Arjo Carevo Instructions For Use Manual Download Page 50

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List of Standards and Certificates

CERTIFICATE

STANDARDS

EN/IEC 60601-1:2005

AMD1:2012

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

ANSI/AAMI ES60601-1
(2005) AMD 1 (2012)

Medical Electrical Equipment - Part 1: General Requirements for Basic 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

ISO 10535:2006

Hoists for the transfer of disabled persons -- Requirements and test methods

EN/IEC 60601-1-
11:2015

Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment

Summary of Contents for Carevo

Page 1: ...04 BA 08_13EN 06 2019 Carevo 04 BA 08_13EN 06 2019 INSTRUCTIONS FOR USE ...

Page 2: ... the Instructions for Use 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 ...

Page 3: ...e Supports 14 Adjustable Back Support 15 Attach Remove Mattress 15 Drainage Plug 16 Drainage 16 Head Pillow 17 Shower Handle Holder 17 Battery 17 Transfer from the Bed 18 Transfer to the Bed 21 Transfer from the Sling Lift 24 Transfer to the Sling Lift 26 Shower the Patient 28 Home Care Use 32 Cleaning and Disinfection Instructions 34 Battery Instructions 38 Care and Preventive Maintenance 39 Alar...

Page 4: ...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 Carevo shower trolley every year by qualified p...

Page 5: ...the following criteria prior to use The product is intended mainly for patients who are passive and totally dependent To remain in a safe laying position on the Carevo shower trolley the patient must have limited physical capacity to move or be able to understand and respond to instructions to remain in such a position If the patient does not meet this description an alternative equipment system s...

Page 6: ...ays make sure that the brakes are applied on all equipment being used WARNING To avoid the device from tipping and the patient from falling do not sit on the head or foot end of the device WARNING To avoid explosion or fire never use the equipment in oxygen rich environment in presence of heat source or flammable anaesthetic gases CAUTION To avoid equipment damage only lift one end head end or foo...

Page 7: ...ntenance on page 39 9 Prepare an area that is dry with good ventilation and out of direct sunlight for storage of the Carevo 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 Actions Before Every Use 5 Steps 1 Check that all parts are in place Compare with section Parts Designation...

Page 8: ... support standard BAC1101 01 Europe and North America BAC1102 01 Japan BAC1103 01 Australia Length 2000 mm 78 3 4 inches Carevo shower trolley with an adjustable back support BAC1111 01 Europe and North America BAC1112 01 Japan BAC1113 01 Australia Length 2000 mm 78 3 4 inches ...

Page 9: ...rally positioned over the flexi zone See Fig 1 The caregiver needs to be positioned at the head end of the Carevo shower trolley during transport In case of an emergency the caregiver will be close to the emergency stop button See Fig 2 NOTE The Carevo shower trolley is designed with a slight tilt down towards the drain Fig 1 Flexi zone Head end Foot end Fig 2 Emer gency stop Transport direction ...

Page 10: ...ate 11 Support plates one for the head end and one for the foot end 12 Shower handle holder 13 Flexi zone 14 Comfort handles 15 Head panel 16 Side support one on each side of the Carevo shower trolley 17 Pillar 18 Castor base 19 Drainage hose holders 20 Foot panel 21 Mattress guides 22 Drainage plug 23 Emergency stop button 24 Battery 25 Battery compartment 26 Straight steering lever green lever o...

Page 11: ...11 3 8 7 9 23 15 1 2 6 12 21 8 18 25 17 19 4 5 24 10 22 2 20 11 13 16 14 26 ...

Page 12: ...he brakes Press down on the gray castor brake lever See Fig 3 Release the brakes Slightly kick up the gray castor brake lever See Fig 4 Straight Steering Device Most often used when one caregiver is transporting the Carevo shower trolley For easier manoeuvring in corridors and around corners use the straight steering device The straight steering devices are green and located on two castors diagona...

Page 13: ... See Fig 2 It is designed for the caregiver to be able to stand in a more ergonomic posture and be able to reach the patient better Flexi Zone The flexi zone is constructed as a suspension area to distribute pressure on the patient s lower back coccyx and hips See Fig 3 For an optimal comfort level position the patient s buttocks centrally in the flexi zone The mattress has a graphic outline with ...

Page 14: ...p on the side support and let the side support fall towards you See Fig 3 Fold up the side support from down folded position Pull the side support up Depending on the speed of the side support being pulled it can lock in either the outer or inner position For the outer position pull up more slowly See Fig 4 Change between inner position and outer position Lift the opening handles and raise lower t...

Page 15: ...the position of the drainage outlet and let the mattress guides fall into the mattress guide holes located on the support plates See Fig 2 Remove 1 Remove the drainage plug from the mattress 2 Pull the mattress up and away from the support plates See Fig 3 CAUTION To avoid the Carevo shower trolley adjustable back support from electrical overheating during constant use of lowering raising make sur...

Page 16: ...ull it down See Fig 2 Attach the lower drainage Push the lower drainage with the drainage connector up to the upper drainage until it clicks into place See Fig 3 Position of drainage hose during transport storage Connect the lower drainage outlet to the drainage hose holder located on the foot panel See Fig 4 Position of drainage hose during a shower Connect the lower drainage outlet to the draina...

Page 17: ...ne For the patient the attached shower handle can be used to sprinkle water over the patient to keep him her warm Battery The battery is located under the head panel The Carevo shower trolley uses the NEA0100 083 battery See Fig 3 The rounded ridge of the battery needs to be upward when inserting it into the Carevo shower trolley battery compartment See Fig 4 Remove the battery by pulling it strai...

Page 18: ...sition the Carevo shower trolley next to the bed s transfer side 8 Fold down the Carevo shower trolley mattress on the transfer side Press down and fixate the Carevo shower trolley mattress corners between the head foot panel and support plate See Fig 2 9 Adjust the Carevo shower trolley height so that its slightly lower than the bed See Fig 3 Push the Carevo shower trolley against the bed Continu...

Page 19: ...n the graphic outline on the mattress See Fig 7 The patient s hip creases should be aligned with the illustrated human figure Use the sliding aid to adjust the patient s position See Fig 8 Continue with the steps on the next page 11 WARNING To avoid falling during a transfer always make sure that the brakes are applied on all equipment being used 12 WARNING To avoid the device in use from tipping ...

Page 20: ...e Carevo shower trolley See Fig 11 19 Adjust the Carevo shower trolley to an ergonomic height See Fig 12 20 Raise the Carevo shower trolley adjustable back support if available See Fig 12 21 Transport the patient to the bath room 18 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 ...

Page 21: ...echnique See Fig 2 7 Release the castor brakes on the Carevo shower trolley See Fig 3 8 Position the Carevo shower trolley close to the bed with enough space to later fold down the Carevo shower trolley side support on the transfer side 9 Adjust the Carevo shower trolley height so that it is slightly higher than the bed Position the Carevo shower trolley close to the bed and fold down the Carevo s...

Page 22: ...re to keep an eye on the patient s head during the transfer Examples of transfer with a sliding aids are Tube See Fig 7 Sliding sheet See Fig 8 Continue with the steps on the next page 12 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 13 WARNING To avoid falling during a transfer always make sure tha...

Page 23: ...e the sliding aid under the patient Use local technique See Fig 9 18 Release the castor brakes on the Carevo shower trolley See Fig 10 19 Move the Carevo shower trolley away from the bed 20 Disinfect the Carevo shower trolley See section Cleaning and Disinfection Instructions on page 34 See Fig 11 Fig 9 Fig 10 Fig 11 ...

Page 24: ...evo shower trolley See Fig 2 Lower the patient in the sling onto the Carevo shower trolley Use the space under the Carevo shower trolley castor base for better positioning of the lift legs See Fig 2 Continue with the steps on the next page 6 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 ...

Page 25: ...shower trolley to an ergonomic height See Fig 5 11 Lower the Carevo shower trolley adjustable back support if available See Fig 5 12 Remove the sling from underneath the patient Use local technique See Fig 6 13 Release the castor brakes on the Carevo shower trolley 14 Raise the Carevo shower trolley adjustable back support if available 15 Transport the patient to the bath room 7 WARNING To make su...

Page 26: ...evo shower trolley adjustable back support if available See Fig 2 4 Apply the sling on the patient Use local technique See Fig 3 5 Lower the Carevo shower trolley to lowest height 6 Raise the Carevo shower trolley adjustable back support if available for comfort and easier attachment of sling 7 Position the lift s spreader bar over the Carevo shower trolley 8 Attach the sling to the spreader bar S...

Page 27: ...id 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 out of the device make sure that all side supports are in a locked position NOTE If the height of the lift is not enough to go over the Carevo shower trolley then fold down the side support on one side Fig 5 Fig 6 ...

Page 28: ... is right above the floor drain See Fig 2 2 Apply all four castor brakes on the Carevo shower trolley See Fig 3 3 Adjust the Carevo shower trolley to an ergonomic height 4 Undress the patient Use the adjustable back support if available for better assistance 5 Set the water temperature First grab the shower handle and direct it away from the patient Then turn the water on See Fig 4 Continue with t...

Page 29: ...xt page NOTE Use the ergo access area to better reach the patient Remember to move around the Carevo shower trolley to avoid twisting and leaning forward when standing in the ergo access area TIPS Use the shower handle holder on the Carevo shower trolley for more effective work flow Use it for sprinkling water over the patient to keep him her warm during the shower routine See Fig 6 Fig 5 Fig 6 Fi...

Page 30: ... the lower drainage outlet back in the drainage hose holder under the foot panel or attach the lower drainage to the upper drainage See Fig 10 12 Release the castor brakes on the Carevo shower trolley See Fig 11 13 Transport the patient See Fig 12 Fig 9 Fig 10 Fig 11 Fig 12 ...

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Page 32: ...dure described in this IFU always is carried out before and after any type of service procedure Using the Shower Trolley Before using the Carevo shower trolley in home environment make sure that See Fig 1 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 stai...

Page 33: ...33 Fig 1 ...

Page 34: ...a physician Always read the IFU and the Material Safety Data Sheet MSDS of the disinfectant WARNING To prevent cross contamination always follow the disinfection instructions in this IFU WARNING To avoid eye and skin irritation never disinfect in the presence of a patient CAUTION To avoid damage on the equipment only use Arjo branded disinfectants Chlorine will bleach the mattress Allowed Disinfec...

Page 35: ...trolley with water Start from the top of the mattress down towards the castors See Fig 3 5 Scrub the Carevo shower trolley with disinfectant using a soft bristle cleaning brush to remove contamination Start from the top of the mattress moving down towards the castors 6 Use a bottle brush soaked in disinfectant to clean the upper drainage 7 Remember to clean the underside of mattress support plates...

Page 36: ...t end foot panel side supports support plate flexi zone and upper drainage with a disposable towel 17 Spray disinfectant on the upper drainage and clean it with a bottle brush 18 Place the mattress in its original position 19 Spray disinfectant and clean the outside of the Carevo shower trolley with a disposable towel Start from the top of the mattress moving down towards the castors 20 Allow a di...

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Page 38: ...on Inhalation of the contents can cause respiratory irritation Provide fresh air and medical attention CAUTION To avoid the battery from overheating and exploding do NOT expose the battery to flames or excessive heat Charging Intervals To prolong the life of the battery charge it at regular intervals i e every night If the Carevo shower trolley is used frequently it is recommended to use two batte...

Page 39: ...nd 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 CAREGIVER OBLIGATIONS Action Check Every USE Every WEEK Every YEAR Clean Disinfect X Visually check all exposed parts X Visually check mechan...

Page 40: ...e e g cuts and tears Replace damaged parts or contact qualified personnel Check mechanical attachments Check the two screws on both sides of the opening handles Check the attachment of the pillar both upper and lower attachment See Fig 2 Perform functionality test See Fig 3 Check opening handles on the side supports and that they lock properly Check the adjustable back support if available Check t...

Page 41: ...Personnel only The Carevo 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 NO...

Page 42: ...trolley can only be lowered not raised Change to a fully charged battery Only a few activities are carried out before the battery indicator will flash and sound 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 The Carevo shower trolley mak...

Page 43: ... replace the damaged control panel 3 Make sure that the emergency stop button is inactivated To inactivate turn the emergency stop button clockwise 4 Check that the battery is correctly inserted in the battery compartment 5 Make sure the battery is charged 6 Contact qualified personnel The opening handles will not lock 1 Remove the patient and make a visual check 2 Contact qualified personnel The ...

Page 44: ...ial performance Medical equipment Type BF Operating forces Control buttons Brake Straight steering Emergency stop button Opening handles 5 N 70 N Activate 50 N Release 20 N Activate 20 N Release 25 N 30 N Lift nominal voltage 24 VDC Battery part number NEA0100 083 Battery type NiMH Nickel metal hydride Battery capacity 2 5 Ah Battery voltage 24 V DC Battery Charger part number NEA 8000 Maximum dut...

Page 45: ...104 F Operating 20 C to 70 C 4 F to 158 F Transport 20 C to 70 C 4 F to 158 F Storage Humidity 15 95 at 20 C 68 F Operating 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 Recycling Package Wood and corrugated cardboard Recyclable End of Life Disposal All batteries in the product mu...

Page 46: ...38 2005 79 605 23 3 4 1144 5 45 1315 51 3 4 1210 5 47 3 4 955 37 1 2 Highest position Lowest position Stroke between the highest A and the lowest B position is 350 mm 13 3 4 A B Dimensions Measurements in mm and in inches ...

Page 47: ...47 888 35 700 27 1 2 57 2 1 4 759 29 3 4 203 5 8 152 6 586 23 2030 80 Foot end view Turning radius Measurements in mm and in inches ...

Page 48: ... Ah Capacity Type BF Applied part protection against electrical shock in accordance with IEC 60601 1 Read the IFU before use Manufacturing date Separate electrical and electronic components for recycling in accordance with the European Directive 2012 19 EU WEEE kg lbs kg lbs kg lbs Emergency stop label Mode of operation ED Adjustable back support Duty Cycle 2 minutes ON 18 minutes OFF Lift Duty Cy...

Page 49: ...ication Label Data Label Identification Label on the Pillow Battery Label Identification Label Data Label Identification Label on the Pillow Battery Label Identification Label on the Mattress Emergency Stop Label ...

Page 50: ...ical Equipment Part 1 General Requirements for Basic 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 ISO 10535 2006 Hoists for the transfer of disabled persons Requirements and test methods EN IEC 60601 1 11 2015 Requirements for medical electrical equipment and medical electrical syste...

Page 51: ...51 Intentionally left blank ...

Page 52: ...twork 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 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 ve...

Page 53: ...Hz 80 AM at 1 kHz Proximity fields from RF wireless communications equipment EN 61000 4 3 385 MHz 27 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 385 MHz 27 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 Electrical fast transient burst EN 61000 4 4 1kV SIP...

Page 54: ...0 mm 59 8564162 1500 Length 2000 mm 78 3 4 8564162 2000 Shower Hose PP0998 For disinfectant contact the local Arjo representative Battery NEA0100 083 Battery charger NEA 8000 Shower Panel BCA 1207 1204 1202 1201 04 1217 1214 1212 1211 04 1227 1224 1222 1221 04 Sink BDA0815 0816 90 Flush sink BDA 0891 04 80 40 50 60 70 20 30 MIX 80 40 50 60 70 20 30 MIX ...

Page 55: ...ail Italy promo arjo com MIDDLE EAST Arjo Middle East FZ LLC Of ce 908 9th Floor HQ Building North Tower Dubai Science Park Al Barsha South P O Box 11488 Dubai United Arab Emirates Direct 971 487 48053 Fax 971 487 48072 Email Info ME arjo com NEDERLAND Arjo BV Biezenwei 21 4004 MB TIEL Postbus 6116 4000 HC TIEL Tel 31 0 344 64 08 00 Fax 31 0 344 64 08 85 E mail info nl arjo com NEW ZEALAND Arjo Lt...

Page 56: ...re 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 WKH VWDQGDUG RI VDIH DQG GLJQL HG FDUH YHU WKLQJ ZH GR ZH GR ZLWK SHRSOH LQ PLQG ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö Sweden www arjo com ...

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