System 2000 Parts Manual
7 Preparations Site Preparation Prior to installation of the System 2000 bath the floor and walls within the required area must be finished. 0DWHULDO 7KHIORRUVKRXOGEHPDGHRIDVOLS
INSTRUCTIONS FOR USE
System 2000
04.AR.12_15EN · 07/2019
WARNING
To avoid injury, always read this Instructions for Use and accompanied documents before using the product.
Mandatory to read the Instructions for Use
Design Policy and Copyright ® and TM 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.
Contents
Foreword ...................................................................................4 Intended Use .............................................................................5 Safety Instructions .....................................................................6 Preparations ..............................................................................7 System 2000 Bathtubs ..............................................................8 Parts Designation ....................................................................10 Control Panels .........................................................................12 Buttons and Displays ...............................................................14 Product Description/Functions ................................................16
Drain Control Knob ..............................................................16 Autofill ..................................................................................16 Shower Handle ....................................................................17 Shower/Disinfection System (UK market only) ....................17 P220 Temperature Display ..................................................18 P300 Display ........................................................................18 Scalding Protection ..............................................................18 Shampoo/Body Wash (optional) ..........................................19 Bath Oil/ArjoSoundTM Water Conditioner (optional) .............19 Raise and Lower Bathtub ..................................................20 Emergency Lowering (optional, not for UK market) .............20 Disinfection Unit (optional) ...................................................20 Pillow ...................................................................................21 Foot Support ........................................................................21 Toiletry Tray (optional) .........................................................21 Hot Water Flush (Kit) ...........................................................21 Hydromassage System ...........................................................22 Hydrosound System ................................................................24 Sound & Vision System ...........................................................26 Change Default Setting (P300 only) ........................................27 Bathe Patient using a Lift Hygiene Chair .................................28 Bathe Patient using a Lift Bath Trolley ....................................34 Cleaning and Disinfection Instructions ....................................40 Care and Preventive Maintenance ..........................................52 Troubleshooting .......................................................................56 Error Codes (P300 only) ..........................................................57 Technical Specifications ..........................................................58 List of Standards and Certificates ...........................................63 Labels ......................................................................................64 Electromagnetic Compatibility .................................................66 Parts and Accessories .............................................................69
3
Foreword
Thank you for purchasing Arjo Equipment
The Arjo System 2000® bath is part of a worldwide family of quality products designed especially for efficient patient hygiene and good ergonomics for the caregiver.
Please read this Instructions for Use thoroughly!
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Service and Support
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Serious incident
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Complementary Information
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Definition in this IFU:
WARNING
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CAUTION 0HDQV )DLOXUHWRIROORZWKHVHLQVWUXFWLRQVPD\FDXVH GDPDJHWRDOORUSDUWVRIWKHV\VWHP
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4
Intended Use
This equipment must be used 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 do not completely understand, ask your Arjo representative.
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Resident Assessment
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Installation Requirements
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Indication for Use
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Expected Service Life
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5
Safety Instructions
WARNING
To avoid injury to both the patient and the caregiver, never modify the equipment or use incompatible parts.
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 electric shock, never use other electrical equipment near this device.
WARNING
To avoid falling, make sure the patient always remains in a seated position.
WARNING
To avoid injury, make sure that the patient is not left unattended at any time. NOTE A medical assessment of the patient must be made in order to ensure their suitability to use this product.
6
Preparations
Site Preparation
Prior to installation of the System 2000 bath the floor and walls within the required area must be finished. 0DWHULDO7KHIORRUVKRXOGEHPDGHRIDVOLS UHVLVWDQWPDWHULDOIUHHRIEXPSV
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Actions Before the First Use
(10 steps) 0DNHVXUHWKDWWKHEDWKKDVEHHQLQVWDOOHG
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WARNING
To prevent scalding, make sure that the water mixer has been calibrated. Confirm that responsible organization has established calibration routines.
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Actions Before Every Use
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Designation on page 10
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WARNING
To prevent cross-contamination, always follow the disinfection instructions in this Instructions for Use.
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NOTE
If you have any questions, please contact your local Arjo representative for support and service. The contact information is listed on the last page of this IFU.
7
System 2000 Bathtubs
Rhapsody®
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Primo®
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Primo® Ferro
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HarmonieTM
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8
Parts Designation
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Type B, Applied part. Degree of Protection Electrical shock
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9 10 11 12
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UNDER THE CONTROL PANEL LID
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Control Panels
P220 Control Panel
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P300 Control Panel
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Buttons and Displays
P300
P220
Autofill Button
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Shower Button
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Raise Bathtub Button
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Lower Bathtub Button
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Temperature Display - Bathtub water (P220)
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Display (P300)
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P300
P220
P300 StandbyMode
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Shampoo/Body Wash Button
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Product Description/Functions
Fig. 1
B Fig. 2
Fig. 3 High Level Normal Level Low Level
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Drain Control Knob
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Autofill
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NOTE
If the Autofill button is pressed after the preset water level is reached, bathtub filling continues.
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Fig. 1 Lock Button Trigger
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Shower Handle
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Fig. 1 P220 World
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P220 USA
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Fig. 2 P300 World
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USA
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Scalding Protection
WARNING
To prevent scalding if the scalding protection is activated, remove the patient from the bath immediately in a safe manner.
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Fig. 1 A
B
Fig. 2 C
Fig. 3
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Fig. 4 C
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19
Fig. 1 Fig. 2 Fig. 3
Raise and Lower Bathtub
WARNING
To avoid entrapment of the patients or caregivers legs or feet, make sure that they are kept clear of all obstacles.
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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Disinfection Unit (optional)
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Fig. 1
Fig. 2 Rhapsody® Primo® HarmonieTM
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Fig. 3
7RXVHWKHGLVLQIHFWDQWVHHVHFWLRQCleaning and Disinfection Instructions on page 40.
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Toiletry Tray (optional)
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Hot Water Flush (Kit)
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21
Hydromassage System
Fig. 1
Fig. 2
Fig. 3 B
WARNING
To avoid hair entrapments under water, always install the Hydromassage system suction cover before use.
CAUTION
Turn the hydromassage water intensity knob clockwise at highest intensity in order to prevent water leakage on the floor. The leakage occurs from the built-up water pressure in the Hydromassage system. (See Fig. 2)
A
Decrease Increase Intensity Intensity
A
Use HydromassageTM System
(12 steps)
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Continue with the steps on the next page.
22
Fig. 4 Fig. 5
Air Inlet
Continue Hydromassage with Treatment Hose (optional)
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Fig. 6 Fig. 7
MAX.
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23
Hydrosound System
Fig. 1
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WARNING
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(10 steps)
A
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Continue with the steps on the next page.
24
Fig. 2
Fig. 3
Fig. 4
20
Fig. 5
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25
Sound & Vision System
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WARNING
To avoid electric shock, only use the USB memory stick in the connector on the bath.
Use Sound & Vision System
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NOTE
The music function will stop automatically 30 minutes after activation. Press the MP3 player button on the hand control for continued listening.
Sound & Vision System Hand Control
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1
2
3
4
5
6
8
7
26
Change Default Setting (P300 only)
(4 steps)
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Default values
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27
Bathe Patient using a Lift Hygiene Chair
Fig. 1
Preparations for Bath
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6HHAlenti, Calypso and Combilift IFU before use.
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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.
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28
Fig. 1 Fig. 2 Fig. 3
Transfer and Bathe Patient
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WARNING
To avoid entrapment, make sure to keep the patients hair, arms and feet close to the body and use designated grab supports during any movement.
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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.
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WARNING
To avoid entrapment of the patients or caregivers legs or feet, make sure that they are kept clear of all obstacles.
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Continue with the steps on the next page.
29
Fig. 4
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Fig. 5
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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.
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30
Shower Patient
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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. 3UHVVWKHWULJJHURQWKHVKRZHUKDQGOHDQGGLUHFWWKHZDWHU VWUHDPDZD\IURPWKHSDWLHQW3ODFH\RXUQDNHGKDQGLQWKH ZDWHUVWUHDPDQGPDNHVXUHWKHZDWHUWHPSHUDWXUHLVQRWWR KRWRUWRFROG
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31
Fig. 1 Fig. 2
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Fig. 1 Fig. 2 Fig. 3
End the Bath
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To avoid entrapment or pinching of genitals, make sure there is enough clearance during movement over the tub edge, toilet, bedpan or other furniture.
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Disinfect After Each Patient
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Bathe Patient using a Lift Bath Trolley
Fig. 1
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Preparations for Bath
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CAUTION To prevent equipment damage when using a lift bath trolley, the foot support and pillow must be removed.
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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.
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Fig. 1 Fig. 2
Manual Drive or Power Drive
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Transfer and Bathe
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Fig. 3
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35
Fig. 4 Fig. 5
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36
Fig. 1
Use the Shower
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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.
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37
Fig. 2
Fig. 3
Fig. 4 Power Drive A
Fig. 5 Manual Drive
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End the Bath
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38
Fig. 1
Disinfect After Each Patient
(1 step)
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Cleaning and Disinfection Instructions
Thorough disinfection routines are necessary to stop the build-up of bacteria on and in the equipment. This is particularly vital in cases where the System 2000 bath is in a shared facility.
WARNING
To prevent cross-contamination, always follow the disinfection instructions in this Instructions for Use.
WARNING
To avoid eye or skin irritation, never disinfect in the presence of a patient.
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Arjo Disinfectants
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Accessories for Cleaning and Disinfection the System 2000 bath
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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.
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To avoid damage on the equipment only use Arjo branded disinfectants.
40
Microbiological Formation Prevention
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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 that 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 behind in the hose. · Let the water flow approximately 5 minutes before the first bath of the day. · Clean and disinfect the bathtub according to the IFU before the first bath of the day and after the bath of each patient. 'RQRWIRUJHWWRFRQWDFW$UMRIRUWKHDQQXDO3UHYHQWLYH 0DLQWHQDQFHYLVLW
41
Fig. 1 Fig. 2 Fig. 3
Replace Disinfectant Bottle (System 2000 bath with disinfection option only)
(12 steps)
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Arjo Guard (60)
Arjo CleanTM (60)
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42
Fig. 1 Fig. 2
Clean and Disinfect with Disinfection Spray Handle (Still Bath and Hydrosound System)
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Fig. 3 Fig. 4 Fig. 5
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Fig. 1
Fig. 2 Fig. 3
Clean and Disinfect with a Spray Bottle
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46
Fig. 4
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Never use green or brown Scotch-Brite nor steel wool on the bath as it may scratch the surface.
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47
Fig. 5 Fig. 6
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48
Fig. 1
Fig. 2 Surface Overflow Outlet Hydromassage System Outlet Suction Inlet
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49
Fig. 1 Fig. 2
Disinfect HydromassageTM System without Automatic Disinfection
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Fig. 5 Surface Overflow Outlet Hydromassage System Outlet Suction Inlet
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50
Fig. 1
Increase Intensity
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51
Care and Preventive Maintenance
7KHSystem 2000 EDWKLVVXEMHFWWRZHDUDQGWHDUDQGWKHIROORZLQJDFWLRQVPXVWEHSHUIRUPHGZKHQVSHFLILHGWR PDNHVXUHWKDWWKHSURGXFWUHPDLQVZLWKLQLWVRULJLQDOPDQXIDFWXULQJVSHFLILFDWLRQ
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: System 2000 bath
CAREGIVER OBLIGATIONS Action/Check
Between Every Every Every Patients DAY WEEK MONTH
Clean and Disinfect Check liquid levels Visually check all exposed parts Check pillow, foot support and toiletry tray Visually check hoses, pipes and connections Perform functionality test Check / clean shower heads Check / clean filters, incoming water Exercise the thermostat mixer (P220 only) Yearly checks by qualified personnel only Check electrical installation (to be performed by authorized electrician)
X X X X X X X X X
Intervals according to local requirements
Every YEAR
X
WARNING
To avoid injury to both the patient and the caregiver, never modify the equipment or use incompatible parts.
52
Fig. 1 Fig. 2 Fig. 3
Caregiver Obligations
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53
Fig. 4
Fig. 1 A
Fig. 2 C
B A
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Every month
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WARNING
Pressurised system and risk of scalding. Make sure that the valve (A) is closed before removing the cap, this is especially important for the hot water valve.
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54
Yearly Checks by Qualified Personnel Only
7KHSystem 2000 EDWKPXVWEHVHUYLFHGRQFHD\HDULQDFFRUGDQFH ZLWKWKHMaintenance and Repair Manual 7RPDNHVXUHWKDW\RXKDYHDSUREOHPIUHHDQGVDIHRSHUDWLRQLWLV UHFRPPHQGHGWRKDYHUHJXODUVFKHGXOHGVHUYLFHVZLWKFDOLEUDWLRQ RIWKHWKHUPRVWDWLFPL[HUDQGWKHUPRPHWHUE\DWUDLQHG WHFKQLFLDQ5HORFDWLRQRIWKHEDWKVLJQLILFDQWFKDQJHVRU PRGLILFDWLRQVLQORFDOZDWHUVXSSO\PD\UHTXLUHUHFDOLEUDWLRQRI WKHWKHUPRVWDWLFPL[LQJYDOYH &RQWDFW\RXUORFDO$UMRVHUYLFHUHSUHVHQWDWLYHWRVLJQIRUDVHUYLFH DJUHHPHQW
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.
55
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 Arjo
authorized technician.
PROBLEM
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56
Error Codes (P300 only)
Display Messages
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Display message
Cause
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5HSODFHWKHGLVLQIHFWDQWERWWOH DFFRUGLQJWRReplace Disinfectant Bottle (System 2000 bath with disinfection option only) on page 42
57
Technical Specifications
$IXOOWHFKQLFDOGHVFULSWLRQRIWKHSystem 2000FDQEHIRXQGLQWKHVHUYLFHGRFXPHQWDWLRQSOHDVHFRQWDFW$UMR IRUDFRS\&RQWDFWLQIRUPDWLRQDSSHDUVRQWKHODVWSDJHRIWKLV,)8
Site Requirements
NOTE All drainage, water and electrical installation work should be carried out by qualified personnel, in
accordance with local and national regulations.
Electric supply, Europe and North America Voltage
Number of phases Frequency
Power consumption (maximum) Fuse
Protective earth Potential equalisation Power supply cord
230/240 V (Europe) 120 V (North America) 100 V (Japan) 220 V (Korea) 230 V (Saudi Arabia)
Single phase AC
50 Hz (Europe) 60 Hz (North America) 50/60 Hz (Japan) 60 Hz (Korea) 60 Hz (Saudi Arabia)
1100 VA
6 A (Europe) 10 A (North America) 12 A (Japan) 6 A (Korea) 6 A (Saudi Arabia)
Yes
Yes
Replaceable by qualified personnel
WARNING
To avoid electric shock, make sure that 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.
58
Mains disconnection device
Permanently installed in wall. Visible and accessible at all times
Mains transient voltage
4 kV*
Creepage distance
3 mm*
Air clearance Direction of movement
1.8 mm*
Up and down, right and left, clockwise and counterclockwise
* If local regulations are higher, then they have to be met.
Water supply
Cold/Warm Water
3/4" B.S.P female
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 except UK market) 2 bar (200 kPa, 29 psi)
Minimum operating pressure (UK market)
1 bar (100 kPa, 14.5 psi)
Required cold water temperature
2 - 20 °C (36 - 68 °F)
Required warm water temperature
60 - 80 °C (140 - 176 °F)
Drain position
Floor or wall
Floor Maximum floor load Maximum floor pressure
990 kg /0.91 m2 1.8 N/mm2
Operating conditions Ambient temperature Relative humidity Atmospheric pressure
40 °C (104 °F) 30% - 75% Rh 800 hPa to 1060 hPa
Transport and storage Ambient temperature
Relative humidity Atmospheric pressure
-20 °C to 70 °C (-4 °F to 158 °F)
10% - 80% at 20 °C (68 °F)
500 hPa to 1100 hPa
59
Environmental
Microbiological demands Fulfil WHOs demands on drinking water and the Drinking Water Directive (DWD) in EU. Specifications below have a different value from microbiological demands above.
Ph Range
Ph 7.5 - Ph 9
Conductivity (minimum)
More than 2.7 mS/m
Chloride (maximum)
Less than 250 mg/l
Hardness
Less than 20 °dH
Alkalinity Installation of the System 2000 bath
60 - 200 mg/I HCO3
Refer to Assembly and Installation Instructions
Pollution degree
2
End of Life Disposal
· Equipment that has electrical and electronic components should be disassembled and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with local or national regulation.
· Disinfection liquids if you have extra liquid, it's safe to pour it down the drain with running water. These products are water soluble and usually mixed with water when used for cleaning, your municipality will treat these cleaners the same way they would if you used them for cleaning.
· The packaging containers should be recycled according to the national or local regulations.
60
Technical Requirement Maximum patient weight Safe Working Load (patient + water) IP Class according to IEC 60529 IP Class according to IEC 60529 Sound & Vision system hand control Electrical Protection Type Electrical Protection Degree Degree of fire protection
Maximum duty cycle, lifting
Maximum duty cycle, Hydrosound system/Hydromassage system
Thermometer Range Accuracy Resolution
182 kg (401 lbs) 500 kg / 1102 lbs IP X4 IP X7 I B In accordance with standard IEC 60601-1 2 minutes ON 18 minutes OFF 15 minutes ON 15 minutes OFF
10-50 °C (50-122 °F) +/-1 °C (1.8 °F) 0.1 °C (0.18 °F) P220 0.5 °C (0.9 °F) P300
Allowed Combinations
Arjo Product
Lift
Alenti
All models
Miranti
All models
Calypso
All models
Bolero
Not pediatric
Bolero
Pediatric
Combilift
Classic
Combilift
Stretcher
Combilift
Hanger bar
Maxi Twin
All models
Maxi Move
Not Large Hanger bar
Maxi Sky
Not Maxi Sky 1000 (Large)
Maxi Sky 2 Plus
All models
Marisa
All models
No other combinations are allowed
Bathtub length System 20, 23 and 25 System 23 and 25 System 20, 23 and 25 System 23 and 25 System 20, 23 and 25 System 20, 23 and 25 System 23 and 25 System 20, 23 and 25 System 20, 23 and 25 System 20, 23 and 25 System 20, 23 and 25 System 20, 23 and 25 System 20, 23 and 25
61
ar
Sound Levels Sound level at raising/lowering, no load Sound level at raising/lowering, full load Sound level at hydromassage/air spa Sound level at bathtub filling Sound level at shower start
69 dBA 68 dBA 76 dBA 80 dBA 55 dBA
Water volumes for bathtubs (interval depending on bathtub model and bathtub size)
Filling time at 3.0 bar (43.5 PSI) dynamic pressure, 80 °C (176 °F) HW
3 - 7.5 minutes
Water content up to overflow level
262 - 409 l 69.2 - 108 US gallons
Water content up to autofill level
185 - 282 l 48.9 - 74.5 US gallons
Drainage time - High Position
4.2 - 6.6 minutes
Drainage time - Low Position
6.9 - 10.8 minutes
Minimum drainage capacity
100 l/minute 26.4 US gallons/minute
Product measure
see Assembly and Installation Instructions
62
List of Standards and Certificates
STANDARD/ CERTIFICATE
DESCRIPTION
EN/IEC 60601-1:2005 AMD1:2012
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ANSI/AAMI ES60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic
(2005) AMD 1 (2012)
Safety and Essential Performance
CAN/CSA-C22.2 No. 60601-1:14
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
CSA B45.5-02
CSA Standard for Plastic Plumbing Fixtures
ANSI Z124.1.2-1995
Standard for Plastic Bathtub Units
ANSI/ASME A112.19.7- Whirlpool Bathtub Appliances 1995
ANSI/ASME A112.19.8- Suction Fittings 1987
ASSE 1001-1988, CSA Pipe Applied Atmospheric Type Vacuum Breaker B64.1.1-2008
ASSE 1056, CSA B64.1.2 Back Siphonage Vacuum Breakers
ANSI/ASSE 1014-1989 Hand Held Shower
ANSI/ASSE 1016-2005
Individual Thermostatic, Pressure Balancing and Combination Pressure Balancing and Thermostatic Control Valves for Individual Fixtures.
EN 1717:2000
Protection against pollution of portable water in water installation and general requirements of devices to prevent pollution by backflow.
63
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Attention Label (under the control panel lid)
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Approval Label
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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.
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68
Parts and Accessories
8331457-03 - Grey Pillow
8138678 - Transparent Foot Support 8154647-04 -Primo® Ferro Foot Support
ARA 0007-01 Toiletry tray
For disinfectant contact the Arjo local representative
SRB4000 Arjo OilTM (Bath Oil) 2 X 2 Litre bottles
SRB5000 Arjo CareTM (Shampoo, Body Wash) 4 X 2 Litre bottles
SRB1000 ArjoSoundTM Water Conditioner (for Hydrosound System) 2 X 2 Litre bottles
ARA 0500-03 Hydromassage Treatment Hose inclusive holder
No picture available
ARA 3333-04 Booster Pump
No picture available
ARA 0300-031 Foundation Frame
69
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