Tierrett Animal Endotracheal Tube
Instructions for use
Contraindicated to re-use[Intended purpose, efficacy or effect]
It is inserted into the trachea via the nasal cavity or oral cavity and used to secure[WARNINGS]<Combined medical device>[1] Make sure to check the connection when connecting this product to abreathing circuit, etc. (No problems such as leaks, blockages, loose
connections, etc.)[If the connection is insufficient, it may cause ventilation problems.]
For details, refer to [Precautions], <Important basic caution> [8].
[2] If high-concentration oxygen is administered through this product, do not
use a laser scalpel or electric scalpel near the site where this product is usedin principle.
[There is a risk of sudden ignition in oxygen, airway burns due to ignition,and the generation of toxic gas.]

the airway.
[Operating or using method]
The below is a general procedure.
<No cuff>[1] Remove the product from the packaging material hygienically and carefully,
check no abnormalities.
[2] Make sure that the connection between the tube body and the slip joint is[CONTRAINDICATIONS・PROHIBITION]
Do not reuse the product (single use only).

secure and does not come off during use.
[3] Have the patient take the proper position for intubation.
[4] Apply an anesthetic near the intubation.

[Shape, structure, principle]
・This product is sterilized with ethylene oxide gas.
・This product uses polyvinyl chloride (plasticizer: di (2-ethylhexyl) phthalate).

[5] 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.

<Shape>[6] After intubation, monitor breath sounds and if breath sounds are diminished or

Valve case coverabsent on one or both sides, adjust the tube position as needed.

Valve[7] The position of the tracheal tube is confirmed by observing the position of theBranch tube

tube tip on a chest X-ray image.
[8] Make sure to fix this product with a fixing tool (bandage, etc.). Fix with a bite

Cuff

block if necessary.

Pilot balloon[To prevent misalignment after intubation, make sure to fix the tube to theBody tube

patient in an appropriate way.]

2725[9] Connect an appropriate ventilation system to the slip joint.

23
21

ID5.0O. D.

ORALNASAL

19

Slip joint<With cuff>
Contrast line

[1] Remove the product from the packaging material hygienically and carefully,

Depth markcheck no abnormalities.

I. D.

[2] Remove the valve case cover before use.
・No cuff
Size
ID2.0

Fig. 1I. D.
2.0mm

Fig. 2

Hold tight the valve case cover and valve as shown in Fig. 1. Keep the valve

O. D.
2.9mm

case cover horizontal and bend the valve down until it comes off the valve
case cover as shown in Fig. 2. Discard the valve case cover after removing.

・With cuff
Size
ID2.5
ID3.0
ID3.5
ID4.0
ID4.5
ID5.0
ID5.5
ID6.0

I. D.
2.5mm
3.0mm
3.5mm
4.0mm
4.5mm
5.0mm
5.5mm
6.0mm

O. D.
3.5mm
4.2mm
4.9mm
5.5mm
6.2mm
6.8mm
7.5mm
8.0mm

SizeID6.5
ID7.0
ID7.5
ID8.0ID8.5
ID9.0ID9.5
ID10.0

I. D.
6.5mm
7.0mm
7.5mm
8.0mm
8.5mm
9.0mm
9.5mm
10.0mm

O. D.
8.7mm
9.3mm
10.0mm
10.7mm
11.3mm12.0mm
12.7mm
13.3mm[3] Make sure that the connection between the tube body and the slip joint issecure and does not come off during use.
[4] Connect a syringe to the valve of this product, inject air, and make sure that thecuff expands normally.

<Raw Materials>[5] After checking the inflated state of the cuff, remove completely the air fromPVC

the cuff. At this time, the wrinkles of the cuff can be reduced by removing theair while grasping the cuff.

<Principles>[6] Have the patient take the proper position for intubation.

This product is intubate orally or nasally. With a cuff, air is injected into the cuff to[7] Apply an anesthetic near the intubation.

fix and indwell to secure the airway. Connect an appropriate ventilation system to[8] Guide the tip of this product to an appropriate intubation position using thethe slip joint.

equipment 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.
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[9] When the product reaches the intubation position, hold tight not to move, and[1] Note that di (2-ethylhexyl) phthalate, which is a plasticizer for polyvinyl

gradually inflate the cuff with air using a syringe until the pressure becomeschloride, may elute from fat-soluble pharmaceuticals or chemicals.

appropriate.

[This product uses polyvinyl chloride.][10] Make sure that the product is placed in the trachea by performing positive[2] Pay attention to anatomical individual differences such as airway length.

pressure ventilation and examining the patient's chest swelling andBased on sufficient clinical judgment without relying on depth marks. Select aauscultation or chest X-ray image.

size suitable for each patient based on sufficient clinical judgment.

[11] Make sure to fix this product with a fixing tool (bandage, etc.). Fix with a bite

[3] Fix it properly with a fixing tool (bandage, etc.) so that the product will notblock if necessary.

come off.

[To prevent misalignment after intubation, make sure to fix the tube to the[The tube may deviate from the trachea due to loose fixing.]

patient in an appropriate way.][4] Properly humidify the patient's airways to minimize coagulation of secretions[12] Connect an appropriate ventilation system to the slip joint.

inside the tube and prevent damage to the tracheal mucosa.
[5] Make sure to check that the tube does not bend and obstruct the lumen when

<Extubation method>changing positions or performing surgery in a special position, and the[1] Disconnect the slip joint and the ventilation system.

insertion position does not shift when changing the position of the patient.

[2] Aspirate the secretions from the top of the cuff and remove the air from the[Can cause dyspnea and damage to the airway mucosa.]

cuff.

[6] Suction is performed as appropriate to prevent obstruction by secretions[3] Extubate slowly.

adhering to the inside of the tube.
[7] Confirm that the cuff internal pressure and respiratory control status are<Precautions for the using method>

appropriate after the suction operation.

[1] Make sure not to damage the cuff during open and take out the product.

[8] When connecting a respiratory circuit, etc. to this product, pay attention not to[2] Test the cuff, branch tube, pilot balloon, and valve for malfunction (leakage /blockage) before use. After checking, remove the air inside the cuff
completely.
[3] Do not block the tube lumen with lubricant.
[The airway may not be open.][4] Make sure not to damage the pilot balloon or cuff with the equipment (forceps,apply excessive force to this product.
[This may cause deviation from the trachea of this product, disconnection
from the respiratory circuit, blockage of this product or the respiratory circuit,etc.][9] Do not pull on the branch tube and pilot balloon.
[May cause a malfunction or leak.]etc.) or internal protrusions (cartilage, etc.) used during insertion.

[10] Do not connect a 3-way stopcock or an infusion extension tube to the valve[5] Pay attention to the following when inflating or deflating the cuff.

of the pilot balloon.

1) Use air to inflate the cuff, inject slowly and carefully.

[The valve was damaged when removing the 3-way stopcock, etc., It may[May damage the tracheal wall.]not be injected air into the cuff or released.]2) Use a general slip-type disposable syringe for cuff inflating.

[11] Before measuring the internal pressure of the cuff, make sure that no liquid[With a lock type syringe, it is impossible to insert very inside of the valve. If

has accumulated in the branch tube, pilot balloon, etc.

the taper does not match, the valve will be damaged.][Condensation events have been reported inside the cuff as water vapor

3) Use a clean syringe to keep foreign matter out of the valve.

permeates the cuff membrane. May not be possible to accurately measure[Foreign matter (dry body fluid, lint, etc.) may get caught in the valve andthe internal pressure of the cuff because it is sealed with water due tothe cuff may not inflate.]condensation on the branch tube.]

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

[12] Completely remove air from the cuff before inserting or removing the[If the insertion is shallow, it may not be possible to inject or remove air.]product and fixing its position.

5) When removing the syringe, make sure to hold the valve and rotate the[May damage the trachea.]syringe to remove.

[13] Aspirate the secretions that have accumulated in the oral cavity before[The valve may shift rarely, sometimes come off.]

remove the air from the cuff.

6) Operate the syringe slowly when shrinking the cuff.

[When the air is removed from the cuff, secretions may flow into the lungs.][If the syringe is operated rapidly, the cuff may stick to the cuff hole and the[14] If the air cannot be removed from the cuff, cut the branch tube and remove

air remaining in the cuff may not be released.]

the air.

[6] Check the cuff pressure during use regularly and manage appropriately.

[15] Replace with a new one according to the condition of the patient, changes in[7] Since the cuff pressure gauge cannot be used with this product, the amount of

the affected area, and the condition of the product.

air injected during use should be the amount when the cuff is gradually[16] If you find that the endotracheal tube is about coming off, do not rush andinflated and the noise due to air leakage disappears by auscultation of the neck.

contact your veterinarian immediately. After re-intubation, confirm that the[May damage the airway wall.]intubation was performed properly by listening to breath sounds.

[8] Always use a bite block for oral intubation.

[If the endotracheal tube is about coming off, the tip of the tube may have

[There is a risk of tube blockage and cutting by biting the tube.]already deviated from the trachea. In this case, if the tracheal tube is pushed[Ventilation may be impossible by biting the tube.]in as it is, there is a risk of being erroneously inserted into the esophagus.][9] When removing, pull out slowly and carefully because granulation may getcaught and this product may not come off easily or bleeding may occur.

<Failures・Adverse events>
Failures[1] Burst of cuff

[10] After removal, observe that no symptoms of ventilatory insufficiency such as
dyspnea.
[11] Prepare for tracheal intubation, etc. so that the airway can be secured[Burst due to the following causes.]

promptly in case of ventilation failure after removal.

・Contact with the patient's teeth.
・Damage due to improper handling when inserting the product (damage by[Precautions]<Important basic caution>

tweezers, forceps, scissors, knives, or other devices)2／3

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・Excessive infusion volume (overexpansion)・Infusion of gas other than air for cuff inflation< Expiration date >・Abrupt load due to self-extubation, etc.

If proper storage is maintained, refer to the expiration date on the individual

・Other multiple causes due to the above-mentioned events

packaging.
[By self-authentication (our data).][2] Disconnection of tube
[Disconnection due to the following causes]
・Damage by tweezers, forceps, scissors, knives, or other devices< Expiration date >・Abrupt load on the product due to self (accidental) extubation

This product has developed as "use within 30 days".

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

[By self-authentication (our data).]・Other multiple causes due to the above-mentioned events[3] If bite block is not used for oral intubation, it may cause obstruction andManufacturer

disconnection of the tube due to biting of the tube.

CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japan[4] Inability of extubation
In the event that the cuff doesn’t deflate, deflate the cuff by disconnecting thebranch tube under the guidance of a doctor.

In-house administration number: DC67281[5] Lumen obstruction and damage of the tube

R0-0 2020.10.21

Excessive application of lubricant on the tube may cause lumen obstruction
resulting in partial or complete inhibition of ventilation.
[6] Air leakage
Use of the product with attachments insecurely connected to the joint may
cause inhibition of ventilation.
Adverse events
When performing endotracheal intubation, the following adverse events areexpected:[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] If bit blok is not used for oral intubation, it 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 suchas injury of the trachea wall and influx of secretion such as saliva to thetrachea.
[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] When 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] When 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.
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