CA-MI M28189EN Askir 30 Surgical Aspirator Instruction Manual
- June 16, 2024
- CA MI
Table of Contents
- GENERAL WARNING
- IMPORTANT SAFETY RULES
- CONTRAINDICATIONS
- TECHNICAL CHARACTERISTICS
- SYMBOLS
- CLEANING DEVICE
- ACCESSORIES SUPPLIES
- CLEANING OF ACCESSORIES
- PERIODICAL MAINTENANCE CHECKS
- INSTRUCTION FOR USE
- RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
- WARRANTY CONDITIONS
- RULES FOR RETURNING AND RAPAIRING
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
NEW ASKIR 30
ASPIRATOR
Instruction manual
110-127V~/60Hz
NEW ASKIR 30 Surgical aspirator is a portable unit, working with 110-127V
~ / 60Hz network electricity, designed for the aspiration of bodily fluids in
adult and children. It’s particularly suitable for nasal, oral or tracheal
aspiration of mucus, catarrh or blood after minor surgical procedures and can
be used in post-operative therapy at home or conveniently transported from one
hospital ward to another. Easily portable equipment designed for continuous
use.
Made of highly heat resistant, electrically insulated plastic material in
conformity with the latest European safety standard, the product is supplied
with a complete polycarbonate autoclavable jar with overflow valve and it is
equipped with aspiration regulator and vacuum indicator located on the front
panel.
GENERAL WARNING
READ INSTRUCTION MANUAL CAREFULLY BEFORE USE.
THE DEVICE IS FOR USE BY QUALIFIED PERSONNEL (SURGEON / PROFESSIONAL NURSE /
ASSISTANT)
THE USE OF THE DEVICE AT HOME IS RESTRICTED TO AN ADULT IN FULL POSSESSION OF
MENTAL FACULTIES AND / OR HOME CARERS
THE INSTRUMENT MUST NOT DISASSEMBLED. FOR TECHNICAL SERVICE ALWAYS CONTACT CA-
MI SRL
IMPORTANT SAFETY RULES
-
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 efficiency and safety of the device;
• The device can be used only with the bacteriological filter;
• Never immerge the appliance into water;
• Do not place or store the aspirator in places where it may fall or be pulled into the bathtub or washbasin. In the event it is accidentally dropped, do not attempt to remove the device from the water whilst the plug is still connected: disconnect the mains switch, remove the plug from the power supply and contact the CA-MI technical service department. Do not attempt to make the device work before it has been thoroughly checked by qualified personnel and/or the CA-MI technical service department.
• Position the device on stable and flat 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 qualified personnel and/or the CA-MI technical service department.
• Don’t use in the presence of inflammable 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.
• Don’t use the device thoracic drainage.
• 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 defined by the manufacturer.
The manufacturer will not be responsible for damage due to improper use or connection to an electrical system not complying with current regulation. -
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 NEW ASKIR 30 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.
-
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 CA-MI Srl. 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
-
Using the device in environmental conditions different than those indicated in this manual may harm seriously the safety and the technical characteristics of the same.
-
Use in Home-Care: Keep all accessories of the device out of reach of children under 36 months of age since they contain small parts that may be swallowed.
-
Do not leave the device unattended in places accessible to children and/or persons not in full possession of mental faculties as they may strangle themselves with the patient’s tube and/or the power cable.
-
The medical device is in contact with the patient by means of a disposable probe (supplied with the device) furnished with the relative CE compliance certification according to the requirements of regulation ISO 10993-1: thus, no allergic reactions and skin irritations may occur.
-
The product and its parts are biocompatible in accordance with the requirements of regulation IEC 60601-1.
-
Operation of the device is very simple and therefore no further explanations are required other than those indicated in the following user manual.
The manufacturer cannot be held liable for accidental or indirect damages
should the device be modified, repaired without authorization or should any of
its component be damaged due to accident or misuse.
Any minimal modification / 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 NEW ASKIR 30, consult the instructions for use: failure to
read all the instructions in this manual can be harmful for the patient.
– Don’t use the device thoracic drainage.
– The device must not be used for suction of explosive, corrosive or easily
flammable liquids.
– NEW ASKIR 30 is not suitable for MRI. Do not introduce the device in MRI
environments.
TECHNICAL CHARACTERISTICS
Model | NEW ASKIR 30 |
---|---|
Typology (MDD 93/42/EEC) | Medical Device Class Ha |
Classification UNI EN ISO 10079-1 | HIGH VACUUM / HIGH FLOW |
Main Voltage | 110-127 V ∼ / 60 Hz |
Power consuption | 165 VA |
Fuse | F 1 x4AL250 V |
Maximum suction aspiration (without jar) | -80kPa (- 0.80bar) |
Minimum suction aspiration (without jar) | Less than -40kPa (-0.40 bar) |
Maximum flow (without jar) | 40 l/min |
Weight | 3.6 Kg |
Dimension | 350 x 210 x 180 mm |
Functioning | NON-STOP OPERATED |
Working condition | Room temperature: 5 ÷ 35 °C |
Room humidity percentage: 10 ÷ 93 % RH
Atmospheric pressure: 700 ÷ 1060 hPa
Conservation and transport condition| Room temperature: – 25 ÷70 °C
Room humidity percentage: 0 ÷ 93% RH
Atmospheric pressure: 500 ÷ 1060 hPa
IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE
WITH EC DIRECTIVE 2012/19/UE-WEEE:
**** The symbol on the device indicates the separated collection of electric
and electronic equipment. At the end of life of the device, don’t dispose it
as mixed solid municipal waste, but dispose it referring to a specific
collection centre located in your area or returning it to the distributor,
when buying a new device of the sample type to be used with the same
functions.
This procedure of separated collection of electric and electronic devices is
carried out forecasting a European environmental policy aiming at
safeguarding, protecting and improving environment quality, as well as
avoiding potential effects on human health due to the presence of hazardous
substances in such equipment or to an improper use of the same or of parts of
the same Caution: The wrong disposal of electric and electronic equipment may
involve sanctions.
SYMBOLS
|
Class 2 isolation equipment
---|---
| CE marking in conformity with EC directive 93/42/CEE and subsequent changes
| General warnings and/or specifications
| Consult the instruction manual
| Manufacturer: CA-MI S.r.I.
Via Ugo La Malfa nr.13 – Frazione Pilastro
43013 Langhirano (PR) Italia
| Applied Part type BF (suction probe)
| Keep in a cool, dry place
| Fuse
| Conservation temperature: – 25 + 70° C
| Atmospheric Pressure
∼| Alternate current
Hz| Mains frequency
I| ON
0| OFF
| Batch production
| Serial number
| Model / Ref number
IP21| Degree of protection an electrical device provides in the case of
accidental or intentional contact with the human body or with objects, and
protection in the case of contact with water.
1st DIGIT
PENETRATION OF SOLIDS| 2nd DIGIT
PENETRATION OF LIQUIDS
Protected against solids having a dimension greater than Ø 12mm| Protected
against the vertical flow of drops of water
CLEANING DEVICE
Use a soft dry cloth with not – abrasive and not – solvent detergents. To clean the device external parts always use a cotton cloth dampened with detergent. Don’t use abrasive or solvent detergents.
PARTICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE
EQUIPMENT DO NOT GET IN TOUCH WITH LIQUIDS. NEVER CLEAN THE EQUIPMENT WITH
WATER.
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 SUPPLIES
DESCRIPTION | CODE |
---|---|
COMPLETE ASPIRATION JAR 1000ml | RE 210001/02 |
CONICAL FITTING | RE 210410 |
TUBES SET 6mm x 10mm (TRASPARENT SILICON) | 51100 |
ASPIRATION PROBE CH20 | 25723 |
ANTIBACTERIAL AND HYDROPHOBIC FILTER | SP 0046 |
The filter is produced with (PTFE) hydrophobic material to prevent fluids
entering the pneumatic circuit. It should be changed immediately if it becomes
wet or if there is any sign of contamination or discolouration. If should also
be changed if the unit is used
with a patient whose risk of contamination is unknown. Don’t use the suction
unit without the protection filter. If the suction unit is used in an
emergency or in a patient where the risk of contamination is not know the
filter must be changed after each use.
Available under request with different versions with complete jar 2000ml.
Suction catheter: Single-use device to be used on a single patient. Do
not wash or re-sterilize after use. Reuse may cause crossinfections. Don’t use
after lapse of the sell-by date
Check the expiry date on the original packaging of the suction catheter and check the integrity of the sterile packaging. CA-MI declines any liability for injury to the patient correlated to the deterioration of the abovementioned sterile packaging due to handling of the original packaging by third parties.
WARNING: Suction tubes for insertion in the human body purchased
separately from the machine should comply with ISO 10993-1 standards on
material biocompatibility.
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 final 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.
Conical fitting: 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 final user to verify
whether the fitting 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 850 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 OF ACCESSORIES
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 contaminating 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 (overflow device, washer).
- Disconnect all tubes from the jar and the protection filter
- 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 fitting 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 overflow valve into its seat in the cover (under VACUUM connector)
- Insert floating 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
After disposing of disposable parts and disassembling the jar wash in running
cold water and rinse thouroughly.
Then soak in warm water (temperature shall not exceed 60°C). Wash thouroughly
and if necessary use a non-abrasive brush to remove incrustations. Rinse in
running warm water and dry all parts with a soft cloth (non-abrasive).
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.
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
PERIODICAL MAINTENANCE CHECKS
The NEW ASKIR 30 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.
Unpack the instrument and always check integrity of plastic parts and feeding
cable, they might have been damaged during previous use. Connect the cable to
electrical network and turn the switch on.
Close the aspirator outlet with your finger and with suction regulator at
maximum check that the vacuum indicators reaches at least -80kPa (-0.80 bar).
Rotate the knob from right to left. The vacuum indicator should go down -40kPa
(-0.40 bar).
Check that no loud noises are present. 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.
Type of fault | Cause | Remedy |
---|---|---|
1. The suction unit doesn’t work | Cable is damaged | |
External power source failure | Replace the cable |
Check the external power source
2. No aspiration| Jar Cap not screwed on correctly| Unscrew the cap, and re-
screw it
3. No aspiration| Lid seal not in its seat| Unscrew the cap and insert the
seal properly in its seat
4. The Vacuum power on the patient side is either very low or absent| •
Vacuum regulator set to minimum
• Protection filter blocked or damaged
• Connection tubes blocked, kinked or disconnected
• Shut-off valve blocked or damaged
• Pump motor damaged| • Turn the vacuum regulator clockwise and check the
value of the vacuum on the gauge
• Replace the filter
• Replace or reconnect the tubes, check the jar connections
• Empty the jar, or disconnect the tube from the jar and unblock the shut-off
valve. The unit twill only work in the upright position
• Refer to authorised service personnel
5. The float doesn’t close| If the cap has been washed, ensure that the float
is not partially
detached| Fit the float into it’s place
6. The float doesn’t close| The float it’s covered by dirty material|
Unscrewed the cap, leave the and put in on autoclave
7. Low suction| Foam inside the jar| Fill the jar to 1/3 full of ordinary
water
Faults 1- 2 – 3 – 4 – 5 – 6 – 7| None of the procedures have achieved the
desired results| Contact CA-MI customer service
If the overfill security system it’s activated, don’t proceede with the liquid
aspiration.
If the overfill security system doesn’t work there are two cases:
1° case – If the overfill security system doesn’t work the aspiration will be
stopped by the bacteriological filter 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 CA-MI
technical service.
CA-MI Srl 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 CA-MI TECHNICAL SERVICE. CA-MI DOES NOT GIVE GUARANTEE IF INSTRUMENT, AFTER THE TECHNICAL SERVICE CHECKING, APPEARS TO BE TAMPERED.
INSTRUCTION FOR USE
- The device must be checked before each use in order to detect malfunctions and / or damage caused by transport and / or storage.
- 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 filter.
- It is recommended not to keep the device in your hands and / or to avoid prolonged contact with the body of apparatus.
WARNING: For proper use, place the aspirator on a flat, stable surface in order to have the full volume of use of the jar and better efficiency of the overflow device.
- Place the unit on a flat, horizontal surface
- Connect one end of the short silicon tube, with antibacterial filter, to the suction connector on the lid of the jar.
- The other tube already connected to the filter has to be connected to the “VACUUM” jar outlet, where has been fixed the red float (security float). When the 90% of the volume of the jar is reached there is the activation of the security float (the float close the aspiration connector on the jar) to avoid liquid penetration inside the device.
WARNING: Ensure that the filter is fitted with the Arrows at the patient side.
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 insufficient vacuum flow.
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 silicone tube to the “PATIENT” jar outlet
- Connect the other end of the long silicon tube to the probe plastic connector, then connect the suction probe to it.
- Connect the power cord to the device then connect the plug to the electrical mains supply.
- Push switch on position I to start suction.
- Unscrew the lid of the jar and fill the jar 1/3 full or ordinary water (this assists the unit to reach peak vacuum performance and makes clean-up easier) then re-screw the lid on the jar correctly.
- During operation the jar has to be in vertical position to avoid overflow valve to cut off aspiration. Should this happen, switch off the device and disconnect the tube from the jar cover (from “VACUUM” outlet).
- Once finished push switch on O position and unplug.
- Remove the accessories and clean.
- At the end of each use, place the device in its box away from dust.
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.
During device operation (and during the first fault condition), temperatures
are higher than the temperature T41°C referred to in requirement 11.1.2.2 of
IEC standard 60601-1, in the non-electric applied part (probe) connection
point.
The connection point (see device nozzle) has a surface greater than T41°C as
it is positioned on the plastic part of the device and due to the internal
development of the heat produced by the electric motor in operation.
Maximum Temperature (recorded in normal conditions): 44°C
Maximum Temperature (recorded in first fault conditions): 45°C
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER MAKE SURE THAT CHILDREN AND/OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT ADULT SURVEILLANCE
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance
with the IEC 60601-1-2 (2014) Standard. CISPR group and category
classification: group 1, category B.
The NEW ASKIR 30 surgical aspirator is an electro-medical device that requires
particular precautions regarding electromagnetic compatibility and which must
be installed and commissioned according to the electro-magnetic 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 configuration (for example, constantly and visually checking for the
absence of anomalies or malfunctions). The use of accessories, transducers and
cables different to those specified, 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.
Guidance and manufacturer’s declaration – electromagnetic Emissions
The surgical aspirator NEW ASKIR 30 is intended for use in the electromagnetic
environment specified below.
The customers or the user of the surgical aspirator NEW ASKIR 30 should assure
that it’s used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance
Irradiated / Conducted emissions CISPR11| Group I| The surgical aspirator NEW
ASKIR 30 only used RF energy only for its internal functioning. Therefore, its
RF emissions are very low and are not cause interference in proximity of any
Electronic appliances.
Irradiated / Conducted emissions CISPR11| Class [B]| The surgical aspirator
NEW ASKIR 30 can be used in all environments, including domestic and those
connected directly to the public mains distribution that supplies power to
environments used for domestic scopes.
Harmonic emissions IEC 61000-3-2| Class [A]
Voltage fluctuations / flicker emissions I EC 61000-3-3| Complies
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical aspirator NEW ASKIR 30 is intended for use in the electromagnetic
environment specified below.
The customers or the user of the surgical aspirator NEW ASKIR 30 should assure
that it’s used in such an environment.
Immunity Test| Level indicated by the
IEC 60601-1-2| Compliance Level| Electromagnetic environment – guidance
Electrostatic
discharge (ESD) IEC 61000-4-2| ± 8kV on contact
± 15kV in air| The device doesn’t
change its state| Floors should be wood, conceret or ceramic tile. If floors
are covered with synthetic material, the relative humidity should be at least
30%.
Electrical fast
transient / burst IEC 61000-4-4| ± 2kV power supply lines
± 1kV for input /output lines| The device doesn’t
change its state| Mains power quality should be that of a typical commercial
environment or hospital.
Surge
IEC 61000-4-5| ± 1kV differential mode| The device doesn’t change its state|
Mains power quality should be that of a typical commercial environment or
hospital.
Loss of voltage, brief voltage interruptions and variations
IEC 61000-4-11| <5%UT (>95% dip UT) for 0.5 cycle
40%UT (>60% dip UT) for 5 cycle
70%UT (>30% dip UT) for 25 cycle
<5%UT (>95% dip UT) for 5 sec| –| Mains power quality should be that of a
typical commercial environment or hospital If the user of the surgical
aspirator NEW ASKIR 30 request that the appliance operates continuously, the
use of a continuity unit is recommended.
Magnetic field IEC 61000-4-8| 30 A/m| The device doesn’t
change its state| The power frequency magnetic field should be measured in the
intended installation location to assure that it’s sufficiently low.
Nota UT is the value of the power supply voltage
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical aspirator NEW ASKIR 30 is intended for use in the electromagnetic
environment specified below.
The customers or the user of the surgical aspirator NEW ASKIR 30 should assure
that it’s used in such an environment
Immunity Test| Level indicated by the
EN 60601-1-2| Compliance Level| Electromagnetic environment –
guidance
Conducted Immunity IEC 61000-4-6| 3Vrms 150kHz to 80Mhz
(for non life-supporting devices)| VI = 3 V rms| The portable and mobile RF
communication devices, including cables, must not be used closer to the NEW
ASKIR 30 device, than the separation distance calculated by the equation
applicable to the transmitter frequency. Recommended separation distance Where
P is the maximum nominal output voltage of the transmitter in Watt (W)
depending on the manufacturer of the transmitter and the recommended
separation distance in metres (m). The intensity of the field from the fixed
RF transmitters, as determined by an electro-magnetic study of the site),
could be lower than the level of conformity of each frequency interval b). It
is possible to check for interference in proximity to devices identified by
the following symbol:
Radiated Immunity IEC 61000-4-3| 10V/m 80MHz to 2.7GHz
(for non life-supporting devices)| El = 10 Vim
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 influenced by the absorption and by reflection
from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for
radiotelephones (mobile and cordless) and terrestrial 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 fixed RF transmitters, an electro-magnetic study of
the site should be considered. If the field 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 field intensity on an interval frequency of 150 kHz to 80 MHz should be
less than 10 V/m.
Recommended separation distance between portable and mobile radio-
communication devices and the monitor
The NEW ASKIR 30 surgical aspirator is intended to operate in an electro-
magnetic environment where RF irradiated interferences are under control. The
client or operator of the NEW ASKIR 30 device can help prevent electro-
magnetic interference by keeping a minimum distance between the portable and
mobile RF communication devices (transmitters) and the NEW ASKIR 30 device, as
recommended below, in relation to the radio-communication maximum output
power.
Maximum nominal output power of the Transmitter W| Separation distance from
the frequency transmitter (m)
150 kHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2.7 GHz
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.
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 influenced by the absorption and by the
reflection from buildings, objects and people.
WARRANTY CONDITIONS
This product is guaranteed for a period of 24 months from the date of
purchase. The warranty includes the repair or replacement of defect spare
parts free of charge, if the defect has been clearly described by the customer
and determined by technical service.
Inspections on the part of the seller, performed at the request of the
customer and intended to determined wjether the device is fully functional,
are not covered by the free-of-charge warranty service. This service will be
charged to the customer depending on
the effort required. The consumables components are not subject to warranty.
Consumable components are silicon tubes, filters, seals, conical adaptor and
suction catheter. Also exluded from warranty is all damage resulting from
improper handling, wilful damage or improper care of the device. The warranty
shall expire if repairs and servicing are not carried out by technical
service.
RULES FOR RETURNING AND RAPAIRING
UNDER NEW EUROPEAN RULES, CA-MI REQUIRES THE FOLLOWING PROCEDURES TO BE
CARRIED OUT TO PROTECT THE INSTRUMENT AND THE SAFETY OF ALL WHO COME IN
CONTACT WITH IT.
Before returning an instrument for repair, the external surfaces and all
accessories MUST be carefully disinfected with a cloth soaked in methylated
spirits or hypochlorite-based solution. The instrument and accessories should
then be placed in a bag with a
note outlining the disinfection undertaken.
Failure to follow this procedure will result in the instrument being returned
to the purchaser unrepaired.
Instruments returned for repair MUST be accompanied by a description of the
problem. CA-MI will not be responsible for damage caused through improper use.
To avoid such damage, please read the instruction carefully.
Where CA-MI determines that an instrument is faulty, a replacement will be
provided only if a SALES RECEIPT and STAMPED GUARANTEE are provided. CA-MI
will not be responsible for damage accessories. These may be replaced at the
customer’s expence.
Warranty Certificate
Retailer’s stamp
**** CA-MI Srl
Via Ugo La Malfa 13 – Frazione Pilastro – 43013 Langhirano (PR) Italia
Tel. +39 0521 / 637133 – 631138
Fax. +39 0521 / 639041
Registro A.E.E : IT8020000000264
Registro Pile e Accumulatori: IT09060P00000971
E-mail: vendite@ca-mi.it / export@ca-
mi.it
www.ca-mi.it