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Electromagnetic compatibility

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

Carevo

is intended for use in the electromagnetic environment

specified below. The customer or the user of the

Carevo

should assure that it is used in such an environment.

WARNING

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

WARNING

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

Guidance and manufacturer's declaration - electromagnetic emissions

Emissions test

Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

Carevo

uses RF energy only for its internal function. Therefore, its RF emis-

sions are very low and are not likely to cause any interference in nearby elec-
tronic equipment.

RF emissions
CISPR 11

Class B

Carevo

is suitable for use in all establishments, those directly connected to the

public low-voltage power supply network that supplies buildings used for
domestic
purposes.

EN 61000-4-8

3A/m at 50/
60 Hz

Magnetic Immunity: If functional disturbance occurs on the

Carevo

it may be necessary to move the

Carevo

further from the source

of power frequency magnetic field. The power frequency magnetic field
should be measured in the intended use locations to assure that it is
sufficiently low.

Guidance and manufacturer's declaration - electromagnetic immunity

Emissions test

IEC 60601 test level

Compliance
level

Electromagnetic environment - guidance

Electrostatic
discharge (ESD)
IEC 61000-4-2

6 kV contact
8 kV air

6 kV contact
8 kV air

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

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Содержание Carevo

Страница 1: ... with people in mind Carevo 04 BA 08_9US CA September 2014 INSTRUCTIONS FOR USE ...

Страница 2: ...ons for Use Design Policy and Copyright and are trademarks belonging to the ArjoHuntleigh group of companies ArjoHuntleigh 2013 As our policy is one of continuous improvement we reserve the right to modify designs without prior notice The content of this publication may not be copied either whole or in part without the consent of ArjoHuntleigh ...

Страница 3: ...ress 15 Drainage Plug 16 Drainage 16 Head Pillow 17 Shower Handle Holder 17 Battery 17 Transfer from Bed to Carevo 18 Transfer from Carevo to Bed 21 Transfer from Sling Lift to Carevo 24 Transfer from Carevo to Sling Lift 26 Shower the patient in the Carevo 28 Home Care Use 32 Cleaning and Disinfection Instructions 34 Battery Instructions 38 Care and Preventive Maintenance 39 Alarms and Sounds 42 ...

Страница 4: ... if any unexpected operations or events occur The contact information appear on the last page of this IFU Service and Support A service routine must be performed on your Carevo every year by qualified personnel to make sure the safety and operating procedures of your product See section Care and Preventive Maintenance If you require further information please contact ArjoHuntleigh for comprehensiv...

Страница 5: ...ing 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 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 shall be used Prior to tra...

Страница 6: ...a transfer always 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 h...

Страница 7: ...ry with good ventilation and out of direct sunlight for storage of the Carevo 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 the Parts Designation list in this IFU 2 Carry out a thorough inspection for damage inc...

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

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

Страница 10: ...e 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 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 on two castors Ent...

Страница 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 ...

Страница 12: ...e 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 For easier manoeuvring in corridors and around corners use the straight steering device The straight steering devices are green and located on two castors diagonally from each other Apply the straight st...

Страница 13: ...or 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 an illustrated human figure...

Страница 14: ...e 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 the side...

Страница 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 adjustable back support from electrical overheating during constant use of lowering raising make sure to lower rais...

Страница 16: ...own 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 drainage hose ...

Страница 17: ...the shower routine 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 Carevo uses the NEA0100 083 battery See Fig 3 The rounded ridge of the battery needs to be upward when inserting it into the Carevo battery compartment See Fig 4 Remove the battery by pulling it straight out Low charge...

Страница 18: ...own the bed rail on the transfer side 7 Position the Carevo next to the bed s transfer side 8 Fold down the Carevo mattress on the transfer side Press down and fixate the Carevo mattress corners between the head foot panel and support plate See Fig 2 9 Adjust the Carevo height so that its slightly lower than the bed See Fig 3 Push the Carevo against the bed continue with the steps on the next page...

Страница 19: ...tline on the mattress See Fig 7 The patient s hip creases should be aligned with the illustrated human figure See Fig 8 Use the sliding aid to adjust the patient s position 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 equip ment being used 12 WARNING To avoid the device in use from tipping do NOT raise or...

Страница 20: ...e Carevo See Fig 11 19 Adjust the Carevo to an ergonomic height See Fig 12 20 Raise the Carevo 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 the patient from falling out of the device ma...

Страница 21: ...g aid under the patient Use local technique See Fig 2 7 Release the castor brakes on the Carevo See Fig 3 8 Position the Carevo close to the bed with enough space to later fold down the Carevo side support on the transfer side 9 Adjust the Carevo height so that it s slightly higher than the bed Position the Carevo close to the bed and fold down the Carevo side support on the transfer side See Fig ...

Страница 22: ...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 that the brakes are applied on all equipmen...

Страница 23: ...ient s head 17 Remove the sliding aid under the patient Use local technique See Fig 9 18 Release the castor brakes on the Carevo See Fig 10 19 Move the Carevo away from the bed 20 Disinfect the Carevo See section Cleaning and Disinfection Instructions See Fig 11 Fig 9 Fig 10 Fig 11 ...

Страница 24: ...revo See Fig 2 Lower the patient in the sling onto the Carevo Use the space under the Carevo 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 To avoid the patient from falling out of the...

Страница 25: ...o 10 Adjust the Carevo to an ergonomic height See Fig 5 11 Lower the Carevo 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 14 Raise the Carevo adjustable back support if available 15 Transport the patient to the bath room 7 WARNING To make sure that the patient cannot slip out t...

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

Страница 27: ... 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 then fold down the side support on one side Fig 5 Fig 6 ...

Страница 28: ...bove the floor drain See Fig 2 2 Apply all four castor brakes on the Carevo See Fig 3 3 Adjust the Carevo 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 the steps on the next page 6 WARNING To pr...

Страница 29: ...steps on the next page NOTE Use the ergo access area to better reach the patient Remember to move around the Carevo to avoid twisting and leaning forward when standing in the ergo access area TIPS Use the shower handle holder on the Carevo 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 Fig 7 Fig 8 ...

Страница 30: ...1 Place 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 See Fig 11 13 Transport the patient See Fig 12 Fig 9 Fig 10 Fig 11 Fig 12 ...

Страница 31: ...31 Intentionally left blank ...

Страница 32: ...ure described in this IFU always is carried out before and after any type of service procedure Using the Shower Trolley Before using Carevo 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 stairs and edges have a ...

Страница 33: ...33 Fig 1 ...

Страница 34: ...ician Always read the Instructions for Use and Material Safety Data Sheet of the disinfectant WARNING To prevent cross contamination always fol low the disinfection instructions in these Instructions for Use WARNING To avoid eye and skin irritation never dis infect in the presence of a patient CAUTION To avoid damage on the equipment only use ArjoHuntleigh branded disinfectants Chlorine will bleac...

Страница 35: ...e the Carevo with water Start from the top of the mattress down towards the castors See Fig 3 5 Scrub the Carevo 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 and outsi...

Страница 36: ...arevo foot 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 with a disposable towel Start from the top of the mattress moving down towards the castors 20 Allow a disinfec...

Страница 37: ...37 Intentionally left blank ...

Страница 38: ...ater 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 CAUTION To avoid the battery from overheating and exploding do NOT expose the battery to flames or excessive heat If the Carevo is used frequently it is recommended to use two batteries o...

Страница 39: ...nance 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 CAREGIVER OBLIGATIONS Action Check Every USE Every WEEK Clean Disinfect X Visually check all exposed parts X Visually check mechanical attachments X Perform...

Страница 40: ...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 the rai...

Страница 41: ...at the correct frequency by qualified personnel using correct tools parts and knowledge of proce dures Qualified personnel must have documented training in maintenance of this device QUALIFIED PERSONNEL Action Check Every YEAR Check battery X Check all vital parts for corrosion damage X Perform full feature functionality test X Check mechanical attachments X Check that the latest updates have been...

Страница 42: ... Carevo 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 makes abnormal sou...

Страница 43: ...ged 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 Carevo is hard to...

Страница 44: ...r essen tial performance Medical equipment Type B 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 Max...

Страница 45: ... 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 The device should be recycled according to national regulations Battery Nickel metal hydride Not for disposal only to be recycled Package Wood and corrugated cardboard Recyclable Carevo Electric metal ...

Страница 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 ...

Страница 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 ...

Страница 48: ...2 minutes ON 6 minutes OFF Lift Duty Cycle 2 minutes ON 18 minutes OFF CE marking in accordance with the Medical Devices Directive 93 42 EEC The equipment has been EMC tested and fulfils all requirements according to EN IEC 60601 1 2 Electric safety according to EN 60601 1 4ML5 Certificate control number for UL Type of battery to be used rechargeable Identification Label The Identification label s...

Страница 49: ...otal load 200kg 440lbs 8618849 C NEA0100 083 24 V 2 5 Ah 350 mm 13 4 5 Data label Battery label mattress for Carevo ArjoHuntleigh AB Verkstadsvägen 5 241 38 Eslöv SWEDEN XXXX XX Material PU 8663449 REF Identification label on the pillow Identification label on the mattress pillow for Carevo ArjoHuntleigh AB Verkstadsvägen 5 241 38 Eslöv SWEDEN XXXX XX Material PU 8663465 REF ArjoHuntleigh AB Verks...

Страница 50: ...ertified for Canada TÜV SÜD EN ISO 10535 2006 Hoists for the transfer of disabled persons Requirements and test methods EN12182 2012 Technical aids for disabled persons General requirement and test methods EN IEC 60601 1 Medical electrical equipment EN 60601 1 11 Requirements for medicial electrical equipment and medical electrical systems used in the home healthcare environment ...

Страница 51: ...51 Intentionally left blank ...

Страница 52: ...ance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 Carevo uses RF energy only for its internal function Therefore its RF emis sions are very low and are not likely to cause any interference in nearby elec tronic equipment RF emissions CISPR 11 Class B Carevo is suitable for use in all establishments those directly connected to the public low voltage power supply network that s...

Страница 53: ...0535 2006 10 v m 10 v m 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 ...

Страница 54: ...500 mm 59 8564162 1500 Length 2000 mm 78 3 4 8564162 2000 Shower Hose PP0998 Disinfectant To order contact local 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 ...

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