Gima HOSPI PLUS User Manual
PROFESSIONAL MEDICAL PRODUCTS
ASPIRATORE CHIRURGICO HOSPI PLUS
HOSPI PLUS SUCTION ASPIRATOR
ASPIRATEUR HOSPI PLUS
CHIRURGISCHER ABSAUGER HOSPI PLUS
ASPIRADOR QUIRÚRGICO HOSPI PLUS
ASPIRATOR CHIRURGICZNY HOSPI PLUS
ASPIRATORUL CHIRURGICAL HOSPI PLUS
ΧΕΙΡΟΥΡΓΙΚΟΣ ΑΝΑΡΡΟΦΗΤΗΡΑΣ HOSPI PLUS
28200 - 20201 - 28203 -28204
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M28200-M-Rev.4-11.20
Made in Italy
0476
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HOSPI PLUS SUCTION ASPIRATOR is a surgical aspirator power-fed at 230V ~ / 50Hz, to be used for suctioning body liquids (such as mucus, phlegm and blood) provided with 4 antistatic wheels, two of which with
braking device, and a pulling handle. This equipment is designed for easy transport and continuous utilization.
Thanks to these characteristics and to its functions, this device is particularly suitable for utilization in hospital
wards and operation theatres both for suctioning body liquids and for gynaecological and dermatological (liposuction) applications. It’s provided with a plastic body, with thermal and electrical isolation in compliance with
European safety standards, two complete suction tanks in polycarbonate suitable for sterilization, and a oat
valve, besides being tted with a suction regulator and a vacuum gauge on the front panel. Versions tted with
footswitch control and ux deviator are available on request. The electronic management system tted on the
front panel allows to perform suction by means of the footswitch control as well as to suction liquids in both
tanks provided without having to switch the equipment off to reconnect the second tank.
ENGLISH
GENERAL WARNING
Read instruction manual carefully before use
Only Higly qualied staff use reserved
The instrument must not be disassembled. For a technical service always contact GIMA
Keep off the reach of children or not capable people without supervision
Full containers must be handled with great care during transfer to the disposal areas, following the
local procedures and regulations
IMPORTANT SAFETY RULES
1. Check the condition of the unit before each use. The surface of the unit should carefully inspected for
visual damage. Check the mains cable and do not connect to power if damage is apparent;
2.
Before connecting the appliance always check that the electric data indicated on the data label and the type
of plug used, correspond to those of the mains electricity to witch it’s to be connected;
3.
Respect the safety regulations indicated for electrical appliances and particularly:
• Use original components and accessories provided by the manufacturer to guarantee the highest ef-
ciency and safety of the device.
• The device can be used only with the bacteriological lter.
• Never immerge the appliance into water.
• Position the device on stable and at surfaces in a way that the air inlets on the back aren’t obstructed.
• To avoid incidents, do not place the aspirator on unstable surfaces, which may cause it to accidentally fall
and lead to a malfunction and/or breakage. Should there be signs of damage to the plastic parts, which
may expose inner parts of the energised device, do not connect the plug to the electrical socket. Do
not attempt to make the device work before it has been thoroughly checked by qualied personnel and/
or the GIMA technical service department.
• Don’t use in the presence of inammable substances such as anaesthetic, oxygen or nitrous oxide.
• Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids.
• Don’t leave the appliance connected to the power supply socket when not in use.
• Don’t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly.
• Store and use the device in places protected against the weather and far from any sources of heat. After
each use, it is recommended to store the device in its own box away from dust and sunlight.
• In general, it is inadvisable to use single or multiple adapters and/or extensions. Should their use be
necessary, you must use ones that are in compliance with safety regulations, however, taking care not to
exceed the maximum power supply tolerated, which is indicated on the adapters and extensions.
4.
For repairs, exclusively contact technical service and request the use of original spare parts. Failure to
comply with the above can jeopardise the safety of the device.
5.
Use only for the purpose intended. Don’t use for anything other than the use dened by the manu-
facturer. The manufacturer will not be responsible for damage due to improper use or connection to an
electrical system not complying with current regulation.
6.
Instrument and accessory discharging must be done according to current regulations in the country of use.
7.
WARNING: Do not change this equipment without the permission of the manufacturer Gima S.p.A. None
of electric or mechanical parts have been designed to be repaired by customers or end-users. Don’t open
the device, do not mishandle the electric / mechanical parts. Always contact technical assistance.
ENGLISH
8.
Using the device in environmental conditions different than those indicated in this manual may harm seri-
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ously the safety and the technical characteristics of the same;
9.
The medical device is in contact with the patient by means of a disposable probe (not supplied with the
device). If this device must be used with a specic suction probe, the end user is responsible for making
sure it complies with the ISO 10993-1 rule;
10.
The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1;
11.
Operation of the device is very simple and therefore no further explanations are required other than those
indicated in the following user manual.
12.
The medical device requires special precautions regarding electromagnetic compatibility and must be
installed and used in accordance with the information provided with the accompanying documents: the
HOSPI PLUS SUCTION ASPIRATOR device must be installed and used away from mobile and portable
RF communication devices (mobile phones, transceivers, etc.) that may interference with the said device.
Under certain failure conditions, the temperature of the casing may become hot and there may be
a risk of burns if you touch those parts. In any case, the temperatures do not exceed the limit of 105°C (ref.
Interpretation Sheet IEC 60601-1 / ISH May 2013).
The manufacturer cannot be held liable for accidental or indirect damages should the device be modied,
repaired without authorization or should any of its component be damaged due to accident or misuse. Any
minimal modication / repair on the device voids the warranty and does not guarantee the compliance with
the technical requirements provided by the MDD 93/42/EEC (and subsequent changes) and its normatives.
CONTRAINDICATIONS
• Before using the HOSPI PLUS SUCTION ASPIRATOR, consult the instructions for use: failure to read all
the instructions in this manual can be harmful for the patient.
• The device cannot be used to drain chest uids;
• The device must not be used for suction of explosive, corrosive or easily ammable liquids.
• HOSPI PLUS SUCTION ASPIRATOR is not suitable for MRI. Do not introduce the device in MRI environments.
TECHNICAL CHARACTERISTICS
TYPOLOGY (MDD 93/42/EEC) Class IIa Medical Decice
MODEL
UNI EN ISO 10079-1 HIGH VACUUM / HIGH FLOW
POWER FEEDING 230V ~ / 50Hz
POWER CONSUMPTION 385 VA
FUSE F 1 x 4A L 250V
MAXIMUM SUCTION PRESSURE (without jar) -90kPa / -0.90 Bar / -675mmHg
MAXIMUM SUCTION FLOW (without jar) 90 l/min
WEIGHT 20 Kg
SIZE 460 x 850 (h) x 420 mm
DUTY CYCLE Non – Stop Operated
SICILICONE TUBE SIZE Ø 8x14 mm
ACCURANCY OF VACUUM INDICATOR ± 5%
WORKING CONDITION
CONSERVATION CONDITION AND TRASPORT
HOSPI PLUS SUCTION ASPIRATOR
Room temperature: 5 ÷ 35°C
Room humidity percentage: 30 ÷ 75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.
Room temperature: - 40°C ÷ 70°C
Room humidity percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa
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ENGLISH
CLEANING THE MAIN UNIT
To clean the device external parts always use a cotton cloth dampened with detergent. Don’t use abrasive or
solvent detergents.
ATTENTION: During cleaning make sure that liquids do not come into contact with the membrane keyboard
(only in versions with footswitch and ux deviator) and adjacent areas as this would damage the component,
with possible inltration of the liquid inside the device..
The symbol positioned in the casing near the membrane keyboard requires the reading of the user
instructions before each use.
PARTICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE
EQUIPMENT DO NOT GET IN TOUCH WITH LIQUIDS. NEVER USE LIQUIDS (e.g. DETERGENTS AND/
OR SANITISING SUBSTANCES) TO CLEAN THE MAIN UNIT (ESPECIALLY NEAR THE MEMBRANE
KEYBOARD) AS THEY MAY PENETRATE INSIDE THE DEVICE
During all clearing operations use protection gloves and apron (if need be, also wear a face mask and glasses)
to avoid getting in contact with contaminating substances (after each utilization cycle of the machine).
ACCESSORIES SUPPLIED
• N°2 COMPLETE ASPIRATION JAR
• CONICAL FITTING
• SILICON SET TUBES 8 mm x 14 mm
• ANTIBACTERIAL AND HYDROFOBIC FILTER
• SAFETY TRAP
• FOOTSWITCH CONTROL (for versions equipped with footswitch)
• EUROPEAN POWER SUPPLY CORD (H05VV-F - 2x0.75mm² - 2mt)
REPLACING THE ANTIBACTERIAL FILTER: The lter is made of hydrophobic material that stops the
passage of liquids into the same lter. If you suspect the lter may have been contaminated and/or got wet
or discoloured, always remove and replace the lter. If the equipment is to be used on patients with unknown
pathological conditions or should you evaluate the possibility of indirect contamination, remove and replace
the lter after each utilization. The lter is not designed for decontamination, disassembly and/or sterilization. If
you suspect the lter may have been contaminated and/or got wet or discoloured, always remove and replace
the lter. If the equipment is to be used on patients whose pathologies are known and not implying any indirect
contamination risks, we recommend to remove and replace the lter at the end of each work shift or else every
month, even if the equipment has not been used. 4000ml or 5000ml complete jar versions are available on
request. Versions tted with FLOVAC® 2000ml or 3000ml disposable collection systems (including a re-usable
rigid polycarbonate container and a disposable Liner) are also available on request.
SAFETY TRAP with 220 ml capacity to collect the liquid that could leak from the overow valve of the vessel.
This ensures additional protection of the lter and pump. The trap is completely removable and autoclavable.
Not available in versions equipped with FLOVAC disposable collection system.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine should
comply with ISO10993-1 standards on material biocompatibility.
WARNING: The medical device is provided without a specic suction probe. If this device must be used with a
specic suction probe, the end user is responsible for making sure it complies with the EN 10079-1 regulation.
Aspiration jar: The mechanical resistance of the component is guaranteed up to 30 cycles of cleaning and
sterilization. Beyond this limit, the physical-chemical characteristics of the plastic material may show signs of
decay. Therefore, we recommend that you to change it.
Silicone tubes: the number of cycles of sterilization and/or cleaning is strictly linked to the employment of the
said tube. Therefore, after each cleaning cycle, it is up to the nal user to verify whether the tube is suitable
for reuse. The component must be replaced if there are visible signs of decay of the material constituting the
said component.
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