards as this could 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 set and patient connections and follow
the priming procedure specified herein.
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 local vascular system by such pumps. Typical examples of those pumps are
used during dialysis, bypass or cardiac assist applications.
• This 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 Cardinal Health for further information).
• 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
• This is a positive pressure pump 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, IV
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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Operating Precautions (continued)
Electromagnetic Compatibility & 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.
• 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 Cardinal
Health 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
Cardinal Health 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 Cardinal Health 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 Cardinal Health may result in increased emissions or
decreased pump immunity.
B
A
V
• 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, this pump emits a certain level of electromagnetic radiation
which is within the levels specified by IEC/EN60601-1-2 and IEC/EN60601-2-24. 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. (Consult Technical
Service Manual for further information).
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 protective covering when not in use. Electrostatic discharge
(ESD) precautions are required when connecting RS232. 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.
Latex Content
• The pump and handset do not contain any Latex.
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Getting Started
Initial Set-up
Before operating the pump read this Directions For Use manual carefully.
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1. Check that the pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power
supply.
2. Items supplied are:
IVAC® PCAM® Syringe Pump
User Support CD (Directions For Use)
AC Power Cable (as requested)
Protective Packaging
3. Connect the pump to the AC power supply for 24 hours to ensure that the internal battery is fully charged (verify that the S is lit).
The pump will automatically operate from its internal battery if the pump is switched on without being connected
to the AC power supply. Prior to use on battery power, verify the pump continues to function on battery power once
A
disconnected from the AC 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.
Do not mount the pump 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.
A
Pole Clamp Installation
The pole clamp is supplied fitted to the rear of the pump 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 pump to be mounted to vertical and horizontal poles,
equipment rails and hospital furniture in a variety of convenient operating orientations.
The pole clamp may be adjusted for use with horizontal fittings by using the existing fixings screws with the alternative fixing holes in the
pole clamp.
The pole clamp may also be secured to the base of the pump in a choice of four positions.
Patient Hand Set
The patient hand set supplied with the pump is designed to be ambidextrous and suitable for both adult and paediatric use. The hand
set provides an indicator light which clearly shows when the pump is available and can be configured to flash when a PCA dose is being
delivered.
The indicator on the patient hand set will reflect the configuration of the pump and will provide feed-back on all, or just
good demands, and the indicator light can be disabled should the clinical situation require.
Where appropriate the hand set can be configured so that the patient will not need to refer to the instrument to assess
if PCA is being delivered, or is available.
The hand set is provided with a clip for attaching it to bedding or clothing.
The pump concept is that the patient can be instructed in the use of the hand set as it will carry all the information
required by the patient using PCA. This design simplifies patient instruction and encourages a smooth transfer to
alternative devices used to treat long term chronic pain, should this be indicated.
A latching (but non locking) connector makes the hand set easy to fit. To remove, hold the body of the
connector and pull away from the pump.
An alarm warning will operate if the hand set is disconnected from the pump while it is in operation or the
hand set is connected to the unit with the PCA button depressed. In addition, the pump can be operated in
continuous or clinician over-ride modes without the hand set connected, should this be required.
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Getting Started (continued)
Loading a Syringe
Only use a syringe of the type stated on the
pump or in this manual. Using an incorrect
A
Place the pump on a stable horizontal surface or secure as described
above.
Prepare, load and prime the single-use disposable syringe and
extension set using standard aseptic techniques.
1. Squeeze the finger grips on the plunger holder and slide
the mechanism to the left. Lift the syringe clamp and rotate
clockwise.
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.
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 set
and retained in the syringe at the end of infusion
as this “dead-space” will not be infused.
Gently advance the syringe until the finger
flanges touch the front of the V slot closest to
A
4. Rotate the syringe clamp anticlockwise until it locks onto the
syringe barrel to secure the syringe.
5. Check that the syringe plunger and finger flanges are correctly
located in their slots.
the syringe clamp. This is important to prevent
delay at the start of the infusion.
Changing a Syringe during an infusion
When changing the syringe LOCK 1 should remain in the RUN position except when a change is required to the
protocol.
A
1. Press the
2. Open the cover using LOCK 2.
3. Close the extension line to the patient.
4. Change the syringe, fitting the new syringe as per instructions above.
5. Follow steps 7 to 10 of 'Starting the Pump' section on the next page.
Xbutton to halt the infusion and place the pump on hold.
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