USE INSTRUCTION
TAIMIN DISPOSABLE UTERINE MANIPULATOR
Please read all information carefully.
The non-compliance of the instructions may have serious surgical consequences
Important: This usage statement is intended to provide information for the use of Taimin
Uterine Manipulator. Not a reference to surgical techniques.
Indications
Taimin Uterine Manipulator is a medical device designed to be used during gynecological
procedures that require manipulation, uterine contraction for Laparoscopic occlusions,
laparoscopy diagnostic or surgical allowing greater visibility of pelvic anatomy.
It is also an efficient intrauterine gun, which effectively seals the internal cervical canal reverse
flow of fluids during injection through the central lumen of the instrument.
Description
Taimin Disposable Uterine Manipulator is a sterilized instrument for use on a single patient,
comprising a handle control, a rod, a pin, a flexible tip with injection ports, a balloon assist
device immobilizing the uterus, one balloon inflation valve and an injection port for the
chrome line.
Principle of Operation and Mechanism of Action:
TAIMIN Disposable Uterine Manipulator has coupled a single, sterile use gun. The depth of
insertion should be determined by the physician, and may be controlled in divisions of 1 cm.
Around the distal tip, but not covering the tip, there is an inflatable balloon through a standard
syringe (not included). The distal tip open, to allow its introduction into the uterus. Support
curved, hard nonremovable manual, has a neck lock shaped distal tip and a fixed elastic clip in
the proximal termination.
Strongly tightens the clamp, cervical latch can be positioned as appropriate depth. When
released, the clip pushes a pin into rigid catheter wall preventing any movement of the
support, since it is in the desired position. The balloon is then inflated in the uterus and
retracts internally. The device will remain safe and traumatic inside the uterus. The surgeon
may safely manipulate the uterus and injecting means internally without refluxing, through the
cervical canal.
Instruction for Use:
Before using the Manipulator, check the compatibility of all instruments and accessories for
the procedure.
1 Submit the uterus analysis sonography to select the appropriate size of the uterine
manipulator.
2 Unpack the instrument using appropriate aseptic technique. To avoid damage, place the
instrument carefully in the sterile field.
3 Using the syringe check the integrity balloon (located at the distal tip), injecting sterile saline
/ air through the balloon inflation valve. Remove the syringe and make sure that the balloon
remains inflated. Replace the syringe and remove the fluid / air, thus deflating the balloon.
4 After placing a speculum, examine the depth and orientation of the uterus using a normal
probe or dilating probe provided. If you must use a spacer, secure it into place it at the end of
the uterine manipulator. Make sure the spacer is properly fitted into place. The manipulator
tip, with the respective injection ports, should be positioned 1.0 cm below the maximum depth
of the uterus. If necessary, make dilatation of the cervix through the dilating probe provided,
or by any other standard surgical procedures.
5 Lubricate the tip and insert it slowly into the uterine cavity. With the location indicator to
neutral, fully insert the tip into the uterus until the spacer face contact with the outer zone of
the lap. Notice: Do not put lubricant on the spacer.
6 Inflate the balloon slowly with sterile saline until the spacer lies against the neck. Hold the
syringe plunger as to remove the balloon inflation valve so as to prevent liquid reflux into the
syringe. Make sure that the inflation indicator is filled with liquid to ensure the balloon
integrity. There inflate the balloon with more than 10 cc of saline.
7 Pull slightly on the uterine manipulator to see if it was properly seated in the womb. Turn
the speed control knob in the direction clockwise to the uterus stay in the desired position.
8 Starting with the rotation control button in the right position, make the handling of the
uterus by rotation of the handle. The rotation in the direction of clockwise to raise the uterus
allows for antevertida position. The rotation in the opposite direction clockwise allows
retroverter the uterus. Also the uterus laterally displaceable, driving the lever to one side or
the other.
Chrome tubing:
9 If necessary, inject the appropriate substance in the dye injection port to make sure that the
fallopian tubes are clear.
10 When the procedure is completed, insert the syringe into the balloon inflation valve and
remove the balloon net. Turn the location indicator to the neutral position and remove.
Warnings and Precautions:
A thorough knowledge of the principles and techniques involved in laser procedures,
electrosurgical and ultrasound to avoid shock and burn hazards to both the patient and the
medical staff, as well as damage to the device or other surgical instruments is essential. Make
sure that the electrical insulation and ground connections are in good condition. Do not
immerse electrosurgical instruments in any liquid.
• Before use make sure the device is working properly
• Before using the device, check the depth and orientation of the uterus using a standard
surgical technique. NEVER use the Disposable Uterine Manipulator as a probe.
• Do not use a tip that is greater than the depth of the uterus. Apply the spacer so that the
insertion depth is 1.0 cm less than the depth of the probe.
• If a spacer is used, make sure that is properly fitted into place.
• During the insertion or manipulation, do not force to meet much resistance.
• Never attempt extensive uterine manipulation without a clear vision of laparoscopic uterus.
• Never use the device without first testing the balloon. A balloon not inflated or underinflated device may result in expulsion from the womb during use.
• Do not inflate the balloon with more than 10 cc sterile saline.
• Do not force the tip into a cervical opening that is not sufficiently long.
• As with all uterine manipulators, should make a careful clinical examination before using the
device.
• The dye injection should be effected slowly. A quick injection can cause spasm of the tubes.
• Discard all open products, used or not. Do not sterilize the instrument. The sterilization may
compromise the integrity of this product, which could cause damage and faults in the device
and compromise the procedure.
• Do not use the Uterine Disposable Taimin Handler pouch is damaged.
ITEM
1
2
3
4
5
6
7
8
9
10
11
PARTS
Handle
Injector
Fixing screw
Sliding sleeve
Vaginal cup
Cervical cup
Balloon
Stem
PVC pipe
Pilot balloon
Air port
FEEDSTOCK
PC
PC
PC
PC
TPU
PVC
TPU
Stainless steel
PVC
PVC
PC
STANDARDS
ASTMF997-98a (2003)
ASTMF997-98a (2003)
ASTMF997-98a (2003)
ASTMF997-98a (2003)
ASTMD5476-99
ASTMD1755-92 (2001)
ASTMD5476-99
ASTMF1744-96 (2002) e1
ASTMD1755-92 (2001)
ASTMD1755-92 (2001)
ASTMF997-98a (2003)
CONTRAINDICATIONS:
The Manipulator Uterine Disposable Taimin should not be used in pregnant patients or
suspected pregnancy.
Below, technical product design with the complete description, including details of the raw
material and its components:
IMPORTADOR E DISTRIBUIDOR AUTORIZADO CIENLABOR IND. E COMÉRCIO LTDA
Rua Industrial José Flavio Pinheiro, no. 1.150 Parque Industrial Postal Code 58082-000
João Pessoa - Paraíba
Phone: 83 3049-8000
Operating Permit at ANVISA No. 8.00.829-1
CNPJ 02.814.280/0001-05
www.cienlabor.com.br
Technician in charge: Adriana Cícera Moretti Barbosa Pereira – CRF/PB: 4075
Manufacturer:
TONGLU QIANYAN MEDTECH CO., LTD
Address: ShenAo Village, Jiangnan Town Tonglu Country – Hangzhow 311509 Zhejiang - China