SHADO Shower Trolleys: Periodical inspection and preventive maintenance operating mode Summary 1. Scope 2. Domain 3. References 4. Definitions 5. Priorities 6. Equipment, components, documentation 7. Content 7.1 General organisation 7.2 Operating modes 7.2.0 Cleaning and disinfection 7.2.1 Base inspection 7.2.2 Structure 7.2.3 Tray 7.2.4 Rails 7.2.5 Commands and actuators 7.2.6 Mattress, cushion 7.2.7 Functionnal tests 7.2.8 Labeling 7.2.9 Recording the inspection 1. Scope This operating mode discribes the organization of the periodic inspections and preventive maintenance visits of the SHADO shower trolley for disabled patients, plus the operationg modes of each action, and what to do once the inspection has been performed. 2. Domain This opeating mode must be used any time a SHADO shower trolley is inspected. Only qualified technicians may use this procedure and inspect SCALEO Medical medical devices, change parts, and perform tests. 3. References Regulation relating to medical devices, in particular when relating to maintenance of medical devices. Recommandations from Health Authorities about the inspections and maintenance of medical devices in use. EN ISO 10535 - european standard relating to hoists for disabled people. Annex B 4. Definitions 1/5
Make sure that the inspected device is safe and can not affect the safety and health of the patients and the nurses. Record all the checks. 5. Priorities None 6. Equipment, components, documentation: Equipment : - enough masses to reach the maximum load of the shower trolley - tray or sheet used to protect the matress during tests with loads - periodical inspection labal Documentation: Present operating mode : PRTE067EN DOTE039EN SHADO inspection checklist DOMA019EN - SHADO user manual DOTE139 - SHADO spare parts catalog (with exploded view) Inspection procedures, inspection checklists, user manuals of the accessories may also be needed. 7. Content 7.1. General Organisation In the case of a periodical inspection, the technician performs an inspection, as defined by the Annex B of the EN 10535 standard. The technician does not intervene on the device In the case of a preventive maintenance, the technician performs a deeper insepction, an intervene on the device. The inspection checklist form lists the operations to be performed depending on the type of control needed. The operating mode discribes the operations If the SHADO trolley is equiped with accessories, complementary inspections have to be performed. The technician will then use the operating mode and the inspection checklist of the accessory. Additionnal regulatory inspection may be needed, they are not covered by SCALEO Medical and depend on the local regulation of the customer. In any case, if the inspection reports that some parts have to be changed, a quotation is established and must be accepted by the customer before the intervention If the customer is trained, parts and inspections my be performed by the customer's technical staff. Most of the inspection concern all the trolleys models. Some inspections concern only the Electrical powered trolleys (E models).some inspections concern only Hydraulic Powered trolleys (H models). In any case, if the inspection leads to the conclusion that the device is deteriorated and can not be used, the technician informs the customer, who is sole responsible of keeping the device our of order until it's repared and inspected again. 2/5
7.2. Operating modes 7.2.0 Cleaning and disinfection Spray all surfaces of the unit with decontaminating product, wait the indicated time so the parts are dry and then wipe with a dry cloth, or use a wipes soaked with disinfectant product. The disinfection by air may be used, as long as that the method does not damage the electronic cards.( peracetic acid based products are prohibited). Carefully read and use the recommandations of the product manufacturer Warning : the skin of the patient comes in contact with some parts of the trolley (mattress, cushion...) Depending on the patients' pathologies, the care givers may use a specific protocol for disinfecting the trolley. In all cases, the trolley must be disinfected by the customer before any physical contact with the device. 7.2.1 Base Geometry/flatness of the base Place the trolley on a perfectly flat surface, check that the base is not deformed, the four wheels must touch the floor. Hexagonal axis and brake pedals Check that the pedals are tightly attached to the axis, no mechanical slack is allowed Cleaning and oiling of the front and back wheel This operation may be performed only with SHADO trolleys using dismountable wheel In this case, the technician must dismantle the wheels, remove any hair, dust... and then oil the wheels. If the wheel is deteriorated, it must be changed. Adjustment of the brakes The SHADO trolleys manufactured before 2011 are equiped with wheels with adjustable brakes. Refer to the user manual of the trolley for details about brake adjustment Electrical emergency lowering Check the function. 7.2.2 Structure Checking the level of wear and tear of the joints Checking the level of wear and tear of the joints found in all the articulations (mobile parts) of the trolley. Change the axis if you experimented any mechanical slack. Checking the actuator pins (main actuator) Check the pins/screws used to attach the actuator, change the deteriorated pins. Checking the actuator pins (slope actuaor) Check the pins/screws used to attach the actuator, change the deteriorated pins. In general : check the security pins and screws Check all the security pins and screws, especially the parts labeled as "security screws". 7.2.3 Tray Visual inspection and planarity Perform a visual inspection. The tray must be in perfect condition without any mark of shock or crack. In the case of pre 2011 models (composite white trays) changing the tray for a PVC grey tray should be envisioned. Check the planarity of the tray. Accessories attached to the tray Check that the accessories (rails and bumpers) are properly tighened to the tray. 3/5
7.2.4 Rails Side rails Check that the side rails can be moved without any effort. Check that the locking system of the rails work properly (refer to the user manual) Head and foot rails Check the general condition of the rails. Check their attachement to the tray, there should be no mechanical slack. Tighten proprely the rails to the tray if needed. 7.2.5 Commands and actuators Battery support (E models) Check that the battery can be easily attached and removed from the support. Check that the support is correctly tightened. Electronic control box (E models) Perform a visual inspection, Check all cables and all electrical plugs Check its attachment to the structure Battery charger (E models) Perform a visual inspection, Check all cables and all electrical plugs Perform a quick test : connect the battery and check the charge light indicator. Up/down pedal (depending on the model) E models: perform a visual inspection, check the cable and the plugs. Perform a functionnal test H models: perform a visual inspection, check the pins and screws. Perform a functionnal test Slope function E models: check the pushbutton, the cable. Perform a functionnal test H model: check the command system ( lever, cable, head). Perform a functionnal test Battery ( E models) Check the eletrical contacts Clean them with a metal brush if needed Press the emergency stop button : no action should be possible when pressed. Note that it is recommanded to replace the battery every three years When commissionning a battery it is recommanded to write the date of commissionning on the battery. 7.2.6 Mattress and cushion Straps and buckles Check the condition of the straps and buckles used to secure the mattress against the tray. Good sealing of the mattress and cushion Check that the mattress and the cushion are perfectly sealed. Draining hose and plug Check that the plug of the draining hose are in lace, and check that the hose is in good condition. Perform a test and check the perfect sealing of the assembly 7.2.7 Functionnal tests Rolling : Perform a rolling test on a flat and clean surface with a load. It is recommanded to use a load value of # half of the maximum load of the hoist. Push and pull the trolley, it should roll without effort or hard spot, without swinging Check the good functionning of brakes and directionnal brakes. Lifting / lowering functioning with no load 4/5
Lift the trolley up and down a few times, the tray should move without noise or hard spot Lifting / lowering functioning with load Load the trolley with the maximum load (refer to the label), and perform the same test again. Lift up and down a few times, the tray should move without noise or hard spot. Positive and negative slope test Check the functionning of the slope command from complete proclive to complete declive. Emergency stop (E models) Push a button on the remote/pedal and press the emergency button on the electric control box. The function should stop immediately. Release the emergency button and press a button/pedal again on the remote; the function should work again. Emergency lowerings (E models) Check the emergency lowering devices with and without load. 7.2.8 Labeling Controling the labels With the help of the user manual, check all the labels, in particular labels pointing out security devices. Identification CE label Check the main label (wearing the CE symbol) condition: product reference (REF) and serial number (SN) should be readable Replace the missing or deteriorated labels. Inspection label Once the inspection/maintenance finished and the hoist is 100% OK, it is strongly recommanded to stick a periodical inspection label to the hoist Contact SCALEO Medical or your local dealer to get labels from SCALEO Medical 7.2.9 Recording the inspection During the inspection the technician will fill the inspection checklist form A copy is given to the customer, another should be kept by the technician for traceability 5/5