18
Precautions
Cautions
• It is recommended to use Luer Lock infusion sets for secure infusion line connection.
• Do not use the tube in the same condition for more than 24 hours. Move the position approx. 15 cm, or replace the infusion
set every 24 hours. [After a long period of use, the tube may be deformed resulting in a flow rate error or Occlusion alarm.]
• When transporting with the pump fixed to the IV pole, do not hold the handle of the pump nor apply pressure from the top.
[The pole clamp may be dislocated or damaged.]
• When this product is transported while in use, do not touch the switches, etc. Use the keypad lock function as needed.
[Touching the switches etc. without the keypad lock enabled may result in an operation (power on/off, stop, start, rapid
infusion) that is not intended by this product.]
• The LCD and the Operation panel (switches etc.) of this product should not be pressed with excessive force and should not
be operated with a pointed object. [It may cause damage to or failure of the LCD or the Operation panel.]
• Do not disassemble, make alterations (including actions that interfere with the functionality or performance such as
taping the LCD or a movable part) to, or repair this product. [This may result in failure, damage or device performance
degradation of this product.]
• This product should only be used with a sufficient power supply. [If the power supply is not sufficient, the internal battery
will be used for the operation, which may result in no power supply in an emergency situation.]
• This product should not be used for the purpose of delivering sterilizing solution such as povidone-iodine. [Being exposed
to the components of sterilizing solution may result in degradation or damage to the components of this product.]
• When using devices (mobile phones, radio devices, radio knives, defibrillators, etc.) that emit an electromagnetic wave
within the area of this product, they should be used as far away as possible and you should verify the normal operation of
this product in the configuration it is used. In addition, this product should use a power supply of a system isolated from
these devices and should obtain secure earth connection.
[Malfunction in this product may result in critical harm to the patient.]
• When used in the vicinity of a radio knife (Medical radio knives are surgical equipment for incision and coagulation by high
energy radiofrequency current), check the following before use.
(1) Radio knives have a different level of high-frequency noise emission depending on the types, and using old models
(vacuum tube gap type) in combination should be particularly avoided as the noise levels from those are higher.
(2) The distance from the radio knife cord (knife holder, knife cord and return electrode cord) and radio knife body to this
product should be kept to a minimum of 25 cm.
(3) The radio knife and this product should be operated by a power supply from a separate system, and both should be
securely earthed.
• When this product is used under a low temperature, the status of solution delivery should be monitored with extra care to
make sure of no flow rate error. [If an infusion set is used with a flow rate of more than 50 mL/h in an ambient temperature
of less than 10°C, this may cause an alarm due to a flow rate error.]
• When connecting this product with other medical equipment or network system, check its conformance to IEC 60601-
1:2005+A1:2012 (EN 60601-1:2006+A1:2013) and IEC 60601-1-2:2007 (EN 60601-1-2:2007) prior to use in order to ensure
the system safety.
• When connecting this product with a network system or other equipment, for safety, checking the manufacturer’s
specifications of the equipment is recommended. In addition, use EMI compliant products for the connection cable.
• When using the external communication function, pay particular attention, as it is more susceptible to the effect from a
radio knife, mobile phone, radio device, defibrillator, etc. Regularly check that this product is operating normally.
• If connecting with a nurse call, always check in advance with the electrical contractor for compatibility, and connect with a
system for which the connection function has been confirmed. [The functions regarding connection are not guaranteed.]
(TE-LF632 only)
• If connecting with a buzzer or lamp instead of a nurse call, it should be used with a capacity of 12V DC, 1A or less. (TE-
LF632 only)
• Connection to a network including other devices may cause unpredicted and unacceptable risks for the patient, the user,
or a third person. Be sure to identify, analyze, evaluate, and control those risks.
• Subsequent changes to the IT-network could introduce new risks and require additional analysis. (TE-LF632 only)
- Changes to the IT-network include:
(1) Changes in the IT-network configuration.
(2) Connection of additional items to the IT-network.
(3) Disconnecting items from the IT-network.
(4) Update of equipment connected to the IT-network.
(5) Upgrade of equipment connected to the IT-network.
• When using the IV pole, follow the instructions for the IV pole.
