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IVAC PCAM

CareFusion IVAC PCAM Directions For Use Manual

IVAC® PCAM® Syringe Pump
Directions For Use
en
s
Contents
Page
Trumpet Curves & Start-up Curves ................................................................................... 30
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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, epidural and subcutaneous 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.
l User configured PCA protocols.
l Comprehensive history.
l Large graphics format display.
l Two key positions providing separation of nursing and programming procedures.
l 10 pre-set hospital PCA protocols.
l Unique electronic hand set with status indicator.
l Communications and nurse call interfaces.
About This Manual
It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service
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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.
Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.
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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
PRINT
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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
g
Type CF applied part (Degree of protection against electrical shock)
k
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 Council Directive 93/42/EEC as amended by 2007/47/EC.
Date of Manufacture
Manufacturer
Not for Municipal Waste
Important information
EC REP
Authorised representative in the European Community
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Main Display
Main Display Features
Current Protocol
PCA Demand
Status
Syringe Type/Infusion Rate
Protocol Summary Screen
MORPHINE
1.0 mg/ml
LOADING
µg
0
Pump Status
PCA AVAILABLE
DEMANDS TOTAL GOOD
IVAC 50 ml
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 0
µg/h
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
amount of drug administered during the limit period (as shown to the left of the icon). If the dose limit reaches the
4h
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 however limited by the Max Dose and the time frame set up in the drug protocol.
BACK icon - Indicates the softkey to press to go back to previous screen.
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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.
• The user must be thoroughly familiar with instructions in this Directions For Use and understand how to load and confirm the syringe on the Pump. Incorrect syringe loading may result in misidentification of the syringe type and size leading to significant under or over infusion.
• 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 CareFusion 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 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.
• 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.
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V
• 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.
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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:
l IVAC PCAM Syringe Pump l User Support CD (Directions For Use) l AC Power Cable (as requested) l 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
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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.
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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
Warning: To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may
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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. Open the cover by turning key in Lock 2.
2. Squeeze the nger grips on the plunger holder and slide the mechanism to the left. Lift the
result in misidentification of the syringe type and size. If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect pump performance.
Only use a syringe of the type stated on the pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion and the performance of the pump.
When initially loading the syringe, allow for the volume of fluid contained in the extension set and retained in the syringe at the end of infusion as this “dead-space” will not be infused.
syringe clamp and rotate clockwise.
3. Insert the syringe into the slots on the plunger holder.
4. Squeeze the nger grips on the plunger holder and slide the mechanism to the right until the syringe nger anges locates in the V slot.
Gently advance the syringe until the finger flanges touch the front of the V slot
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5. Rotate the syringe clamp anticlockwise until it locks onto the syringe barrel to secure the
6. Check that the syringe plunger and nger anges are correctly located in their slots.
7. Check that the syringe type and size being used matches display. If required, the make of syringe can be changed by pressing the
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closest to the syringe clamp. This is important to prevent delay at the start of the infusion.
syringe.
CHANGE TYPE softkey. Press OK to conrm syringe.
To minimise the risk of incorrect confirmation of the syringe type it is recommended that the default syringe type should be locked to only the one brand type used in the hospital where possible.
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.
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1. Press the
2. Open the cover using LOCK 2.
3. Close the extension line to the patient.
4. Change the syringe, tting the new syringe as per instructions above.
5. Follow steps 7 to 10 of 'Starting the Pump' section on the next page.
X button to halt the infusion and place the pump on hold.
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