Arjo Century User Guide User Guide

Download

Page 1

Century

INSTRUCTIONS FOR USE

04.AK.02_10GB. January 2015

0086

...with people in mind

Page 2

WARNING

To avoid injury, always read this Instructions for Use and accompanying documents before using the product.

Mandatory to read the Instructions for Use

Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © ArjoHuntleigh AB 2014.

As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.The content of this publication may not be copied either whole or in part without the consent of ArjoHuntleigh AB.

Page 3

Contents

Foreword ................................................................................... 4

Intended Use .............................................................................5

Safety Instructions ....................................................................6

Preparations .............................................................................. 7

Parts Designation ......................................................................8

Control Panel ..........................................................................10

Buttons and Displays ..............................................................10

Product Description/Functions ................................................12

Drain Control Knob ..............................................................12

Auto Fill Function .................................................................12

Shampoo/Body Wash and Bath Oil/ArjoSound™

Water Conditioner ...............................................................12

Scalding Protection .............................................................13

Patient Shower ....................................................................13

Disinfection Unit ..................................................................14

Hydromassage™ System .......................................................15

Hydrosound® System .............................................................17

Bathe Patient ...........................................................................19

Cleaning and Disinfection Instructions ....................................21

Care and Preventive Maintenance ..........................................29

Troubleshooting ......................................................................33

Technical Specifications .........................................................37

Labels .....................................................................................40

Approvals and List of Standards .............................................42

Electromagnetic Compatibility .................................................43

Parts and Accessories ............................................................46

ArjoHuntleigh Addresses .............................................Last Page

Page 4

Foreword

Thank you for purchasing ArjoHuntleigh Equipment

Your Century quality products designed especially for efficient patient hygiene and good ergonomics for the caregiver .

Please contact us if you have any questions about the operation or maintenance of your Century bath.

Please read this Instructions for Use thoroughly!

Please read this Instructions for Use (IFU) in its entirety before using your Century bath. Information in this IFU is crucial to the proper operation and maintenance of the equipment, will help protect your product, and ensure that the equipment performs to your satisfaction. Some of the information in this IFU is important for your safety and must be read and understood to help prevent possible injury .

Unauthorized modifications on any ArjoHuntleigh equipment may affect its safety. ArjoHuntleigh will not be held responsible for any accidents, incidents or lack of performance that occur as a result of any unauthorized modification to its products.

bath is part of a world-wide family of

Definitions in this IFU

WARNING

Means: Safety warning. Failure to understand and obey this warning may result in injury to you or to others.

CAUTION

Means: Failure to follow these instructions may cause damage to all or parts of the system or equipment.

NOTE

Means: This is important information for the correct use of this system or equipment.

Means: The name and address of the manufacturer.

Service and Support

A routine service must be performed on your Century every year by qualified personnel to maintain safety and reliability of the equipment. See section Care and

Preventive Maintenance on page 29.

If you require further information, please contact ArjoHuntleigh for comprehensive support and service programs to maximize the long-term safety , reliability and value of the product.

Contact ArjoHuntleigh for replacement parts. The contact information is found on the last page of this IFU.

Page 5

Intended Use

This bath is intended for assisted bathing and showering of adult residents in hospital and care facilities. Century must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines in this Instructions for use.

The bath should only be used for the purpose specified in this Instructions for Use. Any other use is prohibited.

Resident Assessment

W e recommend that facilities establish regular assessment routines. Caregivers should assess each resident according to the following criteria prior to use:

• The resident's weight should not exceed 160 kg / 353 lbs (Max Patient Weight)

• Active and semi-active residents (i.e. able to sit upright self supported on the side of the bed or toilet) can use the bath. Correct transfer equipment shall be used if needed.

• The resident should have the ability to understand and respond to instructions, or have limited physical capacity to move, to ensure a safe position during the bathing procedure.

• Hydrosound should not be used by pregnant women.

If the resident does not meet these criteria an alternative equipment/system shall be used.

Expected Lifetime

The expected life of the Century is unless otherwise stated ten (10) years, if subject to preventive maintenance being carried out in accordance with the instruction for Care and Pr eventive Maintenance on page 29.

Indication for Use

T o relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue and it serves as a setting for removal of contaminated tissue.

Installation & Service Requirements

The equipment must be installed by appropriately trained personnel according to the Assembly and Installation Instructions which can only be superseded by local code.

Page 6

Safety Instructions

WARNING

To avoid hair entrapments under water, always install the Hydromassage system suction cover before use.

WARNING

To avoid falling, make sure that the patient is positioned correctly and that the safety belt is being used, properly fastened and tightened.

WARNING

To avoid falling, make sure the patient always remains in a seated position.

WARNING

To avoid explosion or fire, never use the equipment in oxygen rich environment, in presence of heat source or flammable anaesthetic gases.

WARNING

To avoid entrapment or pinching of genitals, make sure there is enough clearance during movement over the tub edge, toilet, bedpan or other furniture.

WARNING

To avoid the device from tipping and the patient from falling, do not use the equipment on floor with recessed drains, holes or slopes exceeding a ratio of 1:50 (1.15°).

WARNING

To avoid electric shock, never use other electrical equipment near this device.

WARNING

To avoid injury, make sure that the patient is not left unattended at any time.

CAUTION Do not use the Hydrosound system for

more than 15 minutes at a time with a 15 minute stop in between.

Safety Practice

For a safe bath and to avoid injuries, make sure the patient is sitting firmly and facing the control panel.

WARNING

To avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.

WARNING

To avoid entrapment, make sure to keep the patient's hair, arms and feet close to the body and use designated grab supports during any movement.

WARNING

To prevent cross-contamination, always follow the disinfection instructions in this

IFU.

Page 7

Preparations

Site Preparations

Prior to the installation of the Century bath, the floor and walls within the required area must be finished.

Material: The floor should be water sealed, made of a slip resistant material and free of bumps.

Floor Slope: When using a floor drain, the slope towards the drain should not exceed 1:50 (1.15°).

Floor attachments: The floor construction must be suitable for anchoring the equipment bolts.

Actions Before First Use

(8 steps)

1 Make sure the bath has been installed according to

the Assembly and Installation Instructions.

2 Check all parts of the product are supplied.

Compare with section Parts Designation on page

8. If any part is missing or damaged - do NOT use

the product. 3 Read this IFU. 4 Disinfect the product according to section

Cleaning and Disinfection Instructions on page

21.

5 Perform a functionality test according to section

Care and Preventive Maintenance on page 29.

Actions Before Every Use

(5 steps)

1 Check that all parts are in place. Compare to

section Parts Designation on page 8. 2 Check bath and accessories for damage. 3 If any part is missing or damaged - do NOT use

the product! 4 Check the liquid level of disinfection bottle.

WARNING

To prevent cross-contamination, always follow the disinfection instructions in this Instructions for Use.

Before every use, make sure the Century bath is

cleaned and disinfected according to section

Cleaning and Disinfection Instructions on page

21.

NOTE If you have any questions, please contact your

local ArjoHuntleigh representative for support and service. The contact information (ArjoHuntleigh addresses) is listed on the last page of this IFU.

6 Choose a designated area, where the IFU should

be kept and is easily accessible at all times.

WARNING

To prevent scalding, make sure that the water mixer has been calibrated. Confirm that responsible organization has established calibration routines.

Make sure the thermostatic mixer has been calibrated by an ArjoHuntleigh service technician according to the Assembly and Installation

Instructions.

8 Make sure to have a rescue plan ready in case of a

patient emergency.

Page 8

Parts Designation

Type B Applied part. Degree of Protection - Electrical shock

1 Bathtub 2Leg 3 Foot 4 Control panel 5 Outlet for bathtub filling 6 Patient shower handle 7 Popup-drain 8Sensors 9 Surface overflow outlet and drain manoeuvring

knob

10 Dispenser for Bath oil or Arjo Sound Water

Conditioner (fo r Hydrosound system) (optional) 11 Shampoo dispenser (optional) 12 Disinfectant spray handle (behind door)

(optional) 13 Flow meter (optional) 14 Storage container area, left; Disinfectant 15 Storage container area, right; Shampoo and

Bath Oil

Hydromassage™ system (optional)

16 Treatment hose with nozzle 17 Suction inlet screen 18 Hydrosound system outlet 19 Water flow and Air mix control

Hydrosound® system (optional)

20 Hydrosound system transducing plate 21 LED 22 Intensity knob

Page 9

left

5 9

9 8

right

19 18

17 16

7 1

21 22

Page 10

Control Panel

Patient shower

Shampoo & Body wash

Bath Oil or ArjoSound Water Conditioner

Temperature setting

Hydromassage/ Hydrosound System

Tub fill Auto fill

Temperature display Bathtub water

Temperature display Fill and shower

Disinfection / Autoclean

Buttons and Displays

Shampoo & Body Wash Button

Press the Shampoo & Body W ash button to dispense shampoo or body wash from corresponding outlet

Tub Filling/Auto Fill Button

(2 steps)

1 Press the Tub Fill/Auto Fill button to fill the bathtub. The

2 Press the Tub Fill/Auto Fill button again to manually stop to

auto fill function will automatically stop to fill at a preset level. The LED is lit while the bathtub is being filled.

fill.

Page 11

Patient Shower Button

(2 steps)

1 Press the Patient Shower button to start the shower. 2 Press the Patient Shower button again to stop the shower.

The LED lights up when active. The shower function automatically shuts off after 15 minutes. Press the Patient Shower button to restart.

Bath Oil/ArjoSound™ Water Conditioner Button

Press the Bath Oil/ArjoSound water conditioner button to dispense Bath Oil/ArjoSound water conditioner from corresponding outlet.

Baths equipped with Hydrosound system have ArjoSound water conditioner instead of Bath Oil.

Hydromassage™ / Hydrosound® System Button (optional)

(2 steps)

The bath is either equipped with Hydromassage or Hydrosound system.

1Press the Hydromassage/Hydrosound system button to start

hydromassage (built-in jets) or hydrosound (low frequency ultra sound).

2Press the Hydromassage/Hydrosound system button again

to stop hydromassage/hydrosound. LED lights up green when active. The Hydromassage/

Hydrosound system will automatically shut itself off after 15 minutes. After completion, wait 15 minutes before the Hydromassage/Hydrosound system can be restarted.

Disinfection/Autoclean Button (Optional)

Press the Disinfection/Autoclean button to activate disinfection unit.

LED lights up when active. Button only works when there is no water in the bathtub and no other functions are activated.

Temperature Display – Bathtub Water

The digital display shows the current water temperature in the bathtub.

Temperature Display – Filling and Shower

The digital display shows the current water temperature in the outlet for bathtub filling or the shower.

Page 12

Fig. 1

Fig. 2

Fig. 3

Product Description/Functions

Drain Control Knob

Turn the drain control knob (A) to open or close the bathtub drainage plug (B). (See Fig. 1)

• Turn Clockwise to open.

• Turn Counter Clockwise to close.

The drain control knob is equipped with a built-in surface overflow outlet to prevent water to overflow the bathtub.

Auto Fill Function

(2 steps)

The bath system is equipped with an auto fill function, which fills the bathtub to a preset water level. For adjustments or assistance, call your ArjoHuntleigh Service Department.

1 To start to fill the bathtub, press the Tub Fill/Auto Fill

button.

2 T o manually stop the fill, press the Tub Fill/Auto Fill button

again. LED lights up when active.

Shampoo/Body Wash and Bath Oil/ ArjoSound™ Water Conditioner

Bottles with Shampoo/Body W ash and Bath Oil/ArjoSound water conditioner are placed behind a door on the right side of the panel. The bottles should be mounted, sufficiently filled and connected to their corresponding hose and bottle connection. (See Fig. 2)

• Press the Shampoo/Body Wash button while holding your hand under the dispenser outlet. Dosage will continue as long as the button is pressed. (See Fig. 3)

• Press the Bath Oil/ArjoSound water conditioner button to dispense directly into the bath water.

When your bath system is equipped with Hydrosound system, t he Bath Oil is replaced with ArjoSound water conditioner.

Page 13

Scalding Protection

Fig. 4

Fig. 5

Century bath is equipped with an electric scalding protection to reach a maximum safety for the patient. The function is used during filling, showering and cleaning.

The scalding protection is activated when the water temperature gets too high. If the bathtub water reaches 45 °C (113 °F) or above, the electronic scalding protection shuts off the water after 10 s, both LEDs on the Disinfection/Autoclean button and the Patient Shower button flash for a short time.

WARNING

To prevent scalding if the scalding protection is activated, remove the patient from the bath immediately in a safe manner.

Reset the scalding protection (5 steps)

1 Make sure both L ED s o n the Disinfection/Autoclean button

and the Patient Shower button have stopped flashing. 2 Turn the knob on the thermostatic mixer to COLD. 3 Press the Tub Filling button until the display shows 30-

35 °C (86-95 °F). 4 Press the Patient Shower button. Lift off the shower handle,

direct it away from yourself down into the bathtub. Press the

trigger on the shower handle. 5 Allow a few seconds for the water to reach correct

temperature.

Patient Shower

(7 steps)

1 The patient shower is on the right side of the panel.

(See Fig. 4)

2 Press the Patient Shower button on the control panel.

The green LED indicates when the patient shower is

activated.

NOTE The shower handle and the fill function cannot be

activate at the same time.

3 Lift off the shower handle, direct it down into the bathtub.

Press the trigger on the shower handle. (See Fig. 5)

Continue with the steps on the next page.

Page 14

Fig. 6

Lock Button

Trigger

Fig. 7

WARNING

To prevent scalding, always check the water temperature with your naked hand before directing the water on the patient. Do note use gloves as it may insulate to the extent that the water temperature can be misjudged. Point the flow of the water away from the patient.

Direct the water stream away from the patient and allow a

few seconds for the water to reach desired temperature. If

desired, adjust the water temperature by using the knob on

the panel. 5 Place your hand in the water stream to make sure the water

temperature feels comfortable before the water stream is

directed on the patient.

To get continuous water flow without having to hold in the trigger:

6 Press the shower handle trigger and push in the Lock button

on the side. The water will continue to flow without having

to press the trigger. (See Fig. 6) 7 Release the lock by pressing the handle trigger and the Lock

button will pop out by itself.

Disinfection Unit

The bath has a built-in disinfection unit. The disinfection bottles are placed behind a door on the left side of the panel together with a disinfection spray handle and a flow meter. The flow meter shows the liquid mix ratio between disinfectant and water. The disinfectant bottle cap is adjustable and regulates the disinfectant/water ratio. (See Fig. 7) For further cleaning and disinfection instructions, see section Cleaning and Disinfection Instructions on page 21.

Page 15

Fig. 1

Fig. 2

Decrease intensity

Increase intensity

Fig. 3

Fig. 4

Hydromassage™ System

WARNING

To avoid hair entrapments under water, always install the Hydromassage system suction cover before use.

Use the Hydromassage™ System

(5 Steps)

1 Before the hydromassage starts, fill the bathtub over the

Hydromassage system outlet (A), according to section

Bathe Patient on page 19. (See Fig. 1)

2Press the Hydromassage system button on the control panel

to start the Hydromassage system built-in jet.

The default runtime is 15 minutes after which the

hydromassage will automatically end. Wait 15 minutes to

restart.

• The hydromassage can be stopped at any time, during the 15 minutes of runtime, by pressing the Hydromassage system button.

• Always turn the Hydromassage system off when the treatment has finished.

3 Adjust the water flow with the knob on the upper right side

of the bathtub.

• Start at a low intensity by turning the knob counter clockwise.

• Increased the water flow intensity by turning the knob clockwise. (See Fig. 2)

4 Adjust the water-jet direction by turning the Hydromassage

system outlet. (See Fig. 3)

• Remove the adjustable Hydromassage system nozzle, by pulling it out, if you want the jet to cover a wider area (See

Fig. 4)

5 When finished the hydromassage, turn the Hydromassage

system off by pressing the Hydromassage system button.

Page 16

Hydromassage with Treatment Hose

Fig. 1 Fig. 2

Fig. 3

Fig. 4

(7 optional steps)

NOTE If hydromassage is active, stop it by pressing the

Hydromassage system button on the control panel before connecting the treatment hose.

1 Remove the Hydromassage system nozzle by pulling it out. 2 Connect the treatment hose to the quick coupling in the

bathtub. (See Fig. 1) The treatment hose and the built-in jet within the bathtub

cannot be used simultaneously.

3 Direct the treatment hose nozzle into the water. Make sure

the air inlet (A) is above the water surface. (See Fig. 2)

4Press the Hydromassage system button on the control panel

to start the hydromassage from the treatment hose.

• The treatment automatically ends after 15 minutes. Press the Hydromassage system button to manually stop the treatment.

5 T o adjust the jet stream intensity, turn the outermost part of

the treatment hose nozzle. (See Fig. 3)

Max.

• When the two dots on the nozzle are aligned, the jet stream is at its most intensity.

• When turning the nozzle 90°, the jet stream intensity decreases.

• When turning the nozzle 90° more, the jet stream intensity increases and so on.

6 When the local treatment is finished, press the

Min.Min.

Hydromassage system button on the control panel to turn it off.

7 Remove the treatment hose from the quick coupling device

by pushing in the hose while pulling the hose bracket back simultaneously. (See Fig. 4)

Page 17

Fig. 1

Fig. 2

Hydrosound® System

Arjo H u n t l e i g h Hydrosound® system is a m e t hod of cleaning patients by means of low frequency , low intensity ultra sound. W orking together with water, it is an effective and skin friendly method of cleaning the skin.

The amount of time and intensity setting used for Hydrosound system cleaning is a matter of choice consistent with the degree of patient cleanliness required and patient comfort. The longer time of exposure and the greater intensity setting, the more efficient cleaning.

For patients experiencing Hydrosound system cleaning for the first time, it is recommended that the intensity is set at the lower levels before using the higher intensity settings.

WARNING

To avoid burns, avoid continuous contact with Hydrosound system transducer plate while in operation. (See Fig. 1)

WARNING

To avoid injury, never use the Hydrosound system function when pregnant.

Use the Hydrosound® System

(7 steps)

1 Before the Hydrosound system starts, fill the bath according

to section Bathe Patient on page 19.

2Press the ArjoSound water conditioner button on the control

panel during the filling process. Check the conditioner mixes into the water.

CAUTION Do not use bath oils and skin conditioners other

than ArjoSound water conditioner together with the Hydrosound system as they may inhibit the ultra sound pressure waves.

3 Make sure the water level covers the top of the Hydrosound

system transducer plate (A). (See Fig. 2)

4Press the Hydrosound system button on the control panel.

The default hydrosound runtime is 15 minutes. After completion, wait 15 minutes before the Hydrosound system can be restarted.

Continue with the steps on the next page.

Page 18

Fig. 3

40 60

8020

Test

100

Fig. 4

Fig. 5

5 It is possible to select different intensity levels by turning

the knob on the upper right side of the bathtub. (See Fig. 3)

• The intensity is increased by turning the intensity knob clockwise.

• The levels 20, 40, 60, 80 or 100 (mW/cm

) and Test can

be chosen step by step.

• The LED (B) will show a steady green light and a buzzing sound will be heard when any active level is selected.

• The buzzing sound will increase with each higher level.

WARNING

To avoid damage to hearing, make sure to keep the patient’s head above the water when using the Hydrosound system.

Bathe the patient with Hydrosound system activated.

(See Fig. 4)

7 Raise the patient out of the water and shower the patient

thoroughly to remove loosened particles from the skin.

(See Fig. 5)

Page 19

Fig. 1

Fig. 2

Fig. 3

Fig. 4

Bathe Patient

Transfer and Bathe the Patient (14 steps)

1 Close the drainage plug by turning the drain control knop

counter clockwise.

2 Press the Tub Fill button to fill the bathtub

WARNING

To prevent scalding, always check the water temperature with your naked hand before directing the water on the patient. Do not use gloves as it may insulate to the extent that the water temperature can be misjudged. Point the flow of the water away from the patient.

Press the Tub Fill button to manually stop the Auto fill function, when desired level is reached.

WARNING

To avoid entrapment, make sure to keep the patient’s hair, arms and feet close to the body and use designated grab supports during any movement.

Sitting patient may be lifted without effort from their bed or wheelchair by using the Alenti or Calypso lift hygiene chair . See corresponding equipment IFU. (See Fig. 1-3).

5 Check the bath water temperature with your bare hand

before the patient enters the water. (See Fig. 4)

Continue with the steps on the next page.

Page 20

Fig. 5

Fig. 6

Fig. 7

Fig. 8

6 Position the lift hygiene chair next to the end of the bath. 7

WARNING

To avoid entrapment or pinching of genitals, make sure there is enough clearance during movement over the tub edge, toilet, bedpan or other furniture.

Raise the lift hygiene chair to a position where it is clear from the edge of the bath and move the patient over.

(See Fig. 5)

WARNING

To avoid entrapment of the patient’s or caregiver’s legs or feet, make sure that they are kept clear of all obstacles.

Position the lift hygiene chair in the middle of the bath and lower the lift as far as possible. (See Fig. 6)

9 If desired and if the patient is capable, rotate the back rest

out of the way, this allows the patient to recline against the back of the bathtub. (See Fig. 7)

WARNING

To avoid injury, make sure that the patient is not left unattended at any time.

Bathe the patient.

11 After the bath, let the water run out of the bath and sit the

patient up. Position the back rest against the patient's back. Raise the lift hygiene chair to a convenient working height and then start showering the patient. (See Fig. 8)

12 Dry the patient, as well as the underside of the seat, to

prevent water from dripping on to the floor.

13 Raise the lift hygiene chair, and pull it away from the end of

the bath. Help the patient to move their legs over the edge of the bath.

14 When moving the patient straight from the bath to the bed,

put a bath towel on the bed under the lift hygiene chair's seat to avoid making the bed wet. Check the patient is thoroughly dry.

Page 21

Cleaning and Disinfection Instructions

ArjoHuntleigh Disinfectant

For optimal performance use only ArjoHuntleigh Disinfectant.

For any questions regarding proper disinfection procedure or for liquid product ordering information (se e section Parts and Accessories on page 46), contact ArjoHuntleigh Customer Service. Disinfection will minimize cross-contamination and removing tissue residue.

WARNING

To prevent cross-contamination, always follow the disinfection instructions in this IFU.

WARNING

To avoid eye or skin irritation, never disinfect in the presence of a patient.

NOTE The disinfection process can only be started

when all other functions are turned off.

Disinfectant spray

The spray handle is placed behind the access door on the left side of the panel and has a trigger handle.

WARNING

To avoid eye and skin damage, always use protective glasses and gloves. If contact occurs rinse with plenty of water. If eyes or skin becomes irritated, contact a physician. Always read the material safety data sheet of the disinfectant.

General

We strongly recommend that you follow the cleaning and disinfection instructions when disinfecting the bathtub, see section Clean and Disinfect with Disinfection Spray Handle or Spray Bottle on page 24.

If you are not sure about the effect on the bath system while using certain disinfectants or need to order more disinfectant, please contact your nearest ArjoHuntleigh office for further information.

• When using bath water additives, make sure the additives are fully dissolved in water before adding it to the filled bathtub. After bathing with bath additives the bathtub must be thoroughly rinsed with clean water.

• For daily disinfection we recommend Arjo Clean (Arjo Cen-Kleen IV), especially developed for use with ArjoHuntleigh Bath Systems, in order to avoid scratches in the plastic surface.

• In the dispenser system it is recommended to only use: Arjo Care, Arjo Oil or for Hydrosound system:ArjoSound water conditioner. In the US and Canada use Arjo Cen-Care II, Arjo Cen-Sol II or for Hydrosound system: ArjoSound water conditioner.

CAUTION Do not use the following substances in the

bath: Lodine, bromide, methylene blue, potassium permanganate etc. (Discoloration) Chlorine, heavy-metal chlorides, petroleum based solvents, trichlorethylene, phenol based disinfectants or similar solvents that can damage the plastic surface.

NOTE Make sure that the disinfection hose, when not

in use, is placed to the right behind the cover.

Page 22

Accessories for Cleaning and Disinfection

• Protective glasses

• Protective gloves

• Spray bottle with disinfectant or disinfection spray handle

• Spray bottle with water or shower handle

• Cloths – wet and dry

• Disposable towels

• Soft bristled brush

• Long handled soft bristled brush

Microbiological Formation Prevention

In order to enhance the on-site curative actions (chlorine or thermal shock), which do not guarantee a reduction of the contamination long term, make sure to follow the instructions below .

Installation precautions

In order to limit the growth of bacterial flora, it is necessary to take action at four levels:

• Avoid stagnating water and make sure proper water circulation;

• Take precautions against the formation of scale and corrosion based on the water quality;

• Maintain a high water temperature all the way from the hot water dispenser to the different distribution pipes;

• Mix hot and cold water as close as possible to the point of use.

Use

• Make sure the water circulates in the bath and the shower on a daily basis even if the bathtub is not used; and particular to make sure to remove any water that may be left in the hose.

• Before every use, make sure the product is clean and disinfected.

Do not forget to contact ArjoHuntleigh for the annual Preventive Maintenance visit.

Page 23

Replace Disinfectant Bottle

Fig. 1

Fig. 2

e.g. Arjo Clean™ (60)

Fig. 3

(10 steps)

1 Put on protective glasses and gloves.

2 Open the access door on the left side of the panel.

(See Fig. 1)

3 Disconnect the suction part (A) from the disinfectant bottle. 4 Discard the old bottle and replace with a new ArjoHuntleigh

Disinfectant bottle.

5 Connect the suction part (A) to the new bottle. 6 Grab the disinfectant spray handle, and direct it against the

bottom of the bathtub.

7 Press the Disinfection button on the control panel. The LED

lights when the disinfection is activated.

8 Adjust water temperature so it reaches approximately 25 °C

(77 °F) to eliminate disinfectant fumes.

9 Spray disinfectant in the bathtub, keeping an eye on the flow

meter so it is in accordance with the setting range due to the mix ration table below. (See Fig. 2)

10 If necessary , adjust the bottle cap by hand to get correct mix

ratio. (See Fig. 3)

Disinfectant

General Purpose Disinfectant 30 Arjo Clean™ 60 Arjo Disinfectant Cleanser IV 30 Cen-Kleen IV™ 30

Flow Meter Mix

Ratio

Page 24

Clean and Disinfect with Disinfection Spray

Fig. 1

Fig. 2

Fig. 3

Handle or Spray Bottle

(Still Bath and Hydrosound® System) (42 steps)

Before every use, make sure that the bath system is clean and disinfected. This procedure cleans and disinfects the bath system.

Remove visual residue (Step 1-6 of 42)

1 Check the level of disinfectant in the disinfectant bottle. 2 Make sure all functions are turned off.

3 Open drain to empty the bathtub from any left over water. 4 Detach and place accessories (if applicable) such as pillow ,

foot support and toiletry tray at the bottom of the bathtub. 5 Press the Patient Shower button on the control panel. 6 Shower and rinse the bathtub and accessories in the bottom

of the bathtub with water to remove visible residue. Turn the

accessories and rinse again. (See Fig. 1)

Clean (Step 7-26 of 42)

7 Put on protective gloves and protective glasses. (See Fig. 2) 8 Open the access door on the left side of the panel and lift out

the disinfection spray handle or use a disinfection spray

bottle. 9 For disinfection spray handle only: Direct the disinfectant

spray towards the bottom of the bathtub and press the

Disinfection button on the control panel. 10 For disinfection spray handle only: Adjust water

temperature so it reaches approximately 25 °C (77 °F) to

eliminate disinfectant fumes. 11 Spray disinfectant in the bathtub, keeping an eye on the flow

meter so it is in accordance with the setting range according

to the mix ration table in section Replace Disinfectant Bottle

on page 23. (See Fig. 3) 12 Spray disinfectant in the drain. 13 Scrub the drain with a long handled brush. 14 Close the drain. 15 Spray disinfectant on all internal bathtub surfaces and the

accessories at the bottom of the bathtub. Pay attention to

knobs and sensors attached to the bathtub surface such as

drain control knob and surface overflow outlet.

Continue with the steps on the next page.

Page 25

Fig. 4

Fig. 5

16 Spray disinfectant into the surface overflow outlet.

(See Fig. 4)

17 For disinfection spray handle only: Press the Disinfectant

button on the control panel to turn it off, and place the

disinfectant spray handle back behind the access door. 18

CAUTION Never use green or brown Scotch-Brite nor steel

wool on the bath as it may scratch the surface.

Scrub the surface of the bathtub, loose parts and accessories

with a soft bristle brush or cloth (to remove any deposits e.g.

skin flakes). Scrub thoroughly, especially on handles and

hand control. (See Fig. 5) 19 Open the drain.

20 Press the Patient Shower button on the control panel. 21 Rinse all parts clean with plenty of water having a

temperature of approximately 25 °C (77 °F), using the

shower handle, to remove disinfectant. 22 Soak a cloth in disinfectant. 23 Wipe all other contact areas with the cloth, such as the

outside of the bath (particularly behind the head), sensors

and hand control. 24 Wet a new cloth with water and remove all traces of

disinfectant on contact areas. The cloth should occasionally

be rinsed in running water. 25 Examine bathtub and accessories to make sure that all of the

disinfectant is removed. Repeat rinse if needed. 26 Examine bathtub and accessories for visible damage.

For Century bath with Hydromassage system, go to section Clean and Disinfect Hydromassage™ System with Automatic Disinfection on page 27, after that proceed with Disinfect (S tep 27-42 of 42) on page 26.

Continue with the steps on the next page.

Page 26

Disinfect (Step 27-42 of 42)

Fig. 5

27 Open the access door on the left side of the panel and lift out

the disinfection spray handle or use a disinfection spray

bottle. 28 For disinfection spray handle only: Direct the disinfectant

spray towards the bottom of the bathtub and press the

Disinfection button on the control panel. 29 Close the drain. 30 For disinfection spray handle only: Adjust water

temperature so it reaches approximately 25 °C (77 °F) to

eliminate disinfectant fumes. 31 Spray disinfectant on all internal bathtub surfaces and

accessories at the bottom of the bathtub. Turn the

accessories and spray on the other side. Pay attention to

knobs and sensors attached to the bathtub surface such as

drain control knob and surface overflow outlet. (See Fig. 5)

After using the disinfectant for a period of time, it will stop

automatically. The system will be locked for a predefined

time, basically as long as the LED on the Disinfection

button is lit. This is a predefined time frame and is there to

ensure disinfectant contact time. 32 For disinfection spray handle only: Press the Disinfection

button on the control panel to turn it off, and place the

disinfectant spray handle back behind the access door. 33 Allow an appropriate contact time of the disinfectant

according to the instructions on the bottle. 34 Open the drain. 35 Press the Patient Shower button on the control panel. 36 Rinse all parts clean with plenty of water having a

temperature of approximately 25 °C (77 °F) using the

shower handle, to remove disinfectant. 37 Soak a cloth in disinfectant.

38 Wipe all other contact areas such as the outside of the

bathtub (particularly behind the head), sensors and hand

control with the cloth. 39 Allow an appropriate contact time of the disinfectant

according to the instructions on the bottle.

Continue with the steps on the next page.

Page 27

40 Wet a new cloth with water and remove all traces of

Fig. 1

Fig. 2

Fig. 3

disinfectant on contact areas. The cloth should occasionally

be rinsed in running water when removing disinfectant. 41 Leave to air dry. 42 Attach any accessories.

NOTE Let the pillow dry with the suction cups upwards.

Clean and Disinfect Hydromassage™ System with Automatic Disinfection

(15 steps)

This procedure is a complement when cleaning the bath system, see section Clean and Disinfect with Disinfection Spray Handle or Spray Bottle on page 24.

T o ensure proper disinfection, the Hydromassage system is automatically disinfected. The treatment hose is an accessory . If you do not have a treatment hose, skip such cleaning instructions.

NOTE Look at the flow meter and make sure there is an

appropriate mixture of disinfectant liquid to the water, according to section Replace Disinfectant Bottle on page 23.

1 Check the level of disinfectant. 2 Open the drain.

3 Remove the suction inlet screen and clean it separately.

(See Fig. 1)

4 For treatment hose only: pull out the Hydromassage system

nozzle and clean it separately. (See Fig. 2) 5 For treatment hose only: Insert the treatment hose in the

Hydromassage system outlet. (See Fig. 3) 6 Press the Disinfection button on the control panel to start the

automatic disinfection cycle. Disinfectant is flushed

through the Hydromassage system nozzle/treatment hose.

The disinfection cycle ends with the Hydromassage system

being rinsed with water. 7 For treatment hose only: When the disinfectant cycle is

completed, remove the treatment hose and let it hang dry on

the holder. Place the Hydromassage system nozzle back into

the Hydromassage system outlet.

Continue with the steps on the next page.

Page 28

Fig. 4

8 Open the access door on the left side of the panel and lift out

the disinfection spray handle or use a disinfection spray

bottle. 9 For disinfection spray handle only: Direct the disinfectant

spray towards the bottom of the bathtub and press the

Disinfection button on the control panel. 10 Spray disinfectant into the surface overflow outlet.

(See Fig. 4)

11 For disinfection spray handle only: Press the Disinfection

button on the control panel to turn it off, and place the

disinfectant spray handle back behind the access door. 12 Let the disinfectant act according to the time printed on

disinfectant bottle. 13 When disinfection is completed, reassemble the suction

inlet screen. 14 Press the Patient Shower button on the control panel. 15 Rinse all treated parts clean with plenty of water having a

temperature of approximately 25 °C (77 °F) using the

shower handle, to remove disinfectant.

NOTE Continue with remaining disinfection instructions

according to section Disinfect (Step 27-42 of 42) on page 26.

Page 29

Care and Preventive Maintenance

The Century bath is subject to wear and tear, and the following maintenance instructions must be performed, when specified, to make sure the equipment remains within its original manufacturing specification.

WARNING

To avoid malfunction resulting in injury, make sure to conduct regular inspections and follow the recommended maintenance schedule. In some cases due to heavy use of the product and exposure to aggressive environment more frequent inspections should be carried out. Local regulations and standards may be more stringent than the recommended maintenance schedule.

Preventive Maintenance Schedule

CAREGIVER OBLIGA TIONS Action/Check

Clean and Disinfect X Check liquid levels X Visually check all exposed parts X Visually check hoses, pipes and connections X Perform functionality test X Hydrosound system functionality test X Check and clean shower head X Check and clean filters, incoming water X Exercise the thermostat mixer X Yearly checks by qualified personnel only X Check electrical installation

(to be performed by authorized electrician)

Between

Patients

Intervals according to local requirements

Every

Day

Every Week

Every

Month

Every

Year

WARNING

To avoid injury to both the patient and the caregiver, never modify the equipment or use incompatible parts.

Page 30

Fig. 1

40 0

00



100

Caregiver Obligations

Caregiver obligations shall be carried out by personnel with sufficient Century bath knowledge following the instructions in this IFU.

If the product deviates from normal (function or in appearance) immediately contact your local ArjoHuntleigh Service for support.

Between Patients

• Clean and disinfect:

Before every use, make sure the Century ba th is cleaned and disinfected according to section Cleaning and Disinfection Instructions on page 21.

Every Day

Check liquid levels: Check liquid levels in the bottles of disinfectant, shampoo and bath oil (ArjoSound water conditioner).

Every Week

• Visually check all exposed parts (2 steps): Especially

where personal contact is made by either the patient or the caregiver.

1 Make sure no cracks or sharp edges have developed that

could cause the patient or caregiver injury or become unhygienic and can cause cross-contamination. Any use of chlorine, alcohol may damage the bathtub and cause cracks. If there is such damage, contact qualified personnel.

2 Check all screws are tightened.

• Visually check hoses, pipes and connections: Visually

inspect for leaks of any kind by looking underneath the bathtub and behind the panel.

• Perform functionality test: T est all panel and disinfection

functions. With the water on, check the shower handle for damage

• Hydrosound system functionality test (2 steps): If the bath

is equipped with Hydrosound system, perform a self test to check that the ultra sound intensity levels are correct.

1 T o perform a self test, start the Hydrosound system from the

control panel.

2 Turn the intensity knob to Test.

The Hydr osound system has successfully passed the self test if

the LED (A) shows a steady yellow light. A flashing yellow

light indicates a problem, contact qualified personnel.

(See Fig. 1)

Page 31

Every Month

Fig. 1

Fig. 2

• Check and clean the shower head (5 steps): Remove and

clean the strainers in the shower head.

1 Loosen the screw. (See Fig. 1) 2 Remove all loose parts (A) according to the illustration. 3 Clean all parts carefully. 4 Reassemble the shower head. The parts (A) must be

assembled before these are set back into the handle.

(See Fig. 1)

5 Tighten the screw carefully.

• Check and clean filters, incoming water (5 steps): A

rinsing valve with a filter is mounted on each of the two water supply hoses found under the front cover. The filter in the cold and hot water valves should be cleaned according to the following procedure.

WARNING

Pressurised system and risk of scalding. Make sure that the valve (B) is closed before removing the cap (C), this is especially important for the hot water valve.

1 Close the valves (B). The handles (red for hot water and

blue for cold) should be in a cross position. (See Fig. 2) 2 Remove the cap (C) with a wrench. 3 Pull out the filter (D) and clean it carefully in water. 4 Reassemble. 5 Open the valves (B).

• Exercise the thermostat mixer: Turn the temperature

control back and forth over the whole temperature range with water on. This is particularly important in areas with hard water.

Page 32

Yearly Checks by Qualified Personnel Only

The Century bath must be serviced once a year in accordance with the Maintenance and Repair Manual.

T o make sure that you have problem-free and safe operation, it is recommended to have regular scheduled services with calibration of the thermostatic mixers by a trained technician. Significant changes/modifications in local water supply may require recalibration of the thermostatic mixing valve.

Contact your local ArjoHuntleigh service representative to sign for a service agreement.

WARNING

To avoid injury and/or unsafe product, the maintenance activities must be carried out at the correct frequency by qualified personnel using correct tools, parts and knowledge of procedures. Qualified personnel must have documented training in maintenance of this device.

NOTE All Caregiver Obligations are to be checked when

performing the Qualified Personnel Service. For details, see separate service instructions.

Page 33

WARNING

Pressurised system and risk of scalding. Make sure that the valve (B) is closed before removing the cap, this is especially important for the hot water valve.

Troubleshooting

NOTE Before starting the troubleshooting check: Power supply, Water supply and the LEDs on control

panel. If the problem can not be solved with the problem solving actions below, please contact an ArjoHuntleigh authorized technician.

General Problems

PROBLEM ACTION

The water is too hot or cold when filling the bath or showering.

Auto fill function will not stop to fill when the water level reaches to the sensors.

• Inlet supply reversed (hot supply to cold supply).

• No hot water reaching the mixer.

• Check strainer and inlet/outlet fittings for blockage, according to section Care and Preventive Maintenance on page 29.

• Installation conditions continuously outside operating parameters - contact qualified personnel.

• The preset filling level can be up to approximately 5cm above the sensor.

• Sensors need cleaning because of collected residue build up. See section Cleaning and Disinfection Instructions on page 21.

• Contact qualified personnel.

Low or bad flow in shower handle. • Check and clean the shower handle head. See

Low or bad flow from filling spout. • Check incoming water valves and pipes.

Water on the floor • Check for leakage from water inlet pipes and

section Care and Preventive Maintenance on page

29.

• Check and clean the incoming water filters. See section Care and Preventive Maintenance on page

29.

• Contact qualified personnel.

• Check and clean incoming water filters. See section Care and Preventive Maintenance on page

29.

• Contact qualified personnel.

bathtub drainage.

• Turn off the electrical supply and water supply.

Page 34

PROBLEM ACTION

Water temperature fluctuates. • Probably caused by supply temperature

fluctuation.

• In order to feel if any hot water is coming in, feel the incoming hot water line to see if hot.

• Check and clean the incoming water filters. See Care and Preventive Maintenance on page 29.

• Contact qualified personnel.

Maximum temperature too hot or cold. Contact qualified personnel. Hydromassage/Hydrosound function stops working. • The function Automatically stops after

15 minutes.

• Check the Hydrosound s ys tem LED, a yellow flash indicates that a problem has occurred.

• If the function stops before 15 minutes - contact qualified personnel.

Water not draining. • Check bath plug and adjust the centre screw if

necessary.

• Contact service engineer.

Water draining during bathing. • Check bath plug and adjust the centre screw if

necessary.

• Check the sealing on the bath plug.

• Contact qualified personnel.

No foam build up while scrubbing the disinfectant in the bath.

Not possible to adjust correct value on disinfectant flow meter.

• Check the disinfectant flow meter value correspond to Replace Disinfectant Bottle on page

23.

• Check level in the disinfection container, replace if low.

• Contact qualified personnel.

• Check level in the disinfection container, replace if low, see Replace Disinfectant Bottle on page 23.

• Contact qualified personnel.

Page 35

Control Panel Problems

WARNING

PROBLEM ACTION

No shampoo, body wash, bath oil/ArjoSound water conditioner emerges from the dispenser when pressing the Shampoo & Body W a sh or Bath Oil/ArjoSound water conditioner button.

• Check power supply and fuses.

• Check level in Shampoo/Bath oil container.

• Contact qualified personnel.

Main power failure. • Check power supply and fuses.

• Contact qualified personnel.

T emperature display read-out failure.

• Check power supply and fuses.

• Contact qualified personnel.

No r e a c tion w h e n p r e s s i n g a b u t t o n o n c o n t r o l p a n e l . • Check power supply and fuses.

Disinfection does not start when pressing Disinfection button.

• Make sure that no other function is activated.

• If the shower and disinfection LED are flashing, the scalding protection is activated, see Scalding Protection on page 13.

• Contact qualified personnel.

• Check power supply and fuses.

• Make sure the bathtub is empty of water.

• Make sure shower, fill or Hydrosound system is not activated.

• Check level in the disinfection container, replace if low. Replace Disinfectant Bottle on page 23.

• Contact qualified personnel.

Page 36

WARNING

PROBLEM ACTION

Hydromassage/Hydrosound function does not start. • Check power supply and fuses.

• Make sure that no other function is activated.

• Make sure that the water level is above the top level sensor in the bathtub.

• Check the Hydrosound s ys te m L ED , a yellow flash indicates that a problem has occurred.

• Contact qualified personnel.

Both LEDs at the Disinfection/Autoclean button and the Patient Shower button are flashing.

• Scalding protection is activated. See Scalding Protection on page 13.

• Contact qualified personnel.

Page 37

Technical Specifications

Technical Data: Still Bath, Hydrosound® System & Hydromassage™ System

NOTE All drainage, water and electrical installation work should be carried out by qualified personnel, in

accordance with local and national regulations.

Market V oltage Frequency Fuse (slow blow)

Power consumption

Europe 230/240 V single

phase AC

North America 120 V single

phase AC

Japan 100 V single

phase AC

50 Hz 6 A maximum

700 VA

60 Hz 10 A maximum

700 VA

50/60 Hz 10 A maximum

700 VA

General

Power supply cord: replaced by qualified personnel The unit must be continuously powered and connected to a separate fuse with a ground fault circuit

interrupter. Fuses according to EN60898. Main switch must be placed close to the bathtub and be visible

for the user. Power supply is activated via the main switch. The unit must be permanently connected to the mains when used in USA and Canada. All electrical

installations must comply with the US National Electrical Code and the Canadian Electrical Code respectively.

Pollution degree 2

Thermometer

Range 10-50 °C (50-122 °F) Accuracy +/-1 °C (1.8 °F) Resolution 0.1°C (0.18°F)

SWL (Safe Working Load, patient + water) 380 kg (838 lbs) Maximum patient weight 182 kg (401 lbs) Maximum floor loading/foot pad 482 kg / 0.4 m Maximum floor pressure 0.5 N/mm

Water Drainage

Minimum drainage capacity 100 l/minute

Page 38

Sound Levels (LwA, maximum)

Sound level at hydromassage 76 dBA Sound level at bathtub filling 80 dBA

Water Supply

Cold water G3/4” male (customers connection) Warm water G3/4” male (customers connection) Connect with shut off valves between unit and supply net Minimum through Ø 16 mm Maximum static pressure 6 bar (600 kPa, 87 psi) Minimum operating pressure (all markets) 2 bar (200 kPa, 29 psi) Minimum flow 25 l/minute (50 l/minute CW+WW) CW temperature 2–20 °C (36–68 °F) WW temperature 60–80 °C (140–176 °F)

Operating Conditions

Ambient temperature 10–40 °C (50–104 ° F) Relative humidity 30–95% Rh Atmospheric pressure 800–1060 hPa

Tr ansport and Storage

Ambient temperature -20 °C to 70 °C (-4 °F to 158 °F) Relative humidity 10% - 80% at 20 °C (68 °F) Atmospheric pressure 500–1100 hPa

Mains Disconnection Device

Permanently installed in wall.Visible and accessible all times Mains transient voltage 4 kV* Creepage distance 3 mm* Air clearance 1.8 mm* Direction of movement Up and down, right and left, clockwise

and counterclockwise

* If local regulations are higher, these must be met.

WARNING

To avoid injury, always follow the allowed combinations listed in this IFU. No other combinations are allowed.

Page 39

Allowed Combinations ArjoHuntleigh Lift Model

Alenti All models Calypso All models

ArjoHuntleigh Upgrade Kit Article Number

Upgrade dispensing system ARC0310 Level sensitivity kit 8543134

Recycling

Package Wood, corrugated cardboard and plastic recyclable. The bath Electric, steel and plastic parts shall be separated and recycled

according to WEEE.

Disposal of Century Bath

Bathtub The device is marked with the WEEE symbol to indicate that it is electronic equipment

covered by the Directive 2012/19/EU on waste electrical and electronic equipment. In European countries the crossed out wheeled-bin WEEE symbol reminds you that all the electrical and electronic products, batteries and accumulators must be taken to separate collection at end of their working life. This requirement applies in the European Union. Do not dispose these products as unsorted municipal waste. You can return your device and accessories to ArjoHuntleigh or you can contact your local authorities for advice on disposal.

WARNING

To avoid electric shock, make sure the equipment is connected to:

• Continuously powered supply mains with protective earth.

• Separate fuse and ground fault circuit interrupter (GFCI)

• A mains disconnection device

• Equipotential bonding point All installations must be in accordance with local codes and regulations.

Page 40

Labels

0086

Label Explanation

Identification Label

States the product identification; serial number, year and month of manufacturing.

For example, 1402XXXXX where “14” states manufacturing year, “02” states manufacturing month and “XXXXX” states serial number.

Data Label States technical performance and

requirements, for example classified safety standard and input voltage.

Water Connection Label

States the minimum/maximum temperature and pressure requirement of inlet water.

Symbol Explanation

SWL Safe Working Load VA Maximum power IP X4 Protection class - Protection against

splashing water.

Manufacturing date.

4ML5 Certificate control number for UL

Label for equipotential connection point (bonding lug).

CE marking in accordance with the Medical Devices Directive 93/42/EEC.

The equipment has been EMCtested and fulfils all requirements according to IEC 60601-1-2. Electric safety according to EN 60601-1. Refer to Notified Body: BSI.

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical hazards and other specified hazards only in accordance with:

UL 2601-1 and CAN/CSA C 22.2 No 601.1-M90.

Maximum 15 minutes “ON” and

Continuous operation with Hydrosound system intermittent

loading minimum 15 minutes “OFF”

V ~ Hz Voltage and AC frequency Class I Insulation class

T ype B

Applied part: protection against

electrical shock in accordance with

IEC 60601-1.

Read the IFU before use.

Name and address of the

manufacturer.

Separate electrical and electronic

components for recycling in

accordance with the European

Directive 2012/19/EU (WEEE).

UL marking (US-models 120 V -60 Hz)

Warning! Hot surface! Label located at the Hydrosound

system plate. Recognized by Underwriters

Laboratories Inc. with respect to electric shock, fire, mechanical hazards and other specified hazards only in accordance with UL 60601-1 and CAN/CSA - C 22.2 No 601.1M90.

Page 41

IFU Label

Hydrosound System warning Label

UL classification Label

Entrapment warning

Attention Label placed on the disinfectant spray handle

Applied part

Data Label

Field wiring box Label

Equipotential Label

Identification Label

Water connection Label

Page 42

Approvals and List of Standards

Plumbing Approval

Standard Description

ANSI, Z124.1.2–2005 Plastic Bathtub and Shower Units ANSI/ASME, A112.19.8–1987 Suction Fittings ANSI/ASME, 1001–2008 Atmospheric Type Vacuum Breakers ANSI/ASME, 1014–1989 Backflow Prevention Devices for Hand-Held Showers ANSI/ASME, 1016–2005 Automatic Compensating Valves for Individual Showers and

Bathtub/Shower Combinations ANSI/ASME, 1056–2001 Spill Resistant Vacuum Breakers CAN/CSA, B45.0–02 Plumbing Fixtures CAN/CSA, B45.5–02 Plastic Plumbing Fixtures

Electric and Electromagnetic Approval

Standard Description

ANSI/AAMI ES60601–1 (2005)

ANSI/AAMI/IEC 60601–1–2 Medical Electrical Equipment, Part 1–2:

CAN/CSA– C22.2 No. 60601– 1 (2008)

CAN/CSA– C22.2 No. 60601–1–2 (2008)

UL 60601–1 Medical Electrical Equipment, Part 1:

CAN/CSA– C22.2 No. 601.1

Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance

General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility – Requirements and Tests

Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance

Medical Electrical Equipment, Part 1–2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility – Requirements and Tests

General Requirements Medical Electrical Equipment, Part 1:

General Requirements

Page 43

Electromagnetic Compatibility

Medical electrical equipment needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be used according to the EMC information below .

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

WARNING

Stacking or placing other electrical equipment next to this device is not recommended, it can interfere with the equipment’s operation and safety. Portable and mobile radio-frequency (RF) communications equipment can interfere with this equipment operation and safety.

WARNING

The equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take action, such as reorienting, relocating the equipment or shielding the location.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions test Compliance Electromagnetic Environment – Guidance

RF emissions CISPR 11

RF emissions CISPR 11 Harmonic emission IEC 61000-3-2 Voltage fluctuations/flicker

emission IEC 61000-3-3

Group 1 The Century bath uses 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.

Class B The Century bath is suitable for use in all establishments, those

directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Class A

Complies

Page 44

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Emissions

test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

IEC 60601 test level Compliance

6 kV Contact 8kV air

+/- 2 kV for power supply lines

+/- 1 kV for input/output lines

+/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth

6 kV Contact 8kV air

+/- 2 kV for power supply lines

+/- 1 kV for input/ output lines

+/- 1 kV differential mode

+/- 2 kV common mode

<5% U U

40% U for 5 cycle

70% U for 25 cycle

<5% U U

(>95% dip in

) for 0.5 cycle

(60% dip in Ut)

(30% dip in Ut)

(>95% dip in

) for 5 s

<5% U U

40% U U

70% U U

<5% U U

(>95% dip in

) for 0.5 cycle

(60% dip in

) for 5 cycle

(30% dip in

) for 25 cycle

(>95% dip in

) for 5 s

Electromagnetic environment – guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power supply should be that of a typical or hospital environment.

Power frequency (50/60 Hz)

Magnetic field IEC 61000-4-8

NOTE U

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

3 A/m 0.3 A/m If functional disturbance occurs on the

Century bath it may be necessary to install magnetic shielding. The power frequency magnetic field should be measured prior to installation to assure that it is sufficiently low.

Page 45

Guidance and manufacturer’s declaration – electromagnetic immunity Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 test level

3 Vr ms 150 MHz to

80 MHz outside ISM bands

10 Vrms 150 MHz to 80 MHz outside

ISM

bands 10 Vr ms 80 MHz to

2.5 GHz

Compliance level

Electromagnetic environment – guidance

1 V rms Portable and mobile RF communications equipment

should be used no closer to any part of the Century bath, including cables, than 1 meter if the transmitters output power rating exceeds 1 W Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey ,

Should be less than the compliance level in each

frequency range.

10 V rms

Interference may occur in the vicinity of equipment marked with the following symbol:

80 MHz to

2.5 GHz 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.

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 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 filed strengths in the location in which the Century bath is used exceeds the applicable RF compliance level above, the Century bath should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary .

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

The compliance level in the ISM frequency bands between 1510 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in the calculating the recommended separation distance for transmitters in these frequency ranges.

Recommended separation distance between portable and mobile RF communications equipment and the Century bath.

The Century bath is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Century bath can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Century bath by maintaining a distance of not less than 1 meter to any part of the Century bath, including cables, if the transmitters output power rating exceeds 1 W .

Page 46

Parts and Accessories

8341958 Dual Hydromassage Nozzle

For Disinfectant contact your local representative

ARA0500-03 Hydromassage Treatment Hose

SRB1000 ArjoSound™ Water Conditioner (for Hydrosound System) 2 X 2 Litre bottles

ARA0007-01 Tray (for bath utensils)

SRB5000 Arjo Care™ (Shampoo, Body Wash) 4 X 2 Litre bottles

SRB4000 Arjo Oil™ (Bath Oil) 2 X 2 Litre bottles

Page 47

AUSTRALIA

ArjoHuntleigh Pty Ltd 78, Forsyth Street OConnor AU-6163 Western Australia Tel: +61 89337 4111 Free: +1 800 072 040 Fax: + 61 89337 9077

BELGIQUE / BELGIË

ArjoHuntleigh NV/SA Evenbroekveld 16 BE-9420 ERPE-MERE Tél/Tel: +32 (0) 53 60 73 80 Fax: +32 (0) 53 60 73 81 E-mail: info@arjohuntleigh.be

BRASIL

Maquet do Brasil Equipamentos Médicos Ltda Rua Tenente Alberto Spicciati, 200 Barra Funda, 01140-130 SÃO PAULO, SP - BRASIL Fone: +55 (11) 2608-7400 Fax: +55 (11) 2608-7410

CANADA

ArjoHuntleigh 90 Matheson Boulevard West Suite 300 CA-MISSISSAUGA, ON, L5R 3R3 Tel/Tél: +1 905 238 7880 Free: +1 800 665 4831 Institutional Free: +1 800 868 0441 Home Care Fax: +1 905 238 7881 E-mail: info.canada@arjohuntleigh.com

ýESKÁ REPUBLIKA

ArjoHuntleigh s.r.o. Hlinky 118 CZ-603 00 BRNO Tel: +420 549 254 252 Fax: +420 541 213 550

DANMARK

ArjoHuntleigh A/S Vassingerødvej 52 DK-3540 LYNGE Tel: +45 49 13 84 86 Fax: +45 49 13 84 87 E-mail: dk_kundeservice@arjohuntleigh.com

DEUTSCHLAND

ArjoHuntleigh GmbH Peter-Sander-Strasse 10 DE-55252 MAINZ-KASTEL Tel: +49 (0) 6134 186 0 Fax: +49 (0) 6134 186 160 E-mail: info-de@arjohuntleigh.com

ESPAÑA

ArjoHuntleigh Ibérica S.L. Ctra. de Rubí, 88 1ª planta - A1 08173 Sant Cugat del Vallés ES- BARCELONA 08173 Tel: +34 93 583 11 20 Fax: +34 93 583 11 22 E-mail: info.es@arjohuntleigh.com

FRANCE

ArjoHuntleigh SAS 2 Avenue Alcide de Gasperi CS 70133 FR-59436 RONCQ CEDEX Tél: +33 (0) 3 20 28 13 13 Fax: +33 (0) 3 20 28 13 14 E-mail: info.france@arjohuntleigh.com

HONG KONG

ArjoHuntleigh (Hong Kong) Ltd 1510-17, 15/F, Tower 2 Kowloon Commerce Centre 51 Kwai Cheong Road Kwai Chung HONG KONG Tel: +852 2207 6363 Fax: +852 2207 6368

INTERNATIONAL

ArjoHuntleigh International Ltd ArjoHuntleigh House Houghton Hall Park Houghton Regis UK-DUNSTABLE LU5 5XF Tel: +44 (0) 1582 745 800 Fax: +44 (0) 1582 745 866 E-mail: international@arjohuntleigh.com

ITALIA

ArjoHuntleigh S.p.A. Via di Tor Vergata 432 IT-00133 ROMA Tel: +39 (0) 6 87426211 Fax: +39 (0) 6 87426222 E-mail: Italy.promo@arjohuntleigh.com

NEDERLAND

ArjoHuntleigh Nederland BV Biezenwei 21 4004 MB TIEL Postbus 6116 4000 HC TIEL Tel: +31 (0) 344 64 08 00 Fax: +31 (0) 344 64 08 85 E-mail: info.nl@arjohuntleigh.com

NEW ZEALAND

ArjoHuntleigh Ltd 41 Vestey Drive Mount Wellington NZ-AUCKLAND 1060 Tel: +64 (0) 9 573 5344 Free Call: 0800 000 151 Fax: +64 (0) 9 573 5384 E-mail: nz.info@ArjoHuntleigh.com

NORGE

ArjoHuntleigh Norway AS Olaf Helsets vei 5 N-0694 OSLO Tel: +47 22 08 00 50 Faks: +47 22 08 00 51 E-mail: no.kundeservice@arjohuntleigh.com

ÖSTERREICH

ArjoHuntleigh GmbH Dörrstrasse 85 AT-6020 INNSBRUCK Tel: +43 (0) 512 204 160 0 Fax: +43 (0) 512 204 160 75

POLSKA

ArjoHuntleigh Polska Sp. z o.o. ul. Ks Piotra Wawrzyniaka 2 PL-62-052 KOMORNIKI (Poznan) Tel: +48 61 662 15 50 Fax: +48 61 662 15 90 E-mail: arjo@arjohuntleigh.com

PORTUGAL

ArjoHuntleigh em Portugal MAQUET Portugal, Lda. (Distribudor Exclusivo) Rua Poeta Bocage n.º 2 - 2G PT-1600-233 Lisboa Tel: +351 214 189 815 Fax: +351 214 177 413 E-mail: Portugal@arjohuntleigh.com

SUISSE / SCHWEIZ

ArjoHuntleigh AG Fabrikstrasse 8 Postfach CH-4614 HÄGENDORF Tél/Tel: +41 (0) 61 337 97 77 Fax: +41 (0) 61 311 97 42

SUOMI

Oy Vestek AB Martinkuja 4 FI-02270 ESPOO Puh: +358 9 8870 120 E-mail: info@vestek.fi

SVERIGE

ARJO Scandinavia AB Hans Michelsensgatan 10 SE-211 20 MALMÖ Tel: +46 (0) 10 494 7760 Fax: +46 (0) 10 494 7761 E-mail: kundservice@arjohuntleigh.com

UNITED KINGDOM

ArjoHuntleigh UK ArjoHuntleigh House Houghton Hall Park Houghton Regis UK-DUNSTABLE LU5 5XF Tel: +44 (0) 1582 745 700 Fax: +44 (0) 1582 745 745 E-mail: sales.admin@arjohuntleigh.com

USA

ArjoHuntleigh Inc. 2349 W Lake Street Suite 250 US-Addison, IL 60101 Tel: +1 630 307 2756 Free: +1 800 323 1245 Institutional Free: +1 800 868 0441 Home Care Fax: +1 630 307 6195 E-mail: us.info@arjohuntleigh.com

www.arjohuntleigh.com

Rev 14: 05/2014

ArjoHuntleigh Addresses

Page 48

www.ArjoHuntleigh.com

ArjoHuntleigh AB

Hans Michelsensgatan 10 211 20 Malmö SXFEFO

GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost eciency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care.

Arjo Century User Guide User Guide

Specifications and Main Features

Frequently Asked Questions

User Manual