Gima TWIN BELLOW INSUFFLATOR User guide

Page 1
PROFESSIONAL MEDICAL PRODUCTS
DOPPIA PERA PER INSUFFLAZIONE TWIN BELLOW INSUFFLATOR
Manuale d’uso - User manual
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità competente dello Stato membro in cui si ha sede.
29427
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
M29427-M-Rev.0-07.20
Page 2
3
Use of the rubber insufation bulb
Always use the Hygiene Filter (2) when connecting the rubber insufation (1) bulb to the Proctoscope / Anoscope / Sigmoidoscope. These lters are intended for single use only and prevent internal contam­ination of the rubber insufation bulb. For this, connect the transparent hose (3) to the insufation port on the Proctoscope / Anoscope / 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 insufation bulb.
Caution! Don’t disassemble the insufation bulb. Caution! Infection! The use of the instrument without the Hygiene Filter may lead to contamination of the
rubber insufation 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 insufation bulb. If there is a risk of contamination inside the twin bellow insufator, the twin bellow insufator 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 insufation 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 insufation bulb.
3. Use surface cleaner e.g. Isopropyl alcohol (IPA), for the disinfection of insufation bulb.
ENGLISH
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
Page 3
ENGLISH
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
Contains or presence of natural rubber latex
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Medical Device compliant with Regulation (EU) 2017/745
4
Loading...