Tierrett Endotracheal Tube for Large Animals
Instructions for use[1] Prepare what is necessary for endotracheal intubation according to a case.

[WARNINGS]<Combined medical device>[1] Make sure to check a connection when connecting this product to abreathing circuit or other equipment. (No problems such as leaks,blockages, loose connections, etc.)[An insufficient connection may cause ventilation problems.]
For details, refer to [Precautions], <Important basic caution> [7].
[2] When high-concentration oxygen is administered through this product,never use a laser scalpel or an electric scalpel near the site where thisproduct is used in principle.
[There is a risk of sudden ignition in oxygen, airway burns due to ignition,and the generation of toxic gas.]

In addition to the size of this product that is assumed to be appropriate,
prepare bigger and smaller sizes.
[2] Remove the product from the packaging material hygienically and carefully,
check no abnormalities.
[3] Inject air into the pilot balloon of this product and check that the cuff expands
normally.
[4] After checking an inflated state of the cuff, remove completely the air from thecuff.
[5] Have a patient take a proper position for intubation.
[6] Apply an anesthetic near the intubation.

[CONTRAINDICATIONS・PROHIBITION]
Never connect this product to a Norman Elbow type connector (the shape of agas supply inner cylinder inside a connector is protruding in the direction of apatient). For details, refer to the section <Interaction (related to combined
use with other medicines, medical devices, etc.)> in [Precautions].

[7] Guide the tip of this product to an appropriate intubation position using theequipment required for intubation of this product. At this time, in the case oforal intubation, the patient's mouth is opened with one hand, the tongue isexcluded by tongue depressor and intubated.
[8] When the product reaches the intubation position, hold tight not to move, and[Shape, structure, principle]

gradually inflate the cuff with air using a syringe until the pressure becomes<Shape>appropriate.
[9] Make sure that the product is placed in the trachea by performing positive

Slip joint
I.D.

O.D.

Pilot balloonpressure ventilation and examining the patient's chest swelling andauscultation.
[10] Make sure to fix this product with a fixing tool (bandage, etc.). Fix with a bite

Cuff expansion valve
CuffBody tube

block if necessary.

Branch tube

[11] Connect an appropriate ventilation system to the slip joint.
<Extubation method>
Depth marks[1] Disconnect the slip joint and the ventilation system.

Total length[2] Aspirate the secretions from the top of the cuff and remove the air from thecuff.

Size

I. D.

O. D.

Total length[3] Extubate slowly.

ID 7.07.0 mm

10.0 mm

ID 9.09.0 mm

12.0 mm

600 mm<Precautions for the using method>

ID 11.011.0 mm

15.0 mm

ID 13.0

13.0 mm18.0 mm

650 mm

ID 15.015.0 mm

20.0 mm

750 mm[1] In sterilizing this product, never perform autoclave sterilization.
[The slip joint and the expansion valve may be damaged.][2] Make sure not to damage the cuff during opening and taking out the product.
[3] Test the cuff, branch tube, pilot balloon, and valve for malfunction (leakage /blockage) before use. After checking, remove the air inside the cuff
completely.
[4] Never block the tube lumen with lubricant.
[The airway may not be open.][5] Make sure not to damage the pilot balloon or cuff with the equipment (forceps,<Raw Materials>
Silicone rubber<Principles>
This product is intubated into the trachea to secure the airway during upper airwayetc.) or internal protrusions (cartilage, etc.) used during insertion.

obstruction, impaired consciousness, administration of anesthetics, etc. Air is[6] Pay attention to the following when inflating or deflating the cuff:
1) Use air to inflate the cuff, inject slowly and carefully.

injected into a cuff to fix and indwell to secure the airway. Connect an appropriate[May damage the tracheal wall.]ventilation system to a slip joint.

2) Use a general slip-type disposable syringe for cuff inflating.
[Inserting very inside of the valve is impossible with a lock type syringe.

[Intended purpose, efficacy or effect]
This product is intubated into the trachea to secure the airway during upper airway

Mismatching taper leads to a damaged valve.]3) Use a clean syringe to keep foreign matter out of the valve.

obstruction, impaired consciousness, administration of anesthetics, etc. Inject air[Foreign matter (dry body fluid, lint, etc.) may be clogged in the valve andthe cuff may not be inflated.]

into a cuff and fix a catheter tube securely not to move after intubation of thecatheter tube.

4) Make sure to push the tip of the syringe into the valve.

[Operating or using method]
The below is a general procedure.

5) In removing a syringe, make sure to hold the valve and rotate the syringe to[If an insertion is shallow, injecting or removing air may be impossible.]
remove.
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[The valve may shift rarely, sometimes come off.][When the air is removed from the cuff, secretions may flow into the lungs.]6) Operate a syringe slowly when shrinking the cuff.

[13] If the air cannot be removed from the cuff, cut the branch tube and remove[If the syringe is operated rapidly, the cuff may stick to the cuff hole and thethe air.

remaining air in the cuff may not be released.][14] Replace with a new one according to the condition of the patient, changes in[7] Check and manage the cuff appropriately by injecting air or using a cuff

the affected area, and the condition of the product.

pressure gauge, etc.

[15] If you find that the endotracheal tube is about coming off, do not rush and[8] The pressure inside the cuff should be controlled by the minimum amount ofcontact your veterinarian immediately. After re-intubation, check that theair that can seal the trachea.

intubation was performed properly by listening to breath sounds.

[Excessive air injection into the cuff may cause damage of the cuff tracheal[If the endotracheal tube is about coming off, the tip of the tube may haveand necrosis.]already deviated from the trachea. In this case, if the tracheal tube is pushed[9] Always use a bite block for oral intubation.

in as it is, there is a risk of being erroneously inserted into the esophagus.][Blockage and cutting of the tube may cause by biting a tube.][Ventilation may be impossible by biting a tube.]<Interaction (related to combined use with other medicines, medical devices,[10] In removing the cuff, pull out slowly and carefully as granulomas may getetc.)>

caught and this product may not come off easily or cause bleeding.

1. Contraindications for combined use
Names of medical
Clinical symptoms /devices, etc.
measuresA medical device with Do not connect to thisa Norman Elbow type product.
connector (the shape ofa gas supply innercylinder inside aconnector is protrudingin the direction of apatient)[11] After removal, observe no symptoms of ventilatory insufficiency such as
dyspnea.
[12] Prepare for tracheal intubation, etc. to quickly secure the airway in case ofventilation failure after removal.
[Precautions]<Important basic caution>[1] Pay attention to anatomical individual differences such as airway length.

Mechanism / riskfactors
This product may be
occluded,causing
hyperinflation of thelungs and inability toventilate.

Make decisions based on sufficient clinical judgment without relying on
2. Precautions for combined use
Names of medical
Clinical symptoms /devices, etc.
measuresA laser treatment Whendevicehigh-concentrationAnelectrosurgical oxygen is administereddevicethrough this product, inprinciple, do not use alaser treatment device(a laser scalpel) or
electrosurgical device(an electric scalpel)
near the site where thisproduct is used.
A hyperbaric oxygen Pay attention to inflate
therapy device
and deflate of the cuff.

depth marks. Select a size suitable for each patient based on sufficient clinicaljudgment.
[2] Fix this product properly with a fixing tool (bandage, etc.) not to come off.
[The tube may deviate from the trachea due to loosen fixing.][3] Properly humidify the patient's airways to minimize coagulation of secretions
inside the tube and prevent damage to the tracheal mucosa.
[4] Make sure to check that the tube does not bend to obstruct the lumen during
repositioning or surgery in a special position. Also, make sure to check theinsertion position does not shift when changing the position of a patient.
[Can cause dyspnea and damage to the airway mucosa.][5] Perform suction as appropriate to prevent obstruction by secretions adheringto the inside of the tube.
[6] Check that the cuff internal pressure and respiratory control status are

Mechanism / riskfactors
Using a laser treatment
device (laser scalpel) or
electrosurgical device(electric scalpel) inoxygen leads tosuddenly igniting and aburned airway due tothe ignition or a toxic
gas outbreak.

Inspiratory leakage andtracheal damage may
occur.

appropriate after the suction.
<Failures・Adverse events>
Failures[1] Burst of cuff

[7] In connecting a respiratory circuit, etc. to this product, pay attention not toapply excessive force to this product.
[This may cause deviation from the trachea of this product, disconnection[Burst due to the following causes.]from the respiratory circuit, blockage of this product or the respiratory circuit,

・Contact with the patient's teeth.

etc.]

・Damage due to improper handling when inserting the product (damage by[8] Never pull on the branch tube and the pilot balloon.

tweezers, forceps, scissors, knives, or other devices)[May cause a malfunction or leak.]・Excessive infusion volume (overexpansion)[9] Never connect a 3-way stopcock or an infusion extension tube to the valve of・Infusion of gas other than air for cuff inflation

the pilot balloon.

・Abrupt load due to self-extubation, etc.

[The valve was damaged when removing a 3-way stopcock, etc., it may not・Other multiple causes due to the above-mentioned events

be injected air into the cuff or released.][2] Disconnection of tube

[10] Before measuring the internal pressure of the cuff, make sure that no liquid is[Disconnection due to the following causes]

accumulated in the branch tube, pilot balloon, etc.

・Damage by tweezers, forceps, scissors, knives, or other devices[Condensation events have been reported inside the cuff as water vapor

・Abrupt load on the product due to self (accidental) extubation

permeates the cuff membrane. May not be possible to accurately measure

・Excessive load on the product placed when peeling the bandage off abruptly.

the internal pressure of the cuff because it is sealed with water due to・Other multiple causes due to the above-mentioned events

condensation on the branch tube.][3] Disusing a bite block for oral intubation may cause obstruction and[11] Completely remove the air from the cuff before inserting or removing thedisconnection of the tube due to biting of the tube.

product and fixing its position.

[4] Inability of extubation[May damage the trachea.]

If the cuff doesn’t deflate, deflate the cuff by disconnecting the branch tube

[12] Aspirate the secretions that have accumulated in the oral cavity before

under the guidance of a doctor.

remove the air from the cuff.

[5] Lumen obstruction and damage of the tube
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Excessive application of lubricant on the tube may cause lumen obstruction
resulting in partial or complete inhibition of ventilation.
[6] Air leakageUse of the product with attachments insecurely connected to the joint may
cause inhibition of ventilation.
Adverse events
In performing endotracheal intubation, the following adverse events are expected:[1] Adverse events during intubation
Lip injury, tooth injury, pharyngeal mucosa injury, vocal cord injury, bleeding,nasal mucosa injury, inadvertent esophageal intubation, and tracheal injury.
[2] Adverse events during the tube placement
Lumen obstruction in endotracheal tube, movement of endotracheal tube,
tracheal injury, pneumothorax, tongue edema, injury/necrosis of the palatine
uvula, intranasal injury/necrosis, hypoglossal nerve paralysis, otitis media, andinability of ventilation due to insecure connection with ventilation unit.
[3] Adverse events during extubation
Laryngeal (glottic) spasm, aspiration’ pharyngeal pain, pharyngeal edema,recurrent nerve paralysis, pulmonary edema, tracheal injury, pneumothorax,
arytenoid cartilage subluxation, laryngeal granuloma, airway narrowing,paradoxical movement of the vocal cord, and cricoid cartilage necrosis.
[4] Disusing a bit block for oral intubation may cause inability of ventilation due
to biting of the tube.
[5] Inappropriate air volume
If air infusion volume in the cuff is inappropriate, it may cause troubles such as
injury of the trachea wall and influx of secretion such as saliva to the trachea.
[6] If laser surgical units or electric surgical instruments are used in the vicinity ofthe product, contact with laser beam or electrode may cause sudden
inflammation.
[7] Remains in the body due to the cutting of the tube.
<Other notes>[1] In performing anesthesia using a gas mixed with nitrous oxide, pay
attention to the shrinking and expanding of the cuff.
[It has been reported that nitrous oxide permeates the cuff, increasing theinternal pressure of the cuff and damaging the trachea.][2] In using this product outside the hospital, healthcare professionals must
explain to the handler of this product how to use and operate safely.
[Storage conditions and duration of use]
<Storage conditions>Store the product hygienically, avoiding the direct sun light, high humidity andultraviolet rays such as a sterilizing lamp and taking care of wetting.
< Expiration date >If proper storage is maintained, refer to the expiration date on the individual
packaging.
[By self-authentication (our data).]< Expiration date >This product has developed as use within 30 days.
[By self-authentication (our data).]

Manufacturer
CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japan
In-house administration number: DC67284

R0-0 2021.2

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