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Summary of Contents for AKS foldy micro
- Page 1 foldy® micro Patient hoist Instructions for use Translation of the original instructions for use...
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Page 2: Table Of Contents
foldy® micro TABLE OF CONTENTS 1 Introduction ____________________________________________________________ 4 _____________________________________________ 6 Explanation of the symbols used 2 Intended use ____________________________________________________________ 7 _______________________________________________________ 7 Intended purpose _____________________________________________________________ 8 Indication ________________________________________________________ 8 Contraindication ____________________________________________________________ 8 Side effects 3 Safety instructions _______________________________________________________ 9 __________________________________________ 9 Explanation of the groups referred to ________________________________________________ 11... - Page 3 foldy® micro 15 Service life _____________________________________________________________ 51 16 Disposal _______________________________________________________________ 52 17 Warranty ______________________________________________________________ 54 18 Declaration of conformity ________________________________________________ 54 19 Maintenance ___________________________________________________________ 55 ___________________________________________ 55 19.1 General maintenance instructions ________________________________ 57 19.2 Maintenance schedule: Inspection by the operator ___________________________________ 64 19.3 Maintenance schedule: Inspection by the user...
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Page 4: Introduction
If you have any difficulty reading these instructions for use (e.g. due to the font size), you can always download the current version of these instructions for use as a PDF document from the aks website Open the PDF document and adjust the display on your screen according to your needs. - Page 5 • Mechanical emergency lowering, emergency stop switch in the event of electric faults • With optional separate wall charging station Using the product in combination with a suitable aks hoist sling (see chapter Accessories/ combinations) means a better quality of life for the patient and makes work easier for the user.
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Page 6: Explanation Of The Symbols Used
foldy® micro Explanation of the symbols used For ease of reading, these instructions for use employ the following symbols to indicate important information: Warning of danger Indicates safety instructions that must be observed under all circumstances in order to avoid an immediate danger to life and limb (risk of serious or fatal injury). Warning of hand injuries Indicates safety instructions for avoiding crushing injuries. -
Page 7: Intended Use
The product is intended for holding, transporting and changing the position of patients with restricted mobility. It may only be used in combination with a matching aks hoist sling (see chapter Accessories/combinations). The product is designed exclusively for holding patients, transporting them across short distances, and changing their position. -
Page 8: Indication
foldy® micro Indication The products are intended for patients who, due to an illness, injury, disability or their age, suff er from reduced mobility. Contraindication Pathologies such as osteogenesis imperfecta, advanced osteoporosis, spinal damage, mental confusion, epileptic fits, sensitivity to contact pain or generalised oedemas in the contact area may be contraindications. -
Page 9: Safety Instructions
foldy® micro Safety instructions The safety instructions apply to all and any persons who perform work in any way with or on the product (incl. accessories). Where a specific group is addressed, this does not exclude any other persons. Read and observe the safety instructions. The safety instructions comprise text or a combination of a symbol with text. - Page 10 foldy® micro Electrically instructed persons are persons who have been instructed and, if necessary, trained by a qualified electrician regarding their assigned tasks and the possible hazards in the event of improper behaviour, as well as regarding the necessary safety equipment and safety measures. In the context of these instructions for use, the word user refers to the person who uses (operates) the medical device (incl.
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Page 11: General Safety Instructions
foldy® micro General safety instructions Training is required in the proper handling of the product (incl. accessories). The training must be documented in an appropriate form. The training must be conducted on the product itself in accordance with the instructions for use, and must observe all the contents of said instructions for use. - Page 12 For hygiene reasons, always use the hoist sling for the same patient. Use only original aks accessories/spare parts in order to avoid danger (see the chapter in the on Accessories/combinations). ement atient.
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Page 13: Safety Instructions For The Operator
foldy® micro Safety instructions for the operator Prior to initial use and every reuse, train the user on the product itself (incl. accessories) on the basis of the instructions for use, explain the safety instructions, test the effectiveness of the training, and properly document said training. - Page 14 foldy® micro If relatives take over responsibility for the patient’s care, check that these relatives are in a position to consult a health care professional when in doubt. Explain to the users when they should ask a health care professional for advice, e.g.: •...
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Page 15: Safety Instructions For The User
foldy® micro Safety instructions for the user Arrange for the operator (e.g. your responsible medical supply store/authorised dealer) to train you in the safe handling of the product (incl. accessories) using the product itself, in accordance with the instructions for use. Only use the product (incl. -
Page 16: Scope Of Delivery
Scope of delivery Cardboard box Content foldy® micro Chassis foldy® micro Stand mast Battery pack (removable) Manual control unit aks patient hoist foldy® micro Bag containing: foldy® micro Mains adapter with European plug Instructions for use Spreader bar (depending on order) -
Page 17: Product Overview
foldy® micro Product overview Power supply line Mains adapter Lifting arm Ergonomic grab handle Spreader bar with padding Removable battery pack Mechanical emergency Manual control lowering unit Control unit with emergency stop Lift drive button Stand mast Stand mast Clamping holder lever Foot pedal... - Page 18 Different aks spreader bars (see chapter Accessories/ combinations) can be mounted on the lifting arm to attach the different aks hoist slings. The necessary electrical energy is provided by a powerful 24 V removable battery pack on the control unit.
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Page 19: Assembly
General assembly instructions Locking plate aks patient hoists are secured at several connection points with a pin with a locking plate. This locking plate enables fast installation and dismantling of individual components without tools, particularly when assembling and folding up the patient hoist and when attaching or replacing a spreader bar. -
Page 20: Assembly Of The Patient Hoist
foldy® micro Assembly of the patient hoist Install and remove the product in line with the specifications in these instructions for use, observe the safety instructions and use protective materials placed on the ground (e.g. cardboard/packaging material) to prevent damage to the flooring. Remove the patient hoist from the packaging. Retain the packaging for future transport or storage of the product. - Page 21 foldy® micro Fig. 6.2.04 – Stand mast installed Fig. 6.2.03 – Dismantling the clamping lever Remove the pin with the locking plate from the retaining plate on the lifting arm and from the lift drive (Fig. 6.2.05). Detach the lift drive which is fastened on the side of the stand mast with cable ties for transport (Fig. 6.2.04).
- Page 22 foldy® micro 11. To mount the spreader bar, open the bar padding (plate). Remove the locking plate and then remove the pin from the hole on the end of the lifting arm. This separates the retaining bolt with collar from the lifting arm (Fig. 6.2.08). 12.
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Page 23: Accessories: Wall Charging Station - Assembly
foldy® micro Accessories: wall charging station – assembly The wall charging station combined with a second battery pack enables continuous use of the product, particularly in the in-patient area. Before commissioning, the wall charging station should be installed on a wall. Inspect the product for damage and defects before assembly. -
Page 24: Commissioning
foldy® micro Commissioning Before commissioning the product for the first time, and every time it is reused, check that the product (incl. accessories) is in safe condition based on the maintenance information in the chapter on Maintenance. Before the product (incl. accessories) is reused, always clean and disinfect it in accordance with the instructions given in the chapter on Cleaning/disinfecting. -
Page 25: Operation
Operation The products (incl. accessories) have been developed for use with an aks hoist sling. Before and during each use of the product, note the following information: Inspect the product at regular intervals (see the section Maintenance schedule: Inspection by the user in the maintenance chapter). -
Page 26: Castors
The product can generally be used on tiles, carpets, laminate flooring and linoleum without any problem, though care should be taken to ensure that any damage that does occur is noticed at an early stage. aks GmbH accepts no liability for damage arising from everyday use on floors. -
Page 27: Manual Control Unit
foldy® micro Manual control unit In order to perform the electrically powered functions, press the corresponding function button on the manual control unit until the desired position is reached (Fig. 8.3.01). If you hear a signal tone when you press a button, this indicates that the battery pack is insufficiently charged. -
Page 28: Spreading
foldy® micro Spreading The chassis is fitted with a spreader function. This function makes it possible, if necessary, to adjust the chassis to the width of the patient’s seat or to increase the stability. Ensure there is sufficient freedom of movement for the spreading. Make sure there are no objects or limbs within the adjustment range. -
Page 29: Emergency Stop Button
foldy® micro Emergency stop button The product is fitted with an emergency stop button. This allows you to interrupt the electricity supply immediately in the event of an emergency. To interrupt the power supply, press the red emergency stop button on the control unit (Fig. 8.5.01). -
Page 30: Battery Pack
foldy® micro Battery pack There are two lead gel batteries in the removable battery pack. The batteries are maintenance-free and have to be recharged at regular intervals. There is no memory effect for the batteries. New, freshly charged batteries have a capacity of approx. 40 lifting/uprighting cycles under full load. Do not charge the battery pack in wet areas. - Page 31 foldy® micro Removal and installation of the battery pack The battery pack can be removed from the product without tools. This makes it possible to change the battery pack quickly. It also enables separate charging on a wall charging station, which is available as an accessory.
- Page 32 Fig. 8.7.05 – Control unit with charging socket Fig. 8.7.06 – Mains adapter with power supply line The aks patient hoist does not function with a mains adapter connected to the mains supply! Improper handling can result in damage to the mains adapter and in hazards such as electric shock.
- Page 33 foldy® micro Proceed as follows to charge the battery pack: Actuate the emergency stop button (see chapter on operation, section Emergency stop button). If you do not do this, there is a risk of the drives being activated during charging. Connect the mains adapter via the power supply line (Fig. 8.7.06) to the charging socket on the control unit (Fig. 8.7.07).
- Page 34 3 days, they are defective and must be replaced. Do not use the aks patient hoist for lifting anymore if the capacity indicator light in the manual control unit lights up red or if the warning tone sounds. In the case of non-observance, damage to the batteries cannot be ruled out.
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Page 35: Shutdown Times
foldy® micro Accessories – charging the battery pack with the wall charging station Remove the battery pack and place it on the wall charging station, as described in the previous section Removal and installation of the battery pack. Check the power supply line of the wall charging station for damage. In case of damage, do not use the wall charging station. -
Page 36: Patient Transport
The type and size of the hoist sling always depends on the stature of the patient and the type of use. aks GmbH provides a wide range of hoist slings (see chapter on Accessories/combinations) that are suited to the respective requirements. - Page 37 foldy® micro The product (incl. accessories) may only be used after careful consideration of the individual patient. The suitability of the product (incl. accessories) for the patient must be checked at regular intervals (e.g. in case of physical changes [amputation] or weight gain/loss).
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Page 38: Lifting From A Lying Position
Lifting from a lying position Using the aks standard sling (Fig. 9.2.01) as an example, these instructions for use describe how to attach a hoist sling and lift a patient from a lying position (for descriptions of other hoist slings and application cases, see the instructions for use for the hoist sling in question). - Page 39 (Fig. 9.2.03). Make sure that the leg loops are the same length. The shoulder loops are now near the patient’s right and left shoulders. Slowly and carefully move the aks patient hoist towards the patient, taking care to avoid injuries caused by a collision.
- Page 40 10. Attach the shoulder loops to the hooks on the spreader bar as described in the Preparation chapter, section Spreader bar of the aks patient hoists (in the instructions for use for the hoist sling in question). Ensure the attachment positions are identical here too, which you can identify by the colour coding on the loops (see Preparation chapter, section Sling loops - instructions for use for the hoist sling in question).
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Page 41: Accessories/Combinations
Combinations that have not been approved by aks GmbH can cause hazards. The following tables list the combinations that have been checked and approved by aks GmbH for safe use - of the aks patient hoists described in these instructions for use. - Page 42 The following table summarises the combinations of aks hoist slings with the products described in these instructions for use that have been checked and approved by aks GmbH for safe use. aks hoist slings Application/...
- Page 43 Application/ Horizontal posture transport Standard Tandem Product REF / SIZE spreader bar spreader bar spreader bar (8-point attach- ment) 88735 88736 Comfort hygiene sling 88737 88738 88739 88786 88787 Hygiene sling with back ...
- Page 44 Latest REF available on request. Compatibility Our hoist slings for lifting hoists can be used with all aks hoists and with a number of hoists from other manufacturers. Please note our declaration of compatibility for hoist slings. This can be found on our website: www.aks.de If hoist slings from another manufacturer are used, the combination must be approved.
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Page 45: Troubleshooting
Manual control unit plug not plugged Plug in manual control unit in or not plugged in correctly Wait until charging is complete; then aks patient hoist does not lift/ Patient hoist connected to mains disconnect the mains adapter from aks patient hoist does not spread... -
Page 46: Cleaning/Disinfecting
foldy® micro 12 Cleaning/disinfecting Cleaning: Achieving a state of cleanliness (visible). Removal of contamination to the extent required for the intended purpose of the product. Disinfection: Reducing the number of or destroying microorganisms (not visible). Procedure designed to reduce the number of viable micro-organisms to a pre-defined acceptable level appropriate to the intended purpose of the product. -
Page 47: General Cleaning And Disinfecting Instructions
foldy® micro Never clean the product, particularly the electrical system, with a high pressure cleaner, water hose or in a continuous batch washing system because the surfaces and seals can be damaged and/or water can penetrate. Never submerge the product in liquid. Do not subject the product to mechanised cleaning/disinfection. Failure to observe the safety instructions can result in significant damage to the product, and may have further aftereffects. -
Page 48: Cleaning By The User/Operator
(dosage) and exposure time. Always use cold water (max. 30°C) when diluting disinfectants. The following disinfectants and disinfection methods have been tested and approved by aks GmbH. Wipe disinfection Effectiveness* Manufacturer of disinfectant Designation / active ingredient (degree of disinfection) -
Page 49: Storage
foldy® micro 13 Storage The storage location should be as cool and dry as possible and not exceed normal room temperature. The climatic conditions are described in the chapter on Technical data and must be complied with. Ensure damage and continual strain are ruled out during the storage period. Do not place anything on the product that could damage it (e.g. -
Page 50: Shutdown
foldy® micro 13.1 Shutdown If the product is no longer to be used and is to be removed from service, proceed as follows: Brake the two rear castors on the operator side by activating the foot lever (Fig. 13.2.03) (see chapter on Operation, section Castors). Move the lifting arm to its lowest position (see chapter on Operation, section Manual control unit). -
Page 51: Reuse
foldy® micro 14 Reuse The products described in the instructions for use are suitable for reuse. Before reusing the product in question (e. g. in the event of a change of patient), make sure that it has been cleaned and disinfected as described in the chapter on Cleaning/disinfecting and serviced as described in the chapter on Maintenance, and that any defects or damage found has been repaired by the appropriate qualified personnel and/or the components in question replaced. -
Page 52: Disposal
The fact that aks GmbH specifies an expected service life/useful life for the products does not represent an additional guarantee. The product has been tested successfully with 11,000 lifts for endurance functionality according to EN ISO 10535. - Page 53 The general terms and conditions of aks GmbH apply to these returns. Batteries can contain hazardous substances that may harm the environment or human health if they are stored or disposed of improperly.
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Page 54: Warranty
Before using the product on parquet/natural wood floors, check whether the floor sealant is suitable for preventing the castors from causing damage (e.g. discolouration). Aks GmbH accepts no liability for damage arising from everyday use on floors (see chapter on operation, section Castors). -
Page 55: Maintenance
Removed, defective/damaged electrical components may only be checked and evaluated by a qualified electrician or aks GmbH. Do not carry out any repairs on the product that would alter the product characteristics. If this instruction is not observed, a safe power supply can no longer be guaranteed. - Page 56 Only original aks spare parts and aks accessory parts that are approved for this product may be used (see chapter on Accessories/combinations). Otherwise, any warranty claims and product liability are excluded. You must not make any technical modifications and additions without permission from aks GmbH.
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Page 57: Maintenance Schedule: Inspection By The Operator
First time use (YYYY/MM) __________/_____ Last inspected on: ______________________ by: ____________________ Inspection prior to initial commissioning by: ____________________ conducted on: _____________ Data for the aks patient hoist Date of manufacture (YYYY/MM) __________/_____ ________________________________________ Inventory number: _______________________________ UDI-DI aks patient hoist Version with locking plate... - Page 58 The following maintenance schedule provides help for this inspection: Item Inspection of the aks patient hoist – check points Check of the basic requirements Appropriate and safe use (no collision points for the lifting/uprighting function and during transfer)
- Page 59 foldy® micro Item ../Visual inspection of the mechanical parts Spreader mechanism, mechanical spreading: both rubber caps present on the foot 2.20 pedal (see chapter on Operation, section Spreading) Retaining bolt with collar (fixes the spreader bar) Collar height must be at least 4 mm (see Figure 21.01), must be replaced if there are signs of wear (e.g.
- Page 60 Adjustable elements: Stand mast can be adjusted as intended and secured with the 4.17 connecting elements Adjustable elements: Lifting arm can be adjusted as intended and secured with the 4.18 connecting elements Overall assessment of the aks patient hoist Maintenance schedule continues on next page. Page 60...
- Page 61 No wear (e.g. worn/abraded areas) Spreader bar padding present and undamaged (e.g. tears, holes, blistering, worn areas) Exception: aks horizontal transport spreader bar with 8-point attachment (no padding) Caps and dummy plugs present and undamaged All hooks present, undamaged and not bent...
- Page 62 Perform maintenance of the aks hoist sling at least every six months and before each reuse. EN ISO 10535 specifies the following among other things in Annex B: “Periodic inspection of a flexible bodily support system should be performed at the intervals specified by the manufacturer, but at least every 6 months.
- Page 63 (see chapter on Operation, section Battery pack) Overall assessment of the wall charging station accessory Overall assessment of aks patient hoist, aks spreader bar, aks hoist sling and wall charging station (optional) aks patient hoist and accessories are in order: ...
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Page 64: Maintenance Schedule: Inspection By The User
No wear (e.g. worn/abraded areas) Spreader bar padding present and undamaged (e.g. tears, holes, blistering, worn areas) Exception: aks horizontal transport spreader bar with 8-point attachment (no padding) Caps and dummy plugs present and undamaged All hooks present, undamaged and not bent... - Page 65 foldy® micro Inspection of the wall charging station accessory – check points No damage to plugs, power supply line, case, rating plate and display Green LED indicates that the power supply line is connected properly (see chapter on Operation, section Battery pack) Yellow LED indicates the charging process (see chapter on Operation, section Battery pack) Power supply line: routed correctly, undamaged, not crushed/shorn, no risk of catching...
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Page 66: Product Labelling
foldy® micro 20 Product labelling Fig. 20.01 – foldy® micro Colour: Water blue, RAL 5021 Page 66... - Page 67 Product labelling Item Item Sticker Date of manufacture Rating plate (technical) Rating plate (organisational) Sticker aks patient hoist aks patient hoist Maximum load (SN: 10-digit) (SN: 10-digit) Sticker Safety instruction for Follow instructions locking plate for use Product sticker...
- Page 68 Use: sitting and lying Only use in combination with aks standard spreader bar Only use in combination with: aks tandem spreader bar or goliath® comfort spreader bar Only use in combination with: aks horizontal transport spreader bar with 8-point attachment Page 68...
- Page 69 foldy® micro Explanation of the symbols EN ISO 15223-1 Observe instructions for use Attention Manufacturer Date of manufacture Article number Serial number Air pressure, limit Humidity, limit Temperature, limit Keep dry/store in a dry place Protect against heat/sunlight Fragile, handle with care Explanation of the symbols IEC 60417 For indoor use only...
- Page 70 foldy® micro 223-1 Explanation of the care symbols EN ISO 3758 Coloured wash (normal washing cycle) Washing temperature 60 °C, normal process Do not bleach Use bleach-free detergents Dry with reduced thermal load Dry at low heat setting (maximum approx. 60 °C) Do not iron Do not dry clean Protection type of the enclosure acc.
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Page 71: Technical Data
foldy® micro 21 Technical data ca. 25 X (1 : 2) Referenz- körper 1 Bewegungsrichtung Direction of motion VORWÄRTS FORWARD ca. 25 Referenz- körper 2 Fig. 21.01 – foldy® micro - Dimensional drawing Dimensions (L x W x H): 1,020 x 570 x 1,210 Page 71... - Page 72 foldy® micro General information on the product Classification active class I medical device according to Regulation (EU) 2017/745, Appendix VIII Basic UDI DI 425181871881013HG Maximum load [kg] Operating force for the < 5 manual control unit [N] Ambient temperature 5 to 35 [°C] Transport/storage -10 to 50...
- Page 73 foldy® micro Additional information on the products - Steel (powder-coated or galvanised) - Commercially available plastics (POM, ABS, PP, PVC, PA6.6) Materials used - Rubber - PUR foam - Polyester Sound pressure level 51 dB(A) at a distance of 1 m Electrical data ilcon GmbH Mains adapter...
- Page 74 foldy® micro Notes: Page 74...
- Page 75 foldy® micro Enter the data for your product here: Type: foldy® micro foldy® mini foldy® e mini foldy® foldy® e foldy® XL foldy® e XL clino® II clino® XL clino® e XL ...
- Page 76 Reprints whether in whole or in part are only allowed with prior permission by the publisher. All rights reserved, particularly the right to make technical amendments. Printing errors excepted.
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