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PROFESSIONAL MEDICAL PRODUCTS
LETTINO DA VISITA ELETTRICO AD ALTEZZA
REGOLABILE CON BARRA PERIMETRALE
ELECTRIC HEIGHT ADJUSTABLE TREATMENT
TABLE WITH FOOTBAR
DIVAN DE TRAITEMENT ÉLECTRIQUE
RÉGLABLE EN HAUTEUR AVEC SYSTÈME
D'ÉLÉVATION PÉRIPHÉRIQUE
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità competente dello
Stato membro in cui si ha sede.
All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent authority of the member state
where your registered ofce is located.
Il est nécessaire de signaler tout accident grave survenu et lié au dispositif médical que nous avons livré au fabricant et à l’autorité compétente de l’état
membre où on a le siège social.
Es necesario informar al fabricante y a la autoridad competente del Estado miembro en el que se encuentra la sede sobre cualquier incidente grave que
haya ocurrido en relación con el producto sanitario que le hemos suministrado.
É necessário noticar ao fabricante e às autoridades competentes do Estado-membro onde ele está sediado qualquer acidente grave vericado em relação
ao dispositivo médico fornecido por nós.
Jeder schwere Unfall im Zusammenhang mit dem von uns gelieferten medizinischen Gerät muss unbedingt dem Hersteller und der zuständigen Behörde
des Mitgliedsstaats, in dem das Gerät verwendet wird, gemeldet werden.
Σε περίπτωση που διαπιστώσετε οποιοδήποτε σοβαρό περιστατικό σε σχέση με την ιατρική συσκευή που σας παρέχουμε θα πρέπει να το αναφέρετε στον
κατασκευαστή και στην αρμόδια αρχή του κράτους μέλους στο οποίο βρίσκεστε.
44520 - 44521 - 44522 - 44525
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Italy
M44520-M-Rev.0-07.21
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ENGLISH
CAUTION
It is important to read the following instructions carefully in order to use the bed correctly. The manufacturer declines all responsibility for any
consequences resulting from using the device for any uses other than the ones described in these operating instructions. The product is a Class
I medical device compliant with Regulation (EU) 2017/745.
DESCRIPTION
The beds are intended for outpatient use in hospitals, community centres, care homes and medical centres.
They are suitable for physiotherapy treatments, professional massages, diagnostic tests and patient monitoring. The device is an examination
bed with electric height adjustment by means of a perimeter bar, tted with a headrest that can be adjusted by means of a gas pump lever. It has
a sturdy, epoxy powder-coated metal structure.
DESCRIPTION OF COMPONENTS
- Structure: Sturdy painted metal structure
- Standard linear actuator connected to the control bars
- Mattress with reproof faux leather cover,
supplied with mouth-nose hole plug, colour on request.
Optional accessories: Paper roll support
with possibility for installation at the head or foot.
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COMPONENTS
1. Backrest
2. Seat
3. Painted frame
4. Motor kit:
A. Linear actuator
B. Transformer
C. Control bar
D. Height adjustment ON/OFF
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D
3 4
A
C
D
B
Take care when making the electrical connections.
Disconnect the power supply before moving the bed.
THE BED IS SUPPLIED READY-ASSEMBLED. INSERT THE POWER CORD CONNECTED TO THE TRANSFORMER B IN THE POWER
SOCKET TO ACTION THE BED.
INSTRUCTIONS FOR USE
For safety reasons the controls have been inverted:
TO LIFT PRESS THE BAR DOWNWARDS
TO LOWER PUSH THE BAR UPWARDS
Before using the electric bed for the rst time, check that it is properly positioned with sufcient space around it to perform the necessary height
and backrest adjustments, and to allow the patient to climb on without any obstructions.
1. Completely lower the bed before getting the patient to lay down. To action the perimeter bar, push it upwards.
2. Once totally lowered, get the patient to lay down.
3. To lift the bed, press the bar downwards.
4. To lift the backrest, press the lever located in the rear part and release it in the desired position.
5. To lower the backrest, press the lever and push the backrest down rmly
Caution! DURING MOVEMENT AND REGULATION OF THE BED AND BACKREST, ALWAYS MAKE SURE THERE ARE NO OBSTACLES IN
THE MOVEMENT AREAS.
TECHNICAL DATA SHEET
Power supply: 100-240 Vac 50-60 Hz. 1.5A
Maximum dimensions 195 x 59.5 x h min 54 - max 71 cm
Max inclination 51°, Max H 94 cm with headrest fully raised
Box 200x71x70 cm
Weight: 65Kg (with box 74kg)
Reclining backrest
Max patient weight: 135kg Max safety weight: 170 kg
Duty Cycle: 2 min ON / 18min OFF (10%)
Conditions of use, storage and transport
Use: Temperature 10 – 40°C/ Humidity 20-60%
Atmospheric pressure 98–105kPa / Max altitude 2000m asl
Transport and storage: Temperature -10 – 50°C / Humidity 20-90%
Atmospheric pressure 98–105kPa
INSTRUCTIONS FOR USE
• Make sure that the fastening nuts are properly tightened.
• Comply with the maximum weights indicated in the technical data sheets.
• Avoid direct contact with open wounds.
• Not suitable for outdoor use.
• When the height of the bed and the backrest are adjusted, make sure that no-one puts their hands, legs or anything else in the adjustment area:
RISK OF CRUSHING!
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ENGLISH
• Move the bed without lifting it off the ground.
• The device may interfere with other electronic devices and, in turn, may receive interference from other electronic devices in the vicinity.
• The plug must always be accessible during use so that it can be easily pulled out in case of danger.
• The power cable must be positioned so that it does not get dragged away, trodden on or damaged when the bed is in use.
• Before moving the bed, make sure that the plug is disconnected from the power socket and store the cable so that it cannot fall onto or drag on
the oor.
• Make sure the cable cannot be damaged when the motor is in use.
• Position and operate the foot control to ensure that the patient is protected from any unexpected motorised movements.
• Do not, under any circumstances, use extension cords or plug power strips under the bed. Extension cords and/or plug power strips should
never be used.
• Check the foot control cable and the power cable for wear every three months. If worn and/or frayed, the damaged cable must be replaced
immediately.
• Every six months, check that no unusual sounds or vibrations are emitted when operating the bed which could be a sign of actuator and/or mechanical faults. After the above-mentioned operations, complete the inspection by passing the work cycle test to raise the bed with the maximum
safety load.
• Periodically, or after intensive use, check that the screws, bolts and pins are tightened; make sure there are no cracks or structural defects.
• Periodically check the state of the cover.
• The bed should be lowered when the patient cannot be monitored.
• Do not bend, tangle or crush the power cable.
• Do not crush the power cables of other devices with the bed frame.
• Do not sit on the headrest of the bed.
• Never use accessories and cables that differ from those specied or supplied with the bed.
• Consult the technical data section to make sure that the current complies with the technical specications of the bed.
• Before using the bed, consult the technical data section to make sure that the room complies with the environmental conditions.
• Avoid exposure to direct sunlight, UV rays, excessive dirt, humidity, vibrations and impacts.
• Do not move the bed with a person or a weight on it. Only move the bed on a at surface.
• The “safe working load” of the bed is 135 kg. i.e. the total weight to which the bed is subjected (the weight of the patient plus other loads, e.g.
the therapist’s manipulations) must not exceed 170 kg.
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MAINTENANCE AND CLEANING
• Use only original spare parts.
• Periodically check all xing points.
• To ensure its efcient, long-term use, it is advisable to avoid prolonged exposure to sun rays, contact with saline environments and storage in
very damp environments.
• Wash the stainless steel surfaces with soapy water and use suitable disinfectants.
• Rinse with a damp cloth and dry carefully.
• Do not pour chlorine- or ammonia-based detergents or greasy and oily substances on the surfaces.
• Do not use metal tools for cleaning. If disinfection is required, only use suitable non-corrosive products.
Instructions for cleaning the fabric
• Clean with a damp and soapy cloth and rinse well with clean water. Do not use solvents, bleach and chemical detergents or sprays to polish.
Attention: In general, the light colours of the faux leather should not come into contact with clothes with unxed dyes (e.g. jeans and similar) to
avoid stains or marks which cannot be removed
ELECTROMAGNETIC COMPATIBILITY
LEVELS OF COMPLIANCE WITH THE EN 60601-1-2:2015 STANDARD
- ESD immunity 15kV in air and 8kV on contact (EN 61000-4-2)
- Burst immunity 2kV/100kHz (EN 61000-4-4) power supply/1kV signals
- Surge immunity (EN 61000-4-5): 1kV common mode/2kV differential mode
- Magnetic eld (EN 61000-4-8): 30A/m
- Dip Immunity: 0% 0.5 cycles; 0% 1 cycle; 70% 25 cycles (50Hz) and 30 cycles (60Hz);
Breaks: 250 cycles (50Hz); 300 cycles (60Hz)
- Immunity to RF currents in the range 150kHz-80MHz (EN 61000-4-6) 3V modulation 80% 1kHz
6V modulation 80% 1kHz for the following frequency ranges:
6.765 MHz ÷ 6.795 MHz
13.553 MHz ÷ 13.567 MHz
26.957 MHz ÷ 27.283 MHz
40.66 MHz ÷ 40.70 MHz
- CISPR 11 class A emissions
- EN 61000-3-2 class A Harmonic currents
- PST, DT, DC Flickers
RF FIELD IMMUNITY (EN 61000-4-3):
FIELD (V/M) FREQUENCY MODULATION
3 80MHz÷2700MHz 1kHz AM 80%
27 380MHz÷390MHz 18Hz PM 50%
28 430MHz÷470MHz 18Hz PM 50%
9 704MHz÷787MHz 217Hz PM 50%
28 800MHz÷960MHz 18Hz PM 50%
28 1700MHz÷1990MHz 217Hz PM 50%
28 2400MHz÷2570MHz 217Hz PM 50%
9 5100MHz÷5800MHz 217Hz PM 50%
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CONFORMITY LEVEL ACCORDING TO EN 60118-13:2011 STANDARD
TEST LEVEL
FIELD MOD. FREQUENCY
90V/M AM 80% 1KHZ 800MHZ-960MHZ
50V/M AM 80% 1KHZ 1.4GHZ-2GHZ
35V/M AM 80% 1KHZ 2GHZ-2.48GHZ
WARNINGS:
Even if it complies with EN 60601-1-2, the medical device may interfere with other devices in the vicinity. The device should not be used next to
or stacked with other equipment. Install the device away from other equipment which radiates high frequencies (short waves, microwaves, electrosurgical units, mobile phones).
The use of this device near to or placed on other appliances should be avoided, as this can lead to its incorrect operation. In these cases, the
device and the other equipment should be kept under observation to verify their normal operation.
Transportable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no less than
30 cm (12 inches) away from any part of the [EM EQUIPMENT or EM SYSTEM], including the cables specied by the MANUFACTURER. Otherwise, performance degradation of this equipment may occur”.
The device is designed to operate in an electromagnetic environment in which RF radiated disturbances are under control. The customer or the
operator can help prevent electromagnetic interference by ensuring a minimum distance between mobile and portable RF communication devices
(transmitters) and the medical device, as recommended below, in relation to the maximum output power of the radio communication devices.
ENGLISH
Rated maximum output power
of 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 whose rated maximum output power is not listed above, the recommended separation distance d in metres (m) can be calculated using the equation applicable to the transmitter frequency, where P is the rated maximum power transmitter output in Watts (W) according
to the transmitter manufacturer.
Notes:
(1) The higher frequency range applies at 80 MHz and 800 MHz.
(2) These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and by the reection from structures,
objects and people.
Index of Symbols
Keep in a cool, dry place Medical Device Temperature limit
Keep away from sunlight
Product code Manufacturer Atmospheric pressure limit
Lot number Serial number Date of manufacture
Distance (m) of separation according to the frequency of the transmitter
from 150kHz to 80MHz
d = 1,2 √P
Caution: read instructions
(warnings) carefully
from 80MHz to 800MHz
d = 1,2 √P
Humidity limit
from 800MHz to 2.5GHz
d = 2,3 √P
Type B applied part
Follow instructions for use Physical description of an adult Workload safely
Maximum patient weight
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 specic recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Medical Device compliant
with Regulation (EU) 2017/745
WEEE disposal
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