G&N PROCTOLUX 702000 Gebrauchsanweisung

PROCTOSCOPE
WITH LIGHT GUIDE
Product Description and Application
Description
PROCTOLUX®
PROCTOLUX®
PROTCOLUX™ is a range of single use, fully disposable and self-illuminating rigid endoscope.
These devices are used during either rectal examination or rectal surgery for use in
examination, diagnosis and treatment in anal cavity, rectum, or sigmoid colon. The
PROTCOLUX™ Proctoscopes come in two sizes 19mm and 25mm diameters.
All PROCTOLUX™ devices are shipped ready for use.
Should light output become impaired in use due to debris or smoke obscuring the light
output the end of the light guide can be cleared by wiping.
Re-use of this device represents an unnecessary and avoidable risk of cross infection to the
patient.
Application
The G&N PROCTOLUX ™ Proctoscope and associated Illuminator are intended to provide a
means of rigid speculum to the anal cavity, rectum, or sigmoid colon and to supply effective
illumination thus permitting direct visual examination and treatment by a suitably qualified
and experienced healthcare professional.
The devices key functions are:
1. To enable trained health and care professionals, to effectively view anal cavity, rectum, or
sigmoid colon to perform invasive investigational procedures.
2. Reduce the complexity and increase the ease of use by having a light source directly attached
to the device enabling the area to be viewed by the operator facilitated by an internal light
source that can illuminate the area without the need for extra equipment.
Intended Use
The G+N Medical 19mm and 25mm PROCTOLUX™ Proctoscopes are intended to provide
means of rigid endoscopic access to the patient's rectum and supply effective illumination to
permit direct visual examination by a suitably qualified and experienced healthcare
professional.
Indication and Patient Group
The Griffiths and Nielsen 19mm and 25mm PROCTOLUX™ Proctoscopes are indicated for use
when a suitably qualified and experienced healthcare professional requires to perform either a
direct rectal examination or surgery of the non-contraindicated patient using a suitable rigid
endoscope.
Instructions for Use
When ready to use the device, remove the device from its packaging Separate the peel
1.
pouch and remove the product. Discard the package. Examine the pack before use. The pack
shall not be issued nor the proctoscope used if the wrapper or seal is broken DO NOT USE IF
PACKAGING OR PROCTOSCOPE IS DAMAGED
To activate the light, pull out the blue tab in the light pack in the device handle. Pull out
2.
the blue tab in the light pack in the device handle to activate the light source before
insertion into the patient. Maximum illumination intensity is maintained for a minimum of
30 minutes. The light pack will operate for a considerably longer period, with gradually
diminishing intensity. Once activated the light cannot be switched off.
Ensure that the appropriate size of proctoscope is selected before commencing the
3.
procedure
Apply a suitable lubricant to the outer aspect of the proctoscope and then gradually and
4.
gently insert the proctoscope into the anal canal and rectum
When the proctoscope is in the required position, remove the inner obturator to facilitate
5.
insufflation (if required) and observation of the rectum
Upon completion of the examination, gradually and gently withdraw the proctoscope
6.
from the anal canal and then confirm that the patient is comfortable
After use, ensure that the product is disposed of safely into an appropriate clinical waste
7.
container in accordance with local policies and procedures as described below.
Dispose the device in an appropriate way as described in the disposal section below.
8.
IMPORTANT Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member State in which
the user and/or patient is established.
Contraindications
Acute Severe Diverticulitis
Acute peritonitis
Recent Colonic Surgery
Colonic Necrosis
Toxic Megacolon
Fulminant Colitis
Griffiths and Nielsen Ltd.
Maydwell Avenue, Stane Street,
Slinfold, Horsham, RH13 0GN, UK
INSTRUCTIONS FOR USE
Model Size Product Code
19mm 702000
25mm 702010
Diverticular Abscess
Anal Fissure
T: +44 (0)1403 799190
E: medsales@gandn.com
www.gandn.com
PROCTOLUX
Do not re-use
Catalogue number
Batch number
Use by date
Date of manufacture
Direct electrical current at voltage
shown
Not made with natural
rubber latex
Do not look directly into the
light source
Fragile – handle package
carefully
No DEHP
Medical Device
GMDN 35255
Global Medical Device Nomenclature
Disposal
Discard PROCTOLUX™ with the light pack still attached, as "clinical waste" according to
hospital, or local protocols. Note: If required the light pack can be removed by firmly pulling
the entire pack downwards. Do be careful as it may well release suddenly. Dispose of the light
pack responsibly.
Warnings
Before each use carefully examine the instrument to ensure that there are no visible
scratches, chips, voids, etc. These could cause the instrument to lose its stability potentially
compromising safety. The patient should be informed when the Proctoscope is to be
introduced and removed.
Adjustments may be necessary to provide improved comfort.
WARNING Inspect each device and packaging for damage prior to use
For hygienic reasons always wear surgical gloves when handling the device
WARNING
before and after use. The device will come into contact with biological fluids
which are potentially infectious.
When in transit or storage, device may be subject to damage beyond the
WARNING
control of the manufacturer or supplier.
WARNING Never use device with laser equipment.
WARNING
Treat used devices as biohazardous infectious material. Dispose of used
devices in suitable disposal unit or in accordance with local regulations.
WARNING Device is not compatible with any sterilization method.
WARNING No modification of this equipment is allowed.
Never use an ultrasonic cleaner for the device, the device should not be
WARNING
cleaned or sterilised in any way as it provided in clean hygienic form for single
use only.
FOR SINGLE USE ONLY:
The G&N Medical device is designed for single use only; do not reuse device. G&N does not
have data regarding reuse of this device. Reuse may cause device failure or procedural
complications including device damage, compromised device biocompatibility, and device
contamination. Reuse may result in infection, serious injury, or patient death. After use,
this product may be a potential biohazard. Handle and dispose of in accordance with
accepted medical practice and applicable laws and regulations.
Cautions:
For use by trained healthcare personnel only
Federal (USA), UK and European Union Law restricts this device to sale, distribution and use
by or on the order of a physician.
Storage
Store devices in their original packaging at room temperature and normal air humidity.
The shelf life is indicated on the product.
CS Lifesciences Europe Limited
3 Inns Quay, Dublin 7, Ireland
®
Do not use if package is
damaged
Keep dry
Shock protection (Type BF
Applied Part)
Federal or EU Law restricts this
device to be sold by or on the
order of a licensed Health
Practitioner
Warning/caution consult
accompanying documents
Consult instructions for
use/consult operating
instructions
Non-sterile
Manufacturer and address of
the manufacturer
Number of items per
pack
IP rating
Medical Device in conformity
with Regulation (EU) 2017/745
110002/3
05/2021