Gima HOSPI PLUS User Manual

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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.

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GENERAL WARNING

Read instruction manual carefully before use

Only Higly qualied 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;

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;

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 qualied personnel and/

or the GIMA technical service department.

• Don’t use in the presence of inammable 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.

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.

Use only for the purpose intended. Don’t use for anything other than the use dened 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.

Instrument and accessory discharging must be done according to current regulations in the country of use.

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.

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Using the device in environmental conditions different than those indicated in this manual may harm seri-

ously the safety and the technical characteristics of the same;

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 specic 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 modied,

repaired without authorization or should any of its component be damaged due to accident or misuse. Any

minimal modication / 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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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 inltration 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 overow 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 specic suction probe. If this device must be used with a specic 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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Conical tting: the number of cycles of sterilization and the number of cleaning cycles is strictly linked to the employment of the said component. Therefore, after each cleaning cycle, it is up to the nal user to verify whether the tting is suitable for reuse. The component must be replaced if there are visible signs of decay in

the material constituting the said component. Service life of the device: More than 10000-12000 hours of operation (or 3 years) in accordance with the

standard conditions of testing and operation. Shelf life: maximum 5 years from the date of manufacture.

CLEANING ACCESSORIES AND INTERNAL PARTS

Before using the device, the manufacturer advises you to clean and/or sterilize the accessories. Washing and / or cleaning the autoclavable jar as to be carried out as follows:

• Wear protection gloves and apron (glasses and face mask if necessary) to avoid contact with contaminat-

ing substances;

• Disconnect the tank from the device and remove the said container from the support of the device.

• Separate all the parts of the cover (overow device, washer).

• Disconnect all tubes from the jar and the protection lter

• Wash each part of the container from secretions under cold running water and then clean every single

part in hot water (temperature not exceeding 60°C)

• Once again, carefully wash each single part using, if necessary, a non-abrasive brush to remove any

deposits. Rinse with hot running water and dry all parts with a soft cloth (non-abrasive). It is possible to wash with commercial disinfectants by carefully following the instructions and dilution values supplied by the manufacturer. After cleaning, leave the parts to dry in an open, clean environment.

• Dispose of the aspiration catheter according to that provided by local laws and regulations.

The silicone aspiration tubes and the conical tting may be carefully washed in hot water (temperature must

not exceed 60°C). After cleaning, leave the parts to dry in an open, clean environment. When cleaning is complete, reassemble the container for liquid aspirations according to the following procedure:

• Place the overow valve into its seat in the cover (under VACUUM connector)

• Insert oating valve keeping the o-ring towards the opening of the cage

• Place the o-ring into its seat around the cover

• After completing assembling operations always make sue that cover seals perfectly to avoid vacuum

leackages or liquid exit

The jar and the cover can be autoclaved by placing the parts into the autoclave and running one sterilization stem cycle at 121°C (1 bar relative pressure – 15 min) making sure that the jar is positioned upsidedown. Mechanical resistance of the jar is guaranteed up to 30 cycles of sterilization and cleaning at the indicated

conditions (EN ISO 10079-1). Beyond this limit the physical-mechanical characteristics of the plastic may

decrease and replacement of the part is therefore recommended. After sterilization and cooling at environment temperature of the parts make sure that these are not damaged and assemble the container for the aspirated liquids. The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pressure – 15 min). The conical connector can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pressure – 15 min).

DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER

Instruction for disposal Liner Flovac®: If the device is equipped with disposable collection systems FLOVAC ® carry out the disposal of the bag as follows: Turn off the Vacuum and remove all the tubes connected to the Liner, giving particular attention to

avoid accidental contamination. Fit the appropriate plugs to the “PATIENT” and “TANDEM” ports, pressing the home rmly, taking care to avoid accidental contamination. Remove the liner bag from the rigid container and

transfer it to the waste disposal area, ensuring that all the openings are sealed, keeping in mind the product is potentially infectious. This product must be disposed of in accordance with the current hospital regulations.

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MAINTENANCE

The HOSPI PLUS SUCTION ASPIRATOR suction equipment does not need maintenance or lubrication. It is,

however, necessary to inspect the unit before each use. With regard to training, given the information contained in the user manual and since it is easy to understand the said device, it doesn’t appear to be necessary. The device must be checked before each use in order to detect malfunctions and / or damage caused by transport and / or storage. Always check the integrity of the footswitch power cord. Connect cable to electrical network

and turn switch on. Close the aspiration outlet with your nger and with suction regulator in maximum vacuum

position check that the vacuum indicators reaches -90 kPa (-0.90 bar) maximum. Rotate the knob from right to left and check the aspiration regulating control. The vacuum indicator should go down -40 kPa (-0.40 bar). Verify that loud noises are not present, these can indicate wrong functioning. A protection fuses (F 1 x 4A L 250V) reachable from exterior and situated in the plug protects the instrument. For fuses replacing, always the type and the range. Before changing the fuse, disconnect the plug from the power supply socket. Internally,

the device (only for devices tted with a circuit board) is protected by a fuse (F 500mA L 250V)

Fault type Cause Solution

1. The suction unit doesn’t work

2. No aspiration Jar Cap badly screwed down Unscrewed the cap, then rescrew it correctly

3. No aspiration Lid seal not in its seat

4. The Vacuum power onthe patient side is either very low or absent

5. The oat doesn’t close

6. The oat doesn’t close The oat it’s covered by dirty material

7. Low suction Foam inside the jar Fill the jar to 1/3 full of ordinary water

8. No aspiration due to ow leakage of material and uid

Faults 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8

Cable is damaged External power source failure

a) Vacuum regulator set to minimum b) Protection lter blocked or damaged c) Connection tubes blocked, kinked or disconnected d) Shut-off valve blocked or damaged e) Pump motor damaged

If the cap has been washed, ensure

that the oat is not partially detached

Filter blocked Replace lter

None of the remedies has achieved

the desired results

Replace the cable Check the external power source

Unscrew the cap and insert the seal properly in its seat

a) Turn the vacuum regulator clockwise and check the value of the vacuum on the gauge

b) Replace the lter

c) Replace or reconnect the tubes, check the jar connections d) Empty the jar, or disconnect the tube from the jar andunblock the shut-off valve. The unit twill only work in theupright position e) Refer to authorised service personnel

Insert the oat into it’s place

Unscrewed the cap, leave the and put in on autoclave

Contact the seller or GIMA After-sales Assistance Service

If the overll security system it’s activated, don’t proceede with the liquid aspiration. If the overll security

system doesn’t work there are two cases:

1° case – If the overll security system doesn’t work the aspiration will be stopped by the bacteriological lter

who avoid the liquid penetration inside the device. 2° case – If both the security system doesn’t work, there is the possibility that liquid comes inside the device, in this case return the device to GIMA technical service.

Gima S.p.A. will provide upon request electric diagrams, components list, descriptions, setting instructions and any other information that can help the technical assistance staff for product repair.

BEFORE EVERY CHECKING OPERATION, IN CASE OF ANOMALIES OR BAD FUNCTIONING,

PLEASE CONTACT GIMA TECHNICAL SERVICE. THE MANUTACTURER DOES NOT GIVE GUARANTEE IF INSTRUMENT, AFTER THE TECHNICAL SERVICE CHECKING, APPEARS TO BE TAMPERED.

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INSTRUCTIONS

• The working position must be such as to allow one to reach the control panel and to have a good view of

the empty indicator, the jar and the antibacterial lter.

• If the device is to be transported from one place to another, to prevent the liquid collection jar from falling

and consequently theliquid from spilling, removing the jar from the device is recommended.

WARNING: For proper use, place the aspirator on a at, stable surface in order to have the full volume of use of the jar and better efciency of the overow device. The vacuum jar, during use, must be used in vertical mode, to prevent the action of the backow valve. If this protection is triggered, turn the device off and disconnect the

pipe connected to the vacuum jar (indicated with the word VACUUM) on its cover.

• Connect the short silicone tube to the antibacterial lter connector (check the lter assembly photo) while

the other end must be connected to the safety trap “IN” nozzle using a short silicone tube.

SAFETY TRAP: The two connections on the sides of the bar can be used to insert a safety trap in the BASIC

and FS versions and two traps in the FULL version. The safety trap is an additional protection for the overow valve of the vessel. In the event that the liquid goes beyond the overow valve during the suction process, the trap collects the liquid thus protecting the antibacterial lter and the internal motor.

• Connect the remaining short silicone tube to the safety trap “OUT” nozzle, while the other end must be

connected to the vessel cover nozzle bearing the word “VACUUM”, which is tted internally with the oat (overow device). When the 90% of the volume of the jar is reached there is the activation of the security oat (the oat close the aspiration connector on the jar) to avoid liquid penetration inside the device.

FILTER ASSEMBLING

Make sure the lter is assembled with the arrows on the side of the patient.

WARNING: The inside of the medical device must be regularly checked for the presence of liquids or other visible contamination (secretions). If liquids or other visible contamination are present, the medical device must

be replaced immediately due to the risk of insufcient vacuum ow. These products have been designed, tested and manufactured exclusively for “single use” and for a period of use not exceeding 24 hours unless stated below.

• Connect the long silicon tube with the lid union still free and marked as “PATIENT”.

• Connect the conical junction for probe insertion with the free end of the long silicon tube.

• Insert the plug of the equipment feeding cable into a power socket.

• Press the ON/OFF button to start the medical equipment.

• To deal with foam formation within the tank, unscrew the tank lid and ll 1/3 of the tank with water (to make

cleaning easier and speed up depression while operating the equipment), place the lid on the jar.

• While using the equipment, the suction tank should always be used vertically to avoid the intervention of

the antireux valve. In case of intervention of this protection, switch the device off and disconnect the tube connected with the suction tank (the one marked as “VACUUM”) on the same lid.

• You can then detach all accessories and perform cleaning operations as described under “Cleaning acces-

sories and internal parts” below.

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WARNING: The power supply cable plug is the element of separation from the electrical mains system: even if the units equipped with a special on / off switch button, the power supply plug must be kept accessible once the device is in use so as to allow a further method of disconnection from the mains supply system.

MULTIPURPOSE BAR- MPR SYSTEM

The device is equipped with a multipurpose bar to easily change accessories (such as rings of different diameters for different collection vessel capacities, safety traps, cannula holders or standard 30x10 mm stainless steel bar, on which any other accessory can be inserted using standard clamps).

USING THE FOOTSWITCH CONTROL:

Connect the footswitch control feeding cable with the plug marked as

After the device has been connected,all Leds are still off. When the ON/OFF button is pressed, all Leds are activated at once for 1 second (autotest). At the end of the autotest cycle, the ON/OFF button led will ash.

Press the button marked as (---) to perform suction using the footswitch control and execute intermittence work cycles. Press the button marked as (-) to perform remote suction using the footswitch control (continuous suction). To stop suction just push on the footswitch control with strength.

USING THE FOOTSWITCH CONTROL AND THE FLOW DEVIATOR:

If using equipment tted with a ow deviator, users may direct suctioned liquids in any of the two collection tanks

provided. Flow deviator comes with two complete suction kits (2 sets of tubes, 2 antibacterial and hydrophobic

lters and two conical junctions). After the device has been connected, all Leds are still off. When the ON/

OFF button is pressed, all Leds are activated at once for 1 second (autotest). At the end of the autotest cycle,

the ON/OFF button led will ash. To decide which side to perform the suction from, press OUT LEFT or OUT

RIGHT and the selected button led will show a blue light.

Press the ON/OFF button again to start the suction cycle. If the device is set up for using the ow deviator, ensure the antibacterial lter has been positioned on both sides. Connect the footswitch control feeding cable

with the plug marked as

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suction). To stop suction just push on the footswitch control with strength. Press the ON/OFF button to stop

the medical equipment. Before removing the feeding plug, ensure autotest has been performed on the panel.

NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER Using FLOVAC® disposable collection system: Before connecting the disposable collection system, remove

the blu ring tted on the tank holder for a more comfortable insertion of the same container.

• After opening the package, fully stretch the bag and then atten it concentrically to eliminate as much air

as possible.

• Insert the bag and apply the cover to an appropriately sized reusable rigid container by pressing rmly

around the entire perimeter. Make sure that the system is completely sealed.

• Close the connector marked as “TANDEM” with the lid provided.

• Connect the power source of the vacuum to the VACUUM port equipped with specic reusable conical

tting with “male” connection.

• Connect the patient tube to the PATIENT port of the cover

• Before use, check all closures and make sure there are no leaks, starting the aspiration source. If the bag

expands to fully adhere to the walls of the rigid container and the cover bends towards the inside of the glass, the system is not leaking.

• Start the aspiration and periodically check the lling level of the container. The overow valve will cause

the interruption of aspiration if the aspirated uids have reached the maximum lling level of the device.

• When the oat valve intervenes signalling the device is too full, the suction source must be disconnected

within no more than 5 minutes.

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES

This section contains information regarding the conformity of the compliance with the EN 60601-1-2 (2015)

Standard.

CISPR group and category classication: group 1, category B.

The HOSPI PLUS surgical aspirator is an electro-medical device that requires particular precautions regarding electro-magnetic compatibility and which must be installed and commissioned according to the electromagnetic compatibility information supplied. Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may interfere with the medical device and should not be used in close proximity with, adjacent to or on top of the medical device. If such use is necessary and unavoidable, special precautions should be taken so that the electro-medical

device functions properly in its intended operating conguration (for example, constantly and visually checking

for the absence of anomalies or malfunctions).

The use of accessories, transducers and cables different to those specied, with the exception of transducers

and cables sold by the appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of the device or system. The following tables supply information regarding the EMC (Electromagnetic Compatibility) characteristics of the electro-medical device .

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Guidance and manufacturer’s declaration – Electromagnetic Emissions

The HOSPI PLUS SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below. The customers or the user of the HOSPI PLUS SUCTION ASPIRATOR should assure that it’s used in such an environment.

Emissions Test Compliance Electromagnetic environment - guidance

Irradiated / Conducted emissions CISPR11

Group 1 The HOSPI PLUS SUCTION ASPIRATOR only used RF energy

only for its internal functioning. Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Irradiated / Conducted emissions CISPR11

Harmonic emissions

EN 61000-3-2

Voltage uctuations /

Class [B] The appliance is suitable fopr use in alla establishments included

domestic establishments and those directly connected to the public

Class [A]

low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

icker emissions EN 61000-3-3

Guidance and manufacturer’s declaration – Immunity Emissions

Immunity Test Level indicated by the

EN 60601-1-2

Electrostatic discharge

+/-8kV contact +/-15kV in air

(ESD) EN 61000-4-2

Compliance Level Electromagnetic environments - guid-

ance

The device doesn’t change its state

Floors should be wood, concrete or

ceramic tile. If oors are covered with

synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst

EN 61000-4-4

+/-2kV power supply lines +/-1kV for input / output

The device doesn’t change its state

Mains power quality should be that of a typical commercial or hospital enviro ment.

lines

Surge

EN 61000-4-5

± 0,5kV ± 1,0kV differential mode

The device doesn’t change its state

Mains power quality should be that of a typical commercial or hospital environment.

Volgate dips, short interruptions and voltage variations on power supply input

lines EN 61000-4-11

Magnetic eld

(50/60 Hz)

EN 61000-4-8

T (>95% dip UT )

<5% U for 0,5 cycle

T (60% dip UT )

40 % U for 5 cycle

T (30% dip UT )

70 % U for 25 cycle

T (>95% dip UT )

<5 % U for 5 sec

30A/m The device doesn’t

- - Mains power quality should be that of a typical commercial or hospital environment. If the user of the HOSPI PLUS SUCTION ASPIRATOR requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

The power frequency magnetic eld

change its state

should be measured in the intended installation location to assure that it’s suf-

ciently low.

Note UT is the value of the power supply voltage.

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Guidance and manufacturer’s declaration – Immunity Emissions

Immunity Test Level indicated by

Conducted Immunity

EN 61000-4-6

Radiated Immunity

EN 61000-4-3

Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied. Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is inuenced by the

absorption and by reection from buildings, objects and people.

a) The eld intensity for xed transmitters such as the base stations for radiotelephones (mobile and cordless) and ter-

restrial mobile radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically

and accurately foreseen. To establish an electro-magnetic environment generated by xed RF transmitters, an electromagnetic study of the site should be considered. If the eld intensity measured in the place where the device will be used

surpasses the above mentioned applicable level of conformity, the normal functioning of the device should be monitored. If abnormal performance arises, additional measures such as changing the device’s direction or positioning may be necessary.

b) The eld intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.

the EN 60601-1-2

da 3Vrms 150kHz a 80MHz (for non life-supporting devices)

da 3V/m 80MHz a 2.7GHz (for non life-supporting devices )

Livello di conformità

V1 = 3 V rms

E1 = 10 V / m

Electromagnetic environments - guidance

Portable and mobile RF communication equipment, including cables, should be used no closer to any part of the device, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

3,5

√P

from 80MHz to 800MHz

√P

Where P is the maximum output power rating of the transmitter in Watt (W) according to the transmitter manufacturer and is the recommended separation

distance in metres (m). Field strengths from xed RF

transmitters, as determined by an electromagnetic site study of the site, should be less that the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

from 800MHz to 2,7GHz

√P

Page 12

ENGLISH

Recommended separation distance between portable and mobile radio-communication devices and the monitor

The surgical aspirator is intended for use in an electromagnetic environment in which radiated RF disturbances are con-

trolled. The customer or the user of the HOSPI PLUS SUCTION ASPIRATOR device can help prevent electromagnetic

interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmit-

ters) and the HOSPI PLUS SUCTION ASPIRATOR device, as recommended below, according to the maximum output

power of the communications equipment.

Maximum nominal output power of the Transmitter W

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres (m) can be calculated using the equation applicable to the transmitter frequency, where P is the maximum nominal output power of the transmitter in Watt (W) depending on the transmitter’s manufacturer.

absorption and by the reection from buildings, objects and people.

Separation distance from the frequency transmitter (m)

150KHz a 80MHz

3,5

√P

80MHz a 800MHz

√P

800MHz a 2,7GHz

√P

SYMBOLOGIE

(—)

Class II applied

General warnings and/or

specications

Medical Device compliant with Directive 93/42/CEE

Type B applied part

Keep away from sunlight Keep in a cool, dry place

Atmospheric pressure limit Humidity limit

Temperature limit WEEE disposal

Manufacturer Date of manufacture

Alternating current

Mains Frequency

On / Off Fuse

Using the footswitch control (for continuous suction)

(---)

Using the footswitch control (for intermittence suction)

Page 13

ENGLISH

Product code Lot number

Serial number Follow instructions for use

IPX1

(on the footswitch

Covering Protection rate

control label)

Please note technical specications may vary upon the manufacturer’s discretion!

Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specic recycling point for electric and electronic equipment.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.