customer manual
[ use & maintenance ]
CMAX™X-RAY
operating transfer table for imaging-assisted surgery
OM201-01EN 2023-06 REVA CMAX X-RAY
operating transfer table for imaging-assisted surgery - CMAX X-RAY
[2]
INDEX
1. QUALITY REQUIREMENTS .................................................................................................................................................3
2. SAFETY INSTRUCTIONS .................................................................................................................................................... 4
3. SYMBOLS USED ...............................................................................................................................................................6
4. OVERVIEW ....................................................................................................................................................................... 8
5. MOUNTING THE VARIOUS ADAPTABLE ACCESSORIES ON THE CARBON TABLETOP ..........................................................11
6. SETTING UP THE TABLE .................................................................................................................................................13
7. OPERATING THE 1CONTROL MAIN HAND CONTROL ........................................................................................................16
8. JOYSTICK OPERATION ....................................................................................................................................................22
9. MOTORISED TRANSFER .................................................................................................................................................. 24
10. OVERRIDE SYSTEM ......................................................................................................................................................26
11. EXAMPLES OF PATIENT POSITIONING ............................................................................................................................27
12. CLEANING AND DISINFECTION ......................................................................................................................................30
13. MAINTENANCE SCHEDULE ...........................................................................................................................................30
14. CMAX™ X-RAY SPARE PARTS LIST ............................................................................................................................... 31
15. QUICK TROUBLESHOOTING GUIDE ................................................................................................................................31
16. ENVIRONMENTAL PROTECTION .....................................................................................................................................31
17. ELECTROMAGNETIC ENVIRONMENT ..............................................................................................................................32
18. COMMISSIONING RECORD ...........................................................................................................................................33
19. COMMISSIONING RECORD ...........................................................................................................................................35
operating transfer table for imaging-assisted surgery - CMAX X-RAY
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Dear customers,
STERIS thanks you for choosing the CMAX™ X-RAY poweredsurgical tables, which is now available to meet all your needs.
Please read this manual carefully to ensure that our products can oer you optimum eciency and safety in use.
1. QUALITY REQUIREMENTS
The STERIS quality system is certified
• ISO 13485*
for the design, manufacture, sales, installation and after-sales service of operating tables, tabletops and transfer carts and their extensions and accessories.
This table is designed in compliance with international regulations for medical electrical equipment :
• IEC 60601-1 (EN 60601-1)* general requirements for basic safety and essential performance
• IEC 60601-2-46 (EN 60601-2-46)* Safety requirements applicable to operating tables
• IEC 60601-1-2 (EN 60601-1-2)* Requirements relating to electromagnetic compatibility.
Intended use
CMAX™ X-RAY surgical tables are medical devices intended for supporting
and positioning patients during surgical procedures carried out in an operating
theatre.
CMAX™ X-RAY surgical tables are also intended to be compatible with
fluoroscopy equipment used during specific surgical procedures (such as
vascular or endovascular surgery)
Indication for use
CMAX™ X-RAY surgical tables have no indication for use, which means that
these medical devices are not used to diagnose, prevent, monitor, treat, alleviate,
compensate, replace, modify or control any clinical condition of a patient.
Clinical benefit
CMAX™ X-RAY surgical tables do not bring any direct positive impact on the
health of the patient which would be measurable or meaningful.
By allowing a patient to be positioned and supported in a safe and appropriate
manner during a surgical procedure, and by ensuring appropriate compatibility
with fluoroscopic equipment used during specific surgical interventions,
CMAX™ X-RAY surgical tables make it possible to facilitate access to the
dierent anatomical regions of the patient where the surgery will be carried out,
and this will have a positive impact on patient management during surgery.
Contraindication - Adverse side eects - Residual risk
There is no contraindication, undesirable side-eect or residual risks associated
with CMAX™ X-RAY surgical tables. All safety instructions related to the use of
these medical devices are listed in chapter 2.
Target patient group
CMAX™ X-RAY surgical tables are not directed to a particular patient population:
these medical devices are supposed to suit any type of patient, regardless of
age, anatomy, gender, etc. However, for the safety of the product, weight limits
of patients are indicated in this user manual.
Intended user
CMAX™ X-RAY surgical tables must be used only by qualified personnel who
are authorized to practice in the healthcare facility. These medical devices
shall be operated in a controlled environment by a professional familiar with
appropriate techniques with such equipment.
Product developed for surgeons, anesthetists, nurses etc. which are working in
operating rooms, pre- anesthesia rooms, recovery rooms.
Essential performance
CMAX™ X-RAY surgical tables shall support a patient without unwanted
movement in a single-fault condition
Expected life cycle
The intended lifetime of CMAX™ X-RAY surgical tables is set at 10 years,
provided that the conditions of use, the cleaning and maintenance instructions
listed in this user manual are correctly followed.
Market release
The CMAX™ X-RAY surgical tables were placed on the market in 2013.
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.
CMAX™ X-RAY surgical tables are Class 1 medical devices and are registered with ANSM (French National Agency for the Safety of Drugs and Healthcare Products)
*in accordance with the most up to date version applicable
STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE
operating transfer table for imaging-assisted surgery - CMAX X-RAY
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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 the medical device without
manufacturer authorisation is prohibited.
!
Pinch points
! When floating is enabled, moving the floating tabletop can cause pinch points to appear
which can injure the patient or the surgical team. Users must therefore be aware of the
risks and monitor the following areas in particular
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.
Floor lock
! Even if the table is not locked to the floor, certain tabletop movements are still possible.
Lock the table to the floor before positioning the patient and starting the surgical
procedure.
! Do not try to move the locked table.
! Once the table is locked to the floor, ensure that it is stable. Move it if necessary to find a
flatter floor surface.
Moving the table with a patient on it
! The table can only be unlocked if the floating tabletop is not activated.
! When moving or adjusting the table with a patient on it, the CMAX™ X-RAY table must be in
the transport position, i.e., the following conditions must be applied:
•
The tabletop must be horizontal and centred on the column
•
Only lateral slide of the tabletop of up to 50 mm is authorised.
•
The tabletop must be lowered to a height of less than 900 mm
•
The patient must be in normal position and the total weight (patient + accessories) must
not exceed 230kg.
! Never attempt to unlock the table and to move it with the patient if it is not in transport
position. The table may tilt.
! It is strongly recommended that you use barriers or another system to hold the patient in
place.
! Ensure that the battery is correctly charged before moving the table.
! Before going anywhere, ensure that there are no obstacles along the way you wish to use.
The table is not intented to cross threshold, to ascend or to descend step. Always move
the table very carefully.
! During motorised transfer with CMAX™ X-RAY, adapt your speed to the environment (i.e.
corridor width, corner angles, doors, wall, etc.).Take care when moving back.
! Do not keep objects on the base as they may fall during motorised manoeuvres and cause
jamming when lowering the column’s sliding covers.
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 patient orientation
pre-selection is memorised.
Switching the table o
! The STOP buttons on the main hand control and on the override system allow you to stop
all table movement.
! In wired mode, the table stops automatically at the end of a preprogrammed cycle.
! The table can also be switched o by pressing the joystick and any other key at the same time.
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 keypad
with too much force or use unsuitable objects to do so.
! Avoid handling the cables roughly when connecting or disconnecting the remote control,
the joystick or the power cord set.
! 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.
! Do not stand on the base of the surgical table because it can damage the covers.
! 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.
Weight capacity
! Do not exceed a patient+accessory weight of 230 kg for the standard described positions
and respect the indications and warnings signalled.
! The use of certain extensions may decrease this patient+accessories weight. When
extensions are installed on the CMAX™ X-RAY surgical table, you should also consult the
user manuals of these extensions to know the possible weight restrictions related to the
use of these extensions.
! In positions where the tabletop will be significantly slide away from the column, ensure
that there is sucient 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 centred position
on the column.
Positioning the patient
! The positions described in this manual are given purely as examples. The accessories
required are not always shown. Under no circumstance should they replace the
instructions given by the surgical team in charge of the patient.
! Ensure that both the patient and the table are stable when combining tabletop movements
(for example reverse trend + lateral tilt).
! 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.
Autonomy
! Two 12V sealed lead batteries are integrated into the base and mean that the CMAX™
X-RAY is autonomous.
Before using the table, check that the batteries are suciently charged.
! The joystick operates in standalone mode using the integrated batteries. Before using the
table in Bluetooth (wireless) mode, check that the batteries are suciently charged.
Connections
! The sockets are equipped with locks: do not pull on the hand control or Joystick to
disconnect them.
! The E-Serve connection is only to be used by STERIS service team and with material
approved by STERIS
! Never try to connect equipment to the surgical table that is not supplied by STERIS or not
approved to be used with the CMAX™ X-Ray table.
! Always use the power cord provided by STERIS.
! The operator should never touch the patient when the operator is plugging or unplugging
the remote control or the joystick, or when the operator is handling the connectors of
these devices.
Potential equalisation conductor
! Connect together potential equalisation conductors to overcome the problem of diering
potentials across 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 a potential equalisation socket allows a medical electrical system to be
created, then this system must meet the requirements of IEC 60601-1.
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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, the appliance
should only be connected to an earthed power supply system.
!
! The CMAX™ X-RAY must always be positioned so that the power cord can be
disconnected easily when connected to the table.
! 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 with the CMAX™ X-RAY table creates a risk of burns, explosion, or
electrical shock.
! In case of any damage to the mains power cable or plug, do not connect the equipment
and immediately contact STERIS technicians.
Accessories
! If accessories made by other manufacturers are used, it is the user’s responsibility to
check that they are compatible with CMAX™ X-RAY 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 shall especially ensure that the intented use and the conditions of use
(including the safe working load) of these accessories made by other manufacturers are
compatible with the claims of CMAX™ X-RAY surgical tables.
! Check that the extensions and accessories are properly attached to the operating table
before each surgical procedure.
Electromagnetic compatibility
! If the table is used close to other electrical equipment, ensure that these comply with the
regulations in force regarding electromagnetic compatibility.
! If high frequency equipment (such as a defibrillator) is being used, make sure that the
manufacturer’s instructions are rigorously followed.
Emergency mode
! Only use the backup system in emergency mode.
! When the back-up system is used, the other control systems including the main hand
control are automatically deactivated. The ALS sensors are deactivated, so when you
move the tabletop you will need to ensure that you look out for potential conflicts between
the sections. The default pre-selected patient orientation is the normal orientation; there
is no inverted orientation. There is no LED for table immobilisation. When the back-up
system is used you should always make sure that the operating table is stable and
correctly locked to the floor. Before starting tabletop floating, ensure that the tabletop is
horizontal and check that the operating table is stable, particularly when you are moving
the tabletop into extremely o-centred positions.
Cleaning
! Chlorine-based solutions may damage the metal parts. After disinfection, ensure that it
is thoroughly rinsed and dry the surface. Prolonged exposure to chlorine-based solutions
may damage the pad material. Prevent chlorine-based solutions and other liquids from
coming into contact with the internal parts of the table.
! Ensure that the socket protection cover eectively protects against fluids getting in. After
cleaning procedures, ensure no residual water remains near the plug (hand control,
joystick, mains.)
! Before cleaning the table, ensure that it is switched o. Put on the socket protection cover, if
necessary.
! Do not immerse the hand control or the joystick and do not spray cleaning products
directly onto the sockets.
Hand control and joystick storage
! When the hand control and joystick are not in use, we recommend hanging them on a
table rail to prevent any buttons being accidentally pressed.
Environmental conditions
•
Transport / storage: temperature 0°C-50°C, humidity 10-85% non-condensing, pressure
500-1060hPa, Table on castors, battery fuses removed
•
Use: temperature 10°C-40°C, humidity 10-75% non-condensing, pressure 800-
1060hPa
•
Floor surface perforation pressure: 0.13kg/cm2 (13kPa) with a patient+accessories load
of 270kg
•
Local pressure on the floor: 15,59kg/cm2 (1,529 Mpa) with a patient+accessories load
of 270kg
! Do not use the table in the presence of flammable anesthetic gas, or in areas subject to
explosive risks.
! CMAX™ X-RAY must not be used in the vicinity of strong magnetic fields (MRI
environment)
! CMAX™ X-RAY and associated extensions and accessories are not intented to operate in
an oxygen rich environment
! CMAX™ X-RAY and associated extensions and accessories are not intented for outdoor
use, and shall not be exposed to high humidity for extented periods.
X-Ray radiation
! The surgical table materials located in the X-ray beam can give rise to parasitic radiation
that is potentially harmful to users. Radiation protection equipment should therefore be
worn by users when using an X-ray system with CMAX™ X-RAY surgical tables.
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 CMAX™ X-RAY surgical table before all
electrical power is switched o and the supplies made safe.
! During maintenance and repair, only original parts must be used.
! No part of the surgical table shall be serviced or maintained while in use with the patient.
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Main hand control
Select locked / unlocked
Trend / Rev trend
Up / Down
Left tilt / Right tilt
Return to horizontal
Patient orientation on the table normal /reverse
MEM
Memory keys
Menu actions
MENU
Menu selection
table stop button on the hand control
Floor lock
Joystick display selected
Floating inactive
Hand control display selected
Floating inactive
Unlock / switch to castors
Please wait - cycle in progress (e.g.
locking/unlocking)
Control interface active:
Joystick / Bluetooth / hand control /
E-serve
Bluetooth joystick battery charge status
Bluetooth joystick battery discharge
status
Fault detected
contact the technical department
TFT screen pictograms
3. SYMBOLS USED
Lock / Unlock floating
Trend / Rev trend
Up / Down
Left tilt / Right tilt
SelectLocked / Unlocked
Validation
(in combination with the desired
movement)
Start up table/joystick In Bluetooth
mode
Return to horizontal
Table stop button on the override
system
Override control / Joystick
Connection panel
Main hand control (wired)
E-SERVE serial port: NOTE: This port is intended to be used by STERIS or personnel
trained by STERIS for maintenance procedures only. It must not be used to move the
table during a surgical procedure.
Wired/Bluetooth joystick
Accessory port (not in use)
NOTE: This port must not be used with the CMAX™ X-Ray or one of its accessories Do not
connect any CMAX™ X-Ray accessory.
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Surgical table labels
Warning: read the accompanying documents
Equipotential plug
WEEE Directive: the product must be recycled
Name and address of manufacturer
Protection from electric shock class 1, type B
IPX4
Protection from water splashing (for surgical table and its accessories)
Date of manufacture
YYYY/MM/DD
Direct Current
Alternating Current
REF Product reference
SN Serial number
MD Medical device
Caution
Compliance with requirements of European legislation
1060
500
Atmosphere pressure limitation
85
10
Humidity limitation
65°C
0°C
Surgical table temperature limit
Stacking forbidden for CMAX™ X-RAY
This way up
Fragile, handle with care
Handle with care
UKCA Marked (UK Conformity Assessed)
Compliance with essential requirements of UK Medical Devices
Regulations 2002
REPUK
UK Authorized Representative
REP
REPCH
Swiss Authorized Representative
Importer
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17
4
5
1
8
10
2
9
7
4. OVERVIEW
12
11
13
1 Mobile base
2 Column
3 Floating tabletop
4 Joystick (floating tabletop control)
5 Head section interface
6 Main hand control
7 25x10 standard accessory rails
8 Connection panel
9 Carbon tabletop rail accessory
10 Override control
11 Electrical characteristics label
12 Mains connection panel
13 Identification label
14 Battery fuses
15 Equipotential plug
16 Battery status
17 Mains power cable
6
16
15
12
14
3
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Characteristics
The CMAX™ X-RAY operating table is equipped with a carbon fibre floating tabletop, is operated in standalone mode and can be used for powered patient transfer.
The control handle and powerful powered wheel provide a unique solution for patient transfer under optimal conditions of ergonomics and safety.
Because of the long transverse and longitudinal slide, CMAX™ X-RAY oers exceptional radiological access.
The CMAX™ X-RAY is suitable for imagery-assisted surgical procedures and has been designed to support patient+accessory weights of up to 230 kg in positions
such as those described in this manual.
The powered sections can be moved using the hand control or the joystick in dual-mode (wired/Bluetooth).
The innovative integrated power supply allows the user to choose whether to operate the table on battery or mains power.
The column movements are powered, with the exception of the transverse and longitudinal slides of the tabletop (floating).
The E-Serve™ smart electronics fitted on the CMAX™ X-RAY mean that diagnostics and maintenance can be carried out via computer by STERIS-accredited techni-
cians (errors, fault log).
The integrated ALS™ linear and angular position sensors prevent collisions between the powered sections and the table or floor.
Electrical charactristics
Mains 100-240 VAC 50-60Hz
420VA
Protection Class 1 type B
Equipotential plug DIN42801, Cord not supplied
Mains cable provided 5m (main sector)
Internal fuses
(accessible to maintenance personnel)
2XT6,3A 250V 5x20 PC1,5kA (mains)
T=Slow acting Fuse ; PC=Breaking Capacity
3xF15A 32V PC1000A (power outputs) F=Fast acting Fuse ; PC=Breaking Capacity
1xF30A 125V 10,3x38mm PC10kA (motorized wheel)
F=Fast acting Fuse ; PC=Breaking Capacity
Batteries 2x 12V 24Ah sealed lead
Batteries fuse 1xT30A 125V PC10kA T=Slow acting Fuse ; PC=Breaking Capacity
Autonomy 15 procedures
Maximum charge duration 12h
Charge /discharge indicator Base led / hand control led
Intermittent running 3 min/h during surgical prodedure
Resistance to liquids IPX4 (for surgical table and its accessories)
Antistatic path Using pads and antistatic feet
Applied parts Pads
Radiocommunication characteristics
Frequency bands used 2,40Ghz - 2,4835Ghz
Maximal radiofrequency power
transmitted on used frequency bands 14.3 dBm
Mechanical characteristics
Up / Down 1040mm / 680mm (stroke 360mm)
Left tilt / Right tilt 20°/20° (When the transverse slide is >50 mm, lateral tilting is no longer permitted.)
Trend / Rev trend 30°/-30°
Longitudinal slide 0mm / 700mm (stroke 700mm)
Transversal slide 130mm / 130mm (stroke 260mm)
Tabletop length 2000mm (excluding extensions)
Tabletop width 520mm (560mm including rails)
O-load table weight 330kg
Maximum weight of patient + accessories 230kg
Maximum capacity up/down: 270kg, Horizontal tabletop, slide and load centred on the column
Floor clearence / wheel diam 16mm / 100mm
Main material used
Covers Polycarbonate
Structures High performance coated steel and aluminium
Tabletop Carbon
Bellows PVC
Pads PU foam with conductive welded cover
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Tabletop dimensions
2000mm
560mm
520mm
490 mm 1000 mm
66°(2X33°) RADIOTRANSPARENCY
RANGE
360° RADIOTRANSPARENCY RANGE
-30°
30°
20°
20°
Tilt
When the transverse slide is >50 mm, lateral tilting is no longer permitted.
Height
125
125
Floating tabletop
longitudinal
1040mm
Trend / Rev trend
0mm 700mm
130mm
130mm
transverse
Range of movements
680mm
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5. MOUNTING THE VARIOUS ADAPTABLE ACCESSORIES ON THE CARBON TABLETOP
Mounting the carbon tabletop radiotransparent head section
-A Present the accessory at the end of the tabletop
-B Slide the accessory along the rail of the carbon tabletop to the centre of the tabletop
-C Screw to lock the accessory
Example of mounting/dismounting of carbon tabletop clamps (TAB 841)
-A Present the clamp with the accessory rod fitted
-B Insert it by inclining it over the rail of the carbon tabletop.
-C Screw to lock the clamp
-B
Mounting / dismounting the carbon tabletop rail accessory (TAB 830)
-A Present the accessory on one of the sides of the tabletop
-B Slide the accessory along the rail to the end of the carbon tabletop, up to its required location
-C Lock the accessory (by one quarter-turn)
-A
-B
-C
-C
Mounting the catheter-holder table (TAB 800KT)
-A Hold the catheter extension at the end of the carbon tabletop, where the metal rails are located
-B Engage the extension hooks under the tabletop rail spacer
-C Allow the table to rest as far as the horizontal position
-A
-C
-B
-A
-B -C
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Mounting/dismounting the Head05D head section
- Simultaneously insert the two head section pins
into the two tabletop struts as far as they will
go. To remove the head section, release the pins
completely while supporting the head section..
Do not handle the table by pulling on the head section. Fall risk.
Y
Mounting/dismounting the powered transfer control handle
The complete system comprises two handles:
• 1 control handle featuring a remote control connection
• 1 accessory handle to assist the control
Fitting the control handle (a)
1. Place the handle in the rail axe ensuring that the locking lever stays open
2. Insert the handle in the rail until you hear it click
3. Pull down the clamping lever (d), checking as you pull that the handle is secure
A
a
B
a
C
c
d
Removing the handle assembly
Release the clamping lever (d) by lowering it and keep the bolt (c) pressed, pull out the rail handle, the handle is now released.
b
AB
b
C
b
Fitting the accessory handle (b)
1. Place the handle in the rail axe, keeping the wing screw unlocked
2. Insert the handle
3. Turn the wing screw to tighten it, pull the handle to check that it is secure
Removing the accessory handle
Follow the assembly instructions in the reverse order
Storing the accessory handle
The handle can be placed in a basket on an accessory trolley, or left on the rail with the handle grip folded down towards the bottom.
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Insertion and removal of the battery fuse
For safety reasons, the fuse protecting the batteries are packaged separately during
shipment.
1. Insert the fuse into the separately provided fuse holder.
2. Insert all of this into the fuse case.
3. Push and turn by 1/4 turn using a screwdriver in order to lock the fuse holder.
4. Check by switching on the table with the main hand control without using the mains.
If the table is not used for a long period of time (>1 month) remove the fuses in order to
limit battery discharge and maintain battery functionality.
Connecting the table to the mains:
1. Check that the mains voltage matches the indications on the table.
2. Connect the power cord to the IEC connector
3. Connect the power cord to a mains socket
The power supply allows the user to choose whether to operate the table on battery or mains
power.
When the table is operating on batteries only:
1. The green indicator of the three coloured diodes indicates that the battery charge is sucient.
2. The orange indicator of the three coloured diodes invites the operator to connect the table to the
mains power supply to charge the batteries.
3. The red indicator of the three coloured diodes orders the operator to connect the table to the
mains power supply.
Battery operation
Battery status
green sucient
orange mains connection
recommended
red mains connection
mandatory
It has three coloured diodes used to monitor the battery status when connected to mains
1. If the batteries are charging, the coloured diodes light up sequentially orange, and green:
2. If the batteries are charged, the coloured diodes light up steadily orange, and green:
If the 3 coloured diodes flash when the mains is connected, this indicates a battery charge error. In
this case, please contact the STERIS technical department.
The charger built into the power supply automatically regulates battery charge, so that the table can
be left permanently connected to the mains.
6. SETTING UP THE TABLE
To extend the working life of the batteries, we recommend the following:
- Charge batteries systematically each day (also in no use conditions)
- Charge batteries systematically when the indicator on the screen of the remote 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)
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Hand control on Corresponding charge level
70
cm
(green) 70< <100%
(orange) 30< <70%
(red) <30%
Battery mode
The battery status is displayed on the hand control when it is turned on. The status can be read when the table is not moving. Dierent table
movements use dierent amounts of power.
Hand control display
Power LED display
Procedures
(without movement)
Procedures
(with movement)
10
70
cm
(Fixed green)
20 - 50 10 - 30
(Fixed orange)
10 - 20 0 - 10
(Fixed red)
1 - 10 0
Flashing red
0 0
*Measurements made with 135kg patient 50m of corridor on hard floor.
Mains mode
Each time the table is connected to the mains, the charger restarts at maximum charge: there is a wait of approximately 2 minutes before the bar
graph display is correct.
If the entire bar graphic is blinking this means there is a problem. Recharging the battery is imperative or the table will automatically shut o. If
the problem persists, please contact STERIS technical department.
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Connecting and activating of 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 until it “clicks,” indicating that it is correctly connected.
The wired main hand control has priority over the E-Serve™ connection.
It switches o automatically after 3 minutes if it has not been used.
Disconnection
1. Switch o the hand control by pressing STOP.
2. The connector is equipped with a lock: unlock the connector by pulling the ring backwards. Never just
pull on the cable.
3. Ensure that the protection cover is covering the sockets.
Connecting and activating the joystick
Connection
1. Lift up the protective cover of the corresponding socket
2. Align the red dots on the joystick cable connector at the top with those on the socket at the table
end.
3. Insert the connector completely until it “clicks”, indicating that it is correctly connected.
In Bluetooth mode
1. The connector is equipped with a lock: unlock the connector by pulling the ring backwards. Never
just pull on the cable.
2. Ensure that the protective cover is covering the socket.
> For more information, see section 8 (joystick operation)
Connecting and activating the E-Serve™ port
Connection
1. Lift up the protection cover of the corresponding socket.
2. Connect the PC using the specific E-Serve™ cable
3. Insert the connector and fix it in place with the 2 side screws if necessary.
The CMAX™ X-RAY smart electronics allow diagnostics and maintenance to be carried out from
a PC. To activate the connection, you need a specific E-Serve™ software package or another
compatible software package approved by STERIS.
Disconnection
1. Remove the screws first and then disconnect the connector.
2. Ensure that the protection cover is once again secured on the socket;
The E-Serve™ port should not be used to connect other types of hardware and devices than the PC used by STERIS-accredited
technicians.
This socket is only for maintenance operations by STERIS personnel and should only be used in the patient’s absence. This socket is
not intended for use by the operator.
Y
Connection Disconnection
operating transfer table for imaging-assisted surgery - CMAX X-RAY
[16]
MENU
MEM
7. OPERATING THE 1CONTROL MAIN HAND CONTROL
The main hand control includes
1. A 5 m spiral cord with a connector at each end making it easy to replace.
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 for easy location of the buttons in the dark.
4. A 2.4” TFT colour screen for easy communication with the user
Switching on the table
Pressing any button (except the STOP button) turns the table on but does not start any movements. A welcome screen is then displayed for a few
seconds. You can then press the button for the required movement.
Back-lit TFT colour screen:
• Battery status, floor lock and active interface
status
• report of table movements from the
integrated motion sensors
Touch and audible sensors:
• Touch: in the case of an anti-collision alert,
the hand control vibrates (ALS)
• Audible: beep in the case of a movement
requiring special attention or at the end of a
movement
Direct column and mobile base controls
(back-lit area)
• Trend (head at bottom) Rev trend (feet at bottom)
• Table up / down
• Left or right tilt
• Table floor lock/unlock
• Blue LED “unlocked”
• Switch o table
Transfer control handle connection:
Transmission of powered wheel descent and speed
information to the table
Spiral cable connection
Blue LED normal patient orientation
Blue LED reversed patient orientation
Date DD/MM/YY/
GMT time HH:MM
Patient orientation on the table
When the hand control is not in use, we recommend hanging it on a table rail to prevent any buttons being pressed accidentally. Handle the hand
control and its cable with care.
Switching o the table / emergency stop
When the STOP button is pressed, the table immediately stops operating.
The Auto-o function puts the table into standby mode after 3 minutes if it is no longer in use in order to avoid any inadvertent movements.
• Return to horizontal Blue LED
• Return to horizontal
Y
Hand control software
Table software
Joystick software
Interactive tabletop
controls:
• 2 movement directions are
available:
up/left, down/right
• Menu selection
Position memories:
• Pressing the button once allows the table to be
positioned in stages
• Some positions are blocked and others may be
saved by the user
Cmax X-RAY
Control V4.07 Date: 01/09/21
Table V6.13 GMT: 15:40
Joyst V5.06
operating transfer table for imaging-assisted surgery - CMAX X-RAY
[17]
10
70
cm
INFORMATION LAYOUT ON THE SCREEN / NORMAL MODE
Representation of the table:
- patient orientation
- tabletop movements
- identification of selected table sections
Active control
wired joystick
Bluetooth joystick
Hand control
E-serve
Operating faults
key + fault No.
Extra information
Cycle in progress
Return tohorizontal in
progress
The values on the TFT screen are given as an
indication only.
Details may vary according to the environment
(altitude, humidity, temperature, etc.)
Conduct a visual inspection of the patient’s
position
Unit of movement in progress
Orientation of movement
Vertical
Trend / Rev Trend
Left / right tilt
Lateral
degree, centimetre
MEM
5
35 00
cm cm
INFORMATION LAYOUT ON THE SCREEN / FLOATING + BLUETOOTH MODE
Tabletop movements
Representation of the table and the
column:
- centre of tabletop (blue X)
- longitudinal / transverse slides
- floating field on blue background
References
longitudinal, transverse axes in relation to
column
For clearer indications, 6 colours
are used:
black not selected, neutral
status
blue selection in progress
blue
Translucent
movement in
progress
green normal status
orange user caution
required
red alarm or fault
detected
Floating
mode
(via joystick)
Display Status
Enabled
Enabled and
moving
Table status
Table power Table battery
charge status
Mains/charging in
progress
Floor lock
On pads
On castors
operating transfer table for imaging-assisted surgery - CMAX X-RAY
[18]
USING THE HAND CONTROL / JOYSTICK
table floor lock/unlock
The mobile base of the CMAX™ X-RAY table allows it to be moved around the operating theatre so that it can be relocated or so that
the floor can be cleaned. Floor lock/unlock is performed automatically using the hand control.
For safety reasons and to ensure that the table is stable on its castors, the tabletop should be returned manually to the central position
“0” (FIG.1) to be able to unlock the table from the floor.
Otherwise, the screen turns red, indicating that you should slide the table first.
Once the lock/unlock button has been selected, the blue LED flashes and the lock/unlock pictograms appear on the screen.
Confirm by pressing one of the interactive buttons.
During locking/unlocking, which takes several seconds, all the buttons except the STOP button are disabled.
Floor lock procedure:
1. Press the lock button
2. The locking pictogram changes colour and the hourglass appears
3. The blue indicator in the button is lit when the table is locked to the floor and the padlock is closed.
Floor unlock procedure:
1- Slide the tabletop longitudinally as far as the head end
2- Slide the tabletop transversely to the centre (Fig.1).
3- Press the lock/unlock button. The blue LED flashes and the lock/unlock symbols
are displayed on the screen.
4- Press the unlock button. The unlocking pictogram changes colour and the
hourglass appears.
5- The button remains a constant blue once the table is unlocked and the padlock
pictogram is open.
Movements, except for table floating, are allowed even when the table is on castors.
Before starting any surgical procedure, check that the table is locked to
the floor and stable.
When moving the table with a patient, ensure that there are no obstacles along the
path you wish to use. When you set o, move the table very carefully.
MEM
5
70 30
00 00
cm cm
Fig.1
Patient orientation on the table
reversed
orientation
normal
orientation
Depending on the type of surgery involved, the patient orientation can be reversed on the table.
The patient is thus in the reversed orientation on the table and the button is used to reconfigure the hand
control to keep the right patient movement when using the controls.
When the table is switched o, the previous position is stored in memory: every time the table is reconfigured,
ensure that it corresponds to the selected patient orientation.
/ Return to horizontal reset
The return to horizontal button / enables the tabletop to be returned to a horizontal position.
Although this action automatically accounts for the patient’s equilibrium on the tabletop, it should nonetheless be monitored during
movements.
To return the tabletop to horizontal using the hand control:
1. The blue LED on the button is o if the tabletop is not already horizontal
2. Press the button, the blue LED will flash
3. The blue LED will be steady when the tabletop is horizontal
4. If you hold down the button, the cycle continues with a quick check than the table is locked/unlocked.
operating transfer table for imaging-assisted surgery - CMAX X-RAY
[19]
To return the tabletop to horizontal using the joystick:
1. The white light flashes if the tabletop is not already horizontal
2. Press the button, the white light will flash
3. The green light will be steady when the tabletop is horizontal
Trend / Rev Trend
30°
30°
Trend / Rev Trend movements are obtained by directly pressing the corresponding buttons on the keypad.
During the movement, the screen displays pictograms of the movement in progress and the angle with respect
to horizontal.
Table up / down
68
cm
104
cm
Up/down movements are obtained by directly pressing the corresponding buttons on the keypad.
During the movement, the screen displays pictograms of the movement in progress and the distance from the
floor.
Left / right tilt
20°
20°
Left/right tilt movements are obtained by directly pressing the corresponding buttons on the keypad.
During the movement, the screen displays pictograms of the movement in progress and the angle with respect
to horizontal; however the representation of the table on the screen does not move.
Floating lock / unlock
MEM
5
70 30
35 00
cm cm
locked
MEM
5
70 30
cm cm
35 00
unlocked
When the joystick is switched on, to perform floating with the tabletop, press the on/o button under the
joystick.
The slide value in relation to its central position and its orientation are displayed on the screen in real time.
YDuring table movements (Rev Trend/Trend, up/down, left/right tilt), it is recommended to leave a
minimum distance between the c-arm and the patient, to avoid any contact between them during
handling.
Tabletop floating is only possible if the table is in the horizontal position
Y
operating transfer table for imaging-assisted surgery - CMAX X-RAY
[20]
MEM
Position memories:
Pre-recorded positions:
To go to the position shown on the screen, press and hold down the interactive button below the control pictograms on the screen. It is possible
to stop at any time by simply releasing the button.
During the movement, a “beep” can be heard.
MEM
5
70 30
MEM
1
MEM 5
70 30
MEM
2
•
MEM1 “Swivel” Switch to castors for manual table rotation on itself, followed by locking.
•
MEM2 “Slow Drive” Low speed Forward/Rear mode followed by locking (without control handle)
User positions:
Using the REC function, it is possible to store a position in memory in order to return to it later.
Saving in floating mode is only possible when the tabletop is horizontal.
MEM 5
70 30
MEM
3
REC
50 00
cm cm
Fig.1
MEM
5
70 30
MEM
3
REC
35 05
cm cm
Fig.2
REC
GO
MEM
7
Saving position memory MEM3 to MEM6 (in Floating mode) / MEM7 to MEM9 (side view)
1- Position the tabletop/table in the desired position using the joystick/hand control, (not using Memory mode).
2- Activate the hand control by pressing any button on it
3- Enter Memory mode by pressing the button MEM .
4- Find an available user memory by scrolling through them using the buttons. MENU
5- Save the position using the
REC
function by pressing the interactive button located beneath it: the position will then appear in
grey on the screen
(Fig.1)
.
Selecting a position memory in floating mode (MEM3 to MEM6)
1- Activate the hand control by pressing any button on it.
2- Enter Memory mode by pressing the button MEM .
3- Find a saved user memory by scrolling through them using the MENU buttons.
4- Operate the tabletop using the joystick to reach the saved position represented by the green cursor assisted by the
increasingly frequent progressive audible beeps.
The beeping becomes continuous when the centre of the tabletop is positioned on the green cursor (Fig.2).
Selecting a position memory in side view mode (MEM7 to MEM9)
To return to a memory (MEM 7 to MEM9) use the function. REC
Note: to exit MEM mode, simply press the MEM button or any other button on the hand control.
IMPORTANT
The use of a pre-programmed cycle requires careful monitoring of the table movements during movement. For this reason, it is strongly
recommended that you use this function to save time during the initial set-up without a patient on the table.
User memories may be deleted or changed by third parties, so it is the user’s responsibility to ensure that the required position is actually
that shown on the screen before using the function.
REC
If the table is not initially stationary, memory mode is disabled.
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