Gima A100-4 User manual

TAVOLO OPERATORIO ELETTRICO CON TR E RTR
ELECTRIC OPERATING TABLE WITH TR AND RTR
TABLE OPÉRATOIRE ÉLECTRIQUE AVEC TR ET RTR
MESA DE OPERACIONES ELÉCTRICA CON TR Y RTR
M44775-M-Rev.0-01.24
MANUALE D’USO – USER MANUAL – MODE D’EMPLOI – MANUAL DE USO
A100-4 (Gima 44775)
Jiangsu Saikang Medical Equipment Co.,Ltd
No. 35 Lehong Road, Modern Agriculture Demonstration
Park, Zhangjiagang City, Jiangsu Province, China
Made in China
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
SUNGO Europe B.V.
Fascinatio Boulevard 522, Unit 1.7,
2909VA Capelleaan den IJssel, The Netherlands
• È necessario segnalare qualsiasi incidente grave verificatosi 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 office 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.
500hPa
1060hPa
-40˚C
+85˚C
20%
90%
%

2
ENGLISH
INTRODUCTION
ABOUT THIS OPERATING MANUAL
This operang manual includes introducon about the symbols and safety in-
strucons. You can see the descripon, instrucon and maintenance about our
product in the followed pages. And some technical data and informaon about the
product.
In case of any queson, we therefore kindly ask you to contact aer-sales service
personnel or distributor.
This operang manual is to be read and observed by any person using or handle this
operang table.
In addion to some accident, we obtest users to be familiar with the usage and the
points of aenon.
Intended Purpose
The electric operang table is used for maternity, childbirth and diagnosis, and for
carrying paents during surgery.
SYMBOLS USED IN THE TEXT
Danger!
This symbol will appear whenever safety instrucon are designed to pro-
tect people from physical harm. The symbol stands for imminent danger
of death or of serious injury.
Cauon!
This symbol will appear where situaons are described which might be
dangerous ,and which might inict slight injuries.
Aenon!
This symbol will appear in front of such hints which shall prevent the
table or other equipment from being damaged
Advice！
This symbol will appear in front of addional helpful pieces of advice.
●A dot in front of the text means:
Please pay aenon and you have to do.
SUMMARY OF THE INSTRUCTIONS
Danger!
Paents may be exposed to danger by electrostac tension.By means of the
potenal equalizaon device electrostac tension are conducted to earth.
Always connect the potenal equalizaon device of the operang table to earth be-
fore use.
Danger！
The paent may get hurt if the operang table is displaced while he or she is
lying on the top in the knee-elbow-posion. Do not displace the table with
the paent in knee-elbow-posion.
Danger！
The paent may get hurt if the operang table is displaced with an aached
extension device, due to its reduced stability against lng.Do not displace the
operang table with an aached extension device when a paent is lying on the top.
Danger！
Do not press two buons at the same me！
Aenon!
never press one buon over 2min!
Aenon!
The cushion will deform if exposed to heat. The operang table, including
its cushion ,must not be sterilized bu super heated steam.
Aenon!
Agents for disinfecon of the paent’s skin may cause discoloraons on
the cushions.Remove such disinfecng agents from the cushion in order to
avoid such discoloraons.
Aenon!
Disinfecng sprays may cause corrosion on mechanical parts,or create
explosive mixtures inside the table components.For this reason,do not use
disinfecng sprays!
advice:
The posion of the castors will inuence the stability of the operang
table.
DESCRIPTION
USE AND BRIEF INTRODUCTION
The product belongs to class I, type B. Non AP or APG device, connuous device.
And possesses applicaon part.
SUMMARY
INTRODUCTION ................................................................................. 2
About this operating manual............................................................... 2
Symbols used in the text ...................................................................... 2
Summary of the instructions................................................................ 2
DESCRIPTION ..................................................................................... 2
Use and brief introduction................................................................... 2
GENERAL CONTENT ........................................................................... 3
Basic data............................................................................................ 3
Product information and feature ......................................................... 3
COMMISSIONING .............................................................................. 3
keeping ............................................................................................... 3
Transportation .................................................................................... 3
Unpacking........................................................................................... 3
Power requirements ............................................................................ 3
Using................................................................................................... 3
Attention before using......................................................................... 3
Attention after using............................................................................ 3
METHOD OF USING OPERATION TABLE ............................................ 4
Preparation before using..................................................................... 4
Displacement ...................................................................................... 4
Using adjust ........................................................................................ 4
MOVEMENTS DIAGRAM OF A100-4................................................... 4
PICTURE OF CONTROL PANEL............................................................ 5
LABEL ON THE TABLE.........................................................................5
FUNCTION OF TELECONTROLLER ......................................................5
CLEAN OUT AND DISINFECTION........................................................ 5
MAINTENANCE .................................................................................. 5
COMMON PROBLEMS AND SOLUTIONS ........................................... 6
MAIN TECHNICAL DATA..................................................................... 6
PACKING LIST..................................................................................... 7
A100-4 WITH ALL STANDARD ACCESSORIES...................................... 7
SYMBOL EXPLANATION: .................................................................... 7

3ENGLISH
- The table should be kept separately from chemicals.
- stock in a venlated place.
TRANSPORTATION
Upon leaving the factory, the operang table are posioned t for transportaon. In
case of further transportaon at a later date, we recommend to adjust the operang
table into the same posion.
- In order to transport the operang table, adjust seat and back secon in to hori-
zontal posion.
- Remove the head and leg plates, and detach other accessories.
- Adjust the table-top into minimum height.
UNPACKING
Carry the operang table, if possible, inside its original packing to its nal site of use.
Check the condion of the operang table.
Any possible damage occurred during transportaon should be reported immedia-
tely to Karen Wu . You will nd their address and telephone no. On the last page of
this operang manual.
POWER REQUIREMENTS
supply voltage ～220V±10%
supply frequency 60Hz±2%
Power capacity ≥1kw
USING
Ambient temperature 10°C~40°C
atmospheric humidify ≤80%
Atmospheric pressure 760 hPa~1060 hPa
• Please pay aenon to supply frequency、electric tension and normal impedance.
• Should choose an-stac cushion.
• Please check the operang table all the mes.
• Once found it out of work ,please stop using.
• Make sure that the paent won’t touch the table.
• Please don’t take them down when they are out of work, contact the serviceman
in me.
• When change the fuse, you should turn o the power.
• It should be separated from the magnec eld when using.
ATTENTION BEFORE USING
• Please read the instrucon before using, people who doesn’t know the operang
method is forbidden to use.
• Please Check the switch, and be sure they can work.
• Please conrm all the power line are connected right and safely.
• When it work with high frequency surgical equipment，the equipment should
comply with GB9706.1.
ATTENTION AFTER USING
• To return to the former condion，and turn it o，cut o the electricity supply.
• Put the telecontroller in the right place.
• Clean the table aer operaons.
A100-4 requires special preliminary measures pertaining to EMC that necessitates
installaon and commissioning in conformity with the EMC informaon given in this
Manual.
Electromagnec Radiaon
Electromagnec Resistance
Resistance Test Test Level as per
EN 60601 Test Level as per EN 60601 EN 60601 Level of Compliance
Electromagnetic
Environment
Severity levels of
electrostatic discharge
IEC60601-1-2:2014
±2KV, ±4KV&±8KV
for air discharge
and ±2KV,
±4KV&±8KV for
contact discharge
±2KV, ±4KV&±8KV
for air discharge and
±2KV, ±4KV&±8KV
for contact discharge
*Ensure that the following
requirements are met:
Floors: wood, concrete
or ceramic tiles Relative
humidity: >30%
Electrical fast transient
response/ Burst
IEC60601-1-2:2014
±2K for A.C. Power
line ±2K for A.C. Power line *Ensure the mains quality is suitable for a
commercial or hospital
environment.
A100-4 is designed specially to meet the dierent demands of the market and accor-
ding to the common advice of users.
Operang table is used for general Ophthalmology operaons, it uses electric hy-
draulic pressure, with a switch to control its elevaon (up/down),easy to operang
and it is reliable. The operang table is widely used, easy to operate and adjust with
reliable performance, which is a ideal table for dierent hospital.
GENERAL CONTENT
BASIC DATA
The technical data should look at Form 1
Form 1: basic data unit:mm
basic
data
Model
length Width lowest height
of tabletop Distance of elevation
L B h min S
A100-4 ≥2070 550 700±10 ≥300
Gross weight、net weight、volume
Gross weight:270kg，net weight:220kg，Volume（long×width×height）1360mm-
×860mm×880mm.
Safe working load of A100-4
The stac safety load of the table is 200kg.
The dynamic safety load of the table is 135kg.
PRODUCT INFORMATION AND FEATURE
Product informaon
The operang is formed by head plate and back plate, waist plate, buocks plate
and leg plate
Please look at the Picture 2
1
4
2
8
9
3
7
5
6
1-Headrest; 2-back rest; 3-leg rest; 4-Handle for kidney bridge; 5-remote control;
6-base; 8-kidney bridge; 7-pedal; 9- buocks plate;
Picture 2 Diagram of structure A100-4 Electric operang table
Feature
- You can adjust the height of the table as you wish（look at picture 2），conve-
nient for doctors.
- you can take the cushion apart from the table for clean up.
COMMISSIONING
KEEPING
Inside its original packing the operang table may be exposed for a period of 15
weeks to environmental condions within the limits of :
Ambient temperature -40°C~85°C
atmospheric humidify ≤20-90%
Atmospheric pressure 500 hPa~1060 hPa
- The table should be kept in a clean place, never put in the places where inuenced
by atmospheric pressure, temperature, humidity, aeraon, sunshine, or dust and
sulfur.
- Please pay aenon to the supply frequency、electric tension and normal impe-
dance.

4
ENGLISH
Severity levels of surge
IEC60601-1-2:2014 ±0.5KV& ±1KV for A.C. power
lines to lines and
±0.5KV,±1KV&
±2KV for A.C. power
lines to PE
±0.5KV& ±1KV
for A.C. power
lines to lines and
±0.5KV,±1KV&±2KV
for A.C. power lines
to PE
*Ensure the mains quality
is suitable for commercial
or hospital environment.
Severity levels of
magnetic eld immunity
IEC60601-1-2:2014
3 A/m 3 A/m *Ensure the magnetic
elds of the network
frequency conform to
the normal levels of
commercial or hospital
environments.
Severity levels of
radio-frequency,
electromagnetic eld
IEC60601-1-2:2014
3 V/m 3 V/m *Do not use portable and
mobile HF communication
equipment near the bed.
*Observe the distances
indicated below.
Recommended distances:
d = 1.2 √P
d = 1.2 √P 80 MHz to
800 MHz
d = 2.3 √P 800 MHz to
2.5 GHz
P is the rated maximum
output power of the
transmitter in Watts (W)
dened by the transmitter's
manufacturer.
d is the recommended
separating distance in
metres (m).
Severity levels of
conduced disturbances
induced by radio-
frequency elds
discharge
IEC60601-1-2:2014
3 V/m
80 MHz 3 V/m 80 MHz
METHOD OF USING OPERATION TABLE
PREPARATION BEFORE USING
•Electric tension: 220V、frequency: 60Hz；
•No objects exist that aect the operaons；
•Conrm if all the power lines are connected well，the switch is in “O”condion；
•Move the table to the right place you need；
•Connect the telecontroller with the table；
•Please check the power supply before turning it on；
•Lock the base of the table；
•Fix up the head plate, leg plate and accessories according to the picture.
•The table adopts short-me work，aenon：never press one buon over 2min.
Danger!
Paents may be exposed to danger by electrostac tension. By means of
the potenal equalizaon device electrostac tension are conducted to ear-
th. Always connect the potenal equalizaon device of the operang table to earth
before use.
Aenon!
never press one buon over 2min!
DISPLACEMENT
Moving and locking the operang table
Danger！
The paent may get hurt if the operang table is displaced with an aached
extension device, due to its reduced stability against lng. Do not displace the
operang table with an aached extension device when a paent is lying on the top.
Danger！
Remember lock the brake when the paent is on the operang table. The
paent will be easily hurt if the operang table suddenly move by itself.
USING ADJUST
•Adjustment of leg plate
Slacken the handle between leg plate and buocks plate，put it to a proper
place and screw up the handle.。
•Fixing of accessories
There is rail on the both side of the table，you can use the xing clamp the set
up all the accessories.
MOVEMENTS DIAGRAM OF A100-4
Tabletop elevation(up/down)
Head plate(up/down)
Back plate(up/down)
Leg plate(up/down)
Trendelenburg/Anti-trendelenburg
Horizontal sliding 300mm
Leg plate outward

5ENGLISH
Kidney bridge(up/down)
Lateral tilt(left/right)
PICTURE OF CONTROL PANEL
Please look at the picture 4:
- Power supply jack:100-240V IN AC socket;
- Switch “|” means “ON”
“O” means “OFF”;
- Fuse :FU1 、FU2 、FU3 ;
- “C IN” means jack;
LABEL ON THE TABLE
1. Normal leg plate 2. Gas spring leg plate
VERTICAL POSITIONING
Lift up slightly on the ending of
leg plate.
Pull the lock hook trigger
outward longitudinally to
reposition the plates.
HORIZONTAL POSITION
loosen fasten
Loosen and fasten the turn button
to reposition the leg plates as the
direction of arrow shows
FUNCTION OF TELECONTROLLER
1
2
3
4
5
6
7
8
9
1
0
1
1
1
1
2
1
3
14
1 STAND BY
Operang table is in the ready mode. Green
LED on.
2 UP
Raise the table top.
3 REVERSE
Reverse trendelenburg (head down).
4 TILT L
Tilt to the le.
5 BACK UP
Raise the back plate.
6 SLIDE FOOT
Move in the direcon of the foot plate.
7 BRAKE LOCK
Can’t move the operang table.
8 WORK
Operang table is in the work mode. White
LED on.
9 DOWN
Lowers the table top.
10 TREND
Trendelenburg (foot down).
11 TILT R
Tilt to the right.
12 BACK DOWN
Lowers the back plate.
13 SLIDE HEAD
Move in the direcon of the head plate.
14 BRAKE UNLOCK
Can move the operang table.
Danger！
Do not press two buons at the same me！
CLEAN OUT AND DISINFECTION
The cushion on the operang table are all removable. Head secon and leg plates can
be removed completely. This way they can easily be cleaned individually.
Stainless steel, sprain paint part and cushions of the operang table may only be
cleaned using appropriate cleansing agents. The cushion should be cleaned twice by
75% alcohol and then use disinfector and ultraviolet radiaon for sterilizaon.
- Turn o the power aer operaons, raise the operang table to the minimum hei-
ght and move seat and back secon into horizontal posion.
- If required, remove the cushion of the seat and back secons.
Aenon!
The cushion will deform if exposed to heat. The operang table, including its
cushion, must not be sterilized bu super heated steam.
Aenon!
Agents for disinfecon of the paent’s skin may cause discoloraons on
the cushions. Remove such disinfecng agents from the cushion in order to
avoid such discoloraons.
Aenon!
Disinfecng sprays may cause corrosion on mechanical parts, or create
explosive mixtures inside the table components. For this reason, do not use
disinfecng sprays!
Aenon!
Agents for disinfecon of the paent’s skin may cause discoloraons on the
cushion. Remove such disinfecng agents from the cushion in order to avoid
discoloraons.
MAINTENANCE
•Users should check the table and maintain it from me to me.
•When the table hasn’t been used for long me, you need to check it before using.
•In order to prolong its using life and keep it in a good condion, you need to pay
aenon to the daily maintenance.
•You cannot use causc cleaner to clean the cushion aer operaons.
•Do not use industrial alcohol to clean the cushion, it will be react with the cushion.
•Please lower the lowest posion aer using.
•When it cannot work any more, the scrap of the equipment should comply with
legal regulaons.
COMMON PROBLEMS AND SOLUTIONS
Wrong operaons
problem：when you press only one buon, but over one and wrong acon worked
cause：the elements of the base become damp.
Soluon：use gauze to dry it，and adopt 300V blow drier .
The table cannot work：
cause1：disabled fuse 。
cause2：the jack of telecontroller has loosen.
soluon1：replace fuse
soluon 2 connect the power of telecontroller with the table again
Some buons cannot work：
Cause 1：the buon are out of work.
Cause 2: the jack didn’t connect well.
Soluon：you can replace the buons or jack
MAIN TECHNICAL DATA
Form 3: Main technical data
Item Basic Data
Trendelenburg forward ≥25°
backward ≥25°
Lateral tilt Left ≥15°
Right ≥15°
Head plate Up ≥45°
down ≥90°
Back plate Up ≥75°
Down ≥20°

6
ENGLISH
Knee support Prostrate
Support Pad Lateral
support pad Stomach Support
Head rest Head rest External kidney
bridge X-ray Board
Skull Clamp Orthopedic Tracon
1005
Orthopedic Tracon
1006
A100-4 WITH ALL STANDARD ACCESSORIES
Picture 3 : A100-4 with all standard accessories
SYMBOL EXPLANATION:
Keep away from sunlight Medical Device compliant with
Regulation (EU) 2017/745
Product code Follow instructions for use
Date of manufacture Lot number
Caution: read instructions (warnings)
carefully Temperature limit
Imported by Serial number
Atmospheric pressure limit Keep in a cool, dry place
Manufacturer Medical Device
Authorized representative in the
European community
%
Humidity limit
Type B applied part WEEE disposal
IPX4 Covering Protection rate
Disposal: The product must not be disposed of along with other domesc 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.
Leg plate Up ≥15°
Out ≥90°
Kidney bridge ≥110mm
Translation ≥300mm
Input power: 200VA
PACKING LIST
Form 4 packing list
NO. Item quantity NO. Item Quantity
1 Anaesthesia screen 1 piece 7 leg plate（cushion）2 piece
2 Shoulder support (cushion）2 piece 8cushion 1 piece
3 Body support（cushion）2 piece 9 Foot plate（cushion）2 piece
4 Arm support（cushion）2 piece 10 Fixing clamp 2 piece
5 Leg support（wrapper）2 piece 11 Telecontroller 1 piece
6 Head plate（cushion）1 piece 12 Power line 1 piece
Noce! Any serious incident that has occurred in relaon to the device shall be re-
ported to the manufacturer and the competent authority of the Member State in
which the user and/or the paent is established
AppendixⅠ：Universal Accessories
Arm board (pad) Shoulder
support (pu) Shoulder support Body support
Body support Body support Universal Clamp Universal Clamp
Universal
Bar Clamp Universal
Bar Clamp Standard Bar Clamp Standard
Bar Clamp
Knee crutch
(pu)
Knee crutch
(leather padded)
Arm board
(leather padded) Foot plate
Appendix Ⅱ：Oponal Accessories
Foot plate Instrument
Tray
Anaesthesia
Screen Lateral arm
support
Leg belt
Instrument
Tray Spine surgery support
Body belt
(Buckle type) Body Belt
Arm Belt
(Buckle type) Infusion Rod Arm belt Stomach Support