Arjo Concerto USER MANUAL

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Concerto/ Basic
04.BA.05_17EN • 06/2019
INSTRUCTIONS FOR USE
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WARNING
To avoid injury, always read this Instructions for Use and accompanied documents before using the product.
Design Policy and Copyright ® and ™ are trademarks belonging to the Arjo group of companies. © Arjo 2019. 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 Arjo.
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Contents
Foreword ...................................................................................4
Intended Use .............................................................................5
Safety Instructions .....................................................................6
Preparations ..............................................................................7
Product Specifications ...............................................................8
Parts Designation ....................................................................10
Assembly .................................................................................12
Product Description / Functions ..............................................14
Manual Raising and Lowering (Concerto Hydraulic
and Basic Shower Trolley) ..................................................14
Electric Raising and Lowering (Concerto Electric
Shower Trolley)....................................................................14
Side Supports ......................................................................14
Attaching the Mattress ........................................................15
Removing the Mattress .......................................................15
Brakes .................................................................................16
Straight Steering (Concerto Shower Trolley Only) ..............16
Length Adjustment of Stretcher ..........................................16
Tilting the Stretcher (Concerto Shower Trolley Only) .........17
Emergency Stop (Concerto Electric
Shower Trolley Only) ..........................................................17
Drainage/Drainage Hose ....................................................18
Attaching the Drainage Hose (3 Steps) ..............................18
To Remove the Drainage Hose (2 Steps) ...........................18
Battery Low Charge Warning ..............................................18
Horizontal Position ..............................................................19
Horizontal Lock (Concerto Shower Trolley Only) ................19
Adjustable Back Support (Accessory for
Concerto Shower Trolley) ...................................................19
Wedge Pillow (Accessory) ..................................................19
Transfers with Concerto/Basic Shower Trolley ........................20
From Bed ............................................................................20
To Bed ................................................................................22
From Bed with a Sliding Aid ................................................24
To Bed with a Sliding Aid ....................................................26
From a Sling Lift ..................................................................28
To a Sling Lift ......................................................................29
Shower with Concerto/Basic Shower Trolley ..........................30
Home Care Use ......................................................................32
Cleaning and Disinfection Instructions ....................................34
Battery Instructions .................................................................36
Care and Preventive Maintenance ..........................................37
Troubleshooting ......................................................................42
Technical Specifications ..........................................................44
Dimensions .............................................................................47
Labels ......................................................................................49
Approvals and List of Standards .............................................51
Electromagnetic Compatibility .................................................52
Parts and Accessories ............................................................54
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Foreword
Thank You for Purchasing Arjo Equipment.
Your Concerto
®
/Basic™ shower trolley is a part of a
series of quality products designed especially for hospitals, nursing homes and other health care use.
Please contact us if you have any questions about the operation or maintenance of your Arjo equipment.
Please Read this Instructions for Use Thoroughly!
Please read this Instructions for Use (IFU) in its entirety before using your Concerto/Basic shower trolley. Information in this IFU is crucial to the proper operation and maintenance of the equipment, will help protect your product, and make sure 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 Arjo equipment may affect its safety. Arjo 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.
maximize the long-term safety, reliability and value of the product.
Contact your local Arjo representative for replacement parts. The contact information appears on the last page of this IFU.
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.
NOTE
Report Unexpected Operations or Events
Contact your local Arjo representative if any unexpected operations or events occur. The contact information appear on the last page of this IFU.
Serious incident
If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or patient should report the serious incident to the medical device manufacturer or the distributor. In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located.
Service and Support
A service routine must be performed on your Concerto/ Basic shower trolley every year by qualified personnel
to make sure the safety and operating procedures of your product. See section Care and Preventive Maintenance on page 37.
Means: This is important information for the correct use of this system or equipment.
Means: The name and address of the manufacturer.
If you require further information, please contact Arjo for comprehensive support and service programs to
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Intended Use
This equipment must be used in line with its intended use and in accordance with these safety instructions. Anyone using this equipment must also have read and understood the instructions in this Instructions for Use (IFU).
If there is anything you are not sure about, contact your Arjo representative.
This equipment is intended for assisted hygiene care, especially showering and bathing of residents in care environments like senior/assisted living, group home, special care, nursing homes, hospitals and home care. The equipment is intended for indoor use.
The Concerto/Basic shower trolley 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 the Instructions for Use (IFU).
The resident transfer to and from the Concerto/Basic shower trolley can be performed with a ceiling lift, mobile passive lift or by lateral transfer to and from a bed e.g. using an appropriate sliding aid.
The Concerto/Basic shower trolley should only be used for the purpose specified in these Instructions for Use. Any other use is prohibited.
Resident Assessment
We recommend that facilities establish regular assessment routines. Caregivers must assess each resident according to the following criteria prior to use:
This equipment is mainly to be used by a resident that is almost completely bedridden and totally dependent.
The resident’s weight must not exceed 150 kg (330 lbs).
The resident’s length must be in the range of 140 and 200 cm (55 1/8” - 78 3/4”).
If a resident does not meet these criteria an alternative equipment/system should be used.
Lifetime of the Equipment
The expected lifetime of this equipment is ten (10) years but depending on the storage of the battery, the use frequency and the charging intervals, the service life of the battery is 2-5 years.
Depending on level of wear some equipment parts such as castors, hand control and mattress may need to be replaced during the equipment lifetime according to information in the Instructions for use (IFU).
Assembly of parts must be mounted according to instructions in the Instructions for Use (IFU).
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Safety Instructions
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 injury, make sure that the patient is not left unattended at any time.
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 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 avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.
WARNING
To avoid the device in use from tipping, do not raise or lower other equipment close to it and be aware of stationary object when lowering.
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Preparations
Right
Head end
Left
Foot end
Actions Before the First Use
(11 Steps)
1 Visually inspect Concerto/Basic shower trolley
for transport damage.
2 The package should be recycled according to
local regulations.
3 Check that all parts of the product are supplied.
Compare with section Parts Designation on page 10. If any part is missing or damaged - do NOT use the product!
4 Read the IFU.
5 Disinfect the product according to section
Cleaning and Disinfection Instructions on page 34.
6 Unpack the battery charger (Concerto electric
shower trolley). For installation see Battery charger IFU.
Action Before Every Use
(5 Steps)
1 Check that all parts are in place. Compare with
section Parts Designation on page 10.
2 Carry out a thorough inspection for damage.
3 If any part is missing or damaged - do NOT use
the product!
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WARNING
To prevent cross-contamination, always follow the disinfection instructions in this IFU.
5 Make sure that the battery is fully charged
(Concerto electric shower trolley).
Concerto/Basic Shower Trolley Directions
7 Charge the battery for 24 hours. See the Battery
Charger IFU.
8 Perform a functionality test on the Concerto/
Basic shower trolley. See section Care and Preventive Maintenance on page 37.
9 Prepare an area that is dry, with good ventilation
and out of direct sunlight for storage of the Concerto/Basic shower trolley.
10 Choose a designated area where the IFU should
be kept, accessible at all times.
11 Make sure to have a rescue plan ready in case of a
patient emergency.
NOTE If you have any questions, please contact your local Arjo representative for support and service. See contact information in section Arjo Addresses on page 55.
The driving direction during transport is illustrated below.
The directions right, left, foot end and head end are illustrated below.
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Product Specifications
Fig. 1
Fig. 2
Fig. 3
The Concerto/Basic shower trolley system includes three versions with following characteristics:
Concerto Hydraulic Shower Trolley
(See Fig. 1)
1600, 1900 and 2250 mm (63”, 74 3/4” and 88 5/8”)
Manual raising and lowering
Straight steering
Tilt stretcher function
Horizontal lock
Concerto Electric Shower Trolley
(See Fig. 2)
1600, 1900 and 2250 mm (63”, 74 3/4” and 88 5/8”)
Electrical raising and lowering
Straight steering
Tilt stretcher function
Horizontal lock
Basic Shower Trolley
(See Fig. 3)
1900 mm (74 3/4”)
Manual raising and lowering
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Intentionally left blank
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Entire Product: Applied part: Type BF Protection against electric shock in accordance with IEC 60601-1.
Parts Designation
1 Shower mattress
2 Head cushion
3 Head support
4 Hand control
(Concerto electric shower trolley)
5 Stretcher
6 Battery holder
(Concerto electric shower trolley)
7 Straight steering
(Concerto hydraulic and electric shower trolley)
8 Castor brake
9 Drainage hose
10 Catches for side support
11 Side support
12 Foot support
13 Emergency stop
14 Filling plug for hydraulic oil
(Concerto electric shower trolley)
15 Drainage hole
16 Drainage outlet
17 Filling plug for hydraulic oil
(Concerto hydraulic and Basic shower trolley)
18 Pedal for raising/lowering
(Concerto hydraulic and Basic shower trolley)
19 Horizontal lock
(Concerto hydraulic and electric shower trolley)
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12
11
10
1
2
3
4
5
9
8
13
14
6
7
17
15
16
18
19
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Assembly of Concerto/Basic Shower Trolley
Fig. 1
Concerto hydraulic/ Basic shower trolley
Concerto electric shower trolley
5 mm
8 mm
Fig. 2
Fig. 3
Follow these 15 Steps
1 Unpack the Concerto/Basic shower trolley.
2 Cut the straps that hold the side supports under the stretcher.
(See Fig. 1)
3 Raise the side supports.
4 Check that the bag hanging on one of the straps contain the
parts to mount the head/foot supports and the oil plug.
(See Fig 2)
5 The head and foot supports at the short ends of the stretcher
are mounted upside down when delivered. The head support is turned 180° sideways as well. (See Fig. 3)
Continue with the steps on the next page.
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Fig. 4 Fig. 5
Concerto hydraulic/ Basic shower trolley
Fig. 6
Concerto electric shower trolley
6 Loosen the screws on the head and foot supports with the
Allen key. Turn the supports 180° upwards on top of the stretcher and then turn the head support 180° sideways.
(See Fig. 4)
7 Place the head support in one of the three positions and the
foot support in its only position. (See Fig. 4)
8 Tighten the screws with the Allen key.
9 Assemble the oil plug for Concerto Hydraulic/Basic
shower trolley according to item 10 to 12 (use the Allen key provided in the bag).
10 Assemble the oil plug from the bag.
11 Remove the transport plug.
12 Replace with the assembled oil plug.(See Fig. 5)
13 Assemble the oil plug for Concerto Electric shower trolley
according to item 14 to 15 (use the Allen key provided in the bag).
14 Remove the transport plug on the oil container.
15 Replace with the enclosed oil plug. (See Fig. 6)
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Product Description / Functions
Fig. 1
Fig. 2
Fig. 3
Fig. 4
Manual Raising and Lowering (Concerto Hydraulic and Basic Shower Trolley)
The pedal can be used from both sides of the stretcher. Press it with your foot and slide it under the beam to the other side.
(See Fig. 1)
To raise the stretcher pump the pedal, using the full range of motion.
To lower the stretcher, keep the pedal pressed down as far as possible.
Electric Raising and Lowering (Concerto Electric Shower Trolley)
Unhook the hand control from its holder. (See Fig. 2)
To raise the Concerto electric shower trolley, press the “up” arrow button on the hand control.
To lower the Concerto electric shower trolley press the “down” arrow button on the hand control.
Side Supports
Fold down the side support by pressing the two catches at the same time. (See Fig. 3)
When raising the side support, make sure the two catches snap into place. (See Fig. 4)
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Attaching the Mattress
Fig. 1
Fig. 2
Fig. 3
(4 Steps)
1 Fold down the side supports.
2 Press the part of the mattress with the drainage into the
stretcher in order to get the right position. (See Fig. 1)
3 Place one side of the mattress side strip around the edge of
the stretcher.
4 Snap the other mattress side strip around the stretcher. Press
with some force and drag one hand along the side strip for it to fasten. (See Fig. 2)
NOTE Do NOT wear jewellery or rings as it can potentially cause tears and holes in the mattress.
Removing the Mattress
(5 Steps)
1 Unscrew the flange nut from the drainage hole and pull the
drainage hose out upwards. Lift up the end part of the mattress from the drainage outlet. (See Fig. 1)
2 Fold down the side supports. (See Fig. 3)
3 Undo one edge of the mattress side strip.
4 Pull and lift along the side strip to detach the mattress from
the stretcher. (See Fig. 2)
5 Push the mattress towards the other side of the stretcher so
the other side strip loosens.
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A
B
Fig. 1
Fig. 2
A
Fig. 3
B
Brakes
Apply the brakes by pressing down the castor lock tab (A) with your foot. (See Fig. 1)
Release the brakes by pressing forward and down on the castor centre tab (B) with your foot. (See Fig. 1)
Straight Steering (Concerto Shower Trolley Only)
To facilitate transportation in corridors etc., the Concerto shower trolley is equipped with a straight steering device. The straight steering tabs are located on the castors diagonally from each other.
The straight steering device is activated by pressing down the tab (A) with your foot. (See Fig. 2)
Release it by lifting the tab (B) with your foot. (see Fig. 2)
Length Adjustment of Stretcher
The head support can be adjusted to alter the length of the stretcher. Unscrew the two screws with an Allen key and move the support to the desired position. Then tighten the screws securely.
(See Fig. 3)
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Tilting the Stretcher (Concerto Shower
Fig. 1
Fig. 2
Fig. 3
Trolley Only)
(2 Steps)
The stretcher can be tilted to help with cleaning and disinfection. This operation is easier done with brakes applied. The tilting mechanism is located under the stretcher.
1 Press the button, then move the catch to one side.
(See Fig. 1)
2
WARNING
To avoid the patient from falling out of the device, make sure that all catches are in a locked position.
Tilt the stretcher. (See Fig. 2)
Emergency Stop (Concerto Electric Shower Trolley Only)
If, for any reason, the Concerto electric shower trolley does not respond to the hand control buttons, stop the raising and lowering movement of the stretcher by pressing the emergency stop button. (See Fig. 3)
Contact qualified personnel if that happens.
If the emergency button is pressed by accident, it can be reset by turning the button clockwise until it pops back out.
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Drainage/Drainage Hose
Fig. 1
Fig. 2
Fig. 3
The Concerto/Basic shower trolley comes with a drainage hose. (See Fig. 1)
The mattress design combined with the slope of the stretcher make sure there is proper drainage.
The flexible drainage hose can be connected to a floor drain to reduce splashing.
Attaching the Drainage Hose (3 Steps)
1 Insert the drainage hose through the drainage hole.
(See Fig. 2)
2 Under the stretcher, screw the flange nut to the end of the
hose. (See Fig. 2)
3 Before transportation, put the drainage hose nozzle in its
holder. (See Fig. 3)
To Remove the Drainage Hose (2 Steps)
1 Under the stretcher, unscrew the flange nut from the
drainage hole.
2 Pull the drainage hose out upwards.
Battery Low Charge Warning
The low charge battery warning LED lamp is located on the cover of the hydraulic unit on the chassis. If the battery is running low, the warning LED will turn yellow when the buttons on the hand control are pushed. The battery should then be recharged as soon as possible.
NOTE To avoid loss of operation, charge the battery when the warning LED lamp is lit.
NOTE It is recommended to use two batteries, one in the charger and one in the Concerto/Basic shower trolley.
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Horizontal Position
Fig. 1
A
Fig. 2
Fig. 3
B
Fig. 4
The Concerto hydraulic and electric shower trolley always adjusts it selves automatically to a horizontal position when lowered onto a bed. (See Fig. 1)
Horizontal Lock (Concerto Shower Trolley Only)
The Concerto shower trolley is equipped with a special fitting which locks the stretcher in a horizontal position for transport or when the mattress is going to be filled with water.
Move the lever (A) to the right to lock the stretcher in a horizontal position. (See Fig. 2)
Adjustable Back Support (Accessory for Concerto Shower Trolley)
Pull the head support up to raise it. Make sure that the catches are in a locked position.
To lower it, press the catches (B) while gently lowering the head support. (See Fig. 3)
Wedge Pillow (Accessory)
Place wedge pillow at the head end of the mattress. (See Fig. 4)
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Transfers with Concerto/Basic Shower Trolley
Fig. 1
Fig. 2
From Bed
(22 Steps)
WARNING
To avoid patient falling out of the device, make sure that all side supports are in a locked position.
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 avoid the patient from falling or caregiver from being injured, make sure that there are two or more caregivers present during the patient transfer process.
1 Apply the wheel brakes on the bed.
2 Raise the bed to an ergonomic height, if possible.
3 Fold down the Concerto/Basic shower trolley side support
on the transfer side.
4 If using a manual hydraulic Concerto/Basic shower trolley,
make sure the foot pump is turned away from the transfer side.
5 Lower the bed rail on the transfer side, if any.
6 Place one caregiver on each side of the bed.
7 Position the patient close to the transfer side.
8 Turn the patient to his or her side, away from the transfer
side.
9 The caregiver, whom the patient is turned towards, holds the
patient. (See Fig. 1)
10 Fold down the other Concerto/Basic shower trolley side
support, opposite to the transfer side and bed.
11 The second caregiver positions Concerto/Basic shower
trolley over the bed as close as possible to the patient.
(See Fig. 2)
Continue with the steps on the next page.
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Fig. 3
Fig. 4
Fig. 5 Fig. 6
12
WARNING
To avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.
Apply the brakes on Concerto/Basic shower trolley. (See Fig. 3)
13 Lower Concerto/Basic shower trolley until it compresses
the mattress on the bed.
14 Turn the patient onto his or her back and onto the Concerto/
Basic shower trolley.
NOTE To ease the transfer process, use a sliding aid, according to section From Bed with a Sliding Aid on
page 24
15
WARNING
To avoid falling, make sure that the patient is positioned in accordance with this IFU.
Both caregivers need to help the patient towards the middle of the Concerto/Basic shower trolley. (See Fig. 4)
16 Fold up the Concerto/Basic shower trolley side support,
opposite from the transfer side and bed. (See Fig. 5)
17 Place the head cushion under the patient’s head for comfort.
18 Raise the Concerto/Basic shower trolley enough to clear the
bed.
19 Release the brakes on Concerto/Basic shower trolley.
20 Move Concerto/Basic shower trolley away from the bed
and fold up the Concerto/Basic shower trolley side support on the transfer side. (See Fig. 6)
21 Cover the patient if undressed.
22 Adjust the Concerto/Basic shower trolley to an ergonomic
height for the caregivers.
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To Bed
Fig. 1
Fig. 2
Fig. 3
(17 Steps)
WARNING
To avoid patient falling out of the device, make sure that all side supports are in a locked position.
WARNING
To avoid the patient from falling or caregiver from being injured, make sure that there are two or more caregivers present during the patient transfer process.
1 Apply the wheel brakes on the bed.
2 Raise the bed to an ergonomic height, if possible.
3 Lower the bed rail on the transfer side, if any.
4 If using a manual hydraulic Concerto/Basic shower trolley,
make sure the foot pump is turned away from the transfer side.
5 Fold down the Concerto/Basic shower trolley side support
on the transfer side, towards the bed. (See Fig. 1).
6 Position Concerto/Basic shower trolley over the bed as far
in as possible. (See Fig. 2)
7
WARNING
To avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.
Apply the brakes on Concerto/Basic shower trolley.
(See Fig. 3)
8Lower Concerto/Basic shower trolley until it compresses
the mattress on the bed.
Continue with the steps on the next page.
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Fig. 4
Fig. 5
Fig. 6
9 Fold down the other Concerto/Basic shower trolley side
support, opposite from the transfer side. (See Fig. 4)
10 Both caregivers need to help the patient towards the bed.
(See Fig. 5)
11 Turn the patient to his or her side, away from the transfer
side. Make sure the patient in not laying on the Concerto/ Basic shower trolley mattress. (See Fig. 6)
12 The caregiver, whom the patient is turned towards, holds the
patient. (See Fig. 6)
13 Raise the Concerto/Basic shower trolley from the bed.
14 Release the brakes on Concerto/Basic shower trolley.
15 Move the Concerto/Basic shower trolley away from bed.
16 Turn the patient onto his or her back.
17 Disinfect Concerto/Basic shower trolley after each use to
prevent cross-contamination according to section Cleaning and Disinfection Instructions on page 34.
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From Bed with a Sliding Aid
Fig. 1
Fig. 2
(18 Steps)
For any sliding aid questions, refer to its respective sliding aid IFU.
WARNING
To avoid patient falling out of the device, make sure that all side supports are in a locked position.
WARNING
To avoid the patient from falling or caregiver from being injured, make sure that there are two or more caregivers present during the patient transfer process.
NOTE For big Basic shower trolley and the bed, use a slide board in between the two, to bridge the gap.
gaps to slide across, between the Concerto/
1 Fold down the Concerto/Basic shower trolley side support
and the long side of the mattress on the transfer side.
(See Fig. 1)
2 If using a manual hydraulic Concerto/Basic shower trolley,
make sure the foot pump is turned away from the transfer side.
3 Apply the wheel brakes on the bed.
4 Raise the bed to an ergonomic height, if possible.
5 Lower the bed rail on the transfer side, if any.
6 Two caregivers must be present, one on each side of the bed.
7 Place the sliding aid under the patient. (See Fig. 2)
8 Position Concerto/Basic shower trolley side to side with the
bed. (See Fig. 3)
9 Adjust height so that Concerto/Basic shower trolley is
slightly lower than the bed.
Continue with the steps on the next page.
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Fig. 3
Fig. 4
Fig. 5 Fig. 6
10
WARNING
To avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.
Apply the brakes on Concerto/Basic shower trolley.
(See Fig. 3)
11 Fold down the Concerto/Basic shower trolley side support,
opposite from the transfer side.
12 Both caregivers transfer the patient with the sliding aid to
the Concerto/Basic shower trolley. (See Fig. 4)
13 Place the head cushion under the patient’s head for comfort.
14 Fold up the Concerto/Basic shower trolley side support
opposite to the transfer side. (See Fig. 5)
15 Release the brakes on Concerto/Basic shower trolley.
16 Move Concerto/Basic shower trolley enough to the side and
fold up the side support on the transfer side. (See Fig. 6)
17
WARNING
To avoid injury, always remove the sliding aid from underneath the patient after every use. Never leave the sliding aid in bed under the patient.
Remove the sliding aid from the patient.
18 Adjust the Concerto/Basic shower trolley to an ergonomic
height for the caregivers.
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To Bed with a Sliding Aid
Fig. 1
(16 Steps)
For any sliding aid questions, refer to its respective sliding aid IFU.
WARNING
To avoid patient falling out of the device, make sure that all side supports are in a locked position.
WARNING
To avoid the patient from falling or caregiver from being injured, make sure that there are two or more caregivers present during the patient transfer process.
NOTE For big Basic shower trolley and the bed, use a slide board in between the two, to bridge the gap.
1 Apply the wheel brakes on the bed.
gaps to slide across, between the Concerto/
2 Raise the bed to an ergonomic height, if possible.
3 Lower the bed rail on the transfer side, if any.
4 Place a sliding aid under the patient.
5 If using a manual hydraulic Concerto/Basic shower trolley,
make sure the foot pump is turned away from the transfer side.
6 Position Concerto/Basic shower trolley close to the bed
enough to be able to fold down the its side support.
7 Fold down the Concerto/Basic shower trolley side support
and its long side of the mattress on the transfer side.
(See Fig. 1)
Continue with the steps on the next page.
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Fig. 2
Fig. 3
Fig. 4
8 Position Concerto/Basic shower trolley side to side with the
bed. (See Fig. 2)
9 Adjust the height of Concerto/Basic shower trolley slightly
higher than the bed.
10
WARNING
To avoid falling during transfer, always make sure that the brakes are applied on all equipment being used.
Apply the brakes on Concerto/Basic shower trolley.
(See Fig. 2)
11 Fold down the Concerto/Basic shower trolley side support,
opposite to the transfer side. (See Fig. 3)
12 Both caregivers transfer the patient with the sliding aid to
the bed. (See Fig. 4)
13 Release the Concerto/Basic shower trolley brakes.
14 Move Concerto/Basic shower trolley away from the bed.
15 Remove the sliding aid from the patient.
16 Disinfect Concerto/Basic shower trolley after each use to
prevent cross-contamination according to section Cleaning
and Disinfection Instructions on page 34.
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From a Sling Lift
Fig. 1
Fig. 2
Fig. 3
Fig. 4
(10 Steps)
For any sling questions, refer to its respective sling and lift IFU.
These transfer steps apply to both floor and ceiling lifts with slings.
1Lower Concerto/Basic shower trolley to lowest height.
(See Fig. 1)
2 Apply the brakes on Concerto/Basic shower trolley.
(See Fig. 2)
3 Make sure both side supports are folded up.
4
WARNING
To avoid falling, make sure that the patient is positioned in accordance with this IFU.
Lower lift with patient onto Concerto/Basic shower trolley. (See Fig. 3)
5 Detach the sling from the lift. (See Fig. 4)
6 Move the lift away from Concerto/Basic shower trolley.
7 Adjust the Concerto/Basic shower trolley to an ergonomic
height.
8 Remove the sling from the patient.
9 Place the head cushion under the patient’s head for comfort.
10 Release the brakes on Concerto/Basic shower trolley.
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To a Sling Lift
Fig. 1
Fig. 2
Fig. 3
Fig. 4
(8 Steps)
For any sling questions, refer to its respective sling and lift IFU.
These transfer steps apply to both floor and ceiling lifts with slings.
1 Apply the brakes on the Concerto/Basic shower trolley.
(See Fig. 1)
2 Raise the Concerto/Basic shower trolley to an ergonomic
height.
3 Position the sling under the patient.
4 Lower the Concerto/Basic shower trolley to its lowest
height. (See Fig. 2)
5 Position the lift over the patient.
6 Attach the sling to the lift. (See Fig. 3)
7 Lift the patient out of the Concerto/Basic shower trolley.
(See Fig. 4)
8 Disinfect Concerto/Basic shower trolley after each use to
prevent cross-contamination according to section Cleaning
and Disinfection Instructions on page 34.
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Shower with Concerto/Basic Shower Trolley
Fig. 1
In case you have an Arjo Shower panel, use it according to its separate Instructions for Use.
(12 steps)
1 Move the Concerto/Basic shower trolley to the Arjo shower
panel or to a bathroom with a shower and toilet/sink.
2 Make sure that the drainage hole goes over the sink.
3 Apply the brakes and lower or raise the Concerto/Basic
shower trolley to a comfortable ergonomic working height.
4 Lift off the shower handle and hold it over the Concerto/
Basic shower trolley.
5 Set the thermostat mixer at the desired temperature.
6
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.
Turn on the shower water.
7 Adjust the temperature and the flow of water so that it suits
the patient.
8 Shower the patient. (See Fig. 1)
9 After the shower, turn off the water and dry the patient.
10 Release the brakes.
11 Raise the Concerto/Basic shower trolley to an ergonomic
height and transport the patient back.
12 Disinfect Concerto/Basic shower trolley after each use to
prevent cross-contamination according to section Cleaning and Disinfection Instructions on page 34.
30
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Intentionally left blank
31
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Home Care Use
For Distributors and Renters
When transporting Concerto shower trolley to the customer with a van:
Make sure the product is properly secured during transport.
Avoid manoeuvring the shower trolley in dirty ground when transporting it to and from the van.
When delivering the Concerto shower trolley make sure that:
You read this IFU together with the receiver (including relatives and caregivers).
Show the features and intended usage described in the IFU with help of the real product.
The user has understood the cleaning and disinfection instructions.
Read all the warnings to the receiver.
Using the Concerto Shower Trolley
Before using the Concerto shower trolley in home environment make sure that: (See Fig. 1-3)
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°).
All caregivers, including relatives, have read and understood the instructions in this IFU.
All carpets and rugs in the environment are removed.
All thresholds in the environment are removed.
All stairs and edges have a fence and safety gate to prevent the shower trolley from rolling down.
The environment fulfils all the requirements described in this IFU.
Cleaning and disinfection:
Make sure that the cleaning and disinfection procedure described in this IFU always is carried out before the product reaches a new user.
Make sure that the cleaning and disinfection procedure described in this IFU always is carried out before and after any type of service procedure.
There is room enough in the environment for use of the shower trolley.
During Storage of Concerto shower trolley make sure that:
WARNING
To avoid strangulation, make sure to never leave children unattended near the equipment.
No children can access the shower trolley.
No pets can come in contact with the shower trolley.
The storage environment fulfils the requirements according to Technical Specifications on page 44.
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2000
79"
1800
71"
1600
63"
1400
55"
1200
47"
1000
39"
2000 1800 1600 1400 1200 1000
79" 71" 63" 55" 47" 39"
Fig. 1
118" (3000 mm)
31" (800 mm)
36" (900 mm) 31" (800 mm)
16" (400 mm)
Fig. 2
Floor drain
106" (2700 mm)
24" (600 mm)
31" (800 mm) 31" (800 mm)
93" (2360 mm)
67" (1700 mm)
138" (3500 mm)
Fig. 3
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Cleaning and Disinfection Instructions
Only use Arjo Branded Disinfectant Cleansers (e.g. Arjo Clean™).
If you have any questions regarding disinfecting the Concerto shower trolley, or wish to order disinfectant, contact Arjo Customer Service. See section Parts and Accessories on page 54.
Make sure to have the Material Safety Data Sheets (MSDS) available for the disinfectant being used.
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 IFU and the Material Safety Data Sheet (MSDS) of the disinfectant.
Allowed Disinfectants
Arjo Clean
Arjo General Purpose Disinfectant
Arjo Disinfectant Cleanser IV
Arjo All Purpose Disinfectant
Arjo CenKleen IV
Accessories for Disinfecting the Concerto Shower Trolley
Protective gloves
Protective glasses
Spray bottle with disinfectant or disinfection spray handle with disinfectant
Spray bottle with water or shower handle with water
Cloths - wet and dry
Disposable towels
Soft bristle brush
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.
CAUTION To avoid damage on the equipment only
use Arjo branded disinfectants.
Long handled soft bristled brush
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Always Follow these 24 Steps for Proper Cleaning and Disinfection
If an Arjo shower panel will be used, see respective IFU.
Removing visual residue (Step 1-4 of 24)
1 Remove drainage hose with all parts according to
section To Remove the Drainage Hose (2 Steps) on page 18. Detach the pillow and the cushions.
If the disinfectant cannot be removed, spray water
13
on the affected part and wipe off with disposable towels. Repeat until all of the removed.
disinfectant has been
Disinfection (Step 14-24 of 24)
14 Spray disinfectant on the Concerto shower trolley.
15 Allow a disinfection time according to the
instructions on the disinfectant bottle label.
2 Clean the Concerto shower trolley from visible
residue using a cloth soaked in water or if more suitable by spraying/showering water using a brush and/or wipe with a clean cloth. Start from the top and move downwards.
3 Clean all removed parts from visible residue with
a cloth soaked in water or shower water using a brush and/or wipe with a clean cloth.
4 Spray/shower with water in drain. Use a long
handled brush to scrub the drainage hole in the mattress and the drainage outlet.
Cleaning (Step 5-13 of 24)
5 Put on protective gloves and eye wear.
6 Make sure the disinfectant is mixed according to
the instructions on the disinfectant bottle label or according to the mix ratio stated in the shower panel IFU.
7 Spray disinfectant on the Concerto shower trolley.
Use a brush and scrub thoroughly, especially on handles and hand control.
16 Spray disinfectant on the removed parts, the
drainage hole in the mattress and the drainage outlet.
17 Allow a disinfection time according to the
instructions on the disinfectant bottle label.
18 Soak a cloth in disinfectant and wipe all other
areas such as chassis.
19 Allow a disinfection time according to the
instructions on the disinfectant bottle label.
20
Spray or shower water approx. 25 °C (77 °F) and wipe with a clean cloth to remove all traces of the
disinfectant on the Concerto shower trolley. The
cloth should occasionally be rinsed in running water during removal of disinfectant.
21 Spray or shower water approx. 25 °C (77 °F) and
wipe with a clean cloth to remove all traces of the
disinfectant on the removed parts, the drainage hole in the mattress and the drainage outlet. The
cloth should occasionally be rinsed in running water during removal of
disinfectant.
8 Rinse the Concerto shower trolley thoroughly
with water approx. 25 °C (77 °F) until all the disinfectant has been removed.
9 Spray disinfectant on the removed parts, the
drainage hole in the mattress and the drainage outlet. Use a brush soaked in disinfectant for cleaning, scrub thoroughly.
10 Rinse the removed parts, the drainage hole in the
mattress and the drainage outlet, thoroughly with water until all the disinfectant has been removed.
11 Soak a cloth in disinfectant and wipe all other
areas such as chassis.
12 Wet a new cloth with water and remove all traces
of disinfectant on other areas. The cloth must occasionally be rinsed in running water when removing disinfectant.
22 Spray or shower water approx. 25 °C (77 °F) and
wipe with a clean cloth to remove all traces of the
disinfectant on remaining areas, such as chassis.
The cloth should occasionally be rinsed in running water during removal of
disinfectant.
23 If the disinfectant cannot be removed, spray water
on the affected part and wipe off with disposable towels. Repeat until all of the removed.
disinfectant has been
24 Let all parts dry.
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Battery Instructions
WARNING
To avoid bodily injury, do NOT crush, puncture, open, dismantle or otherwise mechanically interfere with the battery.
• Should the battery casing crack and cause contents to come in contact with skin or clothing, rinse immediately with plenty of water.
• If contents come in contact with the eyes, rinse immediately with plenty of water and seek medical attention.
• Inhalation of the contents can cause respiratory irritation. Provide fresh air and medical attention.
Be careful not to drop the battery.
Contact the appropriate local authority for advice when disposing of batteries.
Check label on the battery.
Storage of Batteries
The battery is delivered charged but we recommend you recharge the battery when received due to a slow self discharge.
This battery will slowly self discharge when not used.
A battery not in use should be stored in a temperature range of -0 °C (32 °F) to +30 °C (86 °F).
Battery Service Life
Make sure to always have two well functional batteries, one to use and one in storage.
If using a freshly charged battery and the battery indicator starts to flash and sound after only a few activities are carried out, it is time to order a new battery.
NOTE To avoid loss of operation, charge the battery when the warning LED lamp is lit.
NOTE The battery can be left in the charger unit even if it is fully charged without being damaged.
Low Charge Warning
The low charge battery warning LED lamp is placed on the cover of the hydraulic unit on the chassis. If the battery is running low, the warning LED will turn yellow when the buttons on the hand control are pushed. The battery should then be recharged as soon as possible.
Installation of Charger
See NCA-X000, Battery Charger IFU.
How to Change the Battery
See NCA-X000 Battery Charger IFU.
For maximum battery performance do not store the battery above 50 °C (122 °F).
Charging Intervals
To prolong the life of the battery, charge it at regular intervals, i.e. every night.
•If the Concerto shower trolley is used frequently, it is recommended to use two batteries, one in operation and one as a stand-by in the charger.
It’s recommended that a battery not in use is left in the charger. There is no risk of overcharging the battery.
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Care and Preventive Maintenance
Caregiver Obligations
The Concerto/Basic shower trolley is subject to wear and tear, and the following actions must be performed when specified to make sure that the product 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.
NOTE Product cannot be maintained and serviced while in use with the patient.
PREVENTIVE MAINTENANCE SCHEDULE: Concerto/Basic Shower Trolley
CAREGIVER OBLIGATIONS Action/Check
Every
DAY
Every
WEEK
Every YEAR
Disinfect X
Visually check all exposed parts X
Visually check mechanical attachments X
Perform functionality test X
Check hand control and cable (Concerto Electric shower trolley)
X
Check and clean castors X
Visually check battery and charger (Concerto Electric shower trolley)
X
Check mattress and head cushion/wedged pillow X
Yearly checks by qualified personnel only X
WARNING
To avoid injury to both patient and caregiver, never modify the equipment or use incompatible parts.
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Caregiver Obligations
Fig. 1
Fig. 2 Fig. 3
Fig. 4
Caregiver obligations shall be carried out by personnel with sufficient Concerto/Basic shower trolley knowledge following the instructions in this IFU.
Every day
Disinfect
•The Concerto/Basic shower trolley has to be disinfected immediately after usage. Standard disinfectant and shampoos should be used in recommended concentrations. For further cleaning/disinfecting instructions see section Cleaning and Disinfection
Instructions on page 34.
Every week
Visually check all exposed parts
Especially check where personal contact is made by either the patient or caregiver. Make sure no cracks or sharp edges have developed that could cause the patient or caregiver injury or that has become unhygienic. (See Fig. 1)
Check drainage hose with all parts. Replace damaged parts.
(See Fig. 2)
Check mechanical attachments (Concerto shower trolley)
Tilt the stretcher. Visually check the two bolts holding the stretcher to the chassis. No gaps are allowed. (See Fig. 3)
When tilted check for cracks in the stretcher. (See Fig. 4)
Continue with the steps on the next page.
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Perform functionality test, check:
Fig. 5 Fig. 6
Fig. 7
Fig. 8
Catches on the side supports (See Fig. 5)
Back support catches (See Fig. 6)
Tilt function (Concerto shower trolley) (See Fig. 7)
Horizontal lock (Concerto shower trolley) (See Fig. 8)
Make sure the hydraulic system is working smoothly (raising and lowering)
Continue with the steps on the next page.
39
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Fig. 9
Fig. 10
Fig. 11
Fig. 12
Check hand control and cable (Concerto electric shower trolley)
Visually check the condition of the hand control and its cable. (See Fig. 9)
Check and clean castors
Check that the castors are properly fixed and are rolling and swivelling freely. Clean with water (the function can be affected by soap, hair, dust and chemicals from floor cleaning). Check brakes and straight steering devices.
(See Fig. 10)
Visually check battery and charger (Concerto electric shower trolley)
Visually check the condition of the battery charger, its cable and the battery. Withdraw and replace immediately if damaged. (See Fig. 11)
Check the mattress and head cushion/wedged pillow
Make sure there are no cracks or tears that would allow water to get into the filling. If there is such damage, replace damaged parts to avoid cross-infection. (See Fig. 12)
Continue with the steps on the next page.
40
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Yearly Checks by Qualified Personnel Only
The Concerto shower trolley must be serviced once a year in accordance with the Maintenance and Repair Manual.
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.
FOR UK ONLY: LOLER and PUWER legislation requires 6 monthly thorough examination and annual service, or an alternative scheme, carried out by a competent person.
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Troubleshooting
WARNING
To avoid injury, make sure that the patient is not left unattended at any time.
WARNING
To avoid injury, make sure that the patient is not left unattended at any time.
Troubleshooting Concerto Electric Shower Trolley
NOTE If the product does not work as intended, immediately contact your local Arjo representative for support.
PROBLEM ACTION
The Concerto Electric raises or descends after the hand control buttons are released.
The Concerto Electric does not raise or descend when the hand control buttons are pressed.
The Concerto Electric is hard to manoeuvre during transport.
Activate the emergency stop button and pull the battery out. Remove the patient from Concerto Electric and contact qualified personnel.
1 Make sure the emergency stop button is inactivated by
turning the red knob clockwise.
2 Make sure that the battery is fully engaged in the battery
compartment.
3 Make sure that the battery is charged.
1 Make sure all brakes are released.
2 Make sure all castors roll and turn freely.
3 If nothing of the above helps, remove the patient from
Concerto Electric and contact qualified personnel.
The Concerto Electric is making abnormal sounds during lifting or transport.
ALARM ACTION
A yellow LED light on the chassis cover, next to the battery holder, continuously lights up when Concerto Electric is being raised.
Only a few activities are carried out before the battery indicator will flash and sound.
Remove the patient from the Concerto Electric and contact qualified personnel.
The battery needs charging - complete the transfer operation in progress and change to a fully charged battery.
Replace the battery with a fully charged one.
If using a freshly charged battery and the battery indicator starts to flash and sound after only a few activities are carried out, it is time to order a new battery.
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Troubleshooting Concerto Hydraulic and Basic Shower Trolley
PROBLEM ACTION
The Concerto/Basic shower trolley does not raise when the pedal is being pumped.
The Concerto/Basic shower trolley does not descend when the pedal is pressed down.
The Concerto/Basic shower trolley does not raise or descend when the pedal is being used.
Make sure that Concerto/Basic shower trolley is not in its highest position.
Make sure that Concerto/Basic shower trolley is not in its lowest position.
Remove the patient from the Concerto/Basic shower trolley and contact qualified personnel.
NOTE If the problem can not be solved with the written troubleshooting actions, please contact qualified personnel.
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Technical Specifications
General
SWL (Safe Working Load = patient + water) 175 kg (385 Ibs)
Maximum patient weight 150 kg (330 Ibs)
Weight Basic 72 kg (159 Ibs)
Weight Concerto hydraulic shower trolley 75 kg (165 Ibs)
Weight Concerto electric shower trolley 79 kg (174 Ibs)
Maximum total weight of lift Basic (lift + patient + water)
Maximum total weight of lift Concerto hydraulic (lift + patient + water)
Maximum total weight of lift Concerto electric (lift + patient + water)
Protection class IP24
Pollution degree 2
Concerto Hydraulic/Basic shower trolley
Operating force: Push force for pedal when raising stretcher 110 N
Operating force: Push force for pedal when lowering stretcher
247 kg (544 lbs)
250 kg (550 lbs)
254 kg (559 lbs)
IP: Ingress Protection 2: Protection against insertion of figures or similar objects. 4: Water splashing against the product from any direction does not effect safety or essential performance
114 N
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Concerto Electric shower trolley
Medical equipment type
Operating force: Push button on the hand control 3.0 N
Hand control Protection class IP X7
IP: Ingress Protection X: The protection against contact and ingress of objects is not specified for this product. 7: Immersion up to 1 m of the product does not effect safety or essential performance
Lift nominal voltage 12V DC
Battery No. 102193 sealed lead-acid
Battery charger NCA 1000 - EU (Europe)
NCA 2000 - GB (Great Britain) NCA 3000 - CH (Switzerland) NCA 4000 - US (USA) NCA 6000 - AU (Australia)
Battery capacity 6.5 Ah
Battery voltage 12 V DC
Maximum duty cycle- Lift actuator ED: 1 minute ON, 9 minutes OFF
Sound Level 70 dB (A)
Motor power 200 VA
Allowed Combination
The Concerto shower trolley integrate with the following Arjo products
No other combinations are allowed
Operating, Transport and Storage
Temperature +10 °C to + 40 °C (+50 to +104 °F) Operating
Humidity 15-93% at +20 °C (+68 °F) Operating
Maxi Twin, Maxi Move, Maxi Sky, Maxi Sliding Sheet
-20 °C to +70 °C (-4 °F to +158 °F) Transport
-20 °C to +70 °C (-4 °F to +158 °F) Storage
10-80% at +20 °C (+68 °F) Transport 10-80% at +20 °C (+68 °F) Storage
Atmospheric pressure 800 hPa to 1060 hPa Operating
500 hPa to 1100 hPa Transport 500 hPa to 1100 hPa Storage
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Recycling
Package Wood and corrugated cardboard recyclable
End of Life Disposal
All batteries in the product must be recycled separately. Batteries are to be disposed in accordance with national or local regulations.
Slings including stiffeners/stabilizers, padding material, any other textiles or polymers or plastic materials etc. should be sorted as combustible waste.
Lift systems having electrical and electronic components or an electrical cord should be disassembled and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with local or national regulation.
Components that are primarily made up of different kinds of metal (containing more than 90% metal by weight) for example sling bars, rails, upright supports, etc., should be recycled as metals.
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Dimensions
740 (29”)
1850 (73”), 1900 (75”), 1950 (77”)
1155 (45 1/2”)
2030 (80”)
160 (6 1/4”)
755 (29 3/4”)
695 (27 1/4”)
45 (1 3/4”)
810 (32”)
1060 (41 3/4”) - 740 (29”)
490 (19 1/4”)
mm (inches)
Stroke: 320 (12 1/2”)
Tilted lowest position
Tilted Highest Position
mm (inches)
Stroke: 320 (12 1/2”)
Concerto hydraulic shower trolley
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740 (29”)
1850 (73”), 1900 (75”), 1950 (77”)
490 (19 1/4”)
1155 (45 1/2”)
2030 (80”)
1040 (41”) - 740 (29”)
790 (31”)
45 (1 3/4”)
160 (6 1/4”)
755 (29 3/4”)
695 (27 1/4”)
Tilted lowest position
Tilted Highest Position
mm (inches)
Stroke: 300 (11 3/4”)
Concerto electric shower trolley
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Labels
Label explanation
Battery Label States safety and environmental
information for the battery.
Data Label States technical performance and
requirements, e.g. Input Power, Input Voltage and maximum Patient Weight etc.
Identification Label
States the product identification, serial number and year and month of manufacturing.
Symbol explanation
SWL Safe Working Load Max patient
weight
Defines the maximum weight of the patient.
Stroke - Defines the lifting height range of the lift
IP 24 Protection class against splashing
water 12 V DC Supply voltage 200 VA Maximum Motor power
Fuse F1: T15 AL 250 V
1
1 min on / 9 min off
kg/
lbs
kg/
lbs
CE marking indicating conformity with European Community harmonised legislation
Indicates the product is a Medical Device according to EU Medical Device Regulation 2017/745
TÜV marking. The lift has been safety tested in accordance with the Approvals and List of Standards.
A battery is the power source of this equipment.
Mode of operation for Hi/Lo function:
ED maximum 10%; Maximum 1 minute ON; Minimum 9 minutes OFF
Total mass of equipment including
kg/
lbs
its safe working load.
Name and address of the manufacturer
Manufacturing date
6.5Ah Capacity
Type BF, Applied part:
protection against electrical shock
in accordance with EN/IEC 60601-
1.
Read the IFU before use
Separate electrical and electronic
components for recycling in
accordance with the European
Directive 2012/19/EU
Mode of operation (ED)
Mode of operation for Hi/Lo
function:
ED maximum 10%;
Maximum 1 minute ON;
Minimum 9 minutes OFF
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Data Label
(Concerto Electric
shower trolley)
Data Label
(Concerto Hydraulic
and Basic
shower trolley)
Identification Label
Maximum total weight of lift Label
Battery Label (Concerto Electric shower trolley)
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Approvals and List of Standards
CERTIFICATE STANDARDS
EN/IEC 60601­1:2005 AMD1:2012
ANSI/AAMI ES60601-1 (2005) AMD1 (2012)
CAN/CSA-C22.2 No. 60601-1:14
ISO 10535:2006 Hoists for the transfer of disabled persons -- Requirements and test methods
EN/IEC 60601-1­11:2015
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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Electromagnetic Compatibility
Product has been tested for compliance with current regulatory standards regarding its capacity to block EMI (electromagnetic interference) from external sources.
Some procedures can help reduce electromagnetic interferences:
Use only Arjo cables and spare parts to avoid increased emissions or decreased immunity which can compromise the correct functioning of the equipment.
Ensure that other devices in patient-monitoring and/or life-support areas comply to accepted emissions standards.
WARNING
Wireless communications equipment such as wireless computer network devices, mobile phones, cordless telephones and their base stations, walkie-talkies, etc. can affect this equipment and should be kept at least 1.5m away from the equipment.
Intended Environment: Home Healthcare Environment and Professional Healthcare facility environment.
Exceptions: HF Surgical Equipment and the RF Shielded room of an ME SYSTEM for magnetic resonance imaging
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.
Guidance and manufacturer’s declaration – electromagnetic emission
Emission test Compliance Guidance
This equipment uses RF energy only for its internal functions.
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
This equipment is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
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Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test IEC 60601-1-2 test level Compliance level
Electrostatic
±2kV, ±4kV, ±8kV, ±15kV air
±2kV, ±4kV, ±8kV, ±15kV air
discharge (ESD)
EN 61000-4-2
Conducted
±8kV contact
3V in 0,15 MHz to 80 MHz
±8kV contact
3V in 0,15 MHz to 80 MHz disturbances inducted by RF fields
EN 61000-4-6
Radiated RF electromagnetic
6V in ISM and amateur radio bands between 0,15 MHz and 80 MHz
80% AM at 1 kHz Home Healthcare environment
10 V/m
6V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
80% AM at 1 kHz
Home Healthcare environment
10 V/m field
EN 61000-4-3
Proximity fields
80 MHz to 2,7 GHz 80% AM at 1 kHz
385 MHz - 27 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz
385 MHz - 27 V/m
from RF wireless communications equipment
EN 61000-4-3
450 MHz - 28 V/m 710, 745, 780 MHz - 9V/m 810, 870, 930 MHz - 28 V/m 1720, 1845, 1970, 2450 MHz –
28 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/m
810, 870, 930 MHz - 28 V/m
1720, 1845, 1970, 2450 MHz -
28 V/m
5240,5500, 5785 MHz - 9V/m
5240,5500, 5785 MHz - 9V/m
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%.
Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than 1.0m, if the transmitter’s output power rating exceeds 1W
a
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range
b
Interference may occur in the vicinity of equipment marked with this symbol:
Electrical fast
±1kV SIP/SOP port
±1kV SIP/SOP ports transient/burst
EN 61000-4-4
Power frequency Magnetic field
100 kHz repetition frequency 30 A/m
100 kHz repetition frequency
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
EN 61000-4-8
50 Hz or 60 Hz
50 Hz
commercial or hospital environment.
a
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 the product is used exceeds the applicable RF compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
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Parts and Accessories
80
40
50
60
70
20
30
MIX
80
40
50
60
70
20
30
MIX
A
B
C
Head Cushion
8231551-013
Extra high side supports
100805-03
Shower Panel BCA 1204/1202/1201-04 BCA 1214/1212/1211-04 BCA 1224/1222/1221-04
Wedge Pillow
100880-01
Adjustable backrest
100806-03
Extra battery 102193 Battery charger
NCAX000-XX
Drainage Hose 100828
1, 1.5, 2 or 3 m
Drip-feed bottle holder
100830
Sink
BDA0815/0816-90
Flush sink BDA 0891-04
A: Support handle
100837
For disinfectant contact
the Arjo local
representative
B: Sink BDA0890-04
C: Support frame
100836
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At Arjo, we are committed to improving the everyday lives of people affected by reduced mobility and age-related health challenges. With products and solutions that ensure ergonomic patient handling, personal hygiene, disinfection, diagnostics, and the effective prevention of pressure ulcers and venous thromboembolism, we help professionals across care environments to continually raise
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ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden
www.arjo.com
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