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USER AND MAINTENANCE MANUAL
Manufacturer:
SIEM - NOVA SRL - 20089 ROZZANO (MI)
Product: Smoke filtration system - Mod. FILTRUM®
ASSISTANCE
Read the instruction manual before using the device.
This manual should be kept close to the device for future reference.
SIGNS AND SYMBOLS - ISO 15223-1:2021(E)
In compliance with the
2017/745 MDR regulation
concerning medical devices.
CLASS I
Symbol for
"MANUFACTURING DATE"
(4 digits for the year, 2 for
the month and 2 for the
day)
Symbol for
"MANUFACTURER"
This symbol indicates that
there may be interference
close to the device
This symbol indicates the
pressure limitation for
operation, transport and
storage
This symbol indicates that
the device is a medical
device
This symbol indicates the
reference number of the
medical device
This symbol indicates that at
the end-of-life, the device
must be disposed of
according to local disposal
regulations
1 WARNINGS AND SAFETY INSTRUCTIONS
1.1 APPLICATION
The Smoke filtration system Model "FILTRUM®" is approved exclusively for the use as described in this user and maintenance
manual. SIEM – NOVA SRL can only guarantee the safe functioning of the device when it is used with the SIEM – NOVA SRL
accessories and components.
PLEASE READ AND OBSERVE THESE WARNINGS AND SAFETY INSTRUCTIONS BEFORE USING THE DEVICE.
1.2 Please note that these instructions for use are a general guide for the use of the device. Medical
information must be addressed to a doctor.
1.3 WARNING: The product has been designed with particular attention to patient and user safety.
Nevertheless, the following warnings must be observed
IMPORTANT: Users must be able to read, understand and follow the directions in this manual and the instructions
provided by your doctor. If you are dependent on the device for airway aspiration and stopping operation of the
device may lead to a critical situation, you must have another device available that can operate in an emergency.
Revision: 01 - 31.01.2024
VARALLI 1 (ITA) - Italy
- VIA
Code: 81000
This symbol indicates an
insulation class I device
This Symbol indicates a
type B applied part
This symbol indicates
alternating current
Do not reuse / for
disposable use only
This symbol indicates
the moisture limitation
for operation, transport
and storage
Unique Device Identifier
This symbol indicates
the serial number of the
medical device
This symbol indicates to
avoid wetting the device
.
Reproduction forbidden
This symbol indicates to
follow the instructions.
This symbol indicates
"warning or caution"
with the use of the
device
This symbol indicates
the footswitch
This symbol indicates to
avoid direct exposure of
the device to sunlight
This symbol indicates
the temperature
limitation for operation,
transport and storage
This symbol indicates
the model of the
medical device
Degree of protection of
IP21
the casing of the DM
CEI EN 60529/1997
This symbol indicates
the distributor's name
Page: 1 of 11
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Table of Contents
Summary of Contents for Siem Nova FILTRUM
- Page 1 1.1 APPLICATION The Smoke filtration system Model “FILTRUM®” is approved exclusively for the use as described in this user and maintenance manual. SIEM – NOVA SRL can only guarantee the safe functioning of the device when it is used with the SIEM – NOVA SRL accessories and components.
-
Page 2: Description Of The Device
Code: 81000 1.4 WARNINGS Use The Smoke filtration system Model “FILTRUM®” only on the person for whom it was ordered and only for the intended use. No other use is authorized. The Smoke filtration system Model “FILTRUM®” must be used by instructed and qualified operators. -
Page 3: Operating Principle
Particle filters are effective for capturing particles with a ver y varied size. The BRUSHLESS suction motor used in the device Smoke Filtration System, model FILTRUM®, produces an adjustable vacuum up to about 1000 (l/min) liters per minute, through a two meters long tube and with an internal diameter of 22 mm. - Page 4 STERILE CONNECTOR FOR VAGINAL SPECULUM 81014 CAUTIONS: The Smoke filtration system Model “FILTRUM®” device is to be set up in such a way, that a separation from the mains supply can be easly done. WARNING: This device should only be used by personnel with medical training who have received appropriate training and is therefore familiar with suction procedures and the use of vacuum cleaners.
- Page 5 USER AND MAINTENANCE MANUAL Manufacturer: SIEM - NOVA SRL - 20089 ROZZANO (MI) VARALLI 1 (ITA) - Italy - VIA Product: Smoke filtration system - Mod. FILTRUM® Code: 81000 2.11 DESCRIPTION FILTRUM® Code: 81000 INTERNAL HEPA-CARBON FILTER Code: 81001 EXTERNAL...
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Page 6: Preparation For Use
FILTER must be replaced immediately 3.2 Operating instructions CAUTION: Smoke filtration system model FILTRUM® must be positioned so that it is easy to disconnect from the mains supply. CAUTION: The EXTERNAL SINGLE WALLED VIRAL AND ANTIBACTERIAL FILTER if used for a number of... -
Page 7: Troubleshooting
Act with foot pressure when suction is required, act again when you want to end suction CAUTION: Make this adjustment to the Smoke filtration system, model FILTRUM® whenever different instruments are coupled. 4.6 Out of service after use: Press the lighted ON/OFF switch of the auxiliary socket located on the back of the machine. -
Page 8: Maintenance
The Smoke filtration system Model “FILTRUM®” requires few maintenance operations if used following the indication of this manual. If a Smoke filtration system Model “FILTRUM®” falls within the warranty period due to a manufacturing defect, it will be replaced. NOTE: Defective devices must be returned to the supplier. -
Page 9: Technical Specifications
TECHNICAL SPECIFICATIONS 8.1 Transport/Storage conditions The Smoke filtration system Model “FILTRUM®” and accessories must remain in the packaging for storage and stored at a temperature range from –25 °C to +70 °C (–13 °F to +158 °F). 8.2 Operating temperature The Smoke filtration system Model “FILTRUM®”... -
Page 10: Electromagnetic Compatibility
ELECTROMAGNETIC EMISSIONS The Smoke filtration system Model “FILTRUM®” is intended for use in the electromagnetic environment specified below. The customer or the user of the Smoke filtration system Model “FILTRUM®” should ensure that it is used in such conditions: Emissions test... - Page 11 Code: 81000 RECOMMENDED SEPARATION DISTANCES BETWEEN RADIOCOMMUNICATION DEVICES The Smoke filtration system Model “FILTRUM®” is intended for use in an electromagnetic environment in which radiated RF disturbances under control. The customer or the Smoke filtration system Model “FILTRUM®” operator of the device can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication device (transmitters) and the Smoke filtration system Model “FILTRUM®”...
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