ad_ambulatory_syringe_driver_directions_for_use_iss.pdf
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AD Ambulatory Syringe Driver
Directions for Use - English
Page 2
Contents
About this Manual......................................................................................................................................................................3
Introduction...............................................................................................................................................................................3
Applications...............................................................................................................................................................................3
Accessories.................................................................................................................................................................................3
Label and Serial Number Description.......................................................................................................................................4
Symbol Definitions.....................................................................................................................................................................4
Product Description...................................................................................................................................................................5
Operating Precautions...............................................................................................................................................................7
Infusion Precautions..................................................................................................................................................................7
Configuration of the Syringe Driver in a System.......................................................................................................................7
General Precautions..................................................................................................................................................................8
Operating Environment.............................................................................................................................................................8
Hazards....................................................................................................................................................................................10
Patient Protection....................................................................................................................................................................10
Preparing the Syringe Driver for Use.....................................................................................................................................10
Removing and Replacing the Syringe Cover...........................................................................................................................12
Syringe Driver Start-up Sequences..........................................................................................................................................13
Switching On the Syringe Driver.............................................................................................................................................15
Removing and Loading Syringes.............................................................................................................................................16
Purging the Syringe.................................................................................................................................................................18
Setting up an Infusion..............................................................................................................................................................18
Running an Infusion.................................................................................................................................................................19
Stopping an Infusion / Placing On-Hold.................................................................................................................................23
Syringe Driver Settings............................................................................................................................................................24
Warnings/Alerts.......................................................................................................................................................................30
Alarms......................................................................................................................................................................................31
Battery Status...........................................................................................................................................................................33
Cleaning and Maintenance......................................................................................................................................................35
Warranty and Service Information..........................................................................................................................................38
Specifications...........................................................................................................................................................................39
Performance Data....................................................................................................................................................................40
Appendix A. Testing Standards................................................................................................................................................42
Document History
Revision
First Issue
Issue 2
Issue 3
Issue 4
Issue 5
ZI-4-TM-001-5
Change Number
4089
4123
-
Reason for Change
P7, caution added, reduced accuracy at low flow
P34, software version now 1.29
P9, addition of Pre-Use checks
Version for AD1 Timed only, software version 2.12
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Date
July 2006
August 2006
December 2006
May 2007
February 2008
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About this Manual
The operator must be thoroughly familiar with the AD Ambulatory Syringe Driver (hereinafter referred to as
the Syringe Driver or AD) described in this Manual prior to use, and in particular must read and understand
any precautions stated herein. If a software change occurs and the operation/specification for the Syringe
Driver changes, new or additional operating instructions will be issued, if needed.
All illustrations used in this Manual show typical settings and values that may be used in setting up the
functions of the Syringe Driver. These settings and values are for illustrative use only. The complete range
of settings and values are specified in the Specifications section of this Manual.
This Directions for Use document has been developed with consideration to the requirements in relevant
Harmonised Standards. Data presented in the Technical Specifications reflect specific test conditions
defined in this standard. Other external factors such as varying back pressure, temperature, head height,
set usage, fluid restrictions, solution viscosity, syringe characteristics or combinations of these factors, may
result in deviations from the performance data enclosed.
Introduction
The AD Syringe Driver is an ambulatory device that may be worn or carried with the patient. It is intended
for medical use only.
The intended operator can include any patient from paediatric to aged persons. Other operators include
skilled clinical staff and bio-medical technicians. Patients can be trained to operate the Syringe Driver for
home use, or the Syringe Driver can be configured for the patient by a nurse or other trained person. In all
cases, training is required for configuring the Syringe Driver.
The AD Syringe Driver accepts disposable syringes from 5 ml to 30 ml in size. It uses a simple 5 key
control pad, which simplifies programming and makes the Syringe Driver easy to use.
The AD Syringe Driver is portable and has a battery power supply capable of operating the Syringe Driver
for up to 72 hours without recharge. To re-charge the Syringe Driver, it is placed in the AD charging cradle,
which also contains a communications interface allowing connection to a PC for data to be exchanged.
Applications
The Syringe Driver is designed to meet the fluid and drug delivery requirements of today’s changing clinical
environment, either in the hospital or in the home care setting.
The Syringe Driver is intended for infusion via intravenous (IV), intra-arterial (IA), or subcutaneous routes of
administration. It delivers solutions precisely and economically. Infusion rates are programmable from 0.1
to 200 ml/h (depending on syringe size).
The Syringe Driver is designed to follow the patient into a variety of care areas, including, but not limited to
the following environments:
•
•
•
•
•
•
•
•
•
•
General Floor
Medical
Surgical
Critical/Intensive Care Areas
Maternity
Community
Cardiac Catheter Lab
A and E
Burn Unit
Oncology
Note: in all applications, time to alarm under occlusion or other fault conditions will depend on the
infusion rate and levels of alarm settings. It is recommended to consider these parameters when
using drugs requiring infusion stability or low flow rates, and therefore a quick time to alarm, e.g.
Ionotropes.
Accessories
The Syringe Driver is supplied with the following:
Charger cradle with power supply, part number ZI-3-AF-005
Key, part number ZI-3-BA-023 (2 off)
The following items may be purchased on request:
A soft carry case with belt attachment, part no. ZI-3-AF-014 (Pack of 5, part no. ZI-3-AF-011)
A transit case for the Syringe Driver and Charger plus extras, part no. ZI-3-AF-013
A waterproof bag for the Syringe Driver (available soon), part no. ZI-3-AF-017
Spare lid for 5-10ml syringes, part no. ZI-3-BA-004 (Pack of 5, part no. ZI-3-AF-009)
Spare lid for 20-30ml syringes, part no. ZI-3-BA-006 (Pack of 5, part no. ZI-3-AF-010)
ZI-4-TM-001-5
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A cable for connecting the charger cradle to a PC, part no. ZI-3-EZ-001
Label and Serial Number Description
For explanation of the symbols used on the label, see
next section.
SKU is Stock Keeping Unit, part number
81003GB-00 (Standard AD), 81003GB-01 (Monoject)
SN is Serial Number, 0512 is month 12 of year 2005,
representing the time of manufacture and 0296 is a
sequential number.
The Charger Base and its Power Supply may have
different serial numbers.
Symbol Definitions
Please read the general Operational Warnings and Cautions in the Directions for Use
carefully prior to using the Syringe Driver.
CF type device (leakage current protection)
Complies with Medical Devices Directive 93/42/EEC
Class II insulation (double insulated)
t
U
Made in UK by ZiMed Ltd, Unit 4, Fford Richard Davies, St. Asaph Business Park, St.
Asaph, Denbighshire, LL17 0LJ, N. Wales
Not for disposal in domestic or municipal waste: this product is compliant with the
WEEE directive.
The symbol to the right of this box appears throughout
this document, and refers to important information
ZI-4-TM-001-5
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Product Description
Front view
1
2
3
1.
Syringe cover
2.
Control keypad
3.
Colour display
Rear view
1
2
3
1.
Cover lock
2.
Key
3.
Charging contacts
Cover off
5
4
1
2
ZI-4-TM-001-5
3
1.
Syringe barrel clamp
2.
Syringe fingerplate slot (20-30 ml syringes)
3.
Syringe fingerplate slot (5-10 ml syringes)
4.
Carriage locking lever
5.
Thumbplate clamp
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Extended cover (for large syringes, 20-30 ml)
Extended cover
Control panel
Up Key – used to move up the
menu, or increase a number’s
value
Left Key – used to move left, or
return to the menu
Enter Key – used to select a
menu option or confirm an entry
Right Key – used to move right,
or select the main menu
Down Key – used to switch
power on, move down the menu,
or decrease a number’s value
Charger cradle
2
3
1
ZI-4-TM-001-5
1.
Charger Green/Amber LED window
2.
Charging contacts
3.
Infra-red communication window
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Operating Precautions
Although the AD Syringe Driver has been designed and manufactured to exact specifications, it is not
intended to replace trained personnel in the supervision of IV infusions.
DO NOT use the AD Syringe Driver for life support functions or for any treatment where failure to provide
such treatment would endanger life.
Read document VDEO753-5 when performing parallel infusions.
!
This Syringe Driver can operate at very low infusion rates, as low as 0.1ml/h. The operator is cautioned that
long delays could be experienced at the start of an infusion before the patient receives any fluid, due to the
taking up of slack between the drive mechanism and the syringe and overcoming syringe sticktion. Accuracy
and time to detect occlusion is affected at these low infusion rates. Refer to the Performance Data section.
The specified accuracy of the Syringe Driver can only be maintained when the recommended syringes,
extension sets and accessories are used.
The Syringe Driver cannot distinguish between some types of 5ml syringes, due to differences in diameter.
Using a type of syringe other than those programmed could lead to errors of delivery of up to 15%.
A Pre-Use Checklist is shown on page 10. Zimed Ltd recommends that it is followed for every infusion.
Infusion Precautions
Always read and follow the instructions which accompany the syringe and extension sets. Carefully follow
the instructions for priming the set, as well as the recommended set change interval. Administration and
extension set use should not exceed the set change interval as stated on the label.
Drugs for infusion by use of the Syringe Driver may only be prescribed by a qualified medical practitioner.
Caution must be exercised in the selection of drugs and the amount and rate intended to be delivered via
any infusion pump. If the drug contained in the syringe will be exposed to extreme environmental
conditions for prolonged time periods, IT IS IMPORTANT TO SELECT DRUGS THAT WILL NOT
CHANGE PHARMACOLOGICALLY UPON SUCH EXPOSURE. As with all automatic infusion devices,
whenever a TOXIC OR DANGEROUS LEVEL of drug is stored in the reservoir, CONSTANT
MONITORING of the infusion is required.
The syringe should be disposed of in an appropriate manner, considering the nature of the residual fluid
that may be contained within, in accordance with the hospital/homecare provider’s disposal practices.
Always ensure the extension set clamp is closed before removing the syringe.
This Syringe Driver should be used only with ZiMed Ltd specified accessories. There are risks associated
with using anything other than the recommended accessories with this Syringe Driver.
CAUTION must be employed to assure that the Syringe Driver is in good working order before use. When
the Syringe Driver is being operated on battery power alone, ensure that the battery has been charged as
described in the Battery Status section.
Be sure to PURGE THE SYSTEM OF ALL AIR, WHILE NOT CONNECTED TO THE PATIENT, BEFORE
ADMINISTERING ANY MEDICATION. Failure to follow this normal infusion procedure could lead to
serious consequences. The Syringe Driver has no means to detect air presence in the extension set.
Remember that the volume of fluid contained in the connecting tubing is a residual amount and cannot be
infused. Allow for this extra volume of fluid when initially filling the syringe.
It is recommended that the number of parameters, types of syringes, drug names and other functions are
minimised. This will help to avoid errors in programming and thereby decrease patient’s risk.
When using the Syringe Driver with the soft carry case, ensure the lid is locked before sliding the Syringe
Driver into the case. The lid may become detached if it is not locked, stopping the infusion and sounding
an alarm. It is recommended that the lid is always locked when running an infusion.
To avoid cross infection between patients, the Syringe Driver MUST be cleaned in accordance with the
instructions given in this Manual. See the section, “Cleaning and Maintenance”, for details.
Configuration of the Syringe Driver in a System
Inter-connection of several devices into a single infusion system can have substantial influence on the
accuracy of the infusion rate, at least for one of these devices. In such situations, the operation of devices
using gravitational forces can be unstable or impossible at all.
When infusing through a central line catheter, ZiMed Ltd recommends using sets with a Luer lock adapter.
Only use approved and pressure proved syringes with the Luer lock connections and extension sets as
recommended herein. Change the extension sets according to hospital and homecare provider protocols.
ZI-4-TM-001-5
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Use only accessories complying with the system’s safety requirements; failure to do so may lead to
reduced safety levels of the resulting system. Consideration relating to accessory choice shall also
include:
• Use of the accessory in the patient vicinity
• Evidence that the safety certification of the accessory has been performed in accordance with the
appropriate EN 60601-1 or UL2601-1 and/or IEC 601-1 harmonised, national or international standard.
The power supply for the charger cradle must be connected to a 100-240 VAC 50/60 Hz supply.
The assessment for suitability of any software used in the clinical environment to receive data from
Syringe Driver lies with the operator of the equipment.
General Precautions
H
The Syringe Driver must be mounted within 1.0m above or below the patient’s heart.
Do not use hard or sharp objects on the keypad.
The specified accuracy of the Syringe Driver can only be maintained if the Syringe Driver is used,
maintained and serviced in accordance with the instructions given in this manual. If the Syringe Driver has
failed to calibrate during the servicing procedure, it must be returned for repair or disposal.
Do not push the syringe barrel clamp when fitting a syringe. Disengage it from the open position and allow
it to rest on the syringe by the natural action of the return spring. Pushing on the syringe barrel clamp
while it is resting on the syringe may cause the syringe to deform and initiate a system alarm.
If the Syringe Driver is dropped, subjected to excessive moisture, humidity or high temperature, or
otherwise suspected to have been damaged, remove it from service for inspection by qualified personnel.
Follow the cleaning schedule and methods defined under the Maintenance and Storage section, to ensure
proper maintenance of the Syringe Driver. Wipe off spills immediately. Do not allow fluid or residues to
remain on the Syringe Driver as these could cause biological hazards or equipment malfunction. Plastic
materials may cause irritation of the skin. Wearing the Syringe Driver without the soft carry case next to
exposed skin is not recommended.
The Syringe Driver has been designed to be as safe as possible to handle; however, care should be
exercised to avoid trapping of fingers or other body parts in the mechanism.
Operating Environment
ZiMed Ltd will assume no responsibility for incidents which may occur if the product is not used, stored or
transported in accordance with the environmental conditions stipulated in this document and on the
package labelling.
This Syringe Driver is designed for ambulatory use, and should withstand everyday handling. If the
Syringe Driver is dropped onto a hard surface, or is suspected of being dropped, the operation and
calibration should be checked by a qualified technician.
Do not bathe or shower whilst using the Syringe Driver. The Syringe Driver is resistant to a limited amount
of splashing, but its construction does not make it resistant to large amounts of spraying or immersion in
liquids. Damage to the internal components may result.
M
ZI-4-TM-001-5
As with all medical electronic equipment, care must be exercised to avoid exposing
this Syringe Driver to powerful sources of electromagnetic interference. This
Syringe Driver design has been tested to current European standards and
guidelines for medical devices. Refer to the Testing Standards (Appendix A) for
details of the relevant standards.
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The Syringe Driver was not found to be affected adversely by these susceptibility tests and will perform
safely. The Syringe Driver is CISPR11 group 1 class B, and emits a certain level of electromagnetic
radiation, which is within the limits specified by EN 60601-2-24:1998 and EN 60601-1-2:2002.
Using the Syringe Driver near operating equipment which radiates high-energy radio frequencies (such as
electrosurgical/cauterising equipment, two-way radios, or cellular telephones) may cause false alarm
conditions, or failure to operate correctly. If this happens, reposition the Syringe Driver away from the
source of interference; or turn off the Syringe Driver or other equipment as appropriate.
ZI-4-TM-001-5
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Hazards
B
V
An explosion hazard exists if the Syringe Driver is used in the presence of flammable
anaesthetics. Exercise care to locate the Syringe Driver away from such hazardous
sources.
This Syringe Driver contains static-sensitive components. Observe strict precautions
for the protection of static-sensitive components when attempting to repair and
service the Syringe Driver.
The RS232 interface is a standard feature on the charging cradle. Connection to a computer while Syringe
Driver is connected to the patient is prohibited. Do not touch signal input/output parts (RS232 on charger
base) and patient simultaneously. Refer to the Technician Interface Manual (future product) for further
information regarding the RS232 interface.
The charger base and Syringe Driver may become warm after extended periods of charging the Syringe
Driver battery. This is normal, but care should be taken for a few minutes after removing the Syringe
Driver from the Charger base. Do not wear the Syringe Driver next to bare skin. Ensure the ambient
temperature is below 35°C during charging.
During charging, the Syringe Driver may cause a temperature rise in small syringes of 2°C above ambient.
Care must be taken to prevent unwanted heating of drugs or compounds if this could change their
characteristics in such a way that they become ineffective or toxic. Alternatively, avoid the need to charge
the Syringe Driver battery during the use of temperature sensitive drugs or compounds.
When the Syringe Driver is running an infusion and is being carried in the soft carry case, the temperature
can rise by up to 2°C above ambient. Bearing in mind the warmth generated by the human body, the effect
on the drug or compound being infused must be considered.
In exceptional cases of certain internal malfunctions, the Syringe Driver can switch itself off with no
additional warning, although an audible alarm will be heard in most cases. Refer to Alarms section and
Technical Service manual for more information. The operator should be aware that this Syringe Driver
contains software. There is no known method for ensuring that software is completely free from systematic
errors. The risk of such an error interfering with Syringe Driver operation is extremely small, but if such an
error did occur it would most likely result in stopping the infusion and initiating an alarm condition.
Patient Protection
Over or under infusion in the event of a fault in the Syringe Driver is limited to the volumes stated in the
Specifications section of this manual. The means of limitation is twofold: first, the position of the syringe
plunger is constantly monitored and compared to the expected position during the whole of the infusion
and during the loading procedure, and second, by comparing the readings from the primary position
monitor with those from a secondary position monitor. If the expected position and measured position
deviate by more than a set distance, or if the two monitors disagree by more than another set distance,
the Syringe Driver will stop the infusion and initiate an alarm.
Preparing the Syringe Driver for Use
The following pre-use checks should be carried out every time the syringe driver is being prepared for use:
Remove the cover and, if present, the syringe.
Examine the outside of the syringe driver for damage, cracks etc. Do not use the syringe driver if it has been
damaged to the extent that cracks are evident in the casing or parts of it are missing, including the retaining
legs of the lid.
Unlock the carriage with the locking lever, and ensure it can slide freely from one end to the other. Ensure
the drive bar is clean and free from contaminants. Ensure the trough area is also clean. If the syringe driver
needs cleaning, refer to the section on cleaning and maintenance.
Set the carriage to the middle of the trough, and close the locking lever. Ensure the carriage does not move
forwards or backwards, using no more than finger pressure.
Examine the syringe barrel clamp and ensure it can hold the syringe securely in place.
ZI-4-TM-001-5
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Switch on the syringe driver as described below. The power on screen should indicate the correct model and
serial number. After the internal checks are completed, examine the battery indicator and ensure it shows at
least three-quarters full, or sufficient for the current treatment (see specifications). Charge the battery if
necessary - this can take up to 5 hours.
ZI-4-TM-001-5
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Removing and Replacing the Syringe Cover
The syringe cover protects the syringe and the operating mechanism from damage or interference, and
actuates a switch to enable an infusion to start when the cover is on.
To load a syringe, the syringe cover must first be removed. An infusion cannot be run when the cover is
removed. When a syringe has been loaded, replace the syringe cover to programme and run the infusion.
Use the following procedure to remove the syringe cover:
1.
Use the key supplied to release the lock on the rear of the Syringe Driver. Note that the lock can be
set to be “Enabled” or “Disabled”. When set to “Enabled”, it will automatically unlock when the cover
is fitted, and needs to be set to “Enabled” to allow the cover to be locked.
Because the lock mechanism relies on a
sprung catch to remain in the “Enabled” or
“Disabled” condition, moving the Syringe
Driver may cause the mechanism to
unlatch and set itself to “Enabled”. Should
this occur, simply unlock the mechanism
with the key.
Lock
2.
Slide the cover
towards the syringe
tube end. It needs to
move about 0.5 cm to
allow the lugs to clear
their location slots.
3. Lift and remove the cover.
4. Take care of the key - the lid cannot be unlocked without the key (once it has been locked) to change
the syringe. Should the lid become permanently locked in place, remove the Syringe Driver from
service.
Use the following procedure to replace the syringe cover:
1.
Position the cover so that the lugs engage with their location slots.
2.
Use only gentle pressure to slide the cover away from the syringe tube end of the Syringe Driver, while
pressing it against the body of the Syringe Driver. It needs to move about 0.5 cm to allow the lugs to
engage with their location slots.
ZI-4-TM-001-5
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3.
If required, use the key to secure the lid to the Syringe Driver. Do not force the key.
Syringe Driver Start-up Sequences
The sequence of actions to take in order to begin an infusion will depend on the following circumstances:
•
Is there a syringe fitted in the syringe driver (containing a sufficient volume of the drug)?
•
Is this a new infusion, or the continuation of the previous infusion, which was stopped?
•
If a syringe is fitted, has it been purged manually to remove air, or should the syringe driver’s purge
procedure be used?
•
If it is a new treatment, is it a 24 hour infusion? (If it is a 24 hour infusion, the infusion rate is calculated
automatically from the volume present in the syringe. If not, the infusion time must be set up on the
screen before the infusion can be started.)
The main variations of the start-up sequences are shown in the flow chart below.
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YES
YES
NO
NO
PREVIOUS
SYRINGE
UNDISTURBED
NEW SYRINGE
FITTED
NO
SYRINGE NOT
FITTED
YES
YES
NO
YES
NO
ZI-4-TM-001-5
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Switching On the Syringe Driver
Before initially powering on the Syringe Driver, charge the battery for
at least 4 hours (see Battery Charging in the Battery Status section).
Press and hold the Down key for three
seconds to switch on the Syringe Driver.
When the Down key is pressed, the
Syringe Driver checks whether it was
powered down normally; if not, the
screens on the right are displayed,
otherwise an alarm test is performed
consisting of two beeps from each audio
device.
If the Syringe Driver is being powered on for the first time after
a code download (see Technician Software Manual) the
operator will see the screen on the left, warning that all
configuration values such as End of Infusion point have been
reset to their default values.
After further internal checks, the Syringe Driver displays the
initial Power On screen.
The Power On screen is shown left, and shows the product
code, software version and serial number of the Syringe
Driver. If the Syringe Driver requires servicing or detects any
internal problem, it displays an appropriate Alert or Alarm
screen. If the internal data log detects that a service is
required, the Service Overdue warning screen appears after
switch on. When the warning is cancelled only the orange
“spanner” symbol remains and appears on all subsequent
screens.
If the previous infusion was stopped before it had completed,
and the syringe is still present in the device containing a
quantity of the drug, the Resume Previous Infusion screen is
displayed, as shown left.
A Yes response skips the other screens and goes straight to
the Confirm Run screen (see page 19).
A No response (or if the previous infusion was not stopped
before completion) causes the Reset TVI screen to be
displayed, as shown right.
If the TVI is not to be reset (a No response), the screen
display goes straight to the Load or Confirm Syringe screens
(depending on whether a syringe is in place or not). If the TVI
is reset (a Yes response), a screen is displayed confirming
the reset, as shown right and then the Load or Confirm
Syringe screens are shown.
ZI-4-TM-001-5
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Removing and Loading Syringes
Syringe Types
Only syringes that have a tick ( ) in one of the Syringe Size columns in the table below can be used in the
Syringe Driver. Note that the Monoject syringes require a different model of Syringe Driver, and must
not be used in the Standard model.
Syringe
Manufacturer
Product
Name
BD
B Braun
B Braun
Codan/Once
Terumo
Sherwood
Plastipak
Perfusor
Omnifix
Monoject
5
(6)
Syringe Size (ml)
10
20
(12)
30/35
Syringe
Driver model
Standard AD
Standard AD
Standard AD
Standard AD
Standard AD
AD for Monoject only
Removing a Syringe
!
Use the following procedure to remove a syringe from the Syringe Driver.
Always ensure that the extension set clamp is closed before removing the
syringe.
The Syringe Driver has been designed to be as safe as possible to handle; however,
care should be exercised to avoid trapping of fingers or other body parts in the
mechanism.
1.
!
Remove the cover, as described previously (see page 12).
Thumbplate
clamp
Syringe
barrel
clamp
2.
Locking
lever
3.
Raise the syringe barrel clamp away from the syringe body.
4.
Lift the syringe thumbplate out of
the clamp and remove the syringe.
ZI-4-TM-001-5
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Release the Thumbplate
clamp from the syringe
plunger by opening the
locking lever and turning
it 180 degrees.
Page 17
Loading a Syringe
If no syringe is present, the Syringe Driver automatically displays the Load Syringe screen immediately
after the Reset TVI screen.
The LOAD option can also be selected
from the Main Menu.
Use the Up key to move the highlight
up to the Load option (as shown to the
left), if not already highlighted.
Press Enter to select the Load option.
If there is already a syringe present, the Syringe Driver displays a message to confirm the syringe it has
detected. If there is no syringe present, the Syringe Driver waits for the cover to be removed, and a
syringe fitted.
If the syringe needs changing before the end of an infusion that is already running, follow the instructions
given in “Changing the Infusion” under the heading “Running an Infusion” (see page 24).
Remove the cover (see page 12). Raise the syringe barrel clamp and release the locking lever by
pulling it straight and rotating it 180 degrees. Move the carriage to the maximum extent of its travel
(away from the syringe end).
Locking
lever
Thumbplate
clamp
Syringe
barrel
clamp
Carriage
Locking
lever
Monoject
syringe flange
slot
Syringe flange
slots
Pressing No causes the Syringe Driver to cycle through the other
possible syringes that could have been fitted. When the correct
syringe has been identified, press Yes to confirm it. Note: the
Syringe Driver may request that the syringe is re-fitted. This may
occur if the correct syringe was not confirmed and no other syringe
type falls within the parameters measured by the sensors.
ZI-4-TM-001-5
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Insert the syringe, locating the
syringe flange in the correct
flange holder slot. The two slots
are marked with the relevant
syringe sizes (Standard model
only - Monoject model has only
one slot for all syringes). Move
the carriage to engage the
syringe thumbplate.
Release the syringe barrel
clamp to hold the syringe barrel
securely in place. Locate the
plunger against the carriage and
secure it with the Thumbplate
clamp, by closing the locking
lever. Ensure that the
thumbplate is correctly secured
to avoid free flow when the
extension set clamp is opened.
When the syringe is correctly
positioned and secured, replace
the syringe cover.
When the cover is closed, the
Syringe Driver will ask for
confirmation that the syringe is
correct for the syringe type and
size that the device has
detected.
Page 18
Recommended Extension Sets
o
o
IVAC G40015, 1.5m Luer Lock (standard PVC) [or similar]
IVAC G40615, 1.5m Luer Lock, low sorbing (polyethylene) [or similar]
Preparing the Syringe and Extension Set
1.
2.
3.
4.
Prepare the syringe following the manufacturer’s directions of use.
Set the syringe type if necessary (refer to previous section)
Attach an appropriate Syringe Driver extension set to the syringe and purge the
system as described later.
Ensure all air is expelled from the extension set.
Purging the Syringe
Ensure the patient is not connected to the
extension set during the purging operation.
Ensure extension set is re-connected to the
patient after the purging operation.
!
When a syringe has been fitted, close the lid and press Yes as described in
the previous section. Provided the correct syringe type has been detected,
the purge select screen will be displayed.
If all air has been manually primed from the set, press the Left key to select
the No option. The Syringe Driver moves on to the Infusion Set-up process
and the load process is complete.
If the air has not been manually primed from the set, first ensure that the
patient is not connected to the extension set, and that the administration set
clamp is open, then press and hold the Right key to select the Yes option.
If purging the syringe is chosen, hold down the Right key (Yes) until the syringe is
purged or the purging volume has been delivered. The Syringe Driver pumps a preset maximum quantity of fluid through the system. The display increments to indicate
progress of the purging process. When the purging volume has been delivered, the
Syringe Driver moves on to the Infusion Set-up process and the load process is
complete. Releasing the Right key will stop the purging operation; if the Right key is
released before the desired purge volume has been delivered, the purge select
screen will ask whether to continue or terminate purging. When purging is continued,
the volume of purge displayed accumulates during the current operation. If purging is
complete, press the Left key (No) to terminate the purging operation.
Setting up an Infusion
An infusion has to have been set up before it can be run. Use the Set Rate options to program details of the
infusion (volume to be infused, rate, and time). In some circumstances the infusion rate can be changed
while the infusion is in progress (Titration). [Note: The supervisors responsible for administration of the use
of the Syringe Drivers can use the Setup options to preset basic infusion parameters. Check with your
supervisors if this is the case.]
The simplest type of infusion setup is when the syringe has been loaded already
containing the appropriate volume of the drug for a 24 hour infusion. As part of
the normal start-up sequence, in order to bypass the screens where the infusion
rate details are set up, the Syringe Driver displays the screen shown left as
soon as the purge process is complete.
A Yes response moves straight on to the Confirm Run screen. A No response
displays the RATE VALUES screen.
Note: This version of the software is permanently set for Timed mode infusion
only. In this mode, the VTBI (in ml) for the infusion is measured when the
syringe is loaded. The required infusion time is entered, and the Syringe Driver
calculates and displays the Rate that this infusion will use.
!
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When programming an infusion, if none of the control keys are pressed within
the key timeout period, the programming is aborted and the Syringe Driver
returns to the Run Menu. Any values set are not saved.
Programming a TIMED Mode infusion
In TIMED Mode, the VTBI is measured when the syringe is loaded, and the Time
is entered by the operator. The resulting Rate is calculated and displayed.
The VTBI can be any value from 0.1 ml to 5/10/20/30 ml, being the contents of the
syringe less any amount allowed for End of Infusion. The Time can be any value
from 1m to 299h 59m (subject to the rate limit of 0.1ml/h to 50/100/200ml/h).
The cursor (the highlighted digit) waits at the first digit of the Time value.
For each digit, use the Up key to increase the value, or the Down key to
decrease the value. Press the Right key to move on to the next digit.
(If a mistake is made, use the Left key to move back to the previous digit.)
Repeat for each digit of the Time value until all the values are as required, and
then press Enter. The Confirm Rate screen is displayed. The specified values are
shown, with the selected Mode.
Press the Right key to select the Yes option. The Confirm to Run screen is
shown. Press the Left key to select the No option. The values set will not be
saved, and the Syringe Driver returns to the Main Menu screen.
Press the Right key to select the Yes option. The infusion starts to run using the
specified values, and the Running screen is displayed (see page 19).
Invalid Rate indication
When programming an infusion, if a rate is set which is outside the allowable range for the Syringe Driver,
the Syringe Driver immediately displays the invalid rate in red. Note that this can happen as a result of the
chosen Time setting.
Infusion details cannot be saved until the rate is adjusted to a valid value. The Rate can be any value from
0.1 to 50, 100 or 200 ml/h (depending on syringe size, see Specifications). When the rate has been adjusted
to a valid value, press Enter to continue to the confirm screen.
If Enter is pressed while the Rate value is showing red, no action is taken. The infusion cannot begin until a
valid rate value is specified. Note: a valid rate cannot be set if there is insufficient volume of infusate in the
syringe due to over-purging.
Running an Infusion
When an infusion has been programmed by loading a syringe and setting a mode and rate, use the Confirm
to Run confirmation screen to run the infusion.
Pressing Yes on the Confirm to Run confirmation screen starts the infusion and
displays the Running screen (shown left). This screen shows the syringe type and
size, and the infusion details.
Rate and VTBI (Volume To Be Infused) show the values used in the current
infusion. TVI shows the accumulated Total Volume Infused since it was last reset.
Time shows the time the infusion has left to run.
The time of day is shown at the bottom centre of every screen.
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The RUNNING heading on the screen
alternates with MAIN MENU. Press
the Right key to display the Main
Menu.
To return to the Running screen from
the Main Menu, press the Left key.
When the infusion has reached the
NEOI point, the NEOI Running screen
is displayed after the NEOI Warning
At the end of the infusion, if KVO mode has been selected, the Rate value
changes to show the KVO rate. This is explained further in the section entitled At
the end of an infusion.
The battery symbol indicates the charge condition of the battery.
There are two other symbols that can appear on the screen.
The spanner symbol (bottom left) indicates that the Syringe Driver requires a service. This is described in
the Cleaning and Maintenance section (see page 37).
The padlock symbol (between the spanner and the time) indicates that the Keylock function has been
selected. This is explained further on in this section (see next page).
The Main Menu
All the options for programming an infusion or for running a programmed infusion
can be selected from the Main Menu. To access the Main Menu, press the Right
Key from the RUNNING screen, or select the No option from the Confirm to Run
screen.
The Main Menu lists the options for programming and running the Syringe Driver.
Use the Down Key to move down the menu options, the Up Key to move back
up the options, and the Enter Key to select the currently highlighted option from
the menu.
If an option from the menu is not selected within the key timeout period, the
screen automatically reverts to the previous screen. The previous screen can
also be accessed by using the Left Key (Back).
If an infusion has not been programmed, the Start/Hold option will be disabled,
and selecting it will have no effect. Similarly, if a syringe has not been loaded and
confirmed, the Load option will be disabled, and selecting it will have no effect.
Press Enter to select the Start/Hold option. The Syringe Driver starts the infusion
and displays the Running screen.
The options that might be required during the course of an infusion are as follows:
ZI-4-TM-001-5
•
Administering a Bolus
•
Changing the infusion Rate settings (Titration)
•
Resetting the Total Volume Infused (TVI)
•
Options at the end of an infusion
•
Stopping the infusion
•
Changing the infusion
•
Changing the syringe
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These options are explained in later sections of this manual.
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The Keylock Function
If the Key Lock function has been enabled, the Syringe Driver will automatically lock the keypad after a short
delay once the infusion has started. This prevents interruption of the infusion by accidental key presses.
To enable the Keylock function, refer to Enabling Key Lock on page 26.
When the keypad has been locked, pressing any key will bring up a Warning
screen.
Press the Left key to begin unlocking the keypad.
Press and hold the
Down key until the
screen shows that
the keypad is
successfully
unlocked.
The Syringe Driver returns to the
Running screen but now the keypad is
unlocked and other options can be
selected.
When the screen is locked, it shows
the closed padlock icon
in the lower
left. This is replaced by an open
padlock when the keypad is unlocked.
Note: After a few seconds in the unlocked state, the keypad will become locked
again if no key has been pressed within that time. To prevent this from happening,
the keypad lock can be set to disabled, or a key should be pressed. If the Left key is
pressed while an infusion is running or the Syringe Driver is in standby before the
timeout has expired, the keypad will be locked and a Warning screen will indicate
this.
!
Administering a Bolus
A Bolus can be administered at any time the infusion is running. The maximum Bolus set during
programming is available each time a new Bolus is requested. A new Bolus request must be made to
administer a total of more than the programmed maximum.
From the Running screen that is displayed while the infusion is in progress, press Right key to access the
Main Menu.
Use the Down key
to move down to
the Bolus option.
Press Enter to
obtain the Bolus
screen.
While the Yes key is being held to administer the Bolus, the warning screen indicates that the Bolus is
being infused.
The Bolus infusion continues until the Yes key is released, at which point the Syringe Driver returns to
the Bolus screen above.
When the Bolus infusion is complete, or the full amount of the specified Bolus volume has been infused,
the Syringe Driver returns to the Running screen, and the normal running of the infusion continues. When
the Bolus indicator has turned completely red, no more Bolus is available until a new Bolus is requested.
If a Bolus is requested but the Bolus Volume has been set to 0.0ml in the Setup Menu, the Syringe Driver
returns to the Run Menu screen immediately the Yes key is pressed.
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Reset TVI
To reset the accumulated Total Volume Infused, select
Options from the Main Menu, and then select Reset TVI
from the Options Menu. You will then be prompted to
confirm the Reset or cancel it. This action can be
performed during setting up or whilst running an infusion.
If the Yes option is selected, a confirmation screen is
displayed to confirm that the TVI has been reset.
The Syringe Driver then returns to the previous screen.
Note: the TVI accumulator has a range of 0-99.99ml.
At the end of an infusion
The Syringe Driver is designed to give warning alerts when the infusion approaches, and then reaches the
end. The points when these Alerts are displayed are the Near End Of Infusion point (NEOI) and the End Of
Infusion point (EOI).
Depending on the settings of these infusion options, the following Alerts can be displayed close to or at the
end of the infusion. Each alert is accompanied by an alert tone.
This warning screen is
This warning indicates that the
intended only to alert the
programmed infusion is
operator to the approaching
complete, but infusion is
end of the infusion.
continuing at the KVO rate.
This warning indicates that the
programmed infusion is
complete, but that infusion is
continuing.
This warning indicates that the
infusion is complete, and the
Syringe Driver has stopped.
Press the Left key (Mute) to turn off the alert tone. After 2 minutes, the alert tone will sound again.
Press the Right key (Cancel) to cancel the warning and return to the previous screen.
Stopping an Infusion / Placing On-Hold
To put the infusion on hold while it is running, press the Right key to select the Main
Menu from the Running screen.
Press Enter to select the Start/Hold option. The Syringe Driver holds the infusion and
the display remains on the Main Menu screen.
An infusion can only be restarted if the syringe has not been disturbed or the syringe
load procedure has been followed and the rate confirmed. Refer to previous sections
for details of these procedures.
A callback alarm will sound if the Syringe Driver is left on hold and no key is pressed
for longer than two minutes. This alarm is audible only, and consists of two beeps
from the sounder, repeated at regular intervals.
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Changing the infusion
From the infusion Running screen,
stop the infusion as described above.
Press the Right key from the Running
screen. The Main Menu is displayed,
and Start/Hold highlighted.
When the infusion has been stopped,
use the Up key or Down key to move
to the desired option, and change the
parameters as described in Setting Up
and Running an Infusion.
Note: PURGE is not available unless a
LOAD sequence has been followed.
Shutting down the Syringe Driver
The Syringe Driver cannot be shut down while an infusion is in progress. The infusion must first be stopped,
as described above. When an infusion is not in progress, shut down the Syringe Driver from the Main Menu.
Use the Down key to move down to the Power Off option.
This option will be disabled while an infusion is running.
Press Enter to select the Power Off option. The Syringe
Driver displays the Shutdown screen.
After five seconds, power is switched off and the Syringe
Driver shuts down. Pressing any button during the 5 second
countdown cancels the shutdown.
Syringe Driver Settings
To access the Syringe Driver settings, stop the infusion and, from the Main Menu screen, use the Down key
to move down to the Options function. The Options function is normally used to select the Reset TVI
function; however, with permission from the relevant authorities, it can also be used to select the Setup
menu.
With the Option function highlighted, press the Right and Left keys together and
hold until Setup appears instead of Options, then press Enter to select Setup.
The Syringe Driver Setup menu options are:
Date / Time
System
Infusion (see next section)
Occlusion
Key Click
Key Lock
Date / Time
To set the date and/or time, enter the Setup menu and
select Date/Time using the Enter key. Amend the
settings as required by using the Left and Right keys to
move along the digits, and the Up and Down keys to
change their values. Press Enter to save the values
when you have finished.
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System settings
The System settings allow changes to the set values for
Brightness, Contrast, Speaker volume, Alarm and Alert tones.
On the Setup menu, use the Down key to move down to the
System option, and then press Enter to select it.
The Syringe Driver displays the Setup System screen.
Use the Up and Down keys to highlight the item to be
adjusted and then use the Left and Right keys to increase or
decrease the setting.
The blue bar reflects the current setting. The screen settings are changed to the new setting when the key
is released. The speaker gives a sample tone and volume for each change when you release the key.
Press Enter to save the settings. The Syringe Driver returns to the Setup menu.
Infusion
The Infusion option gives access to the Infusion Settings menu. See section entitled Infusion Settings.
Occlusion
Selecting Occlusion
displays the Occlusion
Pressure Value
screen.
Select High or Low as
required.
The selection will be
confirmed as shown.
Enabling Key Click
There is an option to have an audible click to accompany every key press, which can be enabled or
disabled using this option.
On the Setup menu, use the Down key to move down to the
Key Click option, and then press Enter to select it.
The Syringe Driver displays the Enable Key Click screen.
Press the Right key to select the Yes option. Key Click will
now be enabled.
Press the Left key to select the No option. Key Click will now
be disabled.
After either selection, the Syringe Driver displays a
confirmation screen to confirm that the option has been
enabled or disabled. After 3 seconds, the Syringe Driver
returns to the Setup menu screen.
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