Anti-decubitus pressure-reducing support mattress (40 pages)
Summary of Contents for AKS samson
Page 1
Anti-decubitus alternating pressure system 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: 2022-02-09 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.
Page 5
The aks-samson anti-decubitus alternating pressure systems (also referred to in the following as the products) are available in different sizes and each consist of a pump unit and an alternating pressure mattress. They were developed for decubitus prophylaxis and therapy, in particular for the care of heavy patients.
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).
Intended use The products are active Class I medical devices according to Regulation (EU) 2017/745, Appendix VIII. The products are suitable for domestic use as well as for use in inpatient facilities. The products are intended for use by a trained caregiver (user). The products are only suitable for use in dry, indoor areas.
Contraindication In combination with a care bed (EN 60601-2-52), the products are only suitable for adult patients with a body weight of at least 40 kg, a height of at least 146 cm, and a body mass index (BMI) equal to or higher than 17.
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
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.
Page 12
For hygiene reasons, always use the product (incl. accessories) for the same patient. Use only original aks accessories/spare parts in order to avoid danger (see the chapter on Accessories/combinations). Do not leave children unsupervised in the vicinity of the product. The anti-decubitus alternating pressure system is not a toy.
If you experience any serious incidents involving the product (incl. accessories), please contact aks GmbH and the relevant national authorities without delay. Safety instructions for the operator Prior to initial use and every reuse, train the user on the product itself (incl. ...
Page 14
Only allow suitable qualified personnel to perform the commissioning, maintenance, treatment (cleaning/disinfecting) and repair of the product (incl. accessories). Make sure that the user is physically and mentally able to perform the following activities in relation to the medical devices (incl. accessories) described in these instructions for use: •...
When using the product, comply with all the provisions of the EU Medical Devices Adaptation Act (MPEUAnpG), and in particular the Medical Devices Implementation Act (MPDG) contained in Article 1, and all additionally applicable legal regulations as well as with the applicable work health and safety regulations, accident prevention regulations and the general provisions concerning the handling of technical devices.
1 x instructions for use Alternating Instructions Pump pressure mattress for use unit Fig. 4.01 - Scope of delivery The aks-samson alternating pressure mattress is 25 cm high and is available in the following dimensions: W [cm] L [cm] 27600 27601 27605 27606...
Product overview Control panel Retaining bracket Case Air filter Mains power switch Power supply line Mains plug Fig. 5.01 - Front view of pump unit Quick reference guide Rating plate Fuses Rubber strip Connection sockets Fig. 5.02 - Rear view of pump unit...
Page 18
Mattress top side Mattress cover with zip Zip overlap Cells Fastening loop Mattress base Supply hoses with connector CPR emergency deflation Fig. 5.03 - Top side of alternating pressure mattress Mattress rear side Fastening straps (8 x) Anti-slip surfaces (4 x) Fig.
Functional description Fig. 5.1.01 – Control panel for aks-samson pump unit Explanation of the display elements and controls of the pump unit Element Pictogram Function You set a suitable pressure for the patient here. You set the required filling pressure using the “+” and “-”...
Page 20
Element Pictogram Function Pressing the “mute” button switches off the audible alarm for “low pressure” and “system failure” in order to prevent lasting Alarm reset noise nuisance. The red “low pressure” or “system failure” LED remains lit. The audible alarm for power failure cannot be switched off.
Page 21
In alternating pressure mode, the two air chamber circuits of the alternating pressure mattress are In addi alternately inflated and deflated by the microprocessor-controlled control unit of the pump unit. part of This alternating inflation and deflation of the cells relieves pressure alternately on individual parts of static m the body.
Page 22
Operation of the seat function is indicated by a lit (orange) LED. e to the The pump unit of the aks-samson has an automatic key lock. If no buttons on the unit are pressed e areas within a time of approx. 30 seconds, the unit automatically locks out all buttons. This prevents existing accidental adjustment, e.g.
Commissioning The product (incl. accessories) was developed for use on a care bed or a “standard bed”. Do not use a damaged or heavily worn product. Inspect the relevant product (incl. accessories) before and during set-up for damage and defects. The power supply line, the pump unit case as well as the connections and the alternating pressure mattress must not be damaged.
Page 24
Example of an alternating pressure mattress: 120 x 200 cm Fig. 6.01 – Mattress cover imprint Fig. 6.02 – Mattress cover imprint with foot symbol with type designation Next, fit a bed sheet over the alternating pressure mattress or mattress cover. Make sure that the sheet is fitted without creases.
Page 25
Fig. 6.03 – Connection socket Fig. 6.04 – Connector plug 11. Check whether the CPR stopper on the alternating pressure mattress is completely closed (Fig. 8.13.02). The end plugs are located on the right-hand side at the head end of the alternating pressure mattress (Fig.
First time use Before using 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.
Normal operation Before operation, ensure that the alternating pressure mattress is securely attached by the fastening straps to the moving reclining surface of the bed and that the supply hoses are not kinked, pinched or twisted. While using the product, check the support pressure between the patient and the alternating pressure mattress regularly by applying the hand test (Fig. 8.1.01).
Page 28
Fig. 8.1.01 – Performing the hand test Case A Case B Case C You can slide your hand It is not possible to slide your hand You can slide your hand underneath with practically underneath. underneath with slight resistance.
Cycle time The product provides the option of changing the cycle time for the alternating pressure intervals. You can set a cycle time in 4 stages of 10, 15, 20 or 25 minutes on the pump unit. To adjust the setting, press the cycle time button (Fig. 5.1.01) one or more times.
10 mmHg. Adjust the back part of the bed to the required position. The back part of an aks care bed can be adjusted up to 70° without malfunctions for the product occurring and without damage to the alternating pressure mattress.
Place a hand under the patient’s buttocks to check that the patient is not developing bed sores. While the seat function is activated, you can change the pressure with the help of the pressure regulation buttons (Fig. 5.1.01). To deactivate the seat function, press the “seat” button again. First, move the back part of the bed to a horizontal position between 0°...
Power failure A power failure is indicated by a visual and an audible alarm (see chapter on Operation/use, section Power failure alarm). In the event of power failure, there is the risk of rapid pressure loss in the alternating pressure mattress.
Patient transport The power supply cable and the supply hoses must not be driven over. Note the information in the instructions for use for the care bed in question. If the patient is transported on the alternating pressure mattress in a reclining position, the interruption to the power supply can cause rapid pressure loss in the alternating pressure mattress.
Leak alarm The product is equipped with an alarm function to prevent the patient developing bedsores in the case of pressure loss (e.g. due to leaks). If there is a pressure loss in the system, the red “low pressure”...
8.10 Power failure alarm The product has a visual and an audible alarm for the event of a sudden voltage drop. If the power fails or the power supply cable is disconnected in any way while the unit is switched on, the alarm is activated.
8.11 System failure alarm The product has a visual and an audible alarm for the event of a sudden technical defect. If a technical defect occurs, the alarm is activated, the red “system failure” LED flashes and an audible alarm sounds.
8.13 CPR emergency deflation The product is fitted with a CPR stopper (CPR = Cardio Pulmonal Reanimation) which is used for fast deflation of the alternating pressure mattress in an emergency. From the view of a patient lying on their back in the bed, the CPR stopper is located on the right at the head end of the alternating pressure mattress.
8.14 Static head cells The first three cells in the head area of the alternating pressure mattress are static cells, i.e. they are not included in the alternating pressure cycle. Under certain circumstances, the support pressure in the head area can be higher than intended in the following situations: •...
Troubleshooting Not all malfunctions are caused by product faults. The following table provides assistance for troubleshooting in case of malfunctions. If you are unable to rectify the malfunction using the information in this table, please contact your authorised dealer.
10 Accessories/combinations Only original aks accessory/spare parts may be used as accessories/spare parts because only these have been tested by aks GmbH and thus guarantee faultless and safe function. Accessories/spare parts that have not been approved by aks GmbH can cause hazards.
11 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 micro-organisms (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.
11.1 General cleaning and disinfecting instructions The product is suitable for reuse (see the chapter on Reuse). The product is manufactured subject to the highest quality standards. The following manufacturer information on cleaning/disinfecting must always be observed to ensure that the characteristics stated by the manufacturer do not change. This is the only way to guarantee that the product is safe and effective for its intended purpose.
11.2 Cleaning by the user/operator The pump unit and the alternating pressure mattress together with the mattress cover can be cleaned by hand with a mild, alcohol-free cleaning agent and a cloth. In addition, the mattress cover for the alternating pressure mattress can be washed in a washing machine using normal household washing agents.
(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 Manufacturer of cleaning...
12 Shutdown If the products described in these instructions for use will no longer be used and should be shut down, proceed as follows: The patient must no longer be lying on the alternating pressure mattress when removing it from service.
If the products are treated properly and handled carefully, and they are cleaned/ disinfected as described in the chapter on Cleaning/disinfecting, they can also be used for longer. The fact that aks GmbH specifies an expected service life/useful life for the products does not represent an additional guarantee. Page 46...
13 August 2005, the owner is legally obligated not to hand over electrical components to municipal collecting Fig. 16.01 – WEEE marking points but to send them directly to the manufacturer for disposal. The general terms and conditions of aks GmbH apply to these returns. Page 47...
Non-observance of the instructions for use, improper use, improperly carried out maintenance work, and technical modifications and additions (e.g. attachments) without the permission of aks GmbH render the warranty and general product liability void. We reserve the right to make technical changes for the purpose of improvement. For the product designation and information for clear identification (e.g.
Maintenance may only be carried out when the anti-decubitus alternating pressure mattress is unoccupied. 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.
Page 50
In Germany, the EU Medical Devices Adaptation Act (MPEUAnpG) applies, including the Medical Devices Implementation Act (MPDG) and the Medical Devices Operator Ordinance (MPBetreibV). The corresponding national laws, regulations and requirements are applicable in other countries. The latest versions of EN 62353 and the maintenance schedule must be used as test specifications for the products (incl. accessories) described in these instructions for use, and this must be properly...
19.2 Maintenance schedule: Inspection by the operator Perform maintenance of the product (incl. accessories) at least once a year , before every reuse, and after every repair. Article 7 of the MPBetreibV specifies the following: “Maintenance measures refer to inspections and maintenance tasks that are necessary in order to continuously ensure safe and proper operation of medical devices.
Page 52
The following maintenance schedule provides help for this inspection: Item Inspection of the aks anti-decubitus alternating pressure system – inspection points* Check of the basic requirements Appropriate and safe use (see chapter Intended use, section Intended purpose) Permissible combination of pump unit and alternating pressure mattress...
Page 53
Mattress cover is positioned with the “foot symbol” imprint on the foot side of the alternating pressure mattress (see chapter on Product labelling) “samson” product description imprint and “foot symbol” imprint present and legible (see chapter on Product labelling) Supply hoses not kinked, twisted, pinched, no fractures...
Page 54
140 x 200 cm 90 x 220 cm 100 x 220 cm 120 x 220 cm 140 x 220 cm We recommend the certified treatment unit at aks pura GmbH for the periodic monitoring, cleaning and disinfection of the products. Page 54...
19.3 Maintenance schedule: Inspection by the user In addition to the periodic checking by suitable qualified personnel, the user must check that the product (incl. accessories) is in a safe state before each use. Do not use the product/accessories if you are concerned about the safety of using them.
20 Product labelling Product labelling Rating plate Pump unit Sticker (rear of case) see chapter on Technical data Marking X Y Y M M X X X X X YY – year of manufacture MM – month of manufacture...
Page 57
Explanation of the symbols CE-Marking – this product satisfies the applicable requirements of the Regulation (EU) 2017/745 on Medical Devices (MDR) and other legal requirements of the European Union regarding affixing the relevant marking. WEEE marking (the device must not be disposed of with domestic waste)
Page 58
Explanation of the symbols EN ISO 15223-1 ulation Protect against heat/sunlight of the Fragile, handle with care Explanation of the symbols IEC 60417 For indoor use only Protection class II against electric shock VIII Application part type BF umeric...
Page 59
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 Do not dry in a tumble dryer Do not iron Do not dry clean Protection type of the enclosure acc. to EN 60529...
21 Technical data General information on the product Classification active class I medical device according to Regulation (EU) 2017/745, Appendix VIII 425181871227611F4 Basic UDI DI 30 to 300 Permitted patient weight [kg] Ambient temperature 10 to 40 [°C] Transport/storage...
Page 62
Alternating pressure mattress Weight [kg] [cm] 10.3 11.0 20 (200 cm)/22 (220 cm) double cells Number of cells Static head cells Nylon/TPU Material of cells approx. 45 min Air filling time Mattress cover Polyester/PU coated Material Mattress base Nylon/PU coated Material All specifications regarding dimensions and weights are approximate specifications. The sizes of the mattresses are affected by manufacturing tolerances;...
Page 63
Enter the data for your product here: Type: aks-samson (01)042518187 __ __ __ __ __ __________________________________________ Pump unit __________________________________________ Alternating pressure mattress SIZE [cm] 90 x 200 100 x 200 90 x 220 100 x 220 ...
Page 64
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. 09/02/2022 All rights reserved, particularly the right to make technical amendments. Printing errors excepted.
Need help?
Do you have a question about the samson and is the answer not in the manual?
Questions and answers