Steris Gmax Transfer System / Gmax Surgical Table Operating instructions

Type
Operating instructions
OM201-01EN 2021-03 REVA GMAX transfer system
GMAX
Transfer System
Edition available for software package 3.04
Transfer System - GMAX
[2]
INDEX
1. Quality requirement ......................................................................................................3
2. Safety instructions .........................................................................................................4
3. Symbols used ................................................................................................................6
4. General presentation ...................................................................................................... 7
5. Setting up the table .......................................................................................................9
6. Operating the main hand control ...................................................................................11
7. Tabletop ...................................................................................................................... 19
8. Transfer function .........................................................................................................20
9. Backup system ............................................................................................................ 27
10. Examples of patient positioning ..................................................................................28
11. Cleaning and disinfection ...........................................................................................32
12. Maintenance program ................................................................................................ 32
13. spare parts list ..........................................................................................................33
14. Quick troubleshooting ................................................................................................33
15. Disposal of waste equipment ......................................................................................33
16. Electromagnetic environment .....................................................................................34
17. In service form ..........................................................................................................35
18. In service form ..........................................................................................................37
Transfer System - GMAX
[3]
Dear Users,
STERIS would like to thank you for choosing the GMAX™ Transfer System, which is now available to meet all your needs.
Please read this manual carefully to ensure that our product can offer you optimum efficiency and safety in use.
Intended use
The Gmax™ transfer system is a medical device designed to support and
position patients during operations carried out in an operating theatre.
Indication for use
The Gmax ™ transfer system has no indication for use, which means that
this medical device is not used to diagnose, prevent, monitor, treat, relieve,
compensate, replace, modify or control any clinical condition of a patient.
Clinical benefit
The Gmax ™ transfer system provides no direct positive impact on the patient’s
health that would be measurable or significant.
By allowing a patient to be safely and appropriately positioned and supported
during surgery, the Gmax ™ transfer system facilitates access to the various
anatomical regions of the patient where surgery will be performed, and this will
have a positive impact on patient management during surgery.
Contraindication - Adverse side eects - Residual risk
There are no contraindications, adverse side eects, or residual risks associated
with the Gmax ™ transfer system. All safety instructions for the use of this
medical device are listed in section 2.
Target patient group
The Gmax ™ transfer system is not intended for a particular patient population
group: this medical device is intended to be suitable for any type of patient,
regardless of age, anatomy, sex, etc. However, for product safety, patient weight
limits are indicated in this user manual.
Intended user
The Gmax™ transfer system should only be used by qualified sta authorized to
work in the healthcare facility. This medical device must be used in a controlled
environment by a professional familiar with appropriate techniques for using this
equipment.
Product developed for surgeons, anaesthetists, nurses, etc. who work in
operating theatres, pre-anaesthesia rooms, recovery rooms.
Essential performance
The GMAX™ transfer system must support a patient without unwanted
movement in a single-fault condition.
Expected life cycle
The expected life of the Gmax ™ transfer system is set at 10 years, provided
that the operating conditions, cleaning and maintenance instructions mentioned
in this user manual are properly followed.
Market release
The Gmax™ transfer system was first marketed in 2015.
1. QUALITY REQUIREMENT
The STERIS quality system is certified
ISO 13485*
for the design, manufacture, sales, installation and after-sales service of operating tables, platforms and transfer carts and there extensions and accessories.
This table design complies with international regulations for medical electrical equipment :
IEC 601-1 (EN 60601-1)* general requirements for safety applicable to medical equipment
IEC 601-2-46 (EN 60601-2-46)* particular requirements for the safety of operating tables
IEC 601-1-2 (EN 60601-1-2)* relating to electromagnetic interference.
Any use going beyond the aforementioned conditions is deemed to be non-compliant. Only the user is liable for any loss or damage arising from this.
The Gmax™ transfer system is a class 1 medical device and is registered with the ANSM (French National Agency for the Safety of Drugs and Healthcare Products)
STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE
STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE
Transfer System - GMAX
[4]
2. SAFETY INSTRUCTIONS
! Any serious incident that occurs in relation to this medical device should be reported to
STERIS and the competent authority of the member state in which the user and/or patient
is established.
! warning The modification of medical device without manufacturer authorisation is prohibited.
Pinch points
! During patient positioning, moving dierent sections of the tabletop and using extensions and
accessories can cause pinch points to appear, which can injure the patient or the surgical
team. Typical pinch points are shown below:.
! During Trendelenburg and right tilt movements, take care to check that the connections
(charger, hand control or foot pedal) are plugged into the interface to prevent damage to the
cables or connectors.
Precaution during the movements
! Before any movement activation, be sure that there is no risk of contact or collision with an
object, on equipment or a person.
! Do not place any objects on the base of the column because they could become jammed when
the sliding covers on the column are lowered.
Stability
! Once the GMAXTR column is on the floor, ensure that it is stable. If not, move it if necessary to
find a flatter floor surface, or use the adjustable foot of the base.
Moving with a patient
! When moving the tabletop with a patient on it, the patient must be centred more or less over
the trolley attachment.
It is strongly recommended that you use barriers or another system to hold the patient in place.
! The trolley is not intented to cross threshold, to ascend or to descend step. Always move the
trolley very carefully.
! Before going anywhere, ensure that there are no obstacles along the way you wish to use.
When you set o, move the trolley very carefully. Adapt your speed to the environment (i.e.
corridor width, corner angles, doors, etc.).
Switching the table on
! Every time you turn the table on, check that the pre-selected patient orientation corresponds to
what you want to do. When you switch o the table, the automatic patient orientation pre-
selection is memorized, but the manual selection is not.
If the main hand control and the optional pedal are used at the same time, the hand control
overrides the pedal.
Switching the table o
! The STOP keys on the main hand control and on the backup system allow you to stop all table
movements.
They deactivate the optional pedal and other external control mechanisms.
Handling the surgical table
! Avoid handling the surgical table roughly during the operation or transfer. Do not exert excessive
lateral loads on it, do not pull or push the surgical table with the accessories or with the rails.
! Avoid rough handling of the hand control and the backup system. Do not press the keys with
too much force or using unsuitable objects. Protect the hand control from colliding with the
table.
! Do not sit on one of the two ends of the table, especially when the tabletop is not centered, as
this can cause the table to tilt.
! Avoid handling the cables roughly when connecting or disconnecting the hand control, the foot
pedal or the power cord set.
! When power cord is connected to the surgical table, and therefore is lying on the floor, pay
attention to this power cord when moving around the surgical table and remove the cable
before moving the table.
Load limits
! Do not exceed a patient+accessory weight of 250kg for the standard described positions and
respect the indications and warnings signaled.
! The use of certain extensions may decrease this patient + accessories weight. When
extensions are installed on Gmax™ tables, the user manuals of these extensions should also
be consulted to find out the possible weight restrictions related to the use of these extensions.
! It is possible to reach 360kg patient+accessory weight only for the bariatric described
positions.
! In positions where the tabletop will be significantly slide away from the column, ensure that
there is sucient stability for the type of surgical procedure requirements.
! For all other uses, please contact our network for advice. If you are working intensively on the
patient’s chest, we recommend that you bring the tabletop back to a centered position on the
column.
Positioning the patient
! The positions described in this manual are given purely as examples. The required accessories
are not always shown. Under no circumstances should these instructions replace the
instructions given by the surgical team in charge of the patient.
! Ensure the stability of the patient and the table when making combined position.
! Secure the patient properly (ex. using straps), especially when the table has a strongt tilt
inclination.
! Long surgical procedures can cause compression points on patients and have post operative
consequences. Monitor patient during surgical procedures and use gel cushions for extented
procedures.
! During table movements (rev. Trend/Trend, up/down, left/right tilt), a minimum distance should
be left between the c-arm and the patient, to avoid any contact between them during handling.
Autonomy
! A lithium-ion battery is integrated into both the column and the hand control, meaning they can
function with being plugged in. Before using the table, check that the batteries are suciently
charged.
Connections
! The sockets are equipped with locks: do not pull on the hand control or pedal cables to
disconnect them. The internal E-Serve connection is only to be used by technician sta and
with equipment approved by STERIS
! Always use the power cord provided by STERIS.
! The operator should never touch the patient when the operator is plugging or unplugging
the hand control or the the pedal, or when the operator is handling the connectors of these
devices.
Installation (for CPS02G and GMAX ST)
! The fixed components should not be installed in areas where there is a risk of explosion
(presence of flammable anaesthetic gas)
! Installation operations should only be assigned to STERIS technicians or technicians certified by
STERIS, and should be carried out according to the installation instructions prepared by STERIS.
Contact the STERIS installation department
! Disconnect all equipment before installing the table. Do not install the GMAX™ unless all
elements of the GMAX™ System have been properly locked.
Transfer System - GMAX
[5]
Potential equalisation
! Connect potential equalisation conductors to prevent the problem of diering potentials in
networks.
! Originally intended for cardiac areas, it protects the patient from electric shock during
procedures where even small potentials may cause harm.
! When a potential equalisation conductor is connected, the table MUST NOT be used with a
defibrillator
! When the use of the potential equalisation conductor allows an medical electrical system to be
created, then this system must meet the requirements of IEC 60601-1.
Antistatic link
! If antistatic connection is necessary, we recommend that you use only the pads that have been
specially developed for this product. Put the patient in direct contact with them and use the
table on an antistatic floor, or connect it to an equipotential cable using the socket designed
for this.
Electrical safety
! Warning: To prevent any risk of electric shock, this appliance should only
be connected to a grounded power supply.
! The Gmax™ table must always be positioned so that the power cord can be disconnected
easily when connected to the table with mobile power supply CPS01G.
! The power cord with its mains plug is thus the device used to isolate the transportable column
GMAXTR from supply mains.
! The mains supply switch “0 / I” on the front of wall-mounted power supply CPS02G, is used to
isolate the GMAX ST stationary column from the mains supply.
! It is preferable to use the batteries instead of the mains if you have doubts about the protective
ground in the operating room.
! The use of high-frequency surgical equipment, cardiac defibrillators, and cardiac defibrillator
monitors in association with the Gmax™ table creates a risk of burns, explosion, or electrical
shock. The user must be aware of this.
! Comply strictly with the manufacturer’s instructions.
Accessories
! If accessories made by other manufacturers are used, it is the user’s responsibility to check
that they are compatible with Gmax™ and that they do not endanger the patient and the
surgical team
! Before connecting accessories to the surgical table, check the general state of them to ensure
that they are not degraded and that the connection system is not damaged.
! The end user should ensure in particular that the intended use and the conditions of use
(including the maximum patient weight) of accessories made by other manufacturers are
compatible with the claims of the Gmax™ surgical table.
Electro-Magnetic Compatibility
! If the table is used close to other electrical equipment, ensure that the latter complies with the
regulations in force regarding electromagnetic compatibility. If high frequency equipment (such
as a defibrillator) is used, ensure the manufacturer’s instructions are followed closely.
Emergency mode
! When the backup system is used, the other control systems, including the main hand control,
are automatically switched o. The ALS sensors can also be disabled, so when you move the
tabletop you will need to ensure that you look out for potential conflicts between the sections.
The pre-selected patient orientation set as default is the normal orientation.
Cleaning
! Do not use any chlorine-based products or chlorine derivatives due to the risk of corrosion.
Ensure that the socket protection flaps correctly cover the plugs so that fluids do not get in.
Before cleaning the column, ensure that it is switched o and disconnect the hand control. Put
on the socket cover.
! Do not immerse the hand control and do not spray cleaning products directly onto the sockets.
! After cleaning, ensure no residual water remains near the mains plug.
Hand control storage
! When the hand control is not in use, we recommend hanging it on a table rail or placing it on
the charger unit to prevent any keys being pressed accidentally. Handle the hand control and
its cable with care.
Environmental conditions
Transport / storage: temperature 0°C-65°C, humidity 10-85% Pressure non-condensed 500-
1060 hPa, battery fuses removed.
Use: temperature 10°C-40°C, humidity 10-75% non-condensing, pressure 800-1060 hPa
nota: at 40°C, temperature at the pads are equal to 42°C
Local pressure to the floor: 0,2kg/cm2 under the base
! When the RCT01G is used with trolleys and the GTOPGX, the temperature for use should not
exceed 25°C.
! Do not use the table in the presence of flammable anesthetic gas, or in areas subject to
explosive risks.
! Gmax™ must not be used in the vicinity of strong magnetic fields (MRI environment)
! Gmax™ is not intented to operate in an oxygen rich environment
! GMAX™ is not intented for outdoor use, and shall not be exposed to high humidity for extented
periods.
X-Ray radiation
! The GTOPGX tabletop should not be considered to be a patient support system for radiology
procedures. The Gmax™ transfer system does not consist of associated equipment for a
radiological set-up. This means that if the operating table materials are exposed to an x-ray
beam, it does not have optimal radiolucent performance and this may lead to interference with
the information, potentially resulting in harm to users. Radiological protection devices should
therefore be worn by users when using radiology equipment with the Gmax™ transfer system.
Maintenance
! The safety, reliability and proper operation of the surgical table can only be ascertained and
granted by STERIS. Repair and adjustments should only be assigned to STERIS technicians or
approved technicians.
! Observe the maintenance schedule set out by STERIS and described in this document.
! Never try to adjust or repair the surgical table yourself.
! No interventions may be undertaken on the GMAX™ transfer system before all electrical power
is switched o and made safe.
! During maintenance and repair, only original parts must be used.
! While the surgical table is in use with a patient, no software update should take place and no
part of the operating table should be serviced or maintained.
Transfer System - GMAX
[6]
TFT screen pictograms
Trend Rev Trend
Up Down
Left tilt Right tilt
Slide
(according to the indicated
direction)
Slide
(according to the indicated
direction)
Backrest up Backrest down
Upper Back up Upper Back down
Leg plate up Leg plate down
L
Left leg rest up
L
Left leg rest down
R
Right leg rest up
R
Right leg rest down
Transfer Out manuel Manual Transfer In
Patient in normal position Patient in reversed position
TP V4.01
BU V4.01
10
R
R
45°
Defect detected contact our
technical support team
°
Active control interface:
Wired hand control / Bluetooth
/ Backup / pedal / E-serve /
External control
Charge of column battery status
Gmax
Discharge of column battery status
Hand control Bluetooth battery
status full / empty / charging Please wait cycle in progress
Connection panel
Power supply / Main charger
Control pedal
E-SERVE port:
Reserved for STERIS use
Main battery fuse
Wired hand control
3. SYMBOLS USED
Column & charger labels
Warning:
read the accompanying documents
Protection from electric shock
class 1, type B This way up
N
stacking limit
Equipotential plug IPX4 Protection from water splashing Fragile, handle with care
65°C
0°C
Temperature limit
WEEE Directive: the product must
be recycled Hazardous voltage Handle with care
1060
500
Atmospheric pressure limits
Direct Current Name and address of manu-
facturer
Compliance with essential
requirements of applicable
Europeen regulations
85
10
Humidity limits
6min/h Intermittent use
SN
Serial number
Press and release any pedal
to start
(See optional pedal in section 5)
Caution
Alternating Current
REF
Product reference
MD
Medical Device
2015
Year of manufacture
Main hand control
Trend / Rev trend
Up/Down
Left tilt /
Right tilt
Return to horizontal
Transfer in/
Transfer out
Patient direction
Normal / Reverse
MEM
Mem
Memory keys
Tabletop movement (top
left/bottom right)
MENU
Tabletop movement
menu
O button
Backup control
Trend / Rev trend
Up/Down
Right tilt /
Left tilt
Backrest/seat up Backrest/
seat down
Upper backrest up Upper
backrest down
Legs up
Legs down
(Lateral floating)
Slide (direction shown)
(Longitudinal floating)
Return to horizontal
STOP button
Starting the table in Bluetooth
Validation in backup mode
(with the desired movement)
Tabletop pictograms
Patient in normal position Patient in reversed position
Transfer System - GMAX
[7]
29
36
Tabletop
Transfer trolleys
13. GCAR FX 13. GCAR HT
14
19
15
18
17
2
8
10
3
4
5
6
7
9
Columns
24
29
30
21
3332
22
20 23
25 26 27 28
T10A
250V
PC
1500A
1. General surgery tabletop GTOPGX
2. Head section with double articulation HED09G
3. Upper back section length adjustable BAK02G
4. Backrest section
5. Seat section
6. Split leg rests LEG30G
7. Manual controls to attach/remove extensions
8. Head section articulation control levers
9. Electric Interface tabletop / column
10. “V”tabletop fastening
11. Blue pictogram (normal patient direction) slide limit
12. Pink pictogram (reverse patient direction) slide limit
13. GCAR FX/HT transfer trolleys
14. Double swiveling wheels, stoppable
15. Wheel brake pedal used to immobilize the trolley, or to lock the front wheels in forward position
16. Front wheel brake pedal. Additional brake
17. UP/DOWN and TRENDELENBURG/REV. TREND. selection lever and pedals
18. Trolley “V” interface
19. Elongating and down adjustable handle
20. Stationary column Gmax ST
21. Locking lever
22. Base support floor mounted
23. Gmax TR mobile column
24. Connections panel
25. Charger socket
26. Hand control socket
27. Pedal connection point
28. Battery fuse
29. Backup system
30. Electric Interface column / tabletop
31. Potential equalization node
32. Charger / power supply mobile CPS01G
33. Charger / power supply wall mounted CPS02G
34. Hand control cable CAB001
35. Hand control RCW01G
36. Tabletop control RCT01G
37. Adjustable foot
3534
31
16 16
11
12
4. GENERAL PRESENTATION
37
Transfer System - GMAX
[8]
Electrical characteristics:
Power supply:
Input 100V - 240V 50-60Hz
1 phase 600VA max
Output 28V 13A max
Protection Class 1 type B
Equipotential plug DIN42801, cord not supplied
Fuse (accessible to operator) 2xT6,3A 250V PC1500A (IEC inlet CPS01G) T=slow-acting fuse; PC=breaking capacity
1xT10A 250V PC1500A (Column battery fuse) T=slow-acting fuse; PC=breaking capacity
Fuse (accessible to maintenance personnel) 2xT2A, 125V, PC50A (master board) T=slow-acting fuse; PC=breaking capacity
1xT2A, 125V, PC100A (master board) T=slow-acting fuse; PC=breaking capacity
1xT1A, 125V, PC100A (BBI board) T=slow-acting fuse; PC=breaking capacity
1xT6,3A, 250V, PC1500A (Inside CPS02G) T=slow-acting fuse; PC=breaking capacity
1xF20A, 32V, PC1000A (near column battery) F=fast acting fuse; PC=breaking capacity
Battery colonne 25,6V Lithium-ion
Autonomy 50 procedures and transfer
Maximum charge duration 8h
Charge/discharge indicator Hand control bargraph
Intermittent operation 6 min / hour during surgical procedure
Resistance to liquids IPX4 (for surgical table and its accessories)
IPX6 (for optional pedal)
Antistatic device
Using pads and conductive feet (TR) or wire connection (ST)
Applied parts Pads
Radiocomunication characteristics
Frequency band in which the Gmax™ Transfer System
operates
2,40 - 2,4835Ghz
Maximum radiofrequency power transmitted in the frequency
band(s)
10dBm
Mechanical characteristics:
GMAXTR/ST columns:
Up / down (without cushions): 1108 mm / 637 mm (stroke 471mm)
Left tilt / right tilt: 30° / 30°
Trendelenburg / Rev Trend: +45° / -45°
GTOPGX tabletop:
Upper Back section +3/ -65°
Backrest section +80°/ -30°
Leg rest +90°/ -90°
Slide head / Slide foot: 0 mm / 374 mm
Tabletop length: 932 mm (Tabletop without extensions)
Tabletop width: 536 mm (576 mm including rails)
Table weight (alone): 268 kg
Maximum patient + accessories weight:
250 kg following instructions & restrictions in the manual
360 kg in bariatric position
Main materials used:
Covers & structures High performance electropolished stainless steel and aluminium
Tabletops Laminate
Bellows Rubber
Pads On 80 mm welded edges, shaped memory foam
Main characteristics
The Gmax™ Transfer System has been designed to respond to the latest expectations in surgery in the easiest and safest way. Each transfer system is made of multi-
section operating tabletops, columns and bases, a trolley to transfer the operating tabletop and a colour touch screen hand control. It has been designed to optimize
operating theatre procedures and guarantee flexibility, versatility, and intuitive use.
Because it is highly modular and adaptable and makes use of specific tabletops and accessories, the operating table can satisfy all the needs of the dierent surgical
specialties.
The movements allow the user to automatically configure the operating table for dierent surgeries and surgical approaches without the need to manually move the
section.
The tabletop adjusts to the patient, rather than the patient to the tabletop. The capacity of the Gmax™ Transfer System is 360 kg in the bariatric position.
The Gmax™ Transfer System is made up of the following elements, at minimum:
1 operating table column (mobile or fixed) and charger
1 interchangeable operating tabletop (made up of multiple sections)
1 trolley (fixed or with variable height and Rev. Trend/Trendelenburg)
1 hand control with Bluetooth connection and cable
The almost unlimited possible combinations of the sections are matched with automatic detection of the different sections. This makes the table much
easier and safer to use: any changes in the orientation of the head and leg sections are automatically recognized by the system and managed safely.
The transfer trolley can be inserted around the column from the head or foot end within a 100-degree angle range, allowing the trolley to be steered around equipment and
obstacles in the operating theatre. In addition, with the same trolley, you can transfer the tabletop only or move the tabletop and the column together.
Transfer System - GMAX
[9]
5. SETTING UP THE TABLE
Transportable column GMAX TR
This column can be transported
using a transfer trolley or the FLT01G
repositioning trolley. It is powered by a
battery or by an external power supply.
Stationary column GMAX ST
The fixed column can rotate 360°.
Push out the pedal on the base,
turn the column and then reposition
the pedal by pushing it back into its
original location.
The column is available in fixed (ST) or mobile (TR) version. Each version is
equipped with an electro-hydraulic system to:
Move the column up/down
Trendelenburg / Reverse trendelenburg
Left/right tilt
On the top of the column there is an electric interface permitting bidirectional
communication with the tabletop
5.1 Column
T10A
250V
PC
1500A
5.2 Connections
Bargraph
Appearence
% Charge Discharge
(nb of cycles*) Beep
Flashing red <8% 0Continuous beep
Flashing red 8% < to <16% 0 to 3 Continuous beep
Fixed red 16% < to <25% 3 to 7 Beep during the
movement
Fixed orange 25% < to < 50% 7 to 15 No
Fixed green 50% < to < 100% 15 to 30 No
* Based on 6’ cycle operation time
Inserting and removing the battery fuse:
For reasons of safety during transport, the battery fuse is packed
separately.
1. Insert the fuse into the separately provided fuse holder.
2. Push and turn in order to lock the fuse holder.
If the table is not used for a long period of time (>1 month), remove the fuse to
limit loss of battery charge and maintain battery functionality.
CPS01G
All columns are equipped with latest generation lithium-ion batteries, meaning
the table can be used without being plugged in for long durations. The battery
status is displayed on the hand control as shown in the table opposite.
To extend the working life of the batteries, we recommend the following:
Do not leave them permanently charging (connected)
Charge batteries systematically when the indicator on the screen of the hand
control is red
Avoid the deep discharge to prevent degradation of battery life time
Carry out a preventive maintenance (a control of batteries each year)
When charge is less than 8%, all movements are prohibited. A full screen red
battery is displayed.
When you connect the charger, you immediately recover normal functioning.
Connecting the table to the mobile charger:
1. Lift up the protection cover of the charger socket and connect
the CPS01G.
2. Connect the power cord to a mains socket.
Note:
For a fixed column equipped with a wall charger, the
connection can be made directly in the floor; in this case no additional connection
is required
Transfer System - GMAX
[10]
Connecting and activating the E-Serve™ USB internal
port (for STERIS technicians only)
Connection:
It is possible to connect a PC using a specific E-Serve™ USB cable
inside the connectors panel (must be open). Smart electronics allow the table
to be controlled remotely, assessed for diagnosis and maintained. To activate
the connection, a specific E-Serve™ software package is required.
Connecting and activating the foot pedal
Connection:
1. Lift up the protection cover on the corresponding socket.
2. Align the red dot on the pedal cable connector with that on the
socket on the table side.
3. Plug the connector until it “clicks,” indicating that it is correctly connected.
4. The pedal enables users to adjust the 3 main table movements: up/down,
Trend/rev Trend and right/left tilt. To activate it, press the pedal once and
then release.
Disconnection:
1. Switch o the pedal by using the STOP button on the hand control.
2. The connector is equipped with a lock: unlock the connector by pulling the
ring backwards. Never just pull the cable.
3. Ensure that the protection cover is covering the sockets.
Disconnection:
1. Switch o the hand control by pressing STOP.
2. Unlock the connector by pulling the body backwards. Never just pull on the
cable.
3. Ensure that the protection cover is covering the sockets.
Connecting and activating the main hand control
Connection:
1. Lift up the protection cover on the corresponding socket.
2. Align the red dot on the hand control cable connector towards
the top, with those on the socket on the table side
3. Plug the connector in until it clicks, indicating that it is correctly connected. To
activate the hand control, press any button except the STOP button.
It automatically goes into standby mode after 3 minutes if it has not been used.
When the table is plugged in, the Bluetooth batteries of the hand control are
permanently charged (wired mode).
The E-Serve™ port should not be used to connect other types
of hardware and devices than the PC used by STERIS-accredited
technicians.
Y
Transfer System - GMAX
[11]
The hand control includes:
1. A 5 m spiral cable with a connector at each end to facilitate replacement.
2. An elastomer housing equipped with a hook so that it can be attached to the side rails of the table.
3. A back-lit keypad making it easy to locate the keys in the dark.
4. A 2.4 inch TFT colour screen for easy communication with the user
Starting up the table
Pressing any button (except the STOP button) turns the table on but does not initiate any movements. A welcome screen is then displayed for a few
seconds. First press to select the control interface, then you can press the button for the required movement.
Stopping the table
When the STOP button is pressed, the table immediately stops and turns off.
By default, the hand control goes into standby mode after 3 minutes of not being used, in order to prevent any unintentional movements and to
conserve internal battery life in Bluetooth mode. In this mode, the patient direction keys blink simultaneously.
Gmax
RC V4.01
CL V4.01
TP V4.01
BU V4.01
14/01/20 GMT: 15:51
Gmax
RC V3.02
SC V1.04
ST V1.04
BU V2.01
2021/3/29 GMT : 9:24
PACK V03.04_F727ECFC 8 @i
M V3.09.010
Back-lit TFT colour screen:
• Battery status, active interface status
• Report of table movements from the integrated
motion sensors
• Selected tabletop section and patient position
Interactive tabletop controls:
• Depending on the type of tabletop connected, only
certain motorized movements can be accessed.
• For example:
For GTOPGX, the available movements are:
slide, lower backrest, upper backrest, legs, left
leg, right leg
Position memories:
Access to position memories:
• Presets: FLEX, REFLEX, SEAT, KNEECHEST,
Gyn, KIDNEY, BARIATRIC, SHOULDER surgery
• 20 free memories set by users
Motion and sound sensors:
Tactile: in the event of a collision alert, the
hand control vibrates (ALS)
Audible: beep to signal a movement requiring
special attention or at the end of a movement
Trend (head down) Rev trend (feet down)
Table up / down
• Left or right tilt
Spiral cable connection point
When connected to the table, the hand control recharges itself and operates in wired mode
It is only charging when it is mounted on the charger dock.
Software versions:
RC hand control, SC column, M motherboard
ST surgical tabletop (if connected),
BU backup control
PACK = software package Date YYYY/MM/DD
hour GMT HH:MM
• LEVEL Led
• LEVEL return to horizontal
• Patient orientation on the table
Led normal patient orientation
Led reverse patient orientation
• Stop table
Column and base direct controls
(back-lit area)
Transfer in/out
• Ready for transfer LED
6. OPERATING THE MAIN HAND CONTROL
6.1 Wired mode
Transfer System - GMAX
[12]
INFORMATION LAYOUT ON THE SCREEN
For communication purposes, 5 colours are used:
Black not selected, neutral state
Transparent green movement in progress
Green
normal status/current selection
Orange operator vigilance required
Red alarm or fault detected
10
0cm
Representation of the table and the
patient:
-patient orientation
-tabletop sections positions
-Selected tabletop section in green
Interactive keys
Up Down
Left Right
Longitudinal slide
Lateral slide
(GTOPVS)
Backrest
Upper back
Simultaneous leg
rest movements
Left leg rest
LL
Right leg rest
RR
Patient direction
Normal / reversed
cm
°degrees,
centimeters
Unités
Vertical
Longitudinal
Lateral
Orientation of movement
Extra information
Cycle in progress
Return to LEVEL
Tabletop section selection
MENU Menu
GTOPGX tabletop movements
The values on the TFT screen are given as an indication only.
Details may vary depending on the environment (altitude,
humidity, temperature, etc.). Conduct a visual inspection of
the patient’s position during movements
Active command
Wired hand control
Pedal
Bluetooth hand control
USB internal e-serve
External command
Column control
Operating anomalies
10
23cm
Key + fault number
Table status
Table power
supply
Discharge status
Charge status
Status of hand control internal battery
Bluetooth battery charge
Charge in progress
Transfer System - GMAX
[13]
6.2 Bluetooth wireless mode
IMPORTANT:
The Bluetooth protocol is a mode currently commonly used for remote communication between electronic devices. However, as European
legislation is not harmonized, it is the responsibility of the hospital to authorise (or not) the use of this mode of communication. Therefore,
please check the internal rules at your facility before using this mode.
When a column is in wired mode (see 6.1), the hand control memorizes its identification so that it can control this column (and any associated tabletop), and only
this column, in Bluetooth mode. If another hand control is connected to this column in wired mode, the table will take its ID and disable recognition of the previous
hand control.
To switch from wired mode to Bluetooth wireless mode, you simply disconnect
the spiral cable from the hand control: the hand control will then operate
autonomously on its internal battery.
Bluetooth mode can be identified by:
internal battery charge status
Bluetooth pictogram
23cm
Gmax
RC V4.01
CL V4.01
TP V4.01
BU V4.01
14/01/20 GMT: 15:51
Gmax
RC V4.01
CL V4.01
TP V4.01
BU V4.01
14/01/20 GMT: 15:51
23cm
Internal battery discharged:
When the internal battery is out of charge, a red pictogram appears on the
screen.
The hand control then needs to be recharged by connecting it to the table
using the spiral cable (wired mode) or to one of the chargers. When the
battery is completely recharged, the pictogram disappears.
No column detected display:
If the Bluetooth connection is lost, or if the table is switched off by mistake (using
the STOP button), the hand control switches off. Check that the blue Bluetooth
LED is lit on the column. If it is not, restart the table using the Bluetooth button
on the backup keyboard
Gmax
RC V4.01
CL V4.01
TP V4.01
BU V4.01
14/01/20 GMT: 15:51
23
cm
23cm
CPS01G CPS02G
Transfer System - GMAX
[14]
6.3 Access to direct functions
The return to level button enables the tabletop to be returned to a horizontal position. While the tabletop is being moved, even if automatic
mode is being used, make sure that the patient does not slip.
The blue light of the LED button is off if the tabletop is not horizontal:
1. Press the the LED will flash
2. The LED will be permanently on when the tabletop is horizontal
Return to Level
30° 30°
Trend / Rev Trend movements are obtained by directly pressing the corresponding keys on the keypad. During the movement,
the screen displays pictograms of movement in progress and the angle with respect to the horizontal
Trend / Reverse trend
65
cm
80
cm
Up/down movements are obtained by pressing the corresponding keys of the keypad. During the movement, the screen
displays pictograms of the movement in progress and the distance from the floor.
Column UP/DOWN
Right/left tilt movements are obtained by pressing the corresponding keys on the keypad. During the movement, the screen
displays a pictogram of the movement in progress and the angle in relation to horizontal; however, the representation of the
table on the screen does not move.
10° 10°
Tilt left / right
As the Gmax™ Transfer System is a modular design, the head and leg sections can be attached in reverse
in relation to the seat and back sections. The patient can then be in a normal or reverse position on the table.
Although the orientation is automatically recognized by the sections mounted on the table, it is always possible to manually
select it with the patient orientation button which reverse the orientation to keep the right selected movement.
Every time the table is reconfigured, ensure that it corresponds to the selected patient orientation.
Normal
orientation
Reversed
orientation
Patient orientation on the table
Reversed orientationNormal orientation
Head end blue arrow
slide
Head end pink arrow
slide
Transfer System - GMAX
[15]
6.4 Access to the functions of other sections of the tabletop (using the MENU keys)
23cm 23cm
Slide
When the hand control is turned on, the default movement is slide and the interactive keys allow the tabletop to slide
towards the patient’s head or feet, depending which patient direction has been previously chosen.
To slide the tabletop from one side of the column to the other, press the interactive key under the chosen movement.
The slide value relative to its central position are displayed on the screen in real time.
45°
15°
00°
Backrest
Upper Back
RRLLLeg sections
Use the MENU keys to scroll through the different selections. Once the backrest movement appears on the screen, press the
interactive button located below it during the movement.
The angle relative to the central position and its direction are displayed on the screen in real time.
Use the MENU keys to scroll through the different selections. Once the upper back movement appears on the screen, press
the interactive button located below it during the movement.
The angle relative to the central position and its orientation are displayed on the screen in real time.
To change the section of the tabletop to be controlled, you should use the MENU keys to scroll through the different selections.
Once the intended movement appears at the bottom of the screen, press the interactive key below it.
MENU Upper Backrest - Backrest - Slide - Legs - Left/Right
Use the MENU keys to scroll through the different selections.
Once the intended leg movement appears on the screen, press the interactive button located below it. The angle relative to the central position
and its orientation are displayed on the screen in real time.
RR
45°
LL
45°
Right leg rest selected Left leg rest selected
RRLL
45°
Simultaneous leg rest
movement
Transfer System - GMAX
[16]
MEM
Mem MEM position memories
Press the MEM button MEM
Mem to enter in the positions’ memories menu. Then use the menu keys MENU to go to the choosen final position shown
on the screen and press the interactive button GO located below it to start the movement.
The positioning process can be stopped at any moment by releasing the interactive GO button
Pressing the interactive button gradually return the tabletop to a horizontal position
User positions:
Store a position in the memory:
It is possible to record a position in order to return to it later using the GO in the same way as the preset positions.
MEM1 to MEM20 are reserved for storing specific user positions that function REC ,
All movements are taken into account in the case of user-defined positions, height and tilt included.
To store a position:
1- Position the table in the desired position
2- Enter Memory mode by pressing the button MEM
Mem
3- Find an available user memory or one that can be overwritten by the new position by scrolling through them using the keys MENU ,
4- Record the position using the
MEM
Mem
by pressing the interactive button located beneath it: the position will then appear in grey on the screen.
Preset positions:
Reverse orientation
GO
GO
FLEX
GO
GO
REFLEX
6
SHOULDER
SURGERY
GO
6
BARIATRY
GO
GO
User position n° 9
Empty
User position n° 1
Already recorded
Movement
On going
x
MEM 1
Mem
GO
x
MEM 9
REC
GO
x
GO
When a user-defined position is stored, this position can then be obtained with the table following
the same process, using the “GO” button, as for any preset position.
Example of display
Note 1: For patient safety reasons and because of the recognition of extensions, only stored positions with same tabletop configuration will be
displayed and accessible
Note 2: to exit MEM mode, simply press the button
MEM
Mem button or any other button on the hand control.
GO
FLEX
1
REFLEX
GO
GO
3GYN
GO
GO
GO
GO
N
GO
SEAT KNEE -CHEST
GO
GO
N
GO
GO
GO
GO
KIDNEY
Normal orientation
NOTE: For patient safety reason and thanks to extensions recognition, only safe and possible memorised positions will be displayed and accessible
Stored positions do not include the height and tilt.
with GPL01G/LEG01G
only
with BAK05G only
with BAK02G only
Transfer System - GMAX
[17]
Delete a Memory position
IMPORTANT:
The use of a pre-programmed cycle requires careful monitoring of the table movements during the movement of the various sections.
For this reason, it is recommended that you use this function during the initial set-up without a patient on the table to save time.
The user memories may have been erased or changed by somebody else, so it is the user’s responsibility to ensure that the desired position
is in fact that shown on the screen before using the function
GO
,
GO
FLEX MEM 20
DEL DEL
MEM 1MEM 1
DEL
MENU MENU MENU MENU
GO
FLEX
MEM 20
DELDEL
MEM 1
MENU MENU MENU
To delete a user-defined position, position the tabletop in the
configuration in use at the time it was stored and press the
MEM button MEM
Mem and use the LEFT arrow MENU of the
MENU keys.
Go past the preset position “FLEX” and you will enter the
DELETE menu. From 20 to 1, each user-defined position can
be seen and deleted, if needed, by pressing the interactive
key
DEL
.
To exit the DELETE menu, press the RIGHT arrow MENU
of the MENU keys until you go past the MEM 20 position; you
then enter Memories mode via the preset positions.
Transfer System - GMAX
[18]
6.5 ALS (Auto Limit Sensors)
Special case of ALS operation split legs section
Split leg mode is set as the default and takes into account the most restrictive cases.
Thus, it is possible to disable the ALS using “STOP ALS” to continue the movement of one motorized articulation of a leg rest.
Right leg lowered
IMPORTANT:
When the ALS mode is disabled,
the user must look out for
potential collisions between
the sections. ALS mode will be
automatically reactivated when
the configuration of the table is
back to normal.
ALS right leg off = authorized
movement beyond the position
initially blocked.
Disable ALS for right
leg
Collision Column – trolley
Solution: Raise the column
Trolley – lateral/Trend. collision
Solution: return the
tabletop to the horizontal
position (0) or transfer
position, or remove the
trolley
Lateral – Trendelenburg collision
Solution: Reduce tilt or
Trend
23°
R R
48°
-
STOP
ALS ?
!
R
R
45°
RR
STOP
ALS ?
!
RALS
Collision leg – floor
Solution: Reduce reverse
Trend or raise the leg
section
STOP
ALS ?
!
RALS RALS
STOP
ALS ?
!
Collision leg - column
Solution: Reduce reverse
Trend or raise the split leg
section
Collison detection
right leg / floor
Solution: Slide the seat to
central position or raise
backrest
Collision back - slide
-1°
Solution: raise the table then
raise the backrest, possibly
reduce the lateral angle
Backrest – column collision
30°
Collision back – floor
Solution: Raise the table
then raise the back
section, possibly reduce
the lateral angle
-48°
Collision Leg – Slide
Solution: slide the tabletop
to the leg rest side
STOP
ALS ?
!
ALS
The electronic sensors and associated software help to avoid the motorized sections colliding with each other or the floor. When a
potential collision is detected during a movement, the movement is stopped, the hand control vibrates and the screen displays the
potential collision in red. It is therefore necessary to correct the position following the screen display, to reach the final position required.
As some parts of the leg and head sections are moved manually, their positions are not detected by the sensors: they must be carefully monitored during movements.
Main potential collisions occuring ALS stops
Transfer System - GMAX
[19]
The GTOPGX is a universal tabletop with a modular design and all its articulations are motorized. Different extensions and accessories can be fitted to the
backrest section and seat section (refer to the extension and accessories manual to check the options and the weight restrictions for use).
Seat section
Seat section motorised joints
Upper back section
(motorised)
Backrest section
(motorized)
Example of assembling a headrest
Assembly
A B C D
1. present the headrest tilt up 20° 2. align and introduce the headrest hook in the
tabletop lock
3. let the headrest naturally rest it will lock
automatically
4. Check whether it is firmly attached by trying to lift
it up or by checking whether the side indicators
are on green.
A B C
1. Push the 2 lock buttons, which will stay unlocked;
the side indicators will be on red position.
2. Tilt the headrest up 20° to be able to unlock
the 2 hooks
3. Lift the headrest and remove from the hooks
Operating the tabletop (Mounting / demounting extensions)
The tabletop is equipped with a G-LOCK locking system. It is compact, easy to use and secure. With G-LOCK, an extension is automatically locked in when it is
inserted. To remove the extension, simply press the buttons under the articulations.
For convenience, it is preferable to attach and remove the extensions when the table is in horizontal position with the pads removed.
7. TABLETOP
Dismantling
Transfer System - GMAX
[20]
8. TRANSFER FUNCTION
8.1 General information
A Gmax™ transfer system consists of a column, transfer trolley, removable
tabletop and specialized extensions with mechanical articulations that can
be mounted on either side of the tabletop depending on the desired surgical
position.
This multiplicity of possible configurations should not mean that the essential
rule for transfer in and out is forgotten: the patient must be centred over
the column. Although the tabletop/column and tabletop/trolley “V” interface
is very tolerant in position, it is always better to get as close as possible.
A basic approach to locating the centre of gravity “G” of a patient lying in a
supine position is to find his or her navel
Trolley “V” interface
Tabletop “V” interface
with control
G
Patient’s navel Column “V” interface
G
Two trolleys are available to move the tabletops of the Gmax™ Transfer
System: the GCARFX, without position adjustment, and the GCARHT, with
Trend and height adjustment. Both trolleys have superb manoeuvrability and
can be inserted around the column from either side with a free access of
100°.
For the transfer, the GCARHT trolley must be adjusted to the right height and
must be horizontal. This can be checked easily by pressing the button on the
trolley: green=OK, red=horizontal positioning to be corrected.
The 4 red pins for moving the tabletop + column assembly must be pushed
in.
100°
OK
X
X
X
OK
IMPORTANT:
The transfer trolleys are used to carry patients but also
to move the transportable columns with the tabletop.
The 4 red pins should only be removed when the trolley is empty,
meaning the tabletop is already on the column.
When a trolley is introduced around the column, this limits all trolley and
tabletop movements to avoid collisions between them.
The up/down buttons on the hand control are neutralized
On the Gmax hand control, the functions of the “bring to horizontal” and
Automatic Transfer keys are identified:
The “bring to horizontal” function consists of levelling without sliding or
raising the tabletop and its extensions
The Automatic Transfer feature consists of moving the tabletop into a
position compatible with transferring the patient, since a patient may, for
example, be transferred into a seated position (max. 30° for the backrest
and -10° for the leg sections). This feature includes slide and height but not
bringing the tabletop to horizontal.
So, in order to transfer flat, the two functions will need to be used sequentially.
Gmax
RC V4.01
CL V4.01
TP V4.01
BU V4.01
14/01/20 GMT: 15:51
Return to
horizontal
Automatic
Transfer
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Steris Gmax Transfer System / Gmax Surgical Table Operating instructions

Type
Operating instructions

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