BCS
  • Home
  • Contact Us
  • Sign In

Stryker

Stryker Precision IDEAL EYES HD Autoclavable Laparoscope 502-103-xxx User Guide

Revision Not Listed

Stryker Precision IDEAL EYES Laparoscopes

11 Pages

Precision Ideal Eyes™ HD Autoclavable Laparoscopes User Guide   Contents English ... 1 Français... 9 Deutsch ... 9 Italiano...  Português... 9 Español ... 49 Nederlands ... 9 Dansk ... 69 Suomi ... 79 Norsk ...  Svenska... 97 Polski ... 05 Ελληνικά ... 15 Türkçe ... 125 Русский ... 135 简体中文... 45 ඾ུࢊ ... 153 ซ‫ן‬૚ ... 161
File Type: PDF
File Size: 173KB
File Name: Stryker Precision IDEAL EYES HD Autoclavable Laparoscope 502-103-xxx User Guide.pdf
Available for download

Available for download in the BioClinical Services library

If you already belong to a hospital with access, please login via your intranet.

Contact Us to Register Your InterestAlready a member? Log in hereAbout Us

Stryker Precision IDEAL EYES HD Autoclavable Laparoscope 502-103-xxx User Guide.pdf

Page 1

Precision Ideal Eyes™ HD

Autoclavable Laparoscopes

User Guide

Page 3

Contents

English ......................................................1

Français..................................................... 9

Deutsch ..................................................19

Italiano....................................................29

Português...............................................39

Español ...................................................49

Nederlands ............................................59

Dansk ......................................................69

Suomi ......................................................79

Norsk .......................................................87

Svenska...................................................97

Polski .................................................... 105

Ελληνικά .............................................. 115

Türkçe .................................................. 125

Русский ............................................... 135

简体中文.............................................. 145

඾ུࢊ .................................................. 153

ซ‫ן‬૚ .................................................. 161

Page 5

Product Description

Stryker Precision Ideal Eyes™ (Precision IE) HD autoclavable

laparoscopes are tubular optical instruments used to provide a

view of internal patient anatomy for examination, diagnosis, and

therapy during laparoscopic procedures.

Precision Ideal Eyes™ HD autoclavable laparoscopes are offered in

a variety of sizes, working lengths, and directions of view.

Precision Ideal Eyes™ HD Autoclavable Laparoscopes

t Visualize with high image definition

t Visualize using the near-infrared light produced by the Stryker

InfraVision™ Illuminator (220-180-521)

t Autoclavable

t Precision Ideal Eyes™ laparoscopes are easily identifiable by their

distinct purple eye piece and are classified with the following

part numbers:

Precision Ideal Eyes™ HD Autoclavable Laparoscopes

Angle of view

0°

30°

45°

5 mm

502-503-010

502-503-030

502-503-045

10 mm

502-103-010

502-103-030

502-103-045

Bariatric 5 mm

502-513-010

502-513-030

502-513-045

Bariatric 10 mm

502-113-010

502-113-030

502-113-045

All Stryker laparoscopes are intended for use by qualified persons

during laparoscopic procedures to provide an internal view or

image of the patient. In all cases, the surgeon is best advised to use

a method in which his/her own practice and discretion dictate to

be the best for the patient. These instructions are recommended

for the proper function of the device. This material is not intended

as a reference for laparoscopic examination or surgery, nor is it

intended to replace training, including relevant preceptorship(s).

1

2

3

1. Distal End

2. Light Post

3. Proximal End

Indications

Standard Laparoscopes

The Stryker Laparoscope is intended to be used for gynecological

and general procedures that clinicians deem appropriate for the

patient. Laparoscopes have been available for many years and

laparoscopy is considered a mature surgical technique, which has

been established in general and gynecological procedures.

Bariatric Laparoscopes

Laparoscopes are intended to be used by surgeons in diagnostic

and therapeutic procedures. Laparoscopic minimally invasive

procedures are performed in the abdominal cavity by means of

small skin punctures that allow the insertion of the laparoscope

and laparoscopic instruments. This includes, but is not limited

to such uses as gallbladder and appendix removal, hernia

repair, gastric bypass, laparoscopic Nissen and examination of

the abdominal cavity, appendix, gallbladder and liver. Bariatric

laparoscopes allow surgeons to perform procedures on morbidly

obese segments of their patient population.

Contraindications

There are no known contraindications.

Warnings

1.

2.

3.

4.

5.

6.

Federal law (USA) restricts this device to sale by or

on the order of a physician.

This laparoscope is shipped non-sterile. To prevent

infection, clean and sterilize the laparoscope prior to

the first and every subsequent use. Prior to cleaning

or sterilization, remove any protective sheathing that was used

to protect the laparoscope during shipment.

Laparoscopic procedures should be performed only by persons

having adequate training and familiarity with laparoscopic

techniques. Consult medical literature relative to techniques,

complications and hazards prior to performing any

laparoscopic procedure.

Failure to use protective filters or suitable filtering spectacles

during the activation of a surgical laser beam may cause eye

damage to the user.

Activation of a 600 – 1100 nm wavelength surgical laser during

a laparoscopic procedure can cause the image to become

saturated, and therefore unclear. Verify compatibility prior to

surgery.

When used with a light source, the laparoscope can reach

temperatures exceeding 41°C (106°F) near the light cable

inlet and the distal tip, creating a risk for patient burns and

operating room fires. To reduce these risks:

t Never leave the laparoscope in direct contact with patient

tissue or combustible materials, such as drapes or gauze.

t Always start the procedure with the light source at its lowest

possible setting. As needed, gradually increase the light

output to the minimum level where adequate illumination

is achieved.

t Before disconnecting the light cable or connectors, turn off

EN-1

Page 6

the light source and allow the laparoscope to cool.

7. Do not use the laparoscope as a probe or apply pressure with

the laparoscope tip to surrounding tissues. The temperature

and construction of the laparoscope can damage patient

tissue.

8. Before each use, the outer portion of the laparoscope intended

to be inserted into the patient should be checked to ensure

there are no rough edges or protrusions that may accidentally

cut or damage patient tissue.

9. Contact with a rotating or cutting instrument may cause the

surface of the laparoscope to become sharp or jagged or may

result in portions of the laparoscope being broken into the

patient.

10. Failure to remove the laparoscope and laparoscopic accessories

during a cardiac defibrillator discharge may lead to punctured

or injured patient tissue.

11. To ensure a clear image, clean the window at the laparoscope’s

distal tip with sterile alcohol wipes or cotton tip applicators and

isopropyl alcohol.

Cautions

1. Keep the laparoscope clean and dry when not in use. The

stainless steel exterior of the laparoscope is rust-resistant, not

rust-proof.

2. Bending the laparoscope, or using the laparoscope as a lever

or pry bar, may result in lens damage and may render the

laparoscope unusable.

3. Contact with a surgical laser beam may damage the

laparoscope surface and internal optics.

4. Third party repair is not recomended for Precision Ideal

Eyes™ Laparoscopes. Repair by any party other than Stryker

Endoscopy could compromise InfraVision™ IR Illuminator

compatibility.

5. Some surgical lasers may not be visible when used with

Precision Ideal Eyes™ laparoscopes. Prior to surgery, verify that

the selected laser can be viewed through the laparoscope.

6. Only Infrared laparoscopes can be used in conjunction with

the InfraVision™ IR Illuminator (REF P/N 220180521). Using noninfrared laparoscopes with the InfraVision™ IR Illuminator can

lead to decreased visibility of infrared wavelengths. Precision

Ideal Eyes™ laparoscopes are easily identifiable by their distinct

purple eye piece.

Electrical Safety

1. Stryker laparoscopes should only be connected to Type F

devices. Stryker laparoscopes are classified as Type CF when

attached to a Type CF device, and Type BF when attached to a

Type BF device.

2. When laparoscopes are used with energized endoscopicallyused accessories, patient leakage currents may be additive.

To minimize total patient leakage current, use only Type CF or

Type BF endoscopic accessories. Type CF applied parts should

always be used together with other Type CF applied parts.

3. Consult literature for the safe use of electrosurgical equipment.

Inadvertent burns can occur when the patient return path is

obstructed.

Connecting a Light Cable

Three adapters (Wolf, Storz and ACMI) are included to enable

connection of the laparoscope to different styles of light cables.

SafeLight™ adapters may be purchased separately.

Wolf Light-Post Adapter

Storz Scope End Adapter

ACMI Scope End Adapter

SafeLight™ Henke/Dyonics/Storz Scope Adapter

(not included)

Notes:

t For best performance, ensure the light cable is not worn or

damaged.

t Remove the adapter from the laparoscope and light cable before

cleaning and sterilization.

1

2

1

Connect the light post to the appropriate adapter.

2

Connect the adapter to the appropriate cable.

EN-2

Page 7

Using Polishing Paste

Polishing paste is included with the laparoscope. If any of the three

optical surfaces (distal end, light post or proximal end) has deposits

that cannot be removed in normal cleaning practices, they can be

removed with the paste prior to cleaning and sterilization.

1. Apply a small amount of polishing paste to a clean cotton

swab.

2. Gently rub the cotton swab on the optical surface, cleaning in

a circular motion.

3. Use acetone or alcohol on a clean cotton swab to remove the

paste residue.

4. Clean and sterilize the laparoscope before its next use.

Caution: Polishing optical surfaces should not be part of routine

cleaning procedures. Repeated application of polishing paste

to the laparoscope lens can cause damage. It should only be

performed when the laparoscope image is cloudy.

Reprocessing

These reprocessing instructions are provided in accordance

with ISO 17664, AAMI TIR 12, AAMI ST79, and AAMI ST81.

While they have been validated by Stryker as being capable of

preparing the device for re-use, it remains the responsibility of the

processor to ensure that the reprocessing, as actually performed

(using equipment, materials, and personnel in the reprocessing

facility), achieves the desired result. This normally requires

validation and routine monitoring of the process. Stryker

recommends users observe these standards when reprocessing

medical devices.

Warnings

t This device must be cleaned and sterilized prior to the first

use and after every subsequent use.

t The sterilization parameters presented in this document

apply only to laparoscopes sterilized outside of a sterilization

tray. When using a sterilization tray, consult the instructions

provided with the tray for proper sterilization parameters.

Stryker recommends sterilizing device inside of a sterilization

tray.

t Steam sterilization is the recommended method for Stryker

laparoscopes.

t Use only the sterilization cycles outlined in this document.

Using unspecified sterilization cycles may damage the device

or result in incomplete sterilization.

t Failure to follow cleaning instructions may result in

inadequate sterilization.

t Prior to cleaning, disinfection, or sterilization, remove

any protective sheathing that was used to protect the

laparoscope during shipment. These include rubber caps on

the distal and proximal end of the laparoscope as well as a

plastic cover on the light post.

t Prior to cleaning, disinfection, or sterilization, separate the

laparoscope from the camera head, coupler, and adapter,

which may come pre-attached to the laparoscope. If any

of these components are cleaned, disinfected, or sterilized

as a single unit, disconnecting the devices during use will

compromise the sterility of the products. (Refer to the

camera head and coupler product manuals for reprocessing

instructions.)

t Unwrapped immediate-use (“flash”) steam sterilization is not

recommended because water source impurities may cause

hard films to build up on the outer optical windows of the

laparoscope, reducing optical performance.

t Wear appropriate protective equipment: gloves, eye

protection, etc.

Cautions

t Do not use brushes or pads with metal or abrasive tips

during manual cleaning, as permanent scoring or damage

could result.

t To minimize galvanic corrosion, avoid soaking dissimilar

metals in close proximity.

t Allow the device to air cool following steam sterilization.

Rapid cooling or “quenching” in a liquid will damage the

device and void the warranty.

Limitations on Reprocessing

t Using multiple sterilization methods may significantly reduce

the performance of the device and is not recommended.

t Proper reprocessing has a minimal effect on this device. End

of life is normally determined by wear and damage due to

use.

t Damage incurred by improper reprocessing will not be

covered by the warranty.

Instructions for Reprocessing

Point of Use

t Wipe excess soil from the device using disposable paper

towels or lint free cloth.

t If an automated reprocessing method will be used, rinse any

channels in the device with 50 mL of sterile distilled water

immediately after use.

Containment and Transportation

t Reprocess the device as soon as reasonably practical

following use.

t Transport the device in a sterilization tray to avoid damage.

EN-3

Page 8

Preparation for Cleaning

1. Remove any light post adapters from the scope prior to

cleaning.

2. Prepare an enzymatic detergent1 according to the

manufacturer’s recommendations.

3. Wipe the entire device with the detergent, using a clean

cloth.

4. Immerse the device in the detergent. Inject any inside

regions of the device with 50 mL of the detergent solution

to ensure all parts of the device are reached.

5. Soak the device in the detergent for 15 minutes.

Manual Cleaning

1. Brush

t Prepare a fresh solution of enzymatic detergent1

according to the manufacturer’s recommendations.

t Thoroughly brush the exterior of the device with a softbristled brush, focusing on any mated or rough surfaces.

t Using a syringe, inject any mated surface 5 times with

50 mL of the detergent.

2. Rinse

t Rinse the device with water2 at ambient temperature

until all detergent residue is removed.

t Flush any mated surfaces 5 times.

t Once all detergent residues is removed, continue to rinse

for a minimum of 30 seconds.

t Drain excess water from the device and dry it using a

clean cloth or pressurized air.

t Visually inspect the device for cleanliness, paying close

attention to hard-to-reach areas. If visible soil remains,

repeat steps 1 and 2.

3. Soak

t Prepare a non-enzymatic detergent3, according to the

manufacturer’s recommendations.

t Fully immerse the device and inject any mated surfaces

with 50 mL of the detergent.

t Soak the device for 15 minutes.

4. Brush

t Thoroughly brush the exterior of the device using a

soft-bristled brush.

t Inject the prepared detergent into any mated surfaces

5 times.

5. Rinse

t Thoroughly rinse the device with water2 until all

detergent residue is removed. Flush any crevices 5 times.

Once all detergent residue is removed, continue to rinse

for 30 seconds.

t Drain the excess water from the device.

1

Enzol® at 1 oz/gal (US) at 35 – 40°C was validated for cleaning efficacy.

2

Reverse Osmosis/Deionized (RO/DI) water was validated for cleaning efficacy.

Prolystica 2x Neutral Detergent at 1/8 oz/gal was validated for cleaning efficacy.

3

Automated Cleaning

1. Brush

t Thoroughly brush the device with an appropriately sized

soft-bristled brush, focusing on hard-to-clean areas.

2. Rinse

t Rinse the device with water2 at ambient temperature

until all visible detergent residues have been removed.

t Flush all crevices and mated surfaces at least five times.

t Continue to rinse the device for a minimum of

30 seconds after all detergent residue has been removed.

EN-4

Page 9

3. Automated Wash

t Place the device in an automated washer on an incline to

facilitate drainage.

t Program the washer with the following parameters, then

activate the wash:

Pre-Wash

Recirculation Time

2 Minutes

Water Temperature

Cold

Detergent Type

N/A

Enzyme Wash

Recirculation Time

2 Minutes

Water Temperature

Hot

Detergent Type

Enzymatic Detergent4

Wash 1

Recirculation Time

2 Minutes

Water Temperature

66°C Set Point

Detergent Type

Non-Enzyamtic Detergent5

Rinse 1

Recirculation Time

2 Minutes

Water Temperature

Hot (60°C)

Detergent Type

N/A

Dry Phase

Recirculation Time

7 Minutes

Water Temperature

115°C

Detergent Type

N/A

4

Enzol® at 1 oz/gal (US) was validated for cleaning efficacy.

5

Prolystica 2x Neutral Detergent at 1/8 oz/gal was validated for cleaning efficacy.

Drying

t Dry the device using a cleaning cloth.

t Filtered pressurized air can be used to assist in drying.

Inspecting

1. Visually inspect the device, including all internal surfaces,

for remaining soil.

2. If soil remains, repeat manual or automated cleaning

procedure, focusing on those areas.

Disinfection (optional)

Warning: Not to be used in place of sterilization.

1. Remove any light post adapters from the scope prior to

disinfection.

2. Disinfect the device in a disinfecting solution that has the

following active ingredients:

t ≥ 2.4% glutaraldehyde (with minimum immersion time

of 45 minutes at 25°C)6

t ≥ 0.55% ortho-phthalaldehyde (with a minimum soaking

time of 12 minutes at 25°C)7

3. Prepare the disinfecting solution according to the

manufacturer’s instructions.

4. Per the manufacturer’s recommendations, immerse the

device in the disinfecting solution for the required time at

the appropriate temperature.

5. Using a syringe, flush any openings a minimum of 10 times

each with the same disinfecting solution.

6. Thoroughly rinse and flush all interior and exterior

surfaces with running deionized water until the device is

visibly clean and all disinfecting solution and/or residue is

removed.

7. Dry all parts with a lint-free towel immediately after rinsing.

6

7

Cidex® Activated was validated for disinfection efficacy.

Cidex® OPA was validated for disinfection efficacy.

Thermal Disinfection (optional)

Warning: Not to be used in place of sterilization.

1. Disassemble any adapters from the scope prior to

disinfection.

2. Place the scope into the washer disinfector.

3. Program the washer using the following parameters:

Thermal Disinfection

Recirculation Time

1 Minute

Water Temperature

90°C

EN-5

Page 10

Sterilization

After performing the cleaning instructions specified above,

perform one of the following sterilization cycles:

Steam Sterilization for Precision Ideal Eyes™

Laparoscopes

1. Clean and prepare the device as recommended in the

Cleaning and Disinfection sections.

2. Disassemble any adapters from the scope prior to

sterilization.

3. If using a sterilization tray, place the scope and adapters

in the tray and follow instructions provided with the

tray. Use only trays that are approved for sterilization

with steam.

4. Double wrap the device (or tray, if being used) prior to

sterilization.

5. If sterilizing the device without a tray, use the following

parameters for the appropriate length:

Warning: Drying time depends on several

variables, including altitude, humidity, type of wrap,

preconditioning, size of chamber, mass of load,

material of load, and placement in chamber. Users

must verify that drying time set in their autoclave

yields dry surgical equipment.

Standard Length Laparoscopes

Pre-Vacuum (U.S.)

Wrapping

Double

Temperature

132°C (270°F)

Sterilization Time

4 minutes

Dry Time

30 minutes

Pre-Vacuum (E.U.)

Wrapping

Double

Temperature

134°C (273°F)

Sterilization Time

3 minutes

Dry Time

30 minutes

Gravity

Wrapping

Double

Temperature

132°C (270°F)

Sterilization Time

15 minutes

Dry Time

35 minutes

“Flash” Pre-Vacuum

Wrapping

-

Temperature

132°C (270°F)

Sterilization Time

4 minutes

Dry Time

-

Bariatric Length Laparoscopes

Pre-Vacuum (U.S.)

Wrapping

Double

Temperature

132°C (270°F)

Sterilization Time

4 minutes

Dry Time

45 minutes

Pre-Vacuum (E.U.)

Wrapping

Double

Temperature

134°C (273°F)

Sterilization Time

3 minutes

Dry Time

45 minutes

“Flash” Pre-Vacuum

Wrapping

-

Temperature

132°C (270°F)

Sterilization Time

4 minutes

Dry Time

-

6. Allow the laparoscope to completely cool before

reassembling it to a coupler or camera head. Otherwise,

the lens will fog during use.

EN-6

Page 11

STERRAD®

Warning: Not all sterilization trays are

compatible with STERRAD® systems. Using an

incompatible tray may result in incomplete device

sterilization. Consult the instructions that came with

your sterilization tray to determine which sterilization

method is compatible with your tray and devices. If a

compatible tray is not available, the devices can be

double-wrapped for use with the STERRAD® system.

1. Clean and prepare the endoscope as recommended in

the Cleaning and Disinfection sections.

2. Disassemble any adapters from the scope prior to

sterilization.

3. Double wrap the device (or tray, if being used) prior to

sterilization.

4. Sterilize the endoscope following the instructions of the

manufacturer, using the STERRAD® 100S, 200, NX™ or

100NX™ Sterilization System. Select the standard cycle.

5. Allow the endoscope to completely cool before

reassembling it to a coupler or camera head. Otherwise,

the lens will fog during use.

STERIS®/Amsco® V-PRO

1. Clean and prepare the endoscope as recommended in

the Cleaning and Disinfection sections.

2. Disassemble any adapters from the scope prior to

sterilization.

3. Double wrap the device (or tray, if being used) prior to

sterilization.

4. Sterilize the endoscope using the V-PRO maX Sterilizer

(Non-Lumen or Standard Cycle), the V-PRO 1 Plus

Sterilizer (Non-Lumen or Standard Cycle), or the V-PRO 1

Sterilizer (Standard Cycle).

5. Allow the endoscope to completely cool before

reassembling it to a coupler or camera head. Otherwise,

the lens will fog during use.

Maintenance, Inspection, and Testing

t Inspect the device on a continual basis. If a problem is

observed or suspected, the device should be returned for

repair.

t Inspect all components for cleanliness. If fluid or tissue

buildup is present, repeat the above cleaning and

disinfection procedures.

t Inspect the optical surfaces of the laparoscope for clarity.

If there are deposits that need to be removed, follow the

instructions in the “Using Polishing Paste” section.

Caution: Polishing optical surfaces should not be part

of routine cleaning procedures. Repeated application of

polishing paste to the laparoscope lens can cause damage.

It should only be performed when the laparoscope image is

cloudy.

Expected Service Lifetime

The recommended service interval for Stryker Precision Ideal

Eyes™ Laparoscopes is one year.

Technical Specifications

Transport and Storage Conditions:

Temperature: -18 – 60°C (0 – 140°F)

Relative Humidity: 15 – 90%

Insertion portion width of 10 mm Precision Ideal Eyes™

laparoscopes:

10.00 ±.05 mm (standard)

10.00 +.02/-.05 mm (bariatric)

Insertion portion width of 5 mm* Precision Ideal Eyes™

laparoscopes:

5.5 +.02/-.05 mm (standard and bariatric)

*Precision Ideal Eyes™ Laparoscopes marked on device as

5.5 mm are part of and compatible with the 5 mm family of

products.

Laparoscope Disposal

Laparoscopes must be disposed of according to local laws and

hospital practices.

Warranty and Return Policy

Go to http://stryker.com/EndoSalesTerms.

EN-7

Page 12

Symbol Definitions

Consult instructions for use

Caution; see instructions for use

Non-Sterile

Manufacturer

Date of Manufacture

Catalog Number

Serial Number

Quantity

Authorized Representative in the European

Community

Conformance to 93/42/EEC

Made in Germany

Temperature Range

Humidity Range

EN-8

Page 13

Description du produit

Les laparoscopes autoclavables HD Precision Ideal Eyes™

(Precision IE) de Stryker sont des instruments optiques tubulaires

utilisés pour obtenir une vue de l’anatomie interne du patient

pendant l’examen ainsi qu’un diagnostic et un traitement pendant

les procédures laparoscopiques.

Les laparoscopes autoclavables HD Precision Ideal Eyes™ sont

disponibles en plusieurs tailles, longueurs opérationnelles

et directions de visualisation.

Laparoscopes autoclavables HD Precision Ideal Eyes™

t Visualisation avec une définition d’image supérieure

t Visualisation avec la lumière proche infrarouge du dispositif

d’éclairage InfraVision™ de Stryker (220-180-521)

t Autoclavable

t Les laparoscopes Precision Ideal Eyes™ sont facilement

identifiables par leur oculaire violet distinct. Ils sont classés

avec les références suivantes :

Laparoscopes autoclavables HD Precision Ideal Eyes™

Angle de

visualisation

0°

30°

45°

5 mm

502-503-010

502-503-030

502-503-045

10 mm

502-103-010

502-103-030

502-103-045

Bariatrique 5 mm

502-513-010

502-513-030

502-513-045

Bariatrique 10 mm 502-113-010

502-113-030

502-113-045

Tous les laparoscopes Stryker sont conçus pour être utilisés par des

personnes qualifiées pendant les interventions laparoscopiques

afin de fournir une vue ou image interne du patient. Dans tous les

cas, le chirurgien est le mieux placé pour utiliser une méthode qu’il

jugera la plus adaptée au patient sur la base de sa propre pratique

et selon sa discrétion. Ces instructions sont recommandées

pour garantir le bon fonctionnement du dispositif. Ce document

ne constitue pas une référence pour l’examen ou la chirurgie

laparoscopique et ne remplace pas la formation, y compris le(s)

préceptorat(s) correspondants.

1

2

3

1. Extrémité distale

2. Tige d’éclairage

3. Extrémité proximale

Indications

Laparoscopes standard

Les laparoscopes Stryker sont destinés à une utilisation dans le

cadre de toutes les procédures gynécologiques et générales que

les médecins estiment appropriées. Les laparoscopes existent

depuis de nombreuses années et la laparoscopie est aujourd’hui

considérée comme une technique chirurgicale maîtrisée qui a trouvé

sa place en chirurgie générale et gynécologique.

Laparoscopes bariatriques

Les laparoscopes sont destinés à une utilisation par des chirurgiens

dans le cadre de diagnostics et de procédures thérapeutiques.

Les procédures laparoscopiques mini-invasives sont réalisées

dans la cavité abdominale au moyen de petites incisions qui

permettent l’insertion du laparoscope et des instruments

laparoscopiques. Cela inclut notamment les utilisations destinées

à la cholécystectomie et à l’appendicectomie, à la réparation

herniaire, au by-pass gastrique, à l’opération de Nissen par voie

laparoscopique, et à l’exploration de la cavité abdominale, de

l’appendice, de la vésicule biliaire et du foie. Les laparoscopes

bariatriques permettent aux chirurgiens d’opérer des patients

souffrant d’obésité morbide.

Contre-indications

Il n’existe pas de contre-indications connues.

Avertissements

1.

2.

3.

4.

5.

Conformément à la législation des États-Unis,

ce dispositif ne peut être vendu que par un médecin

ou sur prescription médicale.

Ce laparoscope est fourni non stérile. Pour prévenir

l’infection, nettoyer et stériliser le laparoscope

avant la première utilisation et, par la suite, avant

chaque utilisation. Avant de procéder au nettoyage ou à la

stérilisation, retirer le gainage de protection utilisé pour protéger

le laparoscope pendant l’expédition.

Les interventions laparoscopiques doivent être réalisées

exclusivement par des personnes dûment formées et

expérimentées dans les techniques laparoscopiques. Avant

de procéder à une intervention laparoscopique, consulter la

documentation médicale sur les techniques, les complications

et les risques.

La non-utilisation de filtres protecteurs ou de lunettes filtrantes

appropriées pendant le fonctionnement d’un faisceau laser

chirurgical peut causer des lésions oculaires chez l’utilisateur.

L’activation d’un laser chirurgical de longueur d’ondes

600 – 1 100 nm pendant une intervention laparoscopique

peut saturer l’image et par conséquent la rendre floue. Vérifier

la compatibilité avant l’intervention chirurgicale.

FR-9

Previous Page Next Page
© 2021 BioClinical Services Ptd Ltd
Terms of Use
Privacy Statement