McKINLEY T34 User manual

McKinleyT34
Ambulatory Syringe Pump
Operation Manual
IMPORTANT NOTICE: McKinley strongly recommends that this manual is read by
every user of the T34 syringe Pump and that they comprehensively understand its
contents before operating the device. It is also recommended that before being allowed
to use the device all personnel should receive training from either McKinley Medical or
those trained by McKinley to deliver training on this device. Competency of all
attendees should be assessed with both the trainee and assessor signing to confirm their
readiness to operate the device in the clinical setting
0473 March 2006
Ref.: 100-090ST

McKinley T34 Syringe Pump - Operation Manual
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Table of Contents
A. Introduction ....................................................................................3
B. Modes of Operation........................................................................4
C. Feature Recognition (diagram of the pump) ..............................5
D. Identifying Symbols on the pump.................................................6
E. Installation and Inspection ............................................................6
F. Warnings & Cautions ....................................................................7
G. Administration Sets .......................................................................8
H. Recommended batteries, fitting & testing ...................................9
I. Access Codes & Keypad lock.......................................................10
J. Infusion Set up & Programming.................................................11
a. Power Up ................................................................11
b. Syringe Selection ...................................................... 11
c. Priming ................................................................... 11
d. Pre-Loading & Syringe Placement ..................................11
e. Syringe Detection & Confirmation ..................................12
f. Setting Infusion Parameters............................................. 13
g. Setting Infusion rate...........................................................14
K. Accessories for T34.......................................................................15
L. Recommended Checks During Infusion ....................................16
M.Advanced Functions of T34.........................................................17
a. KVO (keep vein open) option............................................17
b. Infusion Rate Titration option..........................................17
N. Alarm Conditions .........................................................................18
O. Troubleshooting............................................................................19
P. Change Set Up (authorised users only) ......................................20
Q. McKinley T34 Specification.........................................................21
R. Service and Maintenance.............................................................22
S. Warranty.......................................................................................23
T. Default Syringes............................................................................24
U. Detailed Index of Contents ..........................................................25

McKinley T34 Syringe Pump - Operation Manual
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A - Introduction
WARNING: Do not operate the T34 until you have read and understood the contents of
this user manual paying attention to Warnings, Cautions & Notes as described below.
If you have any questions about the contents call 01253 894646 for assistance.
This manual will ensure the user will: -
1. Be able to identify the key features of the T34 and understand their function
2. Be able to correctly load a syringe into the T34
3. Be able to program the T34 to deliver the contents of the syringe
4. Be able to access and interpret patient history and event log data
5. Be able to troubleshoot and resolve alarm conditions
In the user manual you will find important information marked as followed: -
WARNING: Indicates the information is a warning. Warnings advise you of
circumstances that could result in INJURY OR DEATH to the patient/operator.
CAUTION: Indicates that the information is a caution. Cautions advise you of
circumstances that could result in DAMAGE to the device.
NOTE: Indicates that the information is additional important information or a tip
that will help you recover from an error or point you to related information.
What is the McKinley T34?
T34 is a small, lightweight, robust, battery powered, ambulatory syringe pump designed to
deliver the contents of most commonly used 2 to 50ml syringes over a specified duration or
at a given rate in milliliters per hour (ml/hr). A screw drives the pump actuator and syringe
plunger forward at a controlled rate. This rate is adjustable from 0.1 to 1000 ml/h in
increments of 0.1 ml/h up to 100 ml and 1 ml from 100 to 1000 ml/h.
The size and weight of the T34 makes it ideal for ambulatory use in either a hospital or
homecare/out-patient setting. It is equally suitable for adults or for paediatric use.
The syringe pump can be easily concealed beneath clothing in a shoulder holster and
combination belt. A compact lockbox is available to protect the Pump from damage and/or
tampering with the pump or displacement of the syringe.
T34 offers 3 point syringe detection enabling the pump to identify all commonly used (or
programmed) syringe brands. This feature ensures the pump can make volume & rate
calculations thereby minimising the risk of user programming errors. The sensors also
activate an alarm if the syringe is removed or partially displaced during infusion.
The pump may be used to deliver via any common infusion routes including central,
peripheral venous, epidural, intra-arterial or subcutaneous providing the medicines being
administered are licensed for such use.
WARNING: T34 is a medical device designed for the safe, accurate delivery of
appropriate infusion regimes and should only be operated by, or under the supervision of, a
medical professional. Incorrect or inappropriate use could lead to serious injury or death.

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B – Modes of Operation
The McKinley T34 Syringe Pump has three modes of operation. In summary these are: -
1) VOLUME OVER TIME (Program Lock OFF) – Pump will deliver the volume
confirmed over the default duration or a new duration confirmed by the user.
THIS MODE IS IDEAL WHERE - it is common to use the same delivery regime
(duration) but some flexibility may occasionally be required.
oAlthough the pump calculates volume in the syringe the user can set a lower
VTBI (e.g. if KVO is required) during set up.
oPump is configured with a Default Duration (e.g. 24 hours) to guide the user
to make the appropriate selection during set up but the user can change this
during set up.
oOPTIONS - Titration can be enabled allowing the user to set upper and
lower infusion rate limits during set up to allow titration of the infusion rate
without stopping the Pump.
2) VOLUME OVER TIME (Program Lock ON - DEFAULT) – Pump will deliver the full
contents of the syringe fitted over the Default Duration set on the pump.
THIS MODE IS IDEAL WHERE – the entire contents of a syringe are always required
to be delivered over the same duration (e.g. 24 hours). The duration is locked so the
user CANNOT change it. This prevents programming errors and makes setting up an
infusion very simple.
oUser CANNOT change either the VTBI or the Default Duration time
oPump calculates the volume, applies the pre-set duration and calculates the
appropriate rate for the infusion.
oUser only checks and confirms infusion summary screen (showing duration,
rate and volume) matches the prescription before Starting the infusion
oUser access code required to change any of the pumps settings
oTitration is NOT possible in Program Lock ON mode
3) RATE PER HOUR MODE – Default Duration is set to Zero under the Change Set Up
menu (access code required).
THIS MODE IS IDEAL WHERE – different infusion rates are used each time and the
users are familiar and comfortable with making the calculation of infusion rate
themselves.
oPump calculates the volume in the syringe and then the user sets the rate in
ml/hr (default is zero so user has to scroll to select the infusion rate or
infusion cannot be started)
oTitration can be enabled in Rate per Hour mode
WARNING: make sure you fully understand all of the possible modes and the
one your pump is configured to before operating the T34.
NOTE: your T34 can be configured to one of the above modes (as appropriate
to your clinic/setting) during installation by either McKinley Medical or your
service centre. Take time to consider which mode is best for your practice.

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C– Feature Recognition
Physical features & function of T34
1Barrel Clamp arm (secures syringe and detects brand & size)
2Syringe flange/collar sensor (detects correct loading of syringe collar)
3Plunger Sensor (detects correct loading of syringe plunger)
44 line LCD display (backlit when any key pressed)
5Operation LED (Green indicates infusing, Red when pump Stopped or alarming)
6Actuator (drives the syringe plunger to deliver syringe contents)
7Info key (accesses Event Log, Volume Infused/To Be Infused and Battery status,
prolonged press activates/deactivates Keypad Lock)
8Up arrow key (increases infusion parameters during programming/titration and
scrolls between options in menus)
9Down arrow key (decreases infusion parameters during programming/titration and
scrolls between options in menus)
10 YES/START key (confirms selection during programming and starts infusion)
11 NO/STOP key (takes user back a step during programming and stops infusion)
12 FF (Forward) key (moves actuator forward when no syringe present)
13 Back (Reverse) key (moves actuator backward when no syringe present)
14 ON/OFF key
15 Instructions for infusion set up
21 63
7 8 10 11 1312
4
514 159

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D – Symbols on pump, consumables & accessories
System Symbols
The following symbols are used on the McKinley T34 Syringe Pump and components.
Labels on the pump or statements in this manual preceded by any of the following words
and/or symbols are of special significance and/or are intended to help you to operate the
pump in a safe and successful manner.
Attention, consult accompanying Instructions.
CSA mark
CE mark indicates conformance to Medical Device Directive 93/42/EEC.
The use of single-use disposable components on more than one patient is a
biological hazard. Do not reuse single-use disposable components.
Type CF applied part.
Date of Manufacture
Serial Number
Expiry Date (consumables)
Lot Number (consumables)
Sterilized with Ethylene Oxide
IPX1 Level of protection against fluid ingress
E – Installation and Inspection
Unpacking
1. Remove the McKinley T34 Syringe Pump & accessories from the packaging and inspect
for damage during shipment or storage.
WARNING: Do not use T34 if there are any obvious signs of damage. Return for
inspection by authorised service personnel.
2. Make sure you have the following items:
•McKinley T34 Syringe Pump
•Operation Manual
•9V alkaline battery
•Carry Pouch
•Lockbox (optional)
If any items are missing or damaged, contact your supplies department to order replacement.
LOT
STERILE EO

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F – Warnings & Cautions
To avoid the possibility of injury or death, please note the following
advice before using the McKinley T34 Syringe Pump: -
WARNING: Pump is not suitable for use in the presence of flammable anesthetic-
air/oxygen/nitrous oxide mixture. Do not use in these environments.
WARNING: A kinked/occluded infusion line may impair the operation and accuracy
of the pump. Before operation, verify that the infusion line is not kinked or occluded.
WARNING: Never take a syringe that is not empty off the Pump if it is still connected
to the patient. The infusion line must be disconnected or clamped before removing the
syringe to prevent free flow and the risk of serious injury or death to the patient.
WARNING: Ensure there is no air present in the syringe and also completely prime
the administration set before loading the syringe into the pump to prevent the risk of
infusing air into the patient (air embolism).
WARNING: Adjustments, maintenance, or repair made by un-certified service
personnel may impair the operation of the pump and/or the accuracy of the infusion.
Make sure any adjustments, maintenance, or repair of the device is carried out by
authorised skilled technicians certified by McKinley Medical.
WARNING: The McKinley T34 Syringe Pump system should be operated within a
temperature range of 15°C (59°F) to 45°C(113°F) and in no more than 85% humidity.
Operation at temperatures and/or humidity outside this range may affect accuracy.
WARNING: Unsafe operation may result from using improper accessories. Use only
accessories and options designed for this system and supplied by McKinley Medical.
WARNING: Disposables must be compatible with the medicine delivered. Please
check with the manufacturer of the giving set before use.
WARNING: Dropping the Syringe Pump could cause damage to components. If the
pump is dropped, return the pump for inspection by qualified service personnel.
WARNING: Use good aseptic technique when filling the syringe and priming the
giving set. Patient infection may result from the use of non-sterile components.
Maintain sterility of all disposable components and do not re-use single use sets.
WARNING: Do not operate the pump near high-energy radio-frequency emitting
equipment, such as electro-surgical cauterizing equipment as this may result in false
alarm signals or error messages being displayed.
WARNING: The maximum volume that may be infused under SINGLE FAULT
CONDITION is 0.03-0.05 ml (depending on syringe size in use).
To avoid possible damage to the equipment, observe the following: -
CAUTION: Do not store the pump for extended periods with the battery in the pump.
CAUTION: Xylene, Acetone or similar solvents could damage components. Do not
clean the pump with these chemicals. Clean solution spills immediately using a damp
cloth or sponge. A mild detergent or 10% bleach solution may be used. Wipe dry.
CAUTION: Immersing the McKinley T34 Syringe pump in liquid could cause damage
to components. Do not immerse the pump into any type of liquid.
CAUTION: Battery damage could occur at ambient temperatures >500C (122°F).

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G - Administration Sets
The McKinley T34 Syringe Pump System can be operated with any extension set with a
luer connection however, it is recommended, to optimize system accuracy & performance,
that the proprietary sets listed below are used.
Proprietary sets available from McKinley Medical are as follows: -
150cm IV infusion set with check valve & clamp 100cm Sub-cut set with needle & clamp
WARNING: Replace the administration set at least every 24 hours (or according to local
guidelines) to reduce the possibility of bacteria formation.
WARNING: Visually inspect packaging and contents before each use. Do not use consumables
if the packaging is in any way damaged as sterility may have been compromised.
WARNING: Air embolism during an IV infusion can cause death or serious injury to the
patient. Do not connect a patient to the McKinley T34 Syringe Pump until all air
has been cleared from the fluid path & syringe. Carefully read the instruction for
loading. Puncturing set components may also cause air embolism.
WARNING: Drugs must not be administered to the epidural space unless the drugs are
indicated for this purpose and are administered in accordance with the indications
included in the drug manufacturers package insert. Epidural administration of
drugs other than those indicated for epidural use could result in serious injury or
death to the patient.
WARNING: Disposables must be compatible with the medicine delivered. Please check
with the manufacturer of the giving set before use.
CAUTION: Component damage may occur if the set is not correctly attached to the syringe.
Assure all connections are secure; do not over tighten. This will help minimize
leaks, disconnection and component damage.

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H – Recommended batteries, fitting & testing
Always use a 9 volt alkaline battery (or a 9v Lithium battery which may extend the pump
operating time). These batteries can easily be identified by the international marking code
6LR61 (a recommended battery of this type is the Duracell MN1604). Suitable Lithium
batteries are available from McKinley Medical.
CAUTION: There is some variation in size between different brands of batteries. Never
try to force a battery into the battery compartment as this may damage the battery contacts.
NOTE: Zinc-carbon batteries (marked 6F22 or 6R61) are not recommended for use with
the T34. These batteries perform poorly and may need to be replaced more often.
To fit or change the battery slide the compartment cover at the back of the pump. Push the
battery into the compartment taking care to ensure that the + / - contacts are aligned as
shown on the label inside the compartment. Slide the cover back on.
NOTE: Incorrectly aligning the battery contacts will not cause any harm to the battery or
the T34 pump. Simply remove the battery and re-align the contacts.
Battery Test
When setting up the pump on a patient always check that there is enough charge in the
battery to cover the infusion being set up. To do so follow one of the procedures below: -
•Check the Summary Screen displayed on power up
•Press INFO key when the pump is stopped and select
Battery Level, press YES
•During infusion press the INFO key twice to check
Battery Level, in all cases verify sufficient battery charge is available to
complete the current program. If not, change the battery.
•Sufficient battery charge may vary depending on your setting, infusion
rate, number of times the information options are used.
Battery Level
98 %
Em
p
t
y
Full

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I – Access Codes & Keypad Lock
Secure User Access Codes
The T34 employs three levels of user access protection to prevent unauthorised changes to
the set up or configuration. Although no access code is required to turn the pump on and
run an infusion certain settings and features may have been configured and locked as
appropriate to the clinical application the Pump is being used for in your practice.
NOTE: No access codes are contained in this manual. Please refer to senior clinical or
technical staff for these codes if you have been trained and certified in their use.
WARNING: Do not attempt to access these areas if you are not trained or authorised to do
so. If you are authorised do not share the access codes with non-authorised personnel.
Placing these settings in a secure area of the pumps menus also simplifies use as everyday
users are not required to repeatedly confirm or change common set up parameters whilst
setting up an infusion.
‘Change Set Up’ mode (see later section) contains configurable settings and features and is
protected by a user code from un-authorised access.
‘Technicians Menu’, used for service and/or repair of the Pump, is also protected by a
special access procedure and different user code from ‘Change Set Up’.
In normal use the nurse will not see these fields or be prompted for the user access codes.
Keypad Lock
As well as the ability to lock or limit certain infusion parameters or pump set up, the T34
allows all users to lock the operation of the keypad during infusion if there is concern about
patients or relatives tampering with the device. To active the keypad lock: -
•with the pump infusing, press and hold the INFO
key until a chart is displayed showing a bar
moving from left to right.
•Hold the key until the bar has moved completely
across the screen and a beep is heard to confirm
the lock has been activated.
•To turn the lock off repeat this procedure. The bar will now move from right
(ON) to left (OFF) and a beep will be heard to confirm activation.
NOTE: for safety reasons the keypad lock does not affect the operation of the START or
STOP keys as users or patients unaware of how to deactivate the lock may need to STOP
an infusion in an emergency and/or re-start the infusion (e.g. when clearing an alarm).
LOCK MODE
OFF ON