Steris Cmax X-Ray Image-Guided Surgical Table Operating instructions

Brand: Steris

Model: Cmax X-Ray Image-Guided Surgical Table

Type: Operating instructions

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

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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 poweredsurgical tables, which is now available to meet all your needs.

Please read this manual carefully to ensure that our products can oer you optimum eciency 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

dierent 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 eects - Residual risk

There is no contraindication, undesirable side-eect 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

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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 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 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 suciently charged.

! The joystick operates in standalone mode using the integrated batteries. Before using the

table in Bluetooth (wireless) mode, check that the batteries are suciently 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 diering

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 eectively 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 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

SelectLocked / 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

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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4. OVERVIEW

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

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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 oers 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°

Tilt

When the transverse slide is >50 mm, lateral tilting is no longer permitted.

Height

125

Floating tabletop

longitudinal

1040mm

Trend / Rev trend

0mm 700mm

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

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.

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

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.

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 sucient.

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 sucient

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

(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. Dierent table

movements use dierent amounts of power.

Hand control display

Power LED display

Procedures

(without movement)

Procedures

(with movement)

(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.

operating transfer table for imaging-assisted surgery - CMAX X-RAY

[15]

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.

Connection Disconnection

operating transfer table for imaging-assisted surgery - CMAX X-RAY

[16]

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

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]

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 tohorizontal 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

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

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°

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

104

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°

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

70 30

35 00

cm cm

locked

MEM

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

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

70 30

MEM

MEM 5

70 30

MEM

•

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

REC

50 00

cm cm

Fig.1

MEM

70 30

MEM

REC

35 05

cm cm

Fig.2

REC

MEM

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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Steris Cmax X-Ray Image-Guided Surgical Table Operating instructions

Brand: Steris

Model: Cmax X-Ray Image-Guided Surgical Table

Type: Operating instructions

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Steris Cmax X-Ray Image-Guided Surgical Table Operating instructions

Steris Cmax X-Ray Image-Guided Surgical Table Operating instructions

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