Steris Kerna Surgical Table Operating instructions

Brand: Steris

Model: Kerna Surgical Table

Type: Operating instructions

Customer manual

[ use & maintenance ]

OM 201-01EN 2023-06 REVA KERNA

General Surgical Table

KERNA™

General Surgical Table - KERNA™

[2]

CONTENTS

1. QUALITY REQUIREMENTS .......................................................................................................................................... 2

2. SAFETY INSTRUCTIONS............................................................................................................................................. 3

3. SYMBOLS USED ......................................................................................................................................................... 5

4. OVERVIEW ................................................................................................................................................................. 7

5. SETTING UP THE TABLE ............................................................................................................................................ 10

6. CONNECT AND OPERATE THE CONTROL DEVICES .................................................................................................... 13

7. OVERRIDE SYSTEM ................................................................................................................................................... 15

8. WEIGHT CAPACITIES ................................................................................................................................................. 16

9. CLEANING / DISINFECTION ....................................................................................................................................... 18

10. MAINTENANCE PROGRAMME ................................................................................................................................. 18

11. KERNA™ SPARE PARTS LIST .................................................................................................................................. 19

12. TROUBLESHOOTING ................................................................................................................................................. 19

13. DISPOSAL OF WASTE EQUIPMENT .......................................................................................................................... 19

14. ELECTROMAGNETIC ENVIRONMENT ....................................................................................................................... 20

15. TFT HAND CONTROL (OPTIONAL) ............................................................................................................................ 21

16. IN SERVICE FORM ................................................................................................................................................... 31

17. IN SERVICE FORM ................................................................................................................................................... 33

Dear Customers,

STERIS thanks you for choosing the KERNA™ General Surgical Table, which helps you focus on your patient.

Please read this manual carefully to ensure that our products can offer you optimum efﬁciency 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, platforms 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 rules applicable to operating tables

• IEC 60601-1-2 (EN 60601-1-2)* relating to electromagnetic compatibility

Intended use: KERNA™ General Surgical Table is medical device intended to support and position the patients during surgical procedures

carried out in an operating room.

KERNA™ General Surgical Table and associated extensions and accessories shall be operated in a controlled environment by a healthcare

professional familiar with appropriate techniques with such equipment.

Essential performance of KERNA™ General Surgical Table: supporting a patient without unwanted movement in a single-fault condition.

Any utilisation going beyond the aforementioned conditions is deemed to be not for intented purposes. Only the user is liable for any loss or

damage arising from this.

The KERNA™ General Surgical Table is Class 1 medical devices and are registered with ANSM (French National Agency for the Safety of Drugs

and Healthcare Products)

KERNA™ General Surgical Table is available in 4 models:

KERNA HV : Kerna Table high height velcro version

KERNA LV : Kerna Table low height velcro version

KERNA HSX : Kerna Table high height snapLINX™ version

KERNA LSX : Kerna Table low height snapLINX™ version

In this manual, these models will be regularly mentioned in order to provide the user with a better understanding of the similiarities and

differences between these models of operating tables.

Placing on the market

KERNA™ General Surgical Table was ﬁrst placed on the market in 2020.

*in accordance with the most up to date version applicable

STERIS SAS

116 Avenue de MAGUDAS

33185 LE HAILLAN - FRANCE

General Surgical Table - KERNA™

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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

! During patient positioning, moving dierent sections of the tabletop and using extensions

and accessories can cause pinch points to appear which can injure the patient or the

surgical team. Users must therefore be aware of the risks and pay particular attention to

the following zones :

Precaution during the movements

! Before any movement activation, be sure that there is no risk of contact or collision with

an object, an 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

! When moving the table with a patient on it, the following conditions are required:

-The tabletop must be centered over the column or above the long part of the base.

-The patient should be in normal position.

! Never try to unlock the table and move it with the patient, if the table is not in the

transport position. The table may tip.

! If moving the table with a patient be careful to hold the patient in place.

! Before going anywhere, ensure that there are no obstacles along the way you wish to

take. The table is not intended to cross thresholds, to ascend or to descend steps.

Always move the table very carefully.

! Do not keep objects on the base as they may fall during motorised manoeuvres and cause

jamming when lowering the column’s sliding covers.

! Consider a safe zone where you’ll not put anything on it.

Safe zone

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.

! If the hand control and the optional pedal are used at the same time, the hand control

overrides the pedal.

Switching the table off

! The STOP buttons on the main hand control and on the override system allow you to

stop all table movement. They deactivate the optional pedal and other external control

mechanisms.

! Note that the battery of the optionnal wireless remote control do not charge anymore when

the table is switched o by the STOP function, even if the table is connected to the Mains.

! The table stops automatically at the end of a preprogrammed cycle (3’ by default with

standard remote control in wired mode. 240’ in wireless mode with optional remote

control).

Handling the surgical table

! Avoid handling the surgical table roughly during the operation. Do not exert excessive

lateral loads on it, do not pull or push the surgical table with the accessories or with the

rails.

! Avoid handling the remote control and the override system roughly. Do not press the

keypad with too much force or using unsuitable objects. Avoid shock on the control

means of the table.

! Avoid handling the cables roughly when connecting or disconnecting the remote control,

the foot pedal 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 a 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 270 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 KERNA™ General 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 positioning of the patient remains under the responsibility of healthcare professional.

It is the responsibility of the operator to ensure that the movements made are under his

control and do not generate any instability or danger to the patient during the surgery

performed.

! Ensure the stability of the patient and the table when making combined position.

! Secure the patient properly (ex. using straps), especially when the table has a strongt tilt inclination.

! Long surgical procedures can cause compression points on patients and have post

operative consequences. Monitor patient during surgical procedures and use gel

cushions for extented procedures.

General Surgical Table - KERNA™

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Autonomy

! Two 12V sealed geliﬁed-lead battery is integrated into the base and mean that

KERNA™ General Surgical Table is autonomous. Before using the table, check that the

battery is suciently charged.

Connections

! The sockets are equipped with locks: do not pull on the hand control or pedal cables to

disconnect them.

! Never try to connect a device not supplied by STERIS to the surgical 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 the pedal, 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 the potential equalisation conductor allows to create an electromedical

system, then this system must meet the requirements of IEC 60601-1.

Antistatic link

! If antistatic connection is necessary, we recommend that you only use 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 KERNA™ General Surgical Table must always be positioned so that the power cord

can be disconnected easily when connected to the table.

! The power cord with its main electrical plug is thus the device used to isolate the table

KERNA™ from the main electrical supply.

! It is preferable to use the battery instead of the main electrical supply if you have doubts

about the protective ground in the operating room.

! The use of high-frequency surgical equipment, cardiac deﬁbrillators, and cardiac

deﬁbrillator monitors in association with the KERNA™ General Surgical Table creates a

risk of burns, explosion, or electrical shock. The user must be aware of this.

! In case of any damage to the power supply or Mains cable or plug or IEC socket, do not

connect the equipment and immediatly 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 KERNA™ General Surgical Table 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 intended use and the conditions of use

(including the safe working load) of these accessories made by other manufacturers are

compatible with the claims of KERNA™ General Surgical Tables.

! Ensure that the extensions and accessories are correctly clamped to the surgical table

before each surgical procedure.

Electromagnetic compatibility

! If the table is used close to other electrical equipment, ensure that these comply with the

current regulations 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

! When the override control panel is being used, the other control systems including the

main hand control are automatically switched off.

! Lock / Ensure the table to the ﬂoor before starting any movements with a patient.

Cleaning

! Ensure that the socket protection correctly protects the plugs so that ﬂuids do not get in.

After cleaning procedures, ensure no residual water remains near the plug.

! Before cleaning the table, ensure that it is switched o. Put on the socket protection.

! Do not immerse the hand control and do not spray cleaning products directly onto the

sockets.

! Hypochlorite solutions can damage metal parts. After disinfection, ensure it is rinsed o

thoroughly with water and dry the surface. Prolonged exposure to hypochlorite solutions

may degrade mattress material. Avoid hypochlorite solutions and other liquids coming

into contact with any internal parts of the table.

Hand control storage

! We recommend hanging the hand control on a table rail when the hand control is not in

use, to prevent any accidental pressing of the buttons. Handle the hand control and the

associated cable with care.

Environmental conditions

Trans

port / storage : temperature 0°C-60°C, humidity 10-85% non-condensing, pressure 500-

1060 hPa, table on castors, battery fuse removed..

Use : temperature 10°C-40°C, humidity 10-75% non-condensing, pressure 800-1060hPa.

Local pressure on the ﬂoor: 17kg/cm2 (1667kPa) with a patient+accessories load of 270kg

Floor surface punching pressure : 1,3t/m2 (13kPa) 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.

! KERNA™ General Surgical Table and associated extensions and accessories must not be

used in the vicinity of strong magnetic ﬁelds (MRI environment).

! KERNA™ General Surgical Table and associated extensions and accessories are not

intended to operate in an oxygen rich environment.

! KERNA™ General Surgical Table and associated extensions and accessories are

not intended for outdoor use, and shall not be exposed to high humidity for extented

periods.

X-Ray radiation

! KERNA™ General Surgical Table shall not be considered patient supporting system for

X-Ray equipment for interventional procedures. KERNA™ General Surgical Table is not

an associated equipment of X-Ray equipment in a radiological installation. The operating

table materials located in the X-Ray beam therefore do not have optimal radiolucent

performance and can operate parasite radiation that is potentially harmful to users.

Radiological protection devices should therefore be worn by users when using a X-Ray

equipment with KERNA™ General Surgical Table.

Maintenance

! The safety, reliability and proper operation of the surgical table and associated

extensions and accessories can only be ascertained and granted by STERIS. Repair and

adjustments should only be assigned to STERIS 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 KERNA™ General 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.

General Surgical Table - KERNA™

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3. SYMBOLS USED

Connection panel

Main hand control

Optional pedal

ACC

OUT

Optional motorised legs

Trend / Rev trend

Table up / Table down

Right tilt / Left tilt

Back up (seat down in reverse

orientation)

Back down (seat up in reverse

orientation)

Sliding towards the feet

Sliding towards the head

Selection

unlocked / locked

Table off button

Start the table

(Option : start the table in bluetooth)

Emergency mode

(in combination with the

desired movement)

Override control

Main hand control (standard version)

Battery discharge status STOP

Trend Rev trend

Table up Table down

Left tilt Right tilt

Slide foot Slide head

Return-to-level

Patient orientation on the

table

Normal / Reverse

Selection

unlocked / locked

Reﬂex Flex

Back up

(leg up in reverse orientation)

Back down

(leg down in reverse

orientation)

General Surgical Table - KERNA™

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Warning:

consult the user’s manual

Risk of tipping:

Do not sit

Equipotential plug

WEEE Directive:

the product must be recycled

Name and address

of manufacturer

Direct Current

Alternating Current

Protection from electric shock

class 1, type B

IPX4 Protection against water projection

(for surgical table and its accessories)

IPX6 Protection against water projection

(optional pedal)

Table battery charge status

Date of manufacture

(YYYY-MM-DD)

REF Reference of the product

SN Serial number

MD Medical Device

Caution

Compliance with requirements of European legislation

1060

500

Atmosphere pressure limitation

Humidity limitation

65°C

0°C

Temperature limitation

Nstacking limit by number (1 for KERNA™)

Main electrical connection

Press and release any

pedal to start

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

Base and column labels + packaging labels

General Surgical Table - KERNA™

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4. OVERVIEW

1. Mobile base

2. Column

3. Tabletop

4. Removable head section

5. Half back section

6. Seat section

7. Removable leg sections

8. Power panel

9. Power cord

10. Battery fuse

11. Connection panel

12. Main hand control

13. Override control

14. Equipotential plug

15. Electrical characteristics label

16. Identiﬁcation label

16 12

The model shown is the KERNA™ General Surgical Table (with standard hand control) HEAD05B and LEG20C in patient normal orientation

General Surgical Table - KERNA™

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Characteristics

The KERNA™ General Surgical Table is a multi-sectional, autonomous, electro-

hydraulic surgical table.

The table will be presented in the rest of the manual equipped with a double

articulation head section and split leg sections for convenience.

KERNA™ General Surgical Table offers exceptional radiological access without

the need for additional extensions or for the patient to be reversed.

The KERNA™ General Surgical Table is suitable for most surgical procedures

and has been designed to support patients+accessories weighing up to 300 kg.*

A standard remote control or an optional remote control can be both used with

the table.

Movements may also be carried out by using the optional pedal.

If using motorized legs (LEG10M or LEG01M), the optional remote control is

necessary.

* Veuillez vous référer au chapitre 8 Capacités de poids

An original integrated power system enables the table to run on battery or on

Mains depending on user preference.

The tabletop movements are motorised, with the exception of the headrest and

manual split leg sections.

KERNA™ General Surgical Table’s intelligent electronic E-Serve™ system

allows users to operate the table remotely, and also allows for diagnostic

and maintenance via computer performed by authorised and trained STERIS

personnel (errors, history).

The integrated ALS™ linear and angular position sensors avoid collisions

between the motorised sections and the table.

Finally, an integrated backup system (emergency panel) covering as many

breakdown issues as possible, allows the user to continue the “in process”

procedure and to remove the table from the room.

Electrical characteristics

Mains 100-240 VAC 50-60Hz

420VA max 1 phase

Protection Class 1 type B

Equipotential plug DIN42801, cord not supplied

Mains cable provided 5m (main sector)

Internal fuses

(accessible to maintenance)

2XT6,3A 250V 5x20 PC1,5kA (Mains)

(T=Slow acting Fuse ; PC=Breaking Capacity)

3xF15A 32V PC1000A (power output)

(F=Fast acting Fuse ; PC=Breaking Capacity)

Batteries 2x 12V 17Ah sealed lead

Batteries fuse 1xF16A 250V 5x20 PC750A

(F=Fast acting Fuse ; PC=Breaking Capacity)

(accessible to operator)

Batteries of table Operating Temperature Range : -15°C to +50°C

Battery of remote control Operating Temperature Range : 0°C to +45°C

Autonomy Up to 60 procedures

Maximum charge duration 10h

Charge /discharge indicator Base LED / hand control LED

Intermittent runningI 3 min/h during surgical prodedure

Resistance to liquids IPX4 (for surgical table and its accessories)

IPX6 (for optional pedal)

Antistatic path Using pads and antistatic feet

Applied parts Pads

Radiocommunication characteristics

(for optional remote control)

Frequency bands used 2,40Ghz - 2,4835 Ghz

Maximal radiofrequency power

transmitted on used frequency bands 10dBm

Mechanical characteristics

Table up/Table down 595mm/945mm (versions LV and LSX)

695mm/1045mm (versions HV and HSX)

Left tilt/Right tilt 20°/20°

Trend/Rev trend 30°/-30°

Back up / Back down 90°/90°

Slide head / Slide foot 0mm / 230mm (stroke 230mm)

Flex / Reﬂex -220°/ 120°

Tabletop length (excluding extensions) 840mm (2025mm with headrest and split legs)

Tabletop width 520mm (560mm including rails)

Off-load table weight 185kg

Maximum weight of patient + accessories 270kg

Maximum capacity up/down 300kg horizontal tabletop, centered

Floor clerance / wheel diam 16mm / 100mm

Main material used

Covers Stainless steel and ABS

Structures High performance coated steel and aluminium

Tabletops Phenolic laminate

Bellows PVC

Pads Polyurethane foam welded seams

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Flex / Reﬂex

Tilt

Rev trend / Trend

down / up

Sliding

BackBack

Tabletop dimensions (Example LEG20C / HEAD05B)

90°

30°

20°

230

2055

530310330

840

885

560

520

220° 120°

Movement possibilities (seat and half back section)

30°

20°

595mm/945mm (versions LV and LSX)

695mm/1045mm (versions HV and HSX)

595mm

695mm

945mm

1045mm

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5. SETTING UP THE TABLE

Clic!

To remove the head section, you only need to press the 2 buttons located on each

side of the tabletop once because of the push spring integrated into the Hi-lock™

system.

Pull the pins out completely while supporting the weight of the head section.

Please refer to the head section user manual.

5.1 Attaching/removing snapLINX™ mattresses

Warning! INFECTION HAZARD

Ensure mattresses are free from cuts, splits and abrasions. Replace worn mattresses for new ones as soon as possible to eliminate possible biological

hazards.

To fix the mattress to the section:

1. Ensure that the tabletop is clean and dry before installation.

2. Offer up the mattress to the section so that the snapLINX™ pins are lined up with attachments in the underside of the mattress.

3. Gently ease one mating attachment at a time onto and over the respective snapLINX™ pin.

4. The mattress should lie flat on the section when this has been achieved without evidence that the snapLINX™ pins are holding the mattress

off the section.

5. Check the fixation, trying to move the mattress laterally.

5.2 Mounting / demounting extensions

The KERNA™ General Surgical Table is equipped with Hi-lock™ locking system using side buttons. It is compact, easy to use and secure.

With Hi-lock™, an extension is automatically locked-in when it is inserted, and just by using the side buttons it is then removed.

Depending on the type of extension and the required safety level, it may be necessary to press the button twice in order to remove the extension. Do not force the

extension if it does not release after pressing the button once.

For convenience, it is preferable to install and remove the extensions when the table is in a horizontal position.

Example – installing / removing a head section

Insert simultaneously the two pins of the head section into the two holes in the back or seat section of the table. The head section should attach easily; you will

hear a click on each side when the automatic locking happens. Check that it is locked correctly by trying to pull the head section out.

Depending on your choice you will have either mattresses with Velcro attachment or mattresses with snapLINX™ attachments.

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Click!

Example – installing / removing the split leg sections

For each leg section, insert the pins into the corresponding holes (left or right) in the back or seat section of the table. When the pin is 3/4 inserted, make sure

that the anti-rotation pin is aligned with the casing on the table upright. Do not force it: the leg section should attach easily. You will hear a click on each side

when it becomes locked automatically. Check that it is locked correctly by attempting to pull out the leg section.

The leg sections are equipped with a double security system: to remove them, the side button on the relevant leg section must ﬁrst be pressed in order to release

the anti-rotation pin.

There are then two ways to remove the leg section completely. The user must be ready to support the weight of the leg section being removed:

-Press the side button on the relevant leg section a second time and completely extract the pin while supporting the weight;(see steps below)

-Rotate the leg section while continuing to extract the pin and supporting the weight.

5.3 Inserting and removing the battery fuse:

For reasons of safety during transport, the battery fuse is packed separately.

1. Insert the fuse into the fuse holders provided separately.

2. Insert all of this into the fuse holders.

3. Push and 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. The three colored LED (green, orange and red) will ﬂash for a few seconds.

If the table is not used for a long period of time (>1 month), remove the fuse in order

to limit battery discharge and maintain battery functionality

For further instructions, please refer to the leg section user manual.

A B C

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Hand control onStandard On the base Procedures Battery status

30-60 sufﬁcient

20-30 Mains connection recommended

1-20 Mains connection mandatory

Caution : The blinking of the red LED warns a problem, the battery must be recharged imperatively or the table will automatically shut down. If the problem

persists, please contact STERIS technical department.

5.5 Using the table on battery

&&

In standard version:

The battery status is displayed on the hand control and on the base

To extend the working life of the battery, we recommend the following:

! Charge battery systematically each day (also in no use conditions)

! Charge battery systematically before 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 battery each year)

5.4 Connecting the table to the main electrical supply and control

the battery charge level

&

1. Check that the Mains voltage matches the indications on the table.

2. Lift the hatch of the rear panel, and 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.

It has three coloured LED used to monitor the battery status when connected to Mains

&

1. If the battery is charging, the coloured LED light up sequentially orange and green.

2. If the battery is charged, the coloured LED light up steadily orange, and green:

This can also be checked on the remote control.

If the 3 coloured LED (red, orange, green) 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.

Bip!

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6. CONNECT AND OPERATE THE CONTROL DEVICES

Connecting and activating the main hand control

Connection:

1. Lift the protection cover off 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 optional pedal. To activate the hand control, press any button except

the STOP button.

It switches off automatically after 3 minutes if it has not been used.

Disconnection:

1. Switch off 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. Replace the protection covers to protect the sockets.

Connecting and activating the optional pedal

Connection:

1. Lift the protection cover off the corresponding socket.

2. Align the red dot on the pedal cable connector with that on the socket on the table side.

3. Plug the connector until it “clicks,” indicating that it is correctly connected.

The pedal enables users to adjust the 3 main table movements: up/ down, trend/rev trend, and right/left tilt. To activate

it, just press a pedal and then release on any movement. It switches off automatically after 3 minutes if it has not been used.

Disconnection:

1. Switch off the pedal by using the STOP button on the hand control.

2. The connector is equipped with a lock: unlock the connector by pulling the ring backwards. Never just pull on the cable.



3. Replace the protection covers to protect the sockets.

Connecting an optional motorized leg extension

ACC

OUT

(LEG01M and LEG10M) with optional TFT remote control only

For more information about the motorized legs, refer to the user manual related to these extensions.

Connecting the E-Serve™ maintenance software

The speciﬁc E-Serve™ cable connects to the same port as the main hand control. Therefore, when the E-Serve™

cable is connected, the main hand control cannot be connected.

Connection:

1. Lift the protection cover off the corresponding socket.

2. Align the red dot on the speciﬁc E-Serve™ connector, with that on the socket on the table side.

3. Plug the connector until it “clicks”, indicating that it is correctly connected.

Disconnection:

1. Switch off the table by pressing STOP button on the override system.

2. The connector is equipped with a lock: unlock the connector by pulling the ring backwards. Never just pull on the cable.

3. Replace the protection covers to protect the sockets.

General Surgical Table - KERNA™

[14]

Tabletop movements / LED indicators

STOP

Return to level

Tilt right

Rev trend

Return to level LED

Trend

Tilt left

Battery discharge status

Floor lock LED

Back up

(leg up in reverse orientation)

Back down

(leg down in reverse orientation)

Reverse patient orientation

Normal patient orientation

Flex

Reﬂex

• Lock/unlock table to ﬂoor

• Blue LED “locked”

Blue LED ﬁxed :the table is locked

Blue LED blinking : the table is unlocked

Slide foot Slide head

Warning:

• Tactile: 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

6.1 OPERATING THE KERNA™ MAIN HAND CONTROL (standard version)

The main hand control includes:

1. A 5 m spiral cord with a connector at each end making it easy to replace.

2. A plastic housing equipped with a hook so that it can be attached to the table’s side rails.

3. A keyboard allowing direct access to the function of the table

To level the table:

The blue LED will permanently light up when the table is in horizontal position.

The return-to-level button enables the tabletop to be returned to a horizontal position.

During the return to level tabletop movements, even if it is automatically realised, always ensure patient safety.

1. To return the tabletop to level: (the level LED is switched off if the tabletop is not horizontal)

2. Press the 0 button; the blue LED will ﬂash during the tabletop movements.

3. The blue LED will be permanently on when the tabletop is horizontal.

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.

Switching o the table

When the STOP button is pressed, the table immediately stops.

The Auto-off function turns off the table after 3 minutes if it is no longer in use in order to avoid any unintentional movement and to conserve battery life.

Locking / unlocking to ﬂoor

The mobile base of the KERNA™ General Surgical Table allows it to be moved around the operating theatre so that it can be relocated or so that the ﬂoor can be cleaned.

Locking / unlocking to the ﬂoor is controled automatically from the hand control.

During locking / unlocking (which takes a few seconds) all of the buttons, except the STOP button, are disabled.

The Locking/unlocking button has to be pressed more than 1 second.

When the blue LED blinks the table is on its castors. When the blue LED is ﬁxed the table is locked.

All movements are authorized even when the table is on its castors.

Before starting any surgical procedure, check that the table is locked to the ﬂoor and stable. The ﬂoor locking pads can compensate by up to 4mm if the ﬂoor is

not quite horizontal: if necessary, move the table to ﬁnd a more stable location.

down

General Surgical Table - KERNA™

[15]

7. OVERRIDE SYSTEM

If the table does not work correctly with the battery or the Mains, an override keypad located on the

column shall be used to replace the main hand control.

When the override system is in use:

-the main hand control is automatically switched off;

-the patient orientation described by the buttons is always in normal orientation;

-the sensors, and therefore the ALS™ system, are on standby.

You should therefore pay particular attention to the patient and look out for potential table section

conﬂicts, and contact the STERIS service.

Operation with the override keypad (powered mode)

-Simultaneously press the desired movement and the Powered Override Validation button. .

-The movement starts with a beep indicating that attention is required.

NB:

-Placing the table on the castors requires also the use of the button .

To unlock the table, keep pressing the buttons long enough until ﬂoor lock cylinders are

fully retracted.

To lock the table , keep pressing the buttons long enough until the ﬂoor lock cylinders

are fully extracted.

Trend

(Rev trend if patient in rev

orientation)

Tilt left

(Right if patient in rev orientation)

Unlocking Move to castors

Tilt right

(Left if patient in rev orientation)

Rev trend

(Trend if patient in rev

orientation)

Back up

(Seat if patient in rev orientation)

Slide head

(Foot if patient in rev orientation)

Slide foot

(Head if patient in rev orientation)

Back down

(Seat if patient in rev orientation)

Table up

Table down

Table ON / Bluetooth

STOP / Stop the table

Floorlock

Override motorised Validation

Override system

General Surgical Table - KERNA™

[16]

8. WEIGHT CAPACITIES

Man height according to current standard 190cm

Table shown with HEAD04B + BACK02B + LEG30C

Patient in reverse orientation

Reverse patient orientation state for the head on the long side of the base. All movements of the table can be performed. Only height adjustment can be permitted

for patient over 270kg.

Patient 270kg

Patient 165kg

Patient 300kg

Centered

Fully slided

Centered

Lithotomy

Centered

Fully slided

Lithotomy

Patient 270kg

Patient 300kg

Patient 270kg

For the weight capacities shown below, the centre of gravity (usually the umbilicus) must be kept within the blue and green and yellow highlighted areas.

The weight of additional accessories ﬁtted to the table must be included in any estimation of applied load.

Due to the modular design of the KERNA™ General Surgical Table, the maximum permissible patient and accessory load will change depending on tabletop

conﬁguration, patient position and accessories used. Please refer to the User Instructions of the Extension and/or Accessory to determine the maximum

permissible load.

?cm - Column - 48cm

Patient in normal orientation

Normal patient orientation state for the head on the short side of the base. All movements of the table can be performed. Only height adjustment can be permitted

for patient over 270kg.

Green : 300kg

Blue : 270kg

Green : 300kg

Blue : 270kg

Yellow : 165kg

35cm - 10cm - Column - 3cm - 55cm

General Surgical Table - KERNA™

[17]

Normal patient orientation

The head support is placed on the half backrest side and the leg supports

on the seat side

- Maximum sliding on head side (intervention via the upper body)

- Maximum sliding on foot side (intervention via the lower body)

Reverse patient orientation

The head support is placed on the seat side and the leg supports on the half

backrest side.

- Maximum sliding on head side (intervention via the upper body)

- Maximum sliding on foot side (intervention via the lower body)

Radiological access

Use of the KERNA™ General Surgical Table with a C-arm have been of particular focus.

It is possible to reverse the orientation of the KERNA™ General Surgical Table in relation to the base by taking off the head and leg sections and attaching them to

opposite sides so that the table is optimally arranged for the type of surgery required. These two options give different kinds of radiological access.

NB: every time the table orientation is reversed, you will need to select the correct patient orientation on the main hand control so that the buttons continue to control the

correct movements.

Below table is presented with LEG20C and HEAD05B+BACK02B - Dimensions will vary depending on extensions mounted.

900mm 1060mm

980mm 980mm

1620mm

1210mm 750mm 670mm 1290mm

Below table is presented with CARBEXT + Carbon headrest

The CARBEXT extension is placed on the seat side

General Surgical Table - KERNA™

[18]

9. CLEANING / DISINFECTION

General information

Before every cleaning session, we recommend to turn off the table and

disconnect it from the charger. Make sure that the socket covers are ﬁtted

correctly.

Do not submerge the hand control.

Before you start, ensure that the active components of the products used are

compatible with the table materials.

You must follow the dilution and temperature instructions recommended by the

detergent-disinfectant manufacturer.

Wear the recommended personal protective equipment (gloves, goggles)

After cleaning procedures, ensure no residual water remains near the plug.

Cleaning between 2 procedures

Cleaning the hand control:

-Wipe it with a paper tissu (or non-woven equivalent) impregnated with a

detergent-disinfectant solution.

-Leave to dry.

Cleaning the table’s visible surfaces:

-Spray a detergent-disinfectant solution on all the visible surfaces including

the pads.

-Clean with a paper tissu. Spray the detergent-disinfectant on all the visible

surfaces.

-Leave to dry.

Full cleaning at the end of the day

The pads can be easily removed thanks to their Velcro bands or their

snapLINX™:

-Remove the pads.

-Spray a detergent-disinfectant directly onto the pads.

-Clean with a paper tissue. Spray the detergent-disinfectant on all the visible

surfaces.

-Leave to dry.

-If necessary brush the Velcro bands, the pads and the tabletop with a non-

metallic brush (e.g. with a clothes brush).

Cleaning the table:

-Raise the table to its maximum height in order to get optimal access to the

column.

-Put the tabletop in a horizontal position.

-Clean with a paper tissue. Spray the detergent-disinfectant on all the visible

surfaces.

-Leave to dry.

If there is a risk of streaming, spray the detergent-disinfectant directly onto the

paper tissu.

Slide rails are sensitive to corrosion and must stay lubricated. If a cleaning

has to be done in this area, remember to lubricate them afterwards with an oil

ﬁlm..

Cleaning the castors:

-Lock the table so that the castors are no longer touching the ﬂoor.

-Spray the detergent-disinfectant on all visible surfaces.

-Leave to dry.

Recommended products / products to avoid

Recommended active ingredients:

You should preferably use products designed for above-ﬂoor surfaces.

STERIS recommends the use of cleaning and disinfectant chemicals whose

compounds are based on isopropyl alcohol (<45%) or based on a quaternary

ammonium.

The use of cleaning chemicals not recommended by STERIS is forbidden

because the compatibility and the effectiveness of the chemicals have not

been demonstrated.

If users are unsure of which products to use they should consult the hygienists

in their hospital or their supervisory authority.

Do not use products that are meant for cleaning ﬂoors.

Hypochlorite solutions can damage metal parts.

After disinfection, ensure it is rinsed off thoroughly with water and dry the

surface.

Prolonged exposure to hypochlorite solutions may degrade mattress material.

Avoid hypochlorite solutions and other liquids coming into contact with any

internal parts of the table.

If you are unsure about whether the active ingredients are compatible, contact

the STERIS technical department.

Recommended daily maintenance:

-Check the table and hand control battery charge level (Optional if you are

using wireless remote control)

-Check the attachment of the extensions

-Check the table locking and its stability

-Check the operation of each movement from the main hand control

-Check the correct fastening of the pads on Velcro strips or snapLINX™

Preventative maintenance must be carried out at least once a year by a STERIS

technician, or another approved technician.

1- Safety points

-Attachment of the cylinders

-Clearance of the joints and protective covers

-Tightness of the side accessory rails

-Operation of the extension locking systems

-Operation of the table locking system

2- Inspection, maintenance, adjustment

-Slide condition

-Castor condition

-Battery condition (table + optional wireless hand control)

-Proper operation of charger / power supply

-Check oil level : The oil level contained in the tank should be between the

min and max levels indicated on the tank.

-Column play

-Condition of ﬂexibles and connections

-Condition of cylinders

-Condition of cables and connectors and guides

-Lubrication of sliding rails

-Grease extension latches

-Condition and operation of the main/optional wireless hand control

-Condition and operation of the override system

-ALS operation

10. MAINTENANCE PROGRAMME

General Surgical Table - KERNA™

[19]

11. KERNA™ SPARE PARTS LIST

In the event of a repeated or major malfunction, contact the STERIS technical department. Any modiﬁcation or repair to this device by

personnel not approved by STERIS is prohibited.

FAULT DETECTED POSSIBLE CAUSE CORRECTIVE ACTION

The table will not switch on

The fuse is blown Replace the battery fuse or connect to Mains power

The hand control is defective Replace the hand control

The hand control cable is defective Replace the hand control

No movement occurs

The battery is completely discharged Connect the table to Mains power

The hand control is defective Replace the hand control

The hand control cable is defective Replace the hand control

The table remains in battery mode when the

Mains power cable is plugged in

Power cord bad connection Reconnect the Power cord

The Power cord is defective Replace the Power cord

A Mains fuse is blown Contact STERIS technical department

The extension will not lock or has a lot of

play

The extension is not correctly latched Re-lock the extension

The extension will not lock Contact STERIS technical department

12. TROUBLESHOOTING

The following table is provided for KERNA™ General Surgical Table operators faced with product fault scenarios.

Recycling the product: this equipment must be disposed by a legal body designated for the recycling of waste electrical and electronic equipment.

Hydraulic ﬂuid: drain the hydraulic ﬂuid off prior scrapping the table, and dispose this ﬂuid properly.

Battery: take battery to an approved disposal facility. They are considered polluants.

13. DISPOSAL OF WASTE EQUIPMENT

DESCRIPTION REFERENCE

80mm mattress without URO cutout, welded seam, with velcro attachment S02CV3

80mm mattress with URO cutout, welded seam, with velcro attachment S01CV3

80mm mattress without URO cutout, welded seam, with snapLINX™ attachment S02CX3

80mm mattress with URO cutout, welded seam, with snapLINX™ attachment S01CX3

Optional wireless hand control (CMAX®) V543004910

HAND CONTROL CABLE (CMAX®) V542501208

HAND CONTROL (KERNA™) V543810995

VELCRO 1 METER LENGTH V654005006

SET OF 2 BATTERIES V342212555

CASTOR V606006408

General Surgical Table - KERNA™

[20]

14. ELECTROMAGNETIC ENVIRONMENT

Essential performance of KERNA™ is supporting a patient without unwanted movement in a single fault condition.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

WARNING: Use of accessories, transducers and cables other than those speciﬁed or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the KERNA™, including cables speciﬁed by the manufacturer. Otherwise, degradation of the

performance of this equipment could result. Before connecting any equipment, the user should make sure that they respect the applicable regulations and that their connections comply with the manufacturers’ recommendations. KERNA™ needs special precautions regarding

electromagnetic compatibility and needs to be installed and put into service according to EMC information provided in this instruction of use. The KERNA™ is compliant with standard IEC 60601-1-2 : 2014 (Ed.4).

Guidance and manufacturer’s declaration - Electromagnetic emissions

List of the cables & accessories in conformity with the emissions and

immunity testing

The KERNA™ are intended for use in an electromagnetic environment speciﬁed below. The customer or the user of KERNA™ should assure that it is used in such

environment. Hand control KERNA™

Remote control 542805998

Foot pedal TAB714

Mains cable 5m 689400010

Remote control cable 0,7m 542605104

Foot pedal cable 4m 542200409

Motorized legs LEG10M & LEG01M

Emission test Compliance Electromagnetic environment

guidance

RF emissions CISPR 11 Group 1

The KERNA™ use RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in

nearby electronic equipment.

RF emissions CISPR 11 Class A The KERNA™ are suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that

supplies building used for domestic purposes.

NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential

environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services.

The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Harmonic emissions IEC 61000-3-2 Class A

Voltage ﬂuctuations/ ﬂicker emissions IEC 61000-3-3 Conforms

Guidance and manufacturer’s declaration - Electromagnetic immunity

The KERNA™ are intended for use in an electromagnetic environment speciﬁed below. The customer or the user of KERNA™ should assure that it is used in such environment.

Immunity test IEC 60601-test level Compliance level Electromagnetic environment guidance

Electrostatic discharge (ESD))

IEC 61000-4-2 ±8 kV contact

±15 kV kV air

±8 kV contact

±15 kV kV air

Professional healthcare facility environment

Floors should be wood, concrete or ceramic tile. If ﬂoors are covered with synthetic material, the relative

humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV

±1 kV Professional healthcare facility environment

Mains power quality should be that of a typical commercial or hospital environment

Surge

IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth

±1 kV

±2 kV

Voltage dips, short interruptions and voltage variations

on power supply input lines

IEC 6100-4-11

<5 % UT (>95% dip in UT) for 0,5 cycle

40 % UT(60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

<5 % UT (>95% dip in UT) for 0,5 cycle

40 % UT(60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

Professional healthcare facility environment

Mains power quality should be that of a typical commercial or hospital environment. If the user of KERNA™

system requires continued operation during power mains interruptions, it is recommended that the

KERNA™ system be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic ﬁeld

IEC 61000-4-8

30 A/m 30 A/m

Professional healthcare facility environment

Power frequency magnetic ﬁelds should beat at levels characteristic of a typical location in a typical

commercial or hospital environment.

RF Conducted IEC 61000-4-6 3V

150 kHz to 80MHz

6V in ISM bands between 0,15 MHz and 80 Mkz

0.8 MA at 1 kHz

150 kHz to 80MHz

6V in ISM bands between 0,15 MHz and 80 Mkz

0.8 MA at 1 kHz

Professional healthcare facility environment

RF Radiated IEC 61000-4-3 3V/m

80 Mkz to 2,7 GHz

80% MA at 1 kHz

9V/m

710 MHz, 745 MHz

780 MHz, 5240 MHz

5550 MHz, 5785 MHz

27V/m

385 MHz

28V/m

450 MHz, 810 MHz

870 MHz, 930 MHz

1720 MHz, 1845 MHz

1970 MHz, 2450 MHz

3V/m

80 Mkz to 2,7 GHz

80% MA at 1 kHz

9V/m

710 MHz, 745 MHz

780 MHz, 5240 MHz

5550 MHz, 5785 MHz

27V/m

385 MHz

28V/m

450 MHz, 810 MHz

870 MHz, 930 MHz

1720 MHz, 1845 MHz

1970 MHz, 2450 MHz

Professional healthcare facility environment

NOTE UT is the a.c. mains voltage prior to application of the test level.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reﬂection from structures, objects and people.

(1) Field strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic

environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which KERNA™ is used exceeds the applicable RF compliance level above, the KERNA™ operating table should be observed to verify