PROFESSIONAL MEDICAL PRODUCTS
SIGMOIDOSCOPIO
SIGMOIDOSCOPE
Manuale d’uso - User manual
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al
fabbricante e all’autorità competente dello Stato membro in cui si ha sede.
All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and
competent authority of the member state where your registered ofce is located.
29410 - 29411 - 29412 - 29413 - 29414
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
M29410-M-Rev.3-07.20
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Read these instructions carefully before using the sigmoidoscope and keep them in a safe place for
future reference.
Attention
The operator/user must carefully read and understand this manual thoroughly to keep the product performance durable and reliable for longer period.
After opening the packaging, rst of all it is necessary to check all the components against the standard
conguration. Check that they are all present and in perfect conditions.
Indications for use
Sigmoidoscope is an instrument primarily used for examination and treatment of the anal passage. The
sigmoidoscope is available in ve different sizes.
Feature
These sigmoidoscopes have anular F/O illumination hence the anal passage is evenly illuminated for
easier examination.
These sigmoidoscope can be powered either with a powerful 120 watt Halogen light source, or by a
more compact and economical 6.0 volt lamp handle. These sigmoidoscopes are made from 18/8 type
stainless steel making them rust proof and most stable under cleaning and disinfection process.
Cautions
Sigmoidoscope must be inserted with obturator, securely locked. The cone of the obturator and the tube
must be lubricated with suitable lubricant before use.
Usage
Check that all parts are correctly attached before usage. All proctoscopes are supplied with ACMI and
Wolf connection. The instrument must be used by qualied medical personnel within a professional
health facility.
A STORZ connector is also supplied in the package, allowing multiple connect ability options.
Attach a F/O cable to a light source and then attach the coupling adaptor to the proximal end of the
adaptor on this sigmoidoscope as shown in g. 1.
If a light source is not available, a lamp handle with a direct main adaptor and a 6.0 volt halogen lamp
can be used as shown in g. 2. An add-on type F/O handle can also be used with the F/O cable which
can then act as the handle for these sigmoidoscope. Align the black mark on the handle with a similar
mark on the sigmoidoscope to achieve proper locking. The handle is locked onto the sigmoidoscope by
twisting the knob towards right. For unlocking, twisting the knob towards left and pull down the handle.
ENGLISH
Black mark
ENGLISH
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Lamp handle
Fig. 2
Loosen the sealing screw and open the window, insert the obturator in the sigmoidoscope by aligning
the top of the sigmoidoscope chamber, if required, connect an insufation bulb to sigmoidoscope head.
Lock the obturator by turning the head clockwise & anti-clockwise as shown in g. 3. Apply a lubricant
to the cone and insert in anal passage way. Unlock the obturator by aligning the pin and round mark
again and pull out the obturator. Now the instrument is ready for use. Turn on the light to light up on the
passage and perform examination and treatment. The plain glass window can be opened and closed
at any time. The instrument can be made airtight by gently tightening the screw. If magnication of the
object is required, insert the loupe into one of the holes provide. Both swivel to allow the window to be
opened or closed.
Screw
Below Nipple
Important
Window can be used as a protection against any unwanted material falling inside the sigmoidoscope.
So if the examination is not being conducted and the sigmoidoscope is still inserted, it is highly recommended to close the window.
Connector
F/O Cable
Fig. 1
Round Mark
Lock pin
Clockwise
Fig. 3
Anti-clockwise
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ENGLISH
INSUFFLATION BULB (NOT INCLUDED
IN THE PRODUCT) COD. 29427
Use of the rubber insufation bulb
Always use the Hygiene Filter (2) when connecting
the rubber insufation (1) bulb to the Proctoscope
/ Anoscope / Sigmoidoscope. These lters are
intended for single use only and prevent inter-
nal contamination of the rubber insufation bulb.
For this, connect the transparent hose (3) to the
Sigmoidoscope. Control the connection between the transparent hose and the Hygiene Filter. If it isn’t
securely attached, x it more tightly. Then connect the Hygiene Filter to the rubber insufation bulb.
Caution! Don’t disassemble the insufation bulb.
Caution! Infection! The use of the instrument without the Hygiene Filter may lead to contamination of
the rubber insufation bulb and thereby to an infection of the following patients.
Therefore, always use the lter. If you have forgotten to use the lter, replace the rubber insufation
bulb. If there is a risk of contamination inside the twin bellow insufator, the twin bellow insufator has
to be replaced and disposed.
Risk of allergic shock: The rubber double bellows contain natural rubber latex. Do not use it in patients
with a latex allergy.
Caution! Infection! The lter is a single use product. If it is reused, the risk of infection increases. The
lter is not suitable for being cleaned, disinfected and sterilized.
Cleaning / Disinfection of insufation bulb
1. Residues and other deposits must be removed immediately after use to avoid any residues drying
on to the surface
2. Autoclave is not recommended, this may damage the insufation bulb
3. Use surface cleaner e.g. Isopropyl alcohol (IPA), for the disinfection of insufation bulb.
insufation port on the Proctoscope / Anoscope /
CARE AND MAINTENANCE OF OBTURATOR
Cleaning
Clean immediately after use to prevent the drying-on of residues. We recommend washing with a soft
brush and soapy or plain water. If machine washing or chemical cleaners are used, the manufacturer’s
instructions regarding duration and concentration must be followed. No ultrasonic cleaning. After cleaning, rinse thoroughly with demineralised water and dry at 65°C max.
Disinfection
We recommend soaking in disinfectant or thermochemical disinfection at up to 65°C in a washer sterilizer. Adhere strictly to manufacturer’s instructions regarding concentration and duration. After disinfection,
rinse with sterile water and wipe dry with a sterile cloth.
STERILIZATION
After cleaning the components can be gas-sterilized with ethylene oxide at up to 65°C. Autoclaving can
be used occasionally, but repeated autoclaving will reduce light transmission and life expectancy of the
optical bers. Flash autoclaving and hot air sterilization are not recommended.
Gas Sterilization
Gas sterilization by Ethylene oxide up to a maximum temperature of 65°C and 8 psi may be performed,
which is preferred especially if sterilization is to be performed regularly.
ENGLISH
Autoclave
In order to perform Autoclave kindly refer to below mentioned table:
Temperature 121°C (250 °F) 134°C (270 °F)
Cycle Time 30 Min 5 Min
Dry Time 15 Min 20 Min
(A) GRAVITY DISPLACEMENT STEAM B) PRE-VACUUM STEAM
Recommended operating environments
Operation
Altitude 0-13123 feet (0-4000 meters)
Storage & Transport
Temperature 10°C - 35°C
Humidity 30% - 75%
Air pressure 700 hPa – 1060 hPa
Temperature -20°C - 50°C
Humidity 10% - 90% (without condensation))
Air pressure 500 hPa – 1060 hPa
INDEX OF SYMBOLS
Caution: read instructions (warnings)
carefully
Keep in a cool, dry place Keep away from sunlight
Product code Lot number
Manufacturer Date of manufacture
Consult instructions for use Medical Device
Medical Device compliant
with Regulation (EU) 2017/745
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GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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