Anti-decubitus alternating pressure system (64 pages)
Summary of Contents for AKS foldo
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Patient hoist with swivel function Instructions for use Translation of the original instructions for use DIN EN ISO 13485 “Certified quality management system for the development, production and distribution Date: 2024-02-20 of equipment and accessories for patient positioning and patient transport”...
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.
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• Mechanical emergency lowering, emergency stop switch in the event of electric faults Apart from the standard version, the foldo® may in rare cases have a longer lifting and support arm and/or a higher stand mast, depending on the application. For more information, see the chapter Accessories/combinations, section Lifting arm/support arm extension and higher stand mast.
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).
Before commissioning and before each subsequent use, the bathtub dimensions must be measured by your authorised dealer and sent to aks GmbH. aks GmbH will then check these and, if necessary, adjust the foldo® patient hoist and the tub support to the specific situation.
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.
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.
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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.
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.
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Use the product (incl. accessories) in line with its intended purpose only and ust be may have to be modified and approved by aks GmbH. Note the information in the For hygiene reasons, always use the hoist sling for the same patient.
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If you experience any serious incidents involving the product (incl. accessories), please ation in the Use only original aks accessories/spare parts in order to avoid danger (see the chapter ctive patient. contact aks GmbH and the relevant national authorities without delay.
As the operator, make sure that the foldo® patient hoist has been adjusted and Only allow suitable qualified personnel to perform the assembly, commissioning, approved by aks GmbH for the specific place of use.
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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.: •...
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.
Scope of delivery Before you received your foldo®, your authorised dealer surveyed the on-site conditions and transferred the FB 40 05 001 form to aks GmbH. aks GmbH then carried out a technical clarification and compiled the necessary components. The product has already been inspected at the factory to ensure completeness and freedom from defects.
Swivel mast Emergency stop Manual control button unit Lift drive Control unit with batteries Foot pedal for spreading Rear castor with locking device Chassis Double castor Fig. 5.01 – foldo® Figure shows European plug Page 18...
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Various different aks spreader bars (see chapter Accessories/combinations) can be installed on the lifting arm to hold the different aks hoist slings. The swivel mast can be rotated electrically to swivel the lifting arm next to the bathtub.
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.
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.
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Set the stand mast upright (Fig. 6.2.03) and fully align the hole on the stand mast with the lower hole on the stand mast holder. Then secure the stand mast again using the pin and the locking plate (Fig. 6.2.04).
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10. 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. 6.2.06).
(additional possibility for adjusting the cross member to hold the pressure piece) When you send in form FB 40 05 001, aks GmbH carries out a technical clarification so that the tub support delivered to you is designed according to your needs.
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Double telescopic tub support (Fig. 6.3.02) 2 M6 fastening bolts 2 M6 fastening bolts 2 M6 fastening bolts (left-hand cross member) (telescopic tubes) (right-hand cross member with limit cone) Side view: 2 M6 fastening bolts Limit cone Stop bracket (left-hand cross member)
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Slide the limit cone against the inside of the bathtub rim and tighten the two fastening bolts (Fig. 6.3.04). Adjust the length of the tub support by extending the telescopic tubes to the outer edge of the bathtub rim (Fig. 6.3.05). Make sure that the two...
In the case of reuse, you will receive an individual part that you install yourself in order to raise the tub support after the technical clarification by aks GmbH. In both versions of the tub support, optional parts to raise the tub support are available (see chapter Accessories/combinations).
(arrow direction); (see chapter on Operation, section Emergency stop button). If the product is used with a bathtub, check that the dimensions of the bathtub, tub support and foldo® patient hoist are consistent with one another (see section Operating conditions for use with a bathtub).
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• In the case of reuse, aks GmbH has been informed of the serial number and the design of the patient hoist. The following options are available: standard design, version with higher stand mast and/or lifting arm and support arm extension (identified as per chapter on Accessories/ combinations, section Lifting arm/support arm extension and higher stand mast).
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).
The product can generally be used on tiles, carpets, laminate flooring and linoleum occur is noticed at an early stage. aks GmbH accepts no liability for damage arising from without any problem, though care should be taken to ensure that any damage that does everyday use on floors.
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). Note that only one function may ever be performed at any one time. Otherwise the electrical system can shut down and/or be damaged due to overload.
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.
Emergency stop button The product is fitted with an emergency stop button. This allows you to interrupt the Emergency electricity supply immediately in the event of stop an emergency. button To interrupt the power supply, press the red emergency stop button on the control unit (Fig.
Battery pack The batteries used in the patient hoists are lead gel batteries. 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.
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The aks patient hoist must not be operated when the mains adapter is connected. Improper handling can result in damage to the mains adapter and in hazards such as electric shock. Never pull the power supply cable of the mains adapter and nev- er drive over it.
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Do not use the aks patient hoist any more for lifting if the capacity control indicator in the manual control unit is lit red. In the case of non-observance, damage to the batteries cannot be ruled out.
Support arm Operating principle Operation The support arm on the tub support helps improve stability by creating a supporting triangle during Extending th swivelling. telescopic an retracted an The support arm is telescopic and is connected to a gas spring that can be locked.
Operation Extending the support arm: the support arm is telescopic and during standard operation it is retracted and pointing vertically upwards. To extend it, pull it until it latches into place. To retract it, press the two catches together (Fig.
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.
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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).
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).
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(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.
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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).
Transferring the patient into the bathtub To transfer the patient into the bathtub, you can use aks-bath slings (chapter Accessories/combinations). Note the individual instructions for use for the hoist slings used. Practice the procedure before using the product with a patient for the first time.
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Press the release mechanism and swivel the support arm down onto the tub support. Make sure that the pressure piece is in the middle of the holder on the tub support (Fig. 9.3.04 and Fig. 9.3.05). Fig. 9.3.04 – Swivelling the support arm Fig.
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Brake the castors (Fig. 9.3.08). Check that the support arm is positioned correctly in the tub support and the patient hoist is stable (Fig. 9.3.09). Fig. 9.3.09 – Locked support arm Fig. 9.3.08 – Braking the castors Now raise the patient so that his or her buttocks are higher than the bathtub rim.
Combinations that have not been approved by aks GmbH can cause hazards. The following tables list the combinations of the aks patient hoists described in these instructions for use that have been checked and approved by aks GmbH for safe use.
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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/...
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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 ...
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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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(see Variants table). In the event of reuse, you have to inform aks GmbH of the serial number ( SN ) for your foldo®. Fig. 10.01 – Variants You can also use the Variants table to determine which version of the foldo®...
Unlock emergency stop button Manual control unit plug not plugged Plug in manual control unit in or not plugged in correctly aks patient hoist does not lift Wait until charging is complete; Patient hoist connected to mains then disconnect the mains adapter...
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.
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.
(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)
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.
The products described in the instructions for use are suitable for reuse, in each case after technical clarification by aks GmbH on the basis of form FB 40 05 001. 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...
Note that in specific application cases, the foldo® is delivered with a lifting arm/support arm extension and/or higher stand mast. Check the dimensions in the chapter on Accessories/combinations, section Lifting arm/support arm extension and higher stand mast to make sure that you have a standard version of the product.
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.
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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.
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).
Removed, defective/damaged electrical components may only be checked and evaluated by a qualified electrician or aks GmbH. Removed, defective/damaged electrical components may only be checked and Do not carry out any repairs on the product that would alter the product characteristics.
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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.
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 ...
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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) Permissible accessories or device combination...
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Visual inspection of the electrical parts - the patient hoist must be disconnected from the mains adapter (see chapter on Operation, section Battery pack) - the emergency stop button must be pressed (see chapter on Operation, section Emergency stop button)
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The limit switch must enable the rotary movement. When rotating back, the lifting arm must switch off in the centre position Overall assessment of the aks patient hoist Perform the operating load test with weight plates, for example. Attach the weight plates to the lifting arm with a suitable holder.
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All hooks present, undamaged and not bent Overall assessment of the aks spreader bar Perform maintenance of the aks hoist sling at least every six months and before each reuse. Annex B to EN ISO 10535 specifies the following, among other information: “Periodic inspection of a flexible bodily support system should be performed at the intervals...
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Do not use a damaged or severely worn product. Failure to observe this requirement may cause the patient to fall, and thus result in severe or even fatal injury to the patient. Overall assessment: aks patient hoist, aks spreader bar, aks hoist sling aks patient hoist and accessories are in order: ...
Contact your authorised dealer immediately. The following maintenance schedule provides help for this inspection: Inspection of the aks patient hoist – check points Patient hoist shows no obvious damage or wear Attachment points show no damage or wear No unusual noises Manual control unit: no damage (e.g.
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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 Rating plate...
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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 74...
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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...
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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)
25 X (1 : 2) Referenz- körper 1 Bewegungsrichtung VORWÄRTS Direction of motion FORWARDS ca. 25 Referenz- körper 2 Fig. 21.01 – foldo® - dimensions drawing Dimensions (L x W x H): 1,315 x 670 x 1,320 Page 77...
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General information on the product Classification active class I medical device according to Regulation (EU) 2017/745, Appendix VIII Basic UDI DI 425181871882011HK Maximum load [kg] Operating force for the < 5 manual control unit [N] Ambient temperature 5 to 35 [°C]...
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Typical use case Head side Foot side Fig. 21.02 – Rotation function Page 79...
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Fig. 21.03 – Dimensions drawing foldo® folded Additional information on the product - 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...
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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 ...
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Aktuelle Krankenpflege Systeme GmbH Antwerpener Straße 6 D-53842 Troisdorf +49 2241 9474-0 +49 2241 9474-88 aks@aks.de www.aks.de 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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