LiNA OperåScope OP-TDK-6-I Gebrauchsanweisung Seite 2

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2021-11 FV0279B
LiNA OperåScope™ Tubing & Drape Kit
INTENDED USE
The LiNA OperåScope™ Tubing & Drape Kit (Tubing
Outflow Inflow
& Drape Kit) is intended for all Hysteroscopic
diagnostic and/or operative procedures, to manage
the fluids used for distending of the uterus.
PATIENT POPULATION
Adolescents or older female patients.
Right Hand
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PRODUCT DESCRIPTION
The Tubing & Drape Kit is delivered as a sterile,
single-use device. The Tubing & Drape Kit are
designed to be used specifically with the LiNA
OperåScope™ hysteroscope for histologic
examination. This tubing and drape kit should not
be used for any other purpose than their intended
function.
CONTRAINDICATIONS
The device is contraindicated for use with the
following conditions:
• Inability to distend the uterus
• Cervical Stenosis
• Cervical/Vaginal infection
• Uterine bleeding or menses
• Known Pregnancy
• Invasive carcinoma of the cervix
• Recent uterine perforation
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• Known Pelvic Inflammatory Disease (PID)
• Medical contraindication or intolerance to
anesthesia
WARNINGS
Failure to follow all instructions or any warnings or
precautions could result in serious patient injury.
• The Tubing & Drape Kit are provided STERILE
via ethylene oxide sterilization.
• Carefully inspect the packaging for any
damage prior to use. Do NOT use the device if
the sterile barrier is damaged.
• Do NOT use the device if exposed to non-sterile
Ready to use
surfaces before procedure.
• Do NOT use if past expiration date or if missing
expiry date.
• For single use only. Do NOT reuse,
reprocess or re-sterilize the components. Any
reprocessing may impede the functions of
this device. Reusing single use devices may
also increase the risk of cross contamination.
Attempts to clean the device results in risk of
device malfunction and/or cross contamination
to residual tissue in the tubing or drape.
Original IFU
2021-11 FV0279B
Ref: OP-TDK-6-I
• A liquid distension medium is used and strict
fluid intake and output surveillance should
be maintained. Intrauterine instillation
exceeding 1 liter should be followed with great
care to reduce the possibility of fluid overload.
• Hysteroscopic diagnostic and/or operative
procedures should ONLY be performed by
medical professionals who have adequate
training in hysteroscopy.
PRECAUTIONS
Potential complications of Continuous Flow
Hysteroscopy:
• Hyponatremia
• Hypothermia
• Uterine perforation resulting in possible injury
to bowel, bladder, major blood vessels and
ureter.
• Pulmonary edema
• Cerebral edema
• Infection
• Bleeding
• Pain
The use of normal saline as a distending medium,
and limiting the infused volume to less than 1000
ml is recommended to decrease the risk of the
above complications. Intrauterine distension can
usually be accomplished with pressures in the
range of 35 - 75 mmHg. Unless the systemic blood
pressure is excessive, it is seldom necessary to use
pressures greater than 75-80 mmHg.
REQUIRED ACCESSORIES
• Infusion bag stand with optional pressure cuff
or fluid management pump
• Saline bag (distending medium)
• Gynecological bench (examination bench)
INSTRUCTIONS FOR USE
The device consists of a drape with a pouch, an
inflow tubing, an outflow tubing, and a collection
bag.
Read the instructions for use prior to using this
device!
1. Throughout the procedure, use sterile
techniques to avoid contaminations.
2. Prior to opening the sterile pouch, hang
the saline bag in the stand/pressure cuff or
connect to the pump.
3. Prepare the LiNA OperåScope™ for use
by closing both luers. Refer to the LiNA
OperåScope™ manual for details.