20
Precautions
Warnings
• When infusing in the TCI mode, the following must be observed:
• Do not inject the same drug before starting solution delivery in the TCI mode.
• After ending the TCI mode, do not inject to the same patient again in the TCI mode during the period that the drug is
assumed to remain in the patient’s body.
• Do not inject the same drug from another route during solution delivery in the TCI mode.
• Do not use the Purge switch to inject drugs to a patient.
Otherwise, the prediction of concentration will be affected since the value is determined based on the calculation of
discharge quantity from the syringe in the TCI mode.
• Before using the TCI mode, make sure the correct drug name, model, target, and target concentration are displayed.
[Incorrect settings of drug name, model, target, and target concentration may cause significant health hazard to the
patient.]
• Since this product does not have an airtight structure, it should not be used or stored in an active gas environment
(including sterilizer gas), nebulizer-sprayed environment, high-humidity environment, etc. It should not be submerged
into water. [If the electronic components inside the product are affected, there may be subsequent damage and time
degradation which will cause failure of this product.]
• The product should not be used or stored in a flammable environment.
• The product should not be used for an extracorporeal circuit etc. that may lead to an extreme negative or positive pressure.
[Solution delivery may not be carried out correctly or rapid infusion may occur due to displacement of the syringe gasket
from the plunger or displacement of the syringe plunger from the slider hook. In addition, solution delivery may not be
carried out correctly because of bolus infusion, back-flow, etc.]
• This product should not be used in conjunction with gravity infusion. [1. If this product suffers a downstream occlusion
lower than the connection with the gravity infusion line, the Occlusion alarm will not operate. 2. If bubbles are entrained in
the downstream of the infusion line due to emptied gravity infusion line first, the normal infusion cannot be carried out.]
• A syringe other than specified should not be used for this product. [If using a syringe other than those specified, the flow
rate accuracy and alarm functions cannot be guaranteed.]
Cautions
• Do not turn off the power or end the TCI mode while the TCI mode is in use. [Otherwise, all important information on the
current TCI mode, such as the predicted concentration, will be erased.]
• When you change any settings, make sure those new settings are effective. [The setting is not applied and the previously
set value is restored if no operations are performed during the process for a certain period of time.]
• When using a syringe (specified sterile syringe for general use) for this product, ensure that the nominal capacity of the
syringe is not exceeded. [If exceeded, the accuracy of flow rate or the alarm function cannot be guaranteed.]
• Use the AC power cable included and connect to an earthed AC power source. The AC power cable included should not
be used for other equipment. [Using an AC power cable other than the one specified may result in failure of this product. In
addition, if used without an earth connection, the electrical safety of this product is not guaranteed.]
• Before inserting an intravenous needle or connecting an infusion line with the connecting site, always bleed the air inside
the infusion line by pressing the purge switch and ensure that the slider pushes the syringe plunger. [1. This product
may cause harm to a patient due to air injection, since it does not have a function to detect air in the infusion line. 2. This
product may not be able to deliver solution for a while after started if there is a gap between the syringe plunger and the
slider, or between the syringe flange and the flange holder (on the clamp side).]
• When using the TCI mode, be sure to select carefully the appropriate model and target for patients based on the patient
characteristics (such as age, physical trait, and medical/physical conditions) and the latest clinical findings. [Incorrect
settings of model and target may cause significant health hazard to the patient.]
• When performing effect-site TCI, it is recommended to set the optimal plasma concentration overshoot before starting.
[There may be the cases where excessive overshoot in plasma concentration adversely affects the patient, in particular,
elderly patients or patients with high blood pressure.]
• Before starting solution delivery, check that the settings for any errors. (e.g. an error in the digit of flow rate etc.) [This
product does not have a function to determine the correct values, possibly resulting in excessive infusion or insufficient
infusion to a patient.]
• If the product is used under conditions that do not meet those specified for the flow rate accuracy described in
"Specifications", such as a low flow rate or short dosing time, the solution delivery should be monitored with extra care.
[The flow rate accuracy cannot be guaranteed.]
