12

5 Description of Devices
5.1 WA950054

Sterile insufflation tubing

1) Filter
2) lnsufflator connector
3) lnstrumenl connector

Tubing w7092551
 7l
2 Safety lnformation
2.1 lntended Use
Tubing
w495005A
Sterile tubing with filter, for insufflation, for use in conjunction
with an insufflator in laparoscopic procedures.
. Do not use for any other purposes.

Tubing
wAg50074
Sterile tubing for smoke evacuation during laparoscopic
procedures with an insufflator.
. Do not use for any other purposes.

2.2 Procedu re Contrai nd ications

- Uncorrectable defect
- Severe heart failure
- Respiratory insufficiency
- Certain cancers
- Certain infections

2.3 Potential Procedure Complications

- Risk of infection
- Excessive water
- Embolism
- Arrhythmias
- Pneumothorax

w7092551 Tubing

I
 I
i

2.4 User Qualification

Medical Use
This product is only intended to be used by a trained physician
or trained qualified medical personnel under the supervision
of a physician.
These instructions for use do not explain or discuss clinical
procedures.

2.5 Environment of Use

Medicaluse
This product is only intended to be used in hospitals and
medical rooms with appropriate endoscopic equipment.

2.6 General Cautions

The following cautions apply to the general handling of
the product. This information is to be supplemented by the
cautions given in each chapter in this document.

CAUTION
Risk of injury to the patient and/or the user
Risk of damage to the product
An insufficient understanding of the cautions and instructions
can result in serious injury or damage to the product.
. Read the cautions and instructions in these instructions for
use.

Tubing w7092551
 I

CAUTION
Risk of injury to the pat¡ent and/or the user
Risk of damage to the product
The product is for single use only and delivered in a sterile
condition. Reuse, reprocessing or resterilization may lead to
malfunction of the product and/or injury of the patient and/or
the user.
. Do not use sterile-packaged products if the packaging has
been opened, is damaged or if there are other signs of non-
sterility.
. Do not use the product after its expiration date.
. Open the packaging only immediately before use.
. Do not attempt to reprocess or resterilize disposable
products.
. Do not reuse disposable products.

w7092551 Tubing

E
t
 11

4 Conditions of Use and Storage

The device should be stored and transported in a normal
environment, i. e. away from extreme temperatures and
humidity. Do not use if the sterile barrier is damaged and/
or deteriorated. These devices are for single use only. Do
not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the integrity of the device and/
or lead to failure, which may result in patient injury, illness
or death. Also reuse, reprocessing and resterilization may
introduce a risk of contamination of the device and/or cause
patient infection or cross infection to another patient, which
may lead to injury, illness or death. Under any circumstances,
the manufacturer will not be held liable in the case of reuse,
reprocessing or resterilization of the tubings. After use,
dispose of the device and packaging in accordance with
hospital, administrative and/or local govern ment pol icy.

w7092551 Tubing

f
r
I

l,n
l
Do not use if package is damaged

Use by date

Sterilized using ethvlene oxide

lsrER{LElEol

Do not reuse

@
Do not resterilize

@ No presence of natural rubber latex

W
w
No presence of phthalate:diethylhexyl phthalate (DEHP)

DEHP

& Biological risks

CE certification mark - symbol for the compliance with the

C€ Medical Device Directive 931 4Z|EEC

0459

Tubing w7092551
 6 Directions for Use
6.1 lnspection
Damaged product
lnspect the lubing. Refer to the instructions for use of the
insufflator.
lf the product is damaged or does not function properly,
contact an Olympus representative or an authorized service
center.

6.2 Assembly and Connection

6.2.1 Connecting the lnsufflation Tubing W495005A

1. Connect the instrument connector of the insufflation tubing
to the trocar tube.
2. Connect the insufflator connector of the tubing to the
respective connection of the insufflator. Refer to the
instructions for use of the insufflator.

6.2.2 Connecting the Smoke Evacuation Tubing

wA950074

1. Connect the instrument connector of the smoke

evacuation tubing to the trocar tube.
2. lnsert the tubing section with the small diameter into the
COz suction control pinch valve of the insufflator. Refer to
the instructions for use of the insufflator.
3. Connect the connector for suction container of the smoke
evacuation tubing to a suction container.

w7092551 Tubing

L
7 Use
7.1 Safety lnformation for Use
CAUTION
Risk of infection
Risk of damage to the Product
Make sure that the product has been properly inspecied, and
tested. Refer to the instructions for use of the insufflator.

7.2 Procedure
CAUTION
Reduced insufflation capacity (only for WA950054)
The filter reduces the insufflator's flow rate. As a result,
the insufflator's maximum insufflation flow rate may not be
reached. Refer to the instructions for use of the insufflator.

7.3 Disposal
Do not reuse or attempt to resterilize.

&L After use, dispose of the device and packaging in

accordance with hospital, administrative and/or local
government policy.

Tubing w7092551
8 Compatible Equipment
CAUTION
Risk of injury to the patient
Risk of damage to the product
Use only compatible equipment as listed in this chapter.

8.1 Liability and Warranty

PROMEPLA S. A. M. and affiliates declare to the first
purchaser that reasonable care has been taken when
designing and manufacturing this product. lf damage
is suspected, contact an Olympus representative or an
authorized service center. The present limited warranty
dispenses all other warranties, express or implied, including
but not limited to any implied warranties concerning usability
or suitability for specific purposes. This limited guarantee
ensures that the responsibility of PROMEPLA S. A. M. and
affiliated companies will be limited to the replacement of
defective products. In no instance will PROMEPLA S. A. M.
and affiliaies be held liable for direct, indirect, incidental and/
or consequential damages of any kind arising from the use
and/or handling of the use and/or handling of the device.

CAUTION
Risk of injury to the pat¡ent
Risk of damage to the product
lf combinations are used that are not listed in this chapter, the
user takes the full responsibility.
Future equipment may also be compatible. For more
information, contact an Olympus representative.

w7092551 Tubing
 UHI-2
UHI-3
UHI.4

wAg50074

Tubing w7092551