CareFusion PCAM IVAC Syringe Pump Directions For Use
Below you will find brief information for Syringe Pump PCAM IVAC. The IVAC® PCAM® Syringe Pump allows a patient to maintain a consistent level of pain relief by providing self administration of a clinician-prescribed dose of analgesic. The device provides convenient Patient Controlled Analgesia (PCA) and detailed information at the bed-side about the patients use of PCA. It promotes improved pain management, more effective use of nursing resources, provides patient comfort and can contribute towards a quicker recovery.
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IVAC® PCAM® Syringe Pump
Directions For Use
en
s
Contents
Page
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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
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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Features of the Pump
LOCK 2
(on side of case)
COVER
START
Display
PURGE
LOCK 1
STOP
PLUS/MINUS
ARROW
HISTORY
Handset
Connector
RS232 Connector
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Controls & Indicators
Controls:
Symbol
Description
H
START button - Press to start the infusion. The green LED will flash during infusion.
X
STOP button - Press to put the infusion on hold. The amber LED will be lit while on
hold.
W PURGE button - Press and hold both buttons to purge the extension set during set
up. See 'Basic Features' for further information.
J
HISTORY button - Press to display PCA demands and drug infused history graphs, 24
hour review and event log.
V
PRINT button - Press to print patient history. Note: A suitable printer must be
connected to the pump.
R Q
PLUS/MINUS buttons - Use to move cursor and to increase or decrease values
shown on main display.
S
ARROW buttons - Use as softkeys in conjunction with the prompts shown on the
display.
OFF
SET
LOCK 1 -
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.
RUN
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)
Indicators:
Symbol
j
Description
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.
S AC POWER indicator - When illuminated the pump is connected to an AC power
supply and the battery is being charged.
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Symbol Definitions
Labelling Symbols:
Symbol Description
w
Attention (Consult accompanying documents)
x
Potential Equalisation (PE) Connector
y
RS232/Nurse call Connector (Optional)
g
Class II Equipment
k
Type CF applied part (Degree of protection against electrical shock)
P
Protected against splashing fluid (degree of protection against fluid ingress)
r
Alternating Current
s
Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
T
Date of Manufacture
t
Manufacturer
U
Not for Municipal Waste
A
Important information
EC REP
Authorised representative in the European Community
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Main Display Features
Main Display
Current Protocol
Pump Status Volume Infused
(Mass/Volume)
PCA Demand
Status
PCA AVAILABLE
DEMANDS
TOTAL
GOOD
1
1
IVAC
50 ml
Syringe Type/Infusion Rate
Time
13:07
DRUG INFUSED
1 . 0 µ g
0 . 1 m l
PROTOCOL
View Protocol Summary
Protocol Summary Screen
Pumping
Pressure Icon*
Maximum
Dose Icon*
PROTOCOL
MORPHINE
1.0 mg/ml
LOADING
0 µ g
PCA DOSE
1.0 mg
DOSE LIMIT
50.0 mg IN 4 h
LOCKOUT
2 min
CONTINUOUS
0 µ g / h
DOSE RATE
STAT
QUIT
* 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.
4h
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 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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Operating Precautions
m
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.
n
•
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.
G
•
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)
M
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.
•
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
B
•
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.
A
•
Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all servicing to qualified service personnel.
V
•
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.
A
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).
A
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 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
A
Warning: To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may 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.
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 finger grips on the plunger holder and slide the mechanism to the left. Lift the syringe clamp and rotate clockwise.
3. Insert the syringe into the slots on the plunger holder.
4. 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.
A
Gently advance the syringe until the finger flanges touch the front of the V slot closest to the syringe clamp. This is important to prevent delay at the start of the infusion.
5.
6.
Rotate the syringe clamp anticlockwise until it locks onto the syringe barrel to secure the syringe.
Check that the syringe plunger and finger flanges 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
CHANGE TYPE softkey. Press OK to confirm syringe.
A
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.
A
1.
2.
3.
4.
5.
Press the X button to halt the infusion and place the pump on hold.
Open the cover using
LOCK 2.
Close the extension line to the patient.
Change the syringe, fitting the new syringe as per instructions above.
Follow steps 7 to 10 of 'Starting the Pump' section on the next page.
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Getting Started (Continued)
Starting the Pump
1. AC POWER - Connect pump to AC power supply using the AC power cable. Note: the pump will operate on an internal battery when not connected to an AC power source for a limited time.
A
Prior to beginning an infusion, disconnect the pump from the AC power supply, confirm the pump continues to function on battery power.
Then reconnect the pump to the AC power source.
2. SET - Insert key into LOCK 1. Turn to SET position.
3. NEW PATIENT? - Answering NO will retain all previous patient history, except for the PCA lockout time remaining which will be reset to PCA AVAILABLE. YES will automatically reset the patient history to zero. Check time and date is correct and answer YES or NO.
4. SELECT/ MODIFY PROTOCOL - Carefully check the protocol displayed. If required, press MODIFY PROTOCOL to adjust the current protocol, or, NEXT PROTOCOL to select an alternative pre-set protocol.
5. RUN - Turn LOCK 1 to the RUN position and remove the key from pump.
6. CONFIRM PROTOCOL - Carefully check that protocol is correct.
Press OK.
7. CONFIRM SYRINGE - Check that the syringe type and size being used matches display. If required, the make of syringe can be changed by pressing the CHANGE TYPE softkey. Press OK.
8. PURGE (if required) - The PURGE buttons can only be used when the cover is open and LOCK 1 is in the RUN position. When the purge operation is complete close the cover.
9. CONNECT PATIENT - Connect the PCA extension set to the patient access device. Recheck the protocol.
10. START - Press the H button to commence pump operation.
Either PCA AVAILABLE or CONTINUOUS INFUSION will be displayed with the rate, demand and drug totals. If selected, a loading dose will be delivered.
11. PROTOCOL - Press PROTOCOL softkey at any time to display the protocol summary. To return to the main screen press QUIT.
A
The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply.
Each time the pump is switched ON, check that the alarm beeps twice and that all the segments of the display, the green and amber lights are illuminated during the self test routine.
LOCK 1 should not be turned from OFF to SET whilst the syringe extension set is connected to the patient.
10
S AR O BEGIN PCA
SIZE
11
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Basic Features
Purge
The
W patient.
button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a
1.
PURGE can only be operated with the cover opened and LOCK 1 in the RUN position.
2. Press the W buttons together until fluid flows and priming of the syringe extension set is complete. The audible alarm will operate during use of the W buttons and the volume used during priming will be shown in the volume infused display.
A
The PURGE feature is not activated when the cover is closed. Ensure that the extension set is disconnected from the patient before purging the line. No alarms are disabled during the operation of the PURGE feature. During PURGE the pressure limit alarms are temporarily increased to their maximum level.
Clinician Over-ride
The clinician over-ride feature can be used in RUN mode to administer an additional bolus dose or continuous background infusion of a limited dose and duration, for example during the PCA lock out period. The clinician over-ride is a special feature which can be configured according to the specific clinical situation. Clinician over-ride can also be used in SET mode to allow modification of the pre-set PCA Protocol when this option has been disabled for normal use.
1. Turn LOCK 1 to RUN position and ensure green light is illuminated on the
H
button.
2. Press and hold down the T button for 2 seconds.
3. Use
R Q
buttons and NEXT softkey to enter three figure pre-programmed clinician access code. See technical service manual.
4. Select BOLUS or CONTINUOUS.
5. Use
R Q
buttons to select the dose delivered, when the correct value has been entered press OK.
6. Use R Q buttons to select period over which the dose is to be delivered. Press OK when correct time has been entered.
7. BEGIN BOLUS? YES - Clinician bolus / continuous infusion will be delivered to the patient. NO - Quit set up and return to normal operation.
A
The delivery of the clinician over-ride continuous infusion will automatically halt while a Patient or Clinician over-ride bolus is being administrated. To cancel clinician over-ride during delivery, press
I
button and press the YES softkey.
During BOLUS the pressure limit alarms are temporarily increased to their maximum level.
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Basic Features (Continued)
Patient History
Each time the pump is switched ON it will ask if this is a new patient. Pressing YES will provide opportunity to re-set patient history. Pressing
NO continues with the current protocol and retains all protocol records, event history, graphs etc. However, any remaining PCA lockout time will be cleared and a PCA demand will be immediately available.
The pump will retain the events in a rolling memory. Following selection of a new patient, it remains possible in technician mode to access previous patient(s) history still held in memory.
Patient history can be accessed at any time by pressing the J button. The pump provides a clear rolling 24 hour graphical representation of the PCA demand pattern and the drug administered to the patient. The graphs are updated when the history button is pressed and give values for each completed hour and the current hour. The cumulative counters on the Drug Infused history screen update in real-time.
24 Hour Review
An hour by hour record of the last 24 hours, showing good and total PCA demands along with the total dose and volume per hour.
This information provides the accurate demand pattern and drug infused values from which the other graphs are derived.
1. To access the 24 Hour Review press the
J
button once.
2. To return to the previous screen press the BACK softkey.
3. To scroll through to the next History screen press the J button.
PCA Demands
Provides a record of the last 24 hours good and failed PCA demands. The good demands are indicated by the shaded section of the graph and the failed demands by the clear section. The latest hour is shown at the right side of the display.
This graph provides a clear picture of good and bad PCA demands and pattern of the patients usage. Used in conjunction with the PCA
Demands graph, this display helps to indicate if the PCA protocol needs modification and when to end treatment.
1. To access the PCA demand graph press the
J
button twice.
2. To exit the screen press the BACK softkey.
3. To scroll through to the next History screen press the
J button.
Drug Infused
Record of the total amount of drug administered to the patient over the last 24 hours. The latest hour is shown at the right side of the display. This graph provides a clear picture of the actual drug administered, including loading dose, continuous background infusions, clinician over-rides and protocol changes. The left side of the display shows cumulative dose and time counters with the time, mass and volume infused since the patient session started or since the counters were last reset. To reset counters press CLEAR and then CONFIRM.
Used in conjunction with the PCA Demands graph, this display helps to indicate relative pattern of the demand pattern and the actual drug administered.
1. To access the Drug Infused graph press the J button three times.
2. To return to the previous screen press the BACK softkey.
3. To scroll through to the next History screen press the J button.
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Basic Features (Continued)
Event Log
Record of events since "NEW PATIENT" selected. Including, protocol selection and changes, patient demands etc. The event log will also record all alarms.
All events are recorded against date, clock and total drug infused.
1. To access the Event Log press the
J
button four times.
2. To return to the previous screen press the BACK softkey.
3. To return to the Protocol Summary press the
J
button again.
Printing
A printer fitted with a serial interface (or cable with parallel to serial converter) can be connected to the pump, either during normal PCA operation or following use. Printing patient history provides a permanent record and can be used for analysis away from the bedside.
All patient history, including protocols and the 24 hour demand pattern and drug dose administered graphs are available for printing.
When connected to the printer, the pump can also be configured to provide line by line continuous printing of all events, patient demands etc. as they occur at the bedside. See General Options.
Protocol Summary
Patient History
Event Log
Event Log at New Patient
Connect Printer then...
• Turn LOCK 1 to SET position
• Press
V
button
Information printed
All protocol information will be printed with patient header.
• Press V button
• Press
J button until event log is displayed.
• Use S buttons to position display at start point for events to be printed.
• Press V button
All protocol information, demand and drug totals,
24 hour graphs and records will be printed with patient header.
All events will be printed from information on screen forward with time, date and patient header.
• Press
V
button
All events will be printed from the patient event log.
Continuous Mode
Enable Continuous printing by selecting YES in General Options.
1. Connect printer.
2. All events will be printed as they occur.
Teach Learn Mode
By programming the configuration of one pump in the conventional way from the front panel buttons other pumps can have the configuration copied over using the “teach” and “learn” modes.
When set to “learn” mode the pump will accept information sets from a pre-configured pump set to “teach” mode.
When set to “teach” mode the pump sends out via the communications interface a sequence of all the information sets required to configure another pump. To fully configure a pump
it is necessary to send 22 complete information sets as described in the protocols and the full cycle takes about 22 seconds.
The two pumps must be connected together using an RS232 Demonstration Cable. Both pumps must be of the same version software and revision and set to a common pump comms identification number (see General Options). The configured pump is set to “teach” mode and the pump
to be configured is set to” learn” mode using the access codes listed in the Technical Service Manual. The pump in “learn” mode will display PASS or FAIL for each information set being received from the “teach” mode device.
The pumps must run through at least one complete sequence of the information sets and then switch off first the “learn” pump and then the “teach” pump. After using this method it is the user’s responsibility to check that the configuration has been copied over correctly.
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Basic Features (Continued)
Pre-Set PCA Protocols
Operation of the pump is greatly simplified by the use of PRE-SET PCA protocols. When LOCK 1 is turned to the SET position the pump will automatically display pre-set PROTOCOL A if NEW PATIENT has been selected or display the previous protocol in use if NEW PATIENT has not been selected.
With LOCK 1 in the SET position, it is possible for the user to modify the pre-set protocol using the MODIFY PROTOCOL button and select another pre-set protocol using the NEXT PROTOCOL button.
To modify a Pre-Set Protocol
1. Press MODIFY PROTOCOL indicated on the screen.
2. The protocol summary will be displayed. Use
S
buttons to highlight a field, press ALTER to enter that field and buttons to select desired values.
R
Q
3. When field is correct press CONFIRM or CANCEL.
A
PROTOCOL
SUMMARY
PCA Dose
1.0 ml
MAX 50.0ml
IN 4h
4. Display will show:
A
Protocol
Drug name
Drug conc.
PCA Dose
Lockout period
Occlusion level
Continuous
Loading dose
Max. limit
Limit duration
PCA delivery
Drug ‘X’
1.0mg/ml
1.0mg
5 mins
4
0µg/h
0µg
50mg
4 hours
STAT
(1.0ml)
(0.0ml/h)
(0.0ml)
(50.0ml)
5. Press OK to return to display.
Notes:
A modified protocol has no pre-set letter.
To utilise this function, “MODIFY PROTOCOL” must be enabled in GENERAL OPTIONS.
DRUG X
1.0mg/ml
Lockout
5 mins
MODIFY
PROTOCOL
Continuous
2.0ml/h
Loading
2.0 ml
NEXT
PROTOCOL
To change to another Pre-Set Protocol
Press NEXT PROTOCOL to display the step through the pre-set protocol.
Pre-set protocols are identified as A to J. When the desired protocol has been selected it can be used by turning LOCK 1 to the RUN position, or, can be modified using the MODIFY PROTOCOL.
To confirm a Protocol
Whenever a new protocol is selected, modified or LOCK 1 is turned to the SET position, the CONFIRM PROTOCOL display will appear.
Pressing OK automatically records the protocol and any changes in the EVENT LOG history.
A
Volumes and rates are typically calculated to more decimal places than are displayed. To achieve this, the values are rounded down to prevent the impression of an over-infusion. The doses and dose rates are calculated from the volume of rate that the pump infuses. Thus, when configuring protocols some combinations of drug concentration and
PCA dose may result in the displayed rate and the dose rate appearing inconsistent or the displayed dose appearing incorrect.
See examples on next page.
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Basic Features (Continued)
Pre-Set PCA Protocols (continued)
Example 1. Displayed rate and dose rate appear inconsistent.
Dose rate = 30µg/h
Drug Concentration = 44µg/ml
This would give a rate of 0.68181818ml/h. The pump would round the calculation to two decimal places, giving an actual infusion rate of
0.68ml/h, whilst the screen will display a rate of 0.6ml/h and a dose rate of 29µg/h.
Example 2. Displayed dose does not appear correct.
PCA Dose = 720µg
Drug Concentration = 500µg/ml
For each PCA demand the pump would infuse 1.4399ml. For the purpose of the displayed volume, the first PCA demand is counted as
1.43ml (715µg) with the remaining 0.0099ml being carried over into the display of the next demand. The next demand would be displayed
(accumulatively) as 2.87ml (1.4399ml + 1.4399ml = 2.8798ml) with the remaining 0.0098ml being carried over into the display of the next demand.
For the purpose of the displayed dose, the first PCA demand is calculated as 715µg (drug concentration 500µg/ml multiplied by calculated dose 1.43ml). The next demand would be displayed (accumulatively) as 1.43mg (500µg/ml multiplied by calculated dose 2.87ml = 1435µg =
1.435mg which is rounded down and displayed to two decimal places = 1.43mg).
If similar inconsistencies are experienced, contact your local CareFusion representative for clarification.
1000DF00451 Issue 2
16/34
Alarms
Alarms are indicated by a combination of an audible alarm, flashing amber STOP light and a descriptive message in the display.
1. First press the MUTE softkey to silence the alarm for a maximum of 2 minutes, then check the display for an alarm message. Press X to cancel the alarm message.
2. If the infusion has stopped, rectify the cause of the alarm then press the H button to resume the infusion.
Message
DRIVE DISENGAGED
COVER OPENED
LINE OCCLUSION
SYRINGE ERROR
CHECK HANDSET
BATTERY LOW
BATTERY EXHAUSTED
SYRINGE NEAR EMPTY
SYRINGE EMPTY
AC POWER FAIL
MALFUNCTION
MAX DOSE EXCEEDED
3 BEEPS
(Alarm without screen prompt)
Cause and Troubleshooting Guide
PUMP DRIVE DISENGAGED
The drive system has been disengaged during operation. Use LOCK 2 to unlock and open the cover.
Check the finger grips and the position of the syringe.
COVER OPENED DURING OPERATION
The cover has been opened during operation. Check cover and LOCK 2.
EXCESSIVE PUMPING PRESSURE
Pumping pressure has reached the alarm limit. Use LOCK 2 to unlock and open the cover, squeeze finger grips on the plunger holder to release the drive mechanism and relieve any excessive pressure in the syringe and patient line. Identify and remove the cause of the blockage in the drive, syringe, or administration system before restarting the infusion.
SYRINGE SIZE ERROR / FITTED INCORRECTLY
Incorrect size of syringe has been fitted, the syringe clamp has not been positioned correctly on the syringe or has been disturbed during operation or plunger is not fitted in plunger slot. Use LOCK 2 to unlock and open the cover, check syringe size, position of syringe clamp, syringe and plunger.
PATIENT HAND SET FAILURE
Patient hand set has become faulty or disconnected during operation. Check operation and connection of the hand set to the pump. Press required.
H to continue if operation without the hand set is
BATTERY CHARGE LOW WARNING
Battery charge low with 30 minutes operation remaining. Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted. Reconnect to AC power supply to continue operation and charge internal battery.
BATTERY EXHAUSTED
Internal battery exhausted. To silence the alarm switch LOCK 1 to the OFF position and reconnect pump to AC power supply. Restart operation on AC power whilst charging the internal battery.
Switch to the RUN position.
NEAR END OF SYRINGE WARNING
Syringe almost empty with about 6% of its volume remaining. Press
TO OPEN COVER.
H
to silence alarm and continue operation. Display will flash SYRINGE NEAR EMPTY. The alarm screen will also flash USE LOCK 2
SYRINGE EMPTY - END OF INFUSION
The pump has reached the end of the infusion. About 1% of the syringe volume will remain in the syringe helping to prevent the infusion of air bubbles into the PCA set. The alarm screen will flash
USE LOCK 2 TO OPEN COVER.
AC POWER SUPPLY DISCONNECTED WARNING
AC Power has been disconnected and the pump is operating on battery power. Reconnect AC power supply or press X to silence the alarm and continue battery operation. The display will light up ON
BATTERY. The alarm will automatically cancel if the AC power supply is reconnected.
INTERNAL MALFUNCTION
The alarm system has detected an internal malfunction. Note the malfunction code. Remove pump from service for examination by a qualified service engineer.
MAX DOSE LIMIT
The maximum dose over time limit has been exceeded. Infusion is stopped when the alarm occurs.
Press
X to cancel the alarm. The max dose icon will flash until dosing is less than the maximum dose limit. Note that this alarm can be disabled under General Options.
NURSE ATTENTION WARNING
Pump left switched ON for more than 2 minutes without starting operation. Press
X
or any of the control buttons to silence the alarm for a further 2 minutes.
To cancel this alarm for 15 minutes, press and hold the are heard.
X
button until 3 rapid, consecutive beeps
1000DF00451 Issue 2
17/34
Configured Options
This menu comprises a list of options which are configurable by the user.
1. Whilst holding down the H button turn the pump ON.
2. The main display will show 000. Enter the access code for Configured Options using the the digits. A full list of access codes can be found in the Technical Service Manual.
R Q buttons, pressing NEXT to move through
3. When the complete code shows on screen, press ENTER. The Configured Options menu will be displayed.
General Options
1. Select GENERAL OPTIONS from the menu using the R Q buttons and press ENTER.
2. Select the option you wish to enable/disable or adjust and press MODIFY.
3. When all the desired modifications have been carried out press QUIT.
4. Either select the next configuration option from the menu or turn the pump OFF, returning it to operation as required.
Option
1. ICONS on display
2. Protocols in use
3. Modify protocol
4. Handset mode
5. Delayed call-back
6. Display Sleep
7. Chirp low alarms
8. Continuous infusions
9. Loading doses
10. Max. dose limits
11. Variable dose rates
12. Comms identity number
13. Comms enabled
14. Nurse call
15. Nurse call inverted
Description
YES - displays Pumping Pressure and Maximum Dose ICONS.
NO - ICONS disabled.
PCA pre-set protocols to be available. Select number from 1 to 10.
YES - allows protocols to be modified in SET mode.
NO - removes modify protocol option in SET mode.
MODE A B C
BEEP
HAND SET LIGHT:
GOOD ALL ALL
PCAM® STOPPED
PCA AVAILABLE
PCA DELIVERING
PCA LOCK-OUT
OFF
ON
FLASH
OFF
OFF OFF
ON
ON
ON
ON
FLASH
ON
YES - call-back alarm can be delayed from 10 mins up to 90 mins.
NO - call-back will be cancelled for up to 2 mins or extended to 15 mins. To extend call-back alarms, press and hold the
X
button for 4 seconds.
YES - display goes blank after 2 minutes.
NO - display stays on during operation.
YES - “chirp” alarm during use on battery/near end.
NO - no “chirp” alarm.
YES - Continuous infusions option in protocols.
NO - Continuous infusions are not available.
YES - Loading dose option appears in protocols. To activate this option “NEW PATIENT” is confirmed.
The protocol also includes the loading dose. Start the PCA.
NO - Loading doses are not available.
YES - Dose limit option appears in protocols.
NO - Dose limits are not available.
YES - Allows the dose rate to be varied, when modifying the protocol. Dose rate can be either STAT rate
(100ml/h max.) or the dose can be delivered over a period of time from 1 to 60 minutes.
NO - Each dose will be delivered at the STAT rate and there is no option to change when modifying the protocol.
Use R Q buttons to set pump identity (between 000 and 127) for use with remote communications.
YES - RS232 Communications enabled.
NO - RS232 Communications disabled.
YES - Nurse call connector enabled.
NO - Nurse call connector disabled.
YES - Nurse call inverted enabled.
NO - Nurse call inverted disabled
1000DF00451 Issue 2
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Option
16. Continuous Print
17. Default Syringe
18. Lock syringe type
19. Quiet mode
20. Generic Drug Enabled
21. Max Dose Limit Alarm
22. Mix Mass & Vol Modes
Configured Options (Continued)
General Options (continued)
Description
YES - Allows printing of events as they happen.
NO - Continuous printing disabled.
Use R Q buttons to select the default syringe brand.
YES - Syringe type locked to default syringe.
NO - Syringe type not locked to default syringe.
YES - Quiet mode enabled.
NO - Quiet mode disabled.
YES - Allows Protocols to be set up to use a Generic Drug, which is preset to maximum safety limits.
NO - Disallows use of Generic Drug.
YES - Alarm is generated when max dose limit is reached.
NO - Alarm is not generated when max dose limit is reached.
YES - Allow a mix of mass and volume dose mode for drugs and protocols.
NO - All drugs and protocols use mass dose mode.
A
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.
Clock Set
1. Select CLOCK SET from the Configured Options menu and press ENTER.
2. Use the
R Q
buttons to adjust the date and time displayed, pressing NEXT to access the next field.
3. When the correct time and date are displayed press OK to return to the Configured Options menu.
A
The internal clock is the reference against which the pump stores patient history and events. Changing the clock will automatically reset the dates against which all new patient history is stored in the pump. After changing the clock, the pump will force a YES response the next time the NEW PATIENT screen appears. This will clear the patient history.
Therefore, patient history should always be recorded and, if required, printed prior to changing the clock.
Pre-Set Protocol Set-Up
1. Select PROTOCOL DEFAULT SET-UP from the Configured Options menu and press ENTER.
2. Press MODIFY PROTOCOL to display current protocol summary. Use the
R Q
buttons to highlight a field, press ALTER to access the field and the
R Q
buttons to select required values.
3. When the field is correct press CONFIRM. Press OK to return to the protocol summary.
A
One of the ten drugs programmed in the Drug Names and Safety Limits are selectable for each protocol. Additionally a default drug with limits set to extremes may be chosen if Generic Drug is enabled in General Options. Default drugs are named “MASS DRUG“ and “VOL DRUG“. The names indicate the underlying dose mode.
Hospital Name
This option allows the user to programme in the name of the hospital, ward or department. This will appear during the power-up display sequence and the 'Display Sleep' screen (if enabled in General Options).
1. Whilst holding down the H button turn the pump ON.
2. The main display will show 000. Enter the access code for Hospital Name using the digits. A full list of access codes can be found in the Technical Service Manual.
R Q buttons, pressing NEXT to move through the
3. When the complete code shows on screen, press ENTER. The Hospital Name Option will be displayed.
4. Use the
R Q
buttons to adjust the character displayed, pressing NEXT to access the next position.
5. When the correct name is displayed turn LOCK 1 to the the OFF position.
1000DF00451 Issue 2
19/34
Configured Options (Continued)
Drug Names and Safety Limits
A
If enabled in General Options, a drug can be configured in either Mass or Volume dosing mode. If this option is disabled, all drugs and protocols are computed in dose units of mass.
On all drug parameter screens except DRUG name, press BACK to return to the previous parameter.
1. Turn LOCK 1 to SET position while pressing down
H
button.
2. Enter the access code using the R Q buttons.
3. Select DRUG NAMES AND SAFETY LIMITS from the menu. Press ENTER.
4. Press MODIFY DRUG to modify the drug summary. Use R Q buttons to select desired values. When field is correct press OK to store the selection.
5. NAME: Use R Q buttons to set highlighted letter. Press NEXT for next character (up to twelve letters). Press OK when complete.
6. DOSE MODE: Use R Q buttons to change dose mode. Changing dose mode resets Drug parameters to defaults and also resets
Protocols that use this drug. To change dose mode, press CONFIRM. Press OK when complete. Note: DOSE MODE will not be displayed if Mix Mass & Volume Modes is disabled in General Options.
7.
MIN DRUG CONC: Use R Q
buttons to set minimum concentration. For volume mode, concentration can be set to OFF, the lowest value. Press OK when complete.
8. MAX DRUG CONC: Use R Q parameter does not appear.
buttons to set maximum concentration. Press OK when complete. If min Drug conc is set to OFF, this
9. MIN LOCKOUT PERIOD: Use R Q buttons to set minimum lockout period. Press OK when complete.
10. MAX LOCKOUT PERIOD: Use R Q buttons to set maximum lockout period. Press OK when complete.
11. MIN PCA DOSE: Use
R Q
buttons to set minimum PCA dose. Press OK when complete.
12. MAX PCA DOSE: Use
R Q
buttons to set maximum PCA dose. Press OK when complete.
13. MAX CONTINUOUS: Use
R Q
buttons to set maximum continuous rate. Press OK when complete.
14. MAX LOADING DOSE: Use
R Q
buttons to set maximum loading dose. Press OK when complete.
15. MAX DOSE LIMIT: Use
R Q
buttons to set maximum dose limit. Press OK when complete.
16. MAX CLINICIAN BOLUS: Use
R Q
buttons to set the maximum clinician bolus. Press OK when complete.
17. NEXT DRUG to display the next drug name and the safety limits. The ten pre-set drug protocols are identified as 1 to 10.
18. Press QUIT to exit and return to configuration menu.
19. When set-up is complete, turn LOCK 1 to OFF position to save selection and to turn pump off.
1000DF00451 Issue 2
20/34
Configured Options Record
General Options
Enter the pump-specific information for your records on a copy of this page.
Option
ICONS ON DISPLAY
PROTOCOLS IN USE
MODIFY PROTOCOL
HANDSET MODE
DELAYED CALLBACK
DISPLAY SLEEP
CHIRP LOW ALARMS
CONTINUOUS INFUSIONS
LOADING DOSES
MAX DOSE LIMITS
VARIABLE DOSE RATES
COMMS PUMP IDENTITY
COMMS ENABLED
NURSE CALL
NURSE CALL INVERTED
CONTINUOUS PRINT
DEFAULT SYRINGE
LOCK SYRINGE TYPE
QUIET MODE
GENERIC DRUG ENABLED
MAX DOSE LIMIT ALARM
MIX MASS & VOL MODES
YES/NO
1 - 10
YES/NO
A / B / C
YES/NO
YES/NO
YES/NO
YES/NO
YES/NO
YES/NO
YES/NO
000 - 127
YES/NO
YES/NO
YES/NO
YES/NO
BD PLASTIPAK
IVAC
TERUMO
B. BRAUN OMNIFIX
MONOJECT
R.R PRONTO
BD WORLDWIDE
ONCE
YES/NO
YES/NO
YES/NO
YES/NO
YES/NO
Range
FRESENIOUS INJECT.
RAPIJECT
PHARMA-JECT
BD PRECISE
BRAUN PERFUSOR*
JANPOL*
* with options kit fitted
NO
NO
YES
YES
NO
001
YES
NO
NO
NO
YES
YES
YES
YES
Default
NO
5
YES
A
YES
YES
NO
BD PLASTIPAK
Syringe Type
UNIVERSAL
BRAUN PERFUSOR
JANPOL
Enabled
Setting
Hospital Name
Approved by
Date
1000DF00451 Issue 2
Serial No.
Configured by
Date
21/34
Software Version
Drugs and Protocols Record
1000DF00451 Issue 2
22/34
Specifications
CONCENTRATION RANGE:
1µg/ml - 999µg/ml in 1µg/ml steps
1.0mg/ml - 99.9mg/ml in 0.1mg/ml steps
VOLUME MODE:
Concentration can also be set OFF, in which case no mass data is displayed.
PCA DOSE RANGE:
Mass Mode:
Volume Mode:
0.0µg - 99 9µg in 1µg steps
1mg - 99.9mg in 0.1mg steps
0.0ml - 99.9ml in 0.1ml steps
PCA DELIVERY RATE:
100ml/h max. STAT rate for 30ml, 50ml and 100ml syringes and 80ml/h for
20ml syringes.
(Option to set duration from 1 to 60 mins in 1 min steps to minimum rate of
0.1ml/h and maximum of the STAT rate).
RATE CONVERSION FACTOR:
When pump is programmed in Mass units the conversion factor is:- ml/h =
(dose/concentration)/(time in minutes/60).
LOCKOUT INTERVAL:
0 - 180 minutes in 1 minute steps
LOADING DOSE RANGE:
Mass Mode: 0µg - 999µg in 1µg steps
0.0mg - 99.9mg in 0.1mg steps (
Delivered at STAT rate
)
Volume Mode: 0.0ml - 99.9ml in 0.1ml steps
CONTINUOUS RATE RANGE:
Mass Mode:
Volume Mode:
0µg/h - 90µg/h in 10µg/h steps
0.0mg/h - 999.0mg/h in 0.1mg/h steps
0.0ml/h - 35.0ml/h in 0.1ml/h steps.
MAX DOSE LIMIT:
Mass Mode:
Volume Mode: off, 1µg - 999µg in 1µg steps
1mg - 999mg in 1mg steps off, 0.1ml to 999ml in 0.1ml steps
1 - 8 hours duration in 1 hour steps.
PURGE RATE:
100ml/h
SYSTEM ACCURACY:
Drive Linearity: +/- 1%
Bolus:
Volumetric:
+/- 0.05ml
+/- 2% (nominal)
(Volumetric accuracy is +/-2% typical by volume at the STAT PCA rate and above when the pump is used with the recommended syringes. Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves.)
Important:
System accuracy is +/-2% typical by volume as measured using the trumpet curve test method defined in EN60601-2-24:1998 at rates of 1.0ml/h and above when the pump is used with the recommended syringes. Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves. Also see trumpet curves section.
Environmental Specifications -
Operating Temperature
Operating Relative Humidity
Operating Atmospheric Pressure
Transport & Storage Temperature
Transport & Storage Relative Humidity
Transport & Storage Atmospheric Pressure
+10°C - +40°C
30% - 75%
700hPa - 1060hPa
-20°C - +50°C
5% - 95%
600hPa - 1060hPa
OPERATION MODE:
Continuous
CRITICAL VOLUME:
The maximum over infusion which can occur in the event of a single fault condition is 0.8ml for 20ml, 30ml and 50ml syringes and 1.5ml for a 100ml syringe.
ALARM CONDITIONS:
Pressure Limit exceeded
Drive Disengaged
Syringe Almost Empty
Low Battery Warning
Battery Exhausted
Cover Open during operation
Syringe Empty
Max Dose Limit (optionally alarmed)
Hand-set Disconnected
Internal Malfunction
Nurse Attention/Call Back
PUMPING PRESSURE / ALARM LEVEL:
Syringe Error
375mmHg (nominal) default alarm level (L-4) with 11 user selectable alarm levels (L-0 to L-10). Syringes may limit below level 10.
(The maximum pressure that can be developed by the system at the maximum user selectable alarm level is 1100mmHg).
CLINICIAN OVER-RIDE:
Bolus or continuous infusion in RUN mode.
(User selectable from 1µg - 99.9mg or 0.1ml to 99.9ml (volume mode) bolus dose administered at the STAT rate (100ml/h) or over 1 to 180 minutes delivery period).
Modify PCA Protocol in SET mode.
(When option to disable MODIFY PROTOCOL has been selected).
BATTERY OPERATION:
6 hours operation from a fully charged battery at 5.0ml/h and 20°C under normal conditions.
BATTERY TYPE AND RECHARGE TIME:
Rechargeable sealed lead acid type. 10 hours from discharge to 80% charge,
24 hours from discharge to 100% charge.
EVENT HISTORY:
2000 events rolling memory.
MEMORY RETENTION:
All calibration and set up information will be retained in the pump memory for a minimum of 3 years.
BOLUS VOLUME ACCURACY:
The following table provides an indication of the accuracy with which a bolus infusion will be delivered. Test carried out as specified in IEC/EN60601-2-24.
Bolus
Volume
(ml)
0.1
2
5
Bolus
Rate
(ml/h)
100
100
100
No. of
Samples
25
25
25
Max.
Positive
(%)
12
2.5
1
Max.
Negative
(%)
-14
0
0
Mean
(%)
-5
1
0.8
1000DF00451 Issue 2
23/34
7
8
5
6
9
10
2
3
0
1
4
Occlusion Pressure Limits
The following tables show the worst case values for line pressure, time to alarm and bolus volume that can be expected in the event of an occlusion when the IVAC
®
50ml syringe and G40020B extension set are selected.
Alarm Level
0
7
8
5
6
3
4
1
2
9
10
Rate
(ml/h)
1
1
1
1
1
1
1
1
1
1
1
Maximum Time to occlusion alarm
(min:sec)
2:00
8:00
20:00
33:00
52:00
65:00
85:00
102:00
120:00
140:00
155:00
Nominal Occlusion
Alarm Pressure
(mmHg)
0
92
184
276
368
460
552
664
736
828
920
Maximum Infusion
Pressure
(mmHg)
50
110
220
330
450
560
670
780
890
1000
1100
Maximum Bolus
Volume
(ml)
0.1
0.2
0.3
0.5
0.7
0.9
1
1.2
1.6
1.8
2
5
5
5
5
5
5
5
5
5
5
5
12:00
15:00
17:00
20:00
24:00
26:00
1:00
2:00
5:00
7:00
10:00
460
552
644
736
828
920
0
92
184
276
368
560
670
780
890
1000
1100
50
110
220
330
450
0.9
1
1.2
1.6
1.8
2
0.1
0.2
0.3
0.5
0.7
Compatible Syringes
The pump is calibrated and labelled for use with single-use disposable Luer lock syringes. Only use the size and type of syringe specified on the pump display. The full list of permitted syringe models is dependent on the software version of the pump.
Syringe Range
UNIVERSAL
Syringe Type
IVAC®
BD Plastipak
B Braun Omnifix
Terumo
Rapiject
BD Worldwide
BD Precise
Pharma-Ject
Once
Fresenius Injectomat
Monoject*
RR Pronto
20ml
ü
ü
ü
ü
ü
ü
ü
30ml
ü
ü
ü
ü
ü
ü
50ml
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
100ml
ü
BRAUN PERFUSOR
JANPOL
B Braun Perfusor
Janpol
* Ξ TYCO / Healthcare KENDALL - MONOJECT.
ü
ü
1000DF00451 Issue 2
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Compatible Extension Sets
The pump uses standard, single-use, disposable extension sets and syringes with Luer lock connectors. The user is responsible for verifying the suitability of a product used if it is not recommended by CareFusion.
Standard Sets
G40015
Standard PVC Syringe Extension Set (150 cm).
Priming Volume: 2.6ml
G40020B
G402EP
Standard PVC Syringe Extension Set (200 cm).
Priming Volume: 1.5ml
Extension set, Luer lock connectors. Kink resistant DEHP free PVC yellow striped tubing. Bore 1mm. Length 200cm.
Priming volume 1.6ml.
Light Protected Sets
G40215
Amber Polyethylene Syringe Extension Set (150 cm).
Priming Volume: 1.2ml
G40320
White PVC Syringe Extension Set (200 cm).
Priming Volume: 3.6ml
Low Sorbing Sets
G40615
Polyethylene Syringe Extension Set (150 cm).
Priming Volume: 1.5ml
G40620 Polyethylene Syringe Extension Set (200 cm).
Priming Volume: 2ml
G40720
Polyethylene Lined Syringe Extension Set with clamp. (200 cm).
Priming Volume: 1.5ml
04105010509
Polyethylene Syringe Extension Set (100 cm).
Priming Volume: 1ml
A
For availability please contact your local CareFusion representative because new sets are continuously being developed for our customers.
It is recommended that extension sets are changed in accordance with the Directions for Use.
Carefully read the Directions For Use supplied with the extension set prior to use.
Please note these drawings are not to scale
1000DF00451 Issue 2
25/34
Compatible Extension Sets (Continued)
The pump uses standard, single-use, disposable extension sets and syringes with Luer lock connectors. The user is responsible for verifying the suitability of a product used if it is not recommended by CareFusion.
Patient Controlled Analgesia (PCA) Sets
30822 PVC Syringe Extension Set with clamp (152 cm).
Priming Volume: 0.5ml
30832
PVC ‘Y’ Syringe Extension Set with back check valve and 2 clamps (178 cm).
Priming Volume: 1.5ml
30842E
PVC Syringe Extension Set with back check valve, SmartSite® Needle-Free Valve Port and clamp (30 cm).
Priming Volume: 1.4ml
30852
PVC ‘Y’ Syringe Extension Set with anti-siphon valve, back check valve and 2 clamps (183 cm).
Priming Volume: 1.8ml
30862
PVC Syringe Extension Set with anti-siphon valve and clamp (156 cm).
Priming Volume: 0.6ml
04102215162
PVC Syringe Extension Set with rotating luer. (150 cm).
Priming Volume: 2.9ml
04100010162
PVC Syringe Extension Set (105 cm).
Priming Volume: 7.2ml
A
For availability please contact your local CareFusion representative because new sets are continuously being developed for our customers.
It is recommended that extension sets are changed in accordance with the Directions for Use.
Carefully read the Directions For Use supplied with the extension set prior to use.
Please note these drawings are not to scale
1000DF00451 Issue 2
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Maintenance
Routine Maintenance Procedures
To ensure that this pump remains in good operating condition, it is important to keep it clean and carry out the routine maintenance procedures described below. All servicing should only be performed by a qualified service engineer with reference to the Technical Service
Manual (TSM).
Circuit diagrams and component parts lists and all other servicing information which will assist the qualified service engineer in performing repair of the parts designated as repairable are available upon request from CareFusion.
A
If the pump is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of service for examination by a qualified service engineer.
All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied. CareFusion will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion.
Refer to the Technical Service Manual for the access code for technical service features.
Interval
As per Hospital Policy
At least once per year
(Refer to TSM for identification of parts)
Routine Maintenance Procedure
Thoroughly clean external surfaces of the pump before and after prolonged period of storage.
1. Inspect AC power supply plug and cable for damage.
2. Perform functional tests as outlined in the Technical Service Manual.
3. Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging.
A
Please refer to Technical Service Manual for calibration procedures. The units of measurement used in the calibration procedure are standard SI (The International System of Units) units.
Replacing the AC Fuses
If the pump continually illuminates the battery symbol and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON, either the power supply fuse in the AC plug, if fitted, or the internal fuses have blown.
First check the power supply fuse in the AC mains plug, if fitted. If the AC power indicator light does not illuminate remove the pump from service.
It is recommended that only a qualified service engineer replaces the AC fuses. For further information regarding the replacement of internal AC fuses refer to the Technical Service Manual.
A
If the fuses continue to blow, suspect an electrical fault and have the pump and power supply checked out by a qualified service engineer.
Battery Operation
The internal rechargeable battery allows continued operation when the AC power is unavailable, for example during patient transfer or AC power failure. A fully charged battery will provide over 6 hours of operation at typical infusion rates. From the battery low alarm it will take about 24 hours to fully recharge when reconnected to the AC power supply, whether the pump is in use or not.
The battery is maintenance free, sealed lead acid type and requires no routine servicing. However, to achieve optimum operation, ensure that the battery is fully recharged after full discharge, before storage, and at regular 3 month intervals during storage.
CareFusion recommend verification that the pump operates on battery power once the pump has been removed from the AC power supply, refer to 'Starting the Pump' section.
Charge retention will eventually degrade. Where retention is critical the internal battery should be replaced every 3 years.
It is recommended that only a qualified service engineer replaces the battery. For further information regarding the replacement of batteries refer to the Technical Service Manual.
Test Routines
The test routines are designed to allow confirmation of many of the pump functions, defaults and calibrations without requiring internal inspection. They do not represent a full calibration check.
See the Technical Service Manual for a complete list of the test procedures, access codes and calibration procedures.
A
1000DF00451 Issue 2
27/34
Maintenance (continued)
Cleaning and Storage
Before the transfer of the pump to a new patient and periodically during the use, clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution.
Recommended cleaners are:
Brand Concentration
Hibiscrub
Virkon
20% (v/v)
1% (w/v)
Do not use the following disinfectant types:
•
Disinfectants which are known to be corrosive to metals must not be used, which include:
•
•
•
•
NaDcc (such as Presept),
Hypochlorites (such as Chlorasol),
Aldehydes (such as Cidex),
Cationic Surfactants (such as Benzalkonium Chloride).
•
Use of Iodine (such as Betadine) will cause surface discoloration.
•
Concentrated Isopropyl alcohol based cleaners will degrade plastic parts.
The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers’ instructions.
If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packaging for protection.
Once every 3 months during storage, carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged.
A
Before cleaning always switch OFF and disconnect from the AC power supply. Never allow liquid to enter the casing and avoid excess fluid build up on the pump. Do not use aggressive cleaning agents as these may damage the exterior surface of the pump. Do not steam autoclave, ethylene oxide sterilise or immerse this pump in any fluid.
Disposal
Information on Disposal for Users of Waste Electrical & Electronic Equipment
This
U
symbol on the product and/or accompanying documents means that used electrical and electronic products should not be mixed with municipal waste.
If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further information.
Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling.
Information on Disposal in Countries outside the European Union
This symbol is only valid in the European Union. The product should be disposed of taking environmental factors into consideration.
To ensure no risk or hazard, remove the internal rechargeable battery and the Lithium battery from the control board and dispose of as outlined by the local country regulations. All other components can be safely disposed of as per local regulations.
1000DF00451 Issue 2
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RS232 and Nurse Call Specification
RS232 / Nurse Call Feature
The RS232 / Nurse call feature is a feature on Alaris® Syringe Pumps.
It allows the pump to be monitored remotely and/or controlled via a suitable central monitoring or computer system.
When the pump is started by a command from the serial interface, communication must take place over the serial interface. A communication must take place every 15 seconds or the pump will alarm, display communications failure and stop infusing. This failure protects against failure of the communications, including the removal of the RS232 cable.
A
The nurse call interface provides a remote backup to the internal audible alarm. It should not be relied upon to replace monitoring of the internal alarm.
Refer to the Technical Service Manual for further information regarding the RS232 interface.
Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient, responsibility for the control of the pump is vested in the software run on the computer control system.
The assessment for the suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment. This software should include detection of the disconnection or other failure of the RS232 cable. The protocol is detailed in the Technical Service Manual and is for general information only.
Any connected analogue and digital components are required to meet IEC/EN60950 for data processing and IEC/EN60601 for medical devices.
Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC/EN60601-1-1.
RS232 / Nurse Call Connection Data
Nurse call Specification -
Connector
D Type - 9 Pin
TXD/RXD EIA RS232-C Standard
TXD Output Voltage Range Minimum: -5V (mark), +5V
(space)
Typical: -7V (mark), +7V (space) with 3KΩ load to ground
RXD Input Voltage Range
-15V to +15V max.
RXD Input Thresholds
RXD Input Resistance
Isolation Socket/Pump
Low: 0.6V minimum / High: 3.0V maximum
3KΩ minimum
4kV (dc, or ac peak)
Baud Rate
Start Bits
Data Bits
Parity
9600 Baud
1 Start Bit
8 Data Bits
Odd Parity
Stop Bits 1 stop bit
Nurse Call Relay Contacts
Pins 6 & 7
IBM
COMPATIBLE
(9 PIN)
PIN 3 (TXD)
PIN 2 (RXD)
PIN 5 (GND)
PIN 7 (RTS)
PIN 8 (CTS)
PIN 4 (DTR)
PIN 6 (DSR)
PUMP
PIN 2 (RXD2)
PIN 3 (TXD2)
PIN 5 (GND)
IBM
COMPATIBLE
(25 PIN)
PIN 2 (TXD)
PIN 3 (RXD)
PIN 7 (GND)
PIN 4 (RTS)
PIN 5 (CTS)
PIN 20 (DTR)
PIN 6 (DSR)
PUMP
PIN 1 (ALM1) RESP ALARM
PUMP
PIN 9 (TXD1)
PIN 4 (PWR1)
PIN 5 (GND)
PIN 8 (CTS1)
PRINTER
(25 PIN)
PIN 3 (RX)
PIN 5 (CTS)
PIN 7 (GND)
PIN 20 (DTR)
GND PWR1 TXD2 RXD2 ALM IN
5 4 3 2 1
29/34
9 8 7 6
TXD1 CTS1 NC NC
1000DF00451 Issue 2
Trumpet Curves & Start-up Curves
In this pump, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause short-term fluctuations in rate accuracy.
The following curves show typical performance of the system in two ways: 1) the delay in onset of fluid flow when infusion commences (start-up curves), and 2) the accuracy of fluid delivery over various time periods is measured (trumpet curves).
The start-up curves represent continuous flow versus operating time from the start of the infusion. They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed per IEC/EN60601-2-24 standard.
Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or 'observation windows', not continuous data versus operating time. Over long observation windows, short term fluctuations have little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have greater effects as represented by the "mouth" of the trumpet.
Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short term fluctuations in rate accuracy may have clinical impact depending on the half-life of the drug being infused, therefore the clinical effect cannot be determined from the trumpet curves alone.
A
Start-up and trumpet curves may not be indicative of operation under negative pressure.
Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented. Additional curves for compatible syringes are available upon written request.
For applications where flow uniformity is a concern, rates of 1.0 ml/h or above are recommended.
Trumpet Curve. BD Plastipak 50ml @ 1.0ml/h
Start-up Trend. BD Plastipak 50ml @ 1.0ml/h
Time (mins)
Start-up Trend. BD Plastipak 50 ml @ 5.0 ml/h
Observation Window (mins)
Trumpet Curve. BD Plastipak 50 ml @ 5.0 ml/h
Time (mins)
Observation Window (mins)
Trumpet curve values show minimum and maximum percentage rate error at 2 minutes and long term accuracy.
1000DF00451 Issue 2
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Trumpet Curves & Start-up Curves continued
Trumpet Curve @ 1.0 ml/h
Trumpet Curve @ 1.0 ml/h
Observation Window (mins)
Trumpet Curve @ 5.0 ml/h
Observation Window (mins)
Trumpet Curve @ 5.0 ml/h
Observation Window (mins)
Observation Window (mins)
Performance with syringes : BD Plastipak, B Braun Omnifix, Monoject, Once. 2 minute minimum/maximum +/- 5% @ 5.0ml/h. Long term mean accuracy +/- 2% is in addition to the trumpet curve percentage error.
Performance with syringes : IVAC, Zeneca, Terumo, Nipro, Fresenius, B Braun
Perfusor & JMS. 2 minute minimum/maximum +/- 7.5% @ 5.0ml/h. Long term mean accuracy +/- 2% is in addition to the trumpet curve percentage error.
Evaluation over the range -100mmHg to +100mmHg equivalent to water height +/- 1.3m, will produce trumpet curves with the limits shown above.
1000DF00451 Issue 2
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Service Contacts
For service contact your local Affiliate Office or Distributor.
AE
CareFusion,
PO Box 5527,
Dubai, United Arab Emirates.
Tel: (971) 4 28 22 842
CN
CareFusion,
Shanghai Representative Office, Suite
A, Floor 24,
Shanghai Times Square Office Building,
No.500 Zhangyang Road,
Shanghai 200122, China.
Tel: (86) 21 58368028
GB
CareFusion,
The Crescent, Jays Close,
Basingstoke,
Hampshire, RG22 4BS,
United Kingdom.
Tel: (44) 0800 917 8776
Fax: (971) 4 28 22 914
AU
CareFusion,
3/167 Prospect Highway,
PO Box 355
Seven Hills, NSW 2147,
Australia.
Tel: (61) 2 9838 0255
Fax: (86) 21 58368017
DE
CareFusion,
Pascalstr. 2,
52499 Baesweiler,
Deutschland.
Tel: (49) 2401 604 0
Fax: (61) 2 9674 4444
BE
CareFusion,
Leuvensesteenweg 248 D,
1800 Vilvoorde,
Belgium.
Tel: (32) 2 267 38 99
Fax: (32) 2 267 99 21
CA
CareFusion,
235 Shields Court,
Markham,
Ontario L3R 8V2,
Canada.
Tel: (1) 905-752-3333
Fax: (49) 2401 604 121
DK
CareFusion,
Firskovvej 25 B,
2800 Lyngby,
Danmark.
Tlf. (45)70 20 30 74
Fax. (45)70 20 30 98
ES
CareFusion,
Edificio Veganova,
Avenida de La Vega, nº1,
Bloque 1 - Planta 1,
28108 Alcobendas, Madrid,
España.
Tel: (34) 902 555 660
Fax: (1) 905-752-3343
CH
CareFusion Switzerland 221
Sàrl
Critical Care
A-One Business Centre
Zone d’activitiés Vers-la-Pièce n° 10
1180 Rolle / Switzerland
Ph.: 0848 244 433
Fax: 0848 244 100
Fax: (34) 902 555 661
FR
CareFusion,
Parc d’affaire le Val Saint Quentin
2, rue René Caudron
78960 Voisins le Bretonneux
France
Tél: (33) 1 30 05 34 00
Fax: (33) 1 30 05 34 43
Fax: (44) 1256 330860
HU
CareFusion,
Döbrentei tér 1,
H-1013 Budapest,
Magyarország.
Tel: (36) 14 88 0232
Tel: (36) 14 88 0233
Fax: (36) 12 01 5987
IT
CareFusion,
Via Ticino 4,
50019 Sesto Fiorentino,
Firenze, Italia.
Tél: (39) 055 30 33 93 00
Fax: (39) 055 34 00 24
NL
CareFusion,
De Molen 8-10,
3994 DB Houten,
Nederland.
Tel: (31) 30 228 97 11
Fax: (31) 30 225 86 58
NO
CareFusion,
Solbråveien 10 A,
1383 ASKER,
Norge.
Tel: (47) 66 98 76 00
Fax: (47) 66 98 76 01
NZ
CareFusion,
14B George Bourke Drive,
Mt Wellington 1060,
PO Box 14-518,
Panmure 1741, Auckland,
New Zealand
Tel: 09 270 2420
Freephone: 0508 422734
Fax: 09 270 6285
SE
CareFusion,
Hammarbacken 4B,
191 46 Sollentuna,
Sverige.
Tel: (46) 8 544 43 200
Fax: (46) 8 544 43 225
US
CareFusion,
10020 Pacific Mesa Blvd.,
San Diego, CA 92121,
USA.
Tel: (1) 800 854 7128
Fax: (1) 858 458 6179
ZA
CareFusion,
Unit 2 Oude Molen Business Park,
Oude Molen Road, Ndabeni,
Cape Town 7405, South Africa.
Tel: (27) (0) 860 597 572
Tel: (27) 21 510 7562
Fax: (27) 21 5107567
1000DF00451 Issue 2
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Spare Parts
Spare Parts
A comprehensive list of spare parts for this pump is included within the Technical Service Manual.
The Technical Service Manual (1000SM00017) is now available in electronic format on the World Wide Web at :-
www.carefusion.com/alaris-intl
A username and password are required to access our manuals. Please contact local customer services representative to obtain login details.
Part Number
0000EL00004
1001FAOPT91
1001FAOPT92
5000SP00008
5000SP00011
1000SP01008
1000SP01015
Description
Internal Battery Pack
AC Power Lead - UK
AC Power Lead - European
Printer cable 9 to 25 pin
Printer cable 9 to 26 pin
Comms Cable (9 pin to 9 pin)
Pole Clamp Assembly
Revision
1
2
CO Number
9685
10654
Date
October 2009
June 2010
Document History
1000DF00451 Issue 2
33/34
Page Intentionally Left Blank
1000DF00451 Issue 2
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Alaris, PCAM, IVAC and SmartSite are registered trademarks of CareFusion Corporation or one of its subsidiaries. All rights reserved.
All other trademarks are property of their respective owners.
© 2000-2010 CareFusion Corporation or one of its subsidiaries. All rights reserved.
This document contains proprietary information of
CareFusion Corporation or one of its subsidiaries, and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell any product described. Reproduction, disclosure, or use other than for the intended purpose without specific written authorization of
CareFusion Corporation or one of its subsidiaries is strictly forbidden.
t
CareFusion Switzerland 317 Sàrl,
CH-1180, Rolle
EC REP CareFusion U.K. 305 Ltd., RG22 4BS, UK
1000DF00451 Issue 2
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