Precioso
Mattress Replacement or Overlay System - Series 2
D9U003VP0-0101
Version: 04
Publication date: 2020-05
Instructions for Use
and Technical Description
Page 1: ...Precioso Mattress Replacement or Overlay System Series 2 D9U003VP0 0101 Version 04 Publication date 2020 05 Instructions for Use and Technical Description ...
Page 2: ... use that relate to the product s technical regulations It is for this reason that the contents of the instructions for use may indicate differences from the current manufacture of the product Reproduction also excerpts only with prior permission of the publisher Subject to changes due to technical developments All technical data are rated data and are subject to construction and manufacturing tol...
Page 3: ...ompatibility 18 6 Use and Storage Conditions 20 6 1 Storage 20 7 Scope of Delivery and Product Variants 20 7 1 Scope of Delivery 20 7 2 List of Parts 20 8 Putting into Service 21 8 1 Installation of Mattress 21 8 2 Installation of SCU System Control Unit 23 8 3 Connecting Mattress and SCU 23 8 4 Cable Management System 24 8 5 Inflation 25 9 Manipulation 26 9 1 Use 26 9 2 Controls and Indicators 27...
Page 4: ...ing key words Caution risk of material damage Warning risk of physical injury Danger risk of fatal injury 1 1 2 Structure of Warning Notices 1 2 Other symbols 1 2 1 Instructions Structure of instructions Perform this step Result if necessary 1 2 2 Lists Structure of bulleted lists List level 1 List level 2 SIGNAL WORD Type and source of danger Measures to avoid the danger ...
Page 5: ...5 40 D9U003VP0 0101_04 1 3 Symbols on the Package FRAGILE HANDLE WITH CARE THIS WAY UP KEEP DRY PROTECT FROM HUMIDITY PAPER RECYCLING SYMBOL DO NOT USE HAND TRUCK HERE DO NOT STACK DURING STORAGE ...
Page 6: ... DUE TO ELECTRICAL CURRENT TYPE B APPLIED PARTS DOUBLE ISOLATION ATTENTION CE MARK OF CONFORMITY WITH EU REGULATION I O MAINS SWITCH I ON CONNECTED TO THE MAINS SUPPLY O OFF DISCONNECTED FROM MAINS SUPPLY DEVICE IS CONNECTED TO MAINS WHEN GREEN INDICATOR IS ON RECYCLING SYMBOL DO NOT POLLUTE THE ENVIRONMENT WEEE SYMBOL RECYCLE AS ELECTRONIC WASTE DO NOT PUT INTO THE HOUSEHOLD WASTE MEDICAL DEVICE ...
Page 7: ... THE COVER FOR CONTAMINATION MACHINE WASH AT MAX 71 C FOR 3 MINUTES TUMBLE DRY ON LOW HEAT SETTING MAX 60 C COVER MATERIALS ARE FIRE RESISTANT TO BS 7175 SOURCE 0 1 AND 5 HANDWASH WITH DETERGENT INITIAL TEMPERATURE OF HOT WATER SHOULD NOT EXCEED 50 C DISINFECT USING SOLUTION CONTAINING LESS THAN 1000 PPM OF CHLORI NE REFER TO INSTRUCTIONS FOR USE RINSE WITH WATER DRY MATTRESS FOOT PART ...
Page 8: ...anation of the signs and fields on the serial labels 1 Address of Manufacturer 2 1D Bar Code GS1 128 Serial Number 3 PI Product Identifier 4 DI Device Identifier GTIN Global Trade Item Number 5 Manufacturing Date Year Month Day 6 2D Bar Code GS1 DataMatrix DI PI UDI 7 Serial Number 8 Symbols 1VPKE20000010 REF SN 20200136267 2020 02 25 01 8592654112038 11 200225 21 20200136267 PRECIOSO 220 240 V 50...
Page 9: ...e GS1 DataMatrix DI PI UDI 7 Serial Number 8 Symbols 1VPKE20000010 REF SN 20200136267 2020 02 25 01 8592654112038 11 200225 21 20200136267 PRECIOSO 100 127 V 50 60 Hz 40 VA 2 1 3 4 6 8 7 5 7 3 2 5 4 6 1VPM000420200 REF SN 20200111530 2020 02 25 01 8592654002360 11 200225 21 20200111530 1 Serial label with UDI Precioso mattress Fig Serial label for Precioso SCU 100 127 V Fig Serial label for Precio...
Page 10: ...ge is not available when the mains switch is turned ON mains switch is turned OFF REPEATED 2 TONE SIGNAL during 6 seconds FIRST TONE BEEP lasting 0 5s and SECOND TONE BEEP lasting 0 5s system error number of the beeps 1 6 indicates the type of error REPEATED BEEP after 25 minutes of Max Mode 0 25s sound 30s silence Max Mode will be ending first activation of the Max Mode REPEATED 2 TONE SIGNAL aft...
Page 11: ...ate HW Hardware ICU Intensive Care Unit IP Ingress Protection IV Intravenous LED Light Emitting Diodes ME Medical Electrical Equipment ON Activation OFF Deactivation ppm parts per million millionth 1000 ppm 0 1 REF Reference Number product type depending on configuration SCU System Control Unit active mattress SN Serial Number SW Software SWL Safe Working Load UDI Unique Device Identification for ...
Page 12: ...ses and power supplies WARNING This medical device is not intended for oxygen enriched environment WARNING This medical device is not intended for use with flammable substances WARNING This medical device is not portable medical electrical equipment WARNING Patient is allowed to use selected control elements only if hospital personnel had assessed that the patient s physical and psychological stat...
Page 13: ...itably qualified personnel Replace any damaged parts immediately with original spare parts only Ensure that maintenance and installation are performed exclusively by qualified personnel who have been trained by the manufacturer Do not exceed the maximum patient weight see Mechanical Specifications Do not use the SCU in near flammable gases This does not apply to oxygen cylinders Do not cover SCU w...
Page 14: ...46 cm BMI 17 at moderate risk levels in the intensive care Application Environment 1 and 2 as in IEC 60601 2 52 Patients with any stage category of pressure ulcers 3 2 Contraindications Mattress system is contraindicated for patients with cervical traction or unstable spinal fractures spinal cord injury fractures at risk of complication by a moving surface or trauma patients where spinal injuries ...
Page 15: ...de of polyurethene coated nylon which has a 270 zip and additional elastic corner straps to prevent the mattress ends from moving when fitted on top of standard hospital foam or a domestic mattress 1 Head section 2 Side formers 3 Torso section 4 Foot section Central set Head section 3 head cells remains inflated static Torso section 11 torso upper leg cells alternates in 3 cell cycle Foot section ...
Page 16: ...ol Unit The SCU inflates and deflates the air mattress It is connected to the air mattress with a custom designed air con nector that is permanently attached to the mattress The microprocessor controlled SCU maintains the set pres sure regardless of the patient s position by continuously monitoring and adjusting the air pressure in the mattress The SCU is equipped with an audio visual alarm system...
Page 17: ...nflated Seat cushion inflated 3 cells 7 5 min 2 cells 12 min Environmental conditions operation and storage Temperature Humidity Atmospheric pressure 0 C 32 F 40 C 104 F 30 75 700 1060 hPa Max load Mattress Seat cushion 160 kg 210 kg with additional foam base 127 kg Inflation time Mattress Seat cushion 10 min 30 min 30 s Deflation time CPR Max 15 s Supply voltage Model 127 V Model 230 V 100 127 V ...
Page 18: ... Maintenance in order to maintain the basic safety with regard to electromagnetic disturbances for the expected service life WARNING Mobile RF communication device including end use devices like antenna cables and external antenna should not be used closer than 30 cm 12 inches from any part of this air mattress system Precioso se ries 2 including cables specified by manufacturer Otherwise this cou...
Page 19: ... 0 UT 0 5 cycle At 0 45 90 135 180 225 270 a 315 0 UT 1 cycle and 70 UT 25 30 cycle Single phase at 0 0 UT 250 300 cycle Table 1 IMMUNITY to RF wireless communications equipment Test frequency MHz Band MHz Service Modulation Immunity Test Level V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 28 710 745 780 704 787 LTE band 13 17 Pulse ...
Page 20: ...ins cable around SCU Pack in suitable cover Store in a place suitable for electronic medical devices When mattress is not in use Deflate mattress and leave air connector open CPR position Roll mattress up to get air out completely Rotate end of umbilical air connector and main body in opposite directions Pack in suitable cover Store in a place suitable for electronic medical devices 7 Scope of Del...
Page 21: ...ible to fix the straps to the bed frame if required Fix the straps in such a way that they do not put any strain on the mattress or bed frame when the bed frame is moving WARNING Risk of injury due to incorrect use When using mattress replacement or overlay systems make sure to use safe and appropriate siderail positions and bed height settings Which positions and settings are safe and appropriate...
Page 22: ...ame Prevent air pipe from getting trapped by moving parts of the bedframe or getting looped or bent in such a way as to block or restrict the air flow Loosely fasten safety straps to suitable parts of the bedframe 1 Elastic corner strap on head end overlay 2 Profiling strap and buckle 3 Knee break strap and buckle replacement or knee break buckle overlay 4 Webbing corner strap on foot end overlay ...
Page 23: ...rame If foot end of bed frame is not suitable for hanging SCU Put SCU on floor with integrated mounting feet 8 3 Connecting Mattress and SCU Ensure that air connector is in open mode see Fig Open Mode Insert air connector 1 in the socket 2 at an angle of approximately 45 Push air connector 1 down until it clicks into place 1 Air connector plug 2 Air connector CAUTION Risk of injury when installing...
Page 24: ...ming a tripping hazard Safe cable routing Route cable through cable routing clips Ensure that cable is not hanging over head end to prevent it from getting stretched or trapped when rai sing or lowering the backrest WARNING Risk of injury due to exposed cable Ensure that cable is not twisted crushed or strained Use cable routing clips in order to avoid tripping hazards Ensure that it is not possib...
Page 25: ...shes during inflation process and audio alarm signal sounds Check if air pipe is connected correctly Fig Switching on SCU To switch off SCU Switch off SCU using green illuminated power switch on side of SCU see Switching on SCU Disconnect mains cable from mains NOTE When switched on the SCU will return to the last mode APT or CLP and pressure setting The mode and pressure settings are only valid w...
Page 26: ...ace any additional sheets blankets etc between mattress and patient WARNING Risk of injury when putting patient into bed Before putting the patient into bed Ensure that mattress is completely and correctly inflated Ensure that mattress is correctly secured with safety straps WARNING Danger of suffocation due to air impermeable mattress cover Use mattress cover correctly The nursing staff are respo...
Page 27: ...tenance requirements with indicators and alarm sounds Fig SCU Control Panel 1 Buttons Pressure Control 2 Indicator CLP Mode 3 Indicator MAX Mode 4 Indicator APT Mode 5 Button Mode Selection 6 Indicator Seat Mode 7 Indicator CPR Air Connector Open 8 Indicator System Error 9 Button Mute 10 Indicator Service Due 11 Button GO 12 Indicator Pressure Level 1 2 3 4 5 6 7 9 10 11 8 12 ...
Page 28: ...l will sound In order to guarantee optimum protection the system adjusts the pressure automatically to the patient s weight and posi tion every 7 5 minutes in APT mode Button Indicator Function Pressure Control Button Changing air pressure in mattress Mode Indicators Indicate selected mode APT Alternating Pressure Therapy MAX Maximum Inflate CLP Constant Low Pressure Mode Selection Button Selects ...
Page 29: ...esired pressure lights yellow or green Pressure levels below recommended optimum pressure for small or light patients above recommended optimum pressure for big or heavy patients for patients sitting up in the bed for patient positions or body shapes that concentrate the patient s weight on small areas of the mattress WARNING Risk of injury due to incorrect pressure setting Consult qualified hospi...
Page 30: ...MAX mode is required for less than 30 min Set new mode If MAX mode is required for more than 30 min Set MAX mode again within the last 5 min When MAX mode is selected SCU inflates all mattress cells to the same pre set pressure Indicator 3 flashes yellow until preset pressure is reached Once the set pressure is reached indicator 3 will remain solid on During the last 5 min an alarm signal will sou...
Page 31: ...NOTE The number of times that the alarm sounds and indicator 8 flashes indicates the type of error This information will be required when contacting a service engineer To mute audio alarm signal Mute audio alarm signal see Mute To stop audio alarm signal Reset system by switching SCU off and back on NOTE The error signal will repeat every time the device is switched on until the cause of the error ...
Page 32: ...emove air connector plug from air connector Mattress deflates 9 3 2 CPR umbilical disconnected To allow resuscitation in Transport mode Rotate end of air connector and main body in opposite directions until the red symbols and o are aligned and air starts to escape Mattress deflates Fig CPR SCU connected Fig CPR SCU connected ...
Page 33: ...red symbol and black symbol are aligned and no air is escaping 9 5 Power Failure In case of a power failure the mattress will remain inflated for at least 24 hours However alternating pressure therapy is not possible If no power supply will be available for more than 24 hours Switch to Transport mode see Transport Mode WARNING Risk of injury due to incorrect positioning of patient Prior to more th...
Page 34: ...l Seat cushion six cells two sets of three cells are inflated and deflated in 12 minute cycles 9 6 2 Installation of Seat Cushion Remove existing seat cushion if possible Ensure that chair supports weight of seat cushion Place the seat cushion directly on the seat base Ensure that there are no protruding parts or sharp objects on the chair to avoid damage to the seat cushion Put seat cushion on se...
Page 35: ...flation process is finished Indicator 6 lights green Cushion is ready for placement of patient NOTE Pressure adjustment is not available in this mode If indicator 6 flashes during inflation process and audio alarm signal sounds Check if air connector is connected correctly 9 6 4 Use Preparation Inflate seat cushion see Initial Operation Seating of Patient Sit patient on seat cushion For an ideal s...
Page 36: ... Observe local directives concerning infection control LINET recommends the following cleaning agents 10 1 Cleaning CAUTION Incorrect cleaning disinfection can damage the mattress and SCU Do not use pressure or steam cleaners Use the recommended cleaning agents only Follow the instructions and observe the dosages recommended by the manufacturer Ensure that disinfectants are selected and applied by...
Page 37: ...for any signs of damage Replace or repair and completely disinfect mattress cover top and base if damaged Check mattress cover top and base for signs of liquid ingress Replace or clean and completely disinfect mattress cover top and base if damp inside Clean all mattress cells and pipes with 60 C warm water and cleaning detergent Rinse mattress with cold water Allow mattress to dry or wipe it dry ...
Page 38: ...nd outside of mattress and outside of SCU for mechanical damage and signs of severe wear and tear Check if mattress and SCU are working properly Check external air filter in side of SCU for dust and dirt If dust or dirt is visible replace filter 11 2 Spare Parts The serialt label is located on the SCU and on the mattress The serial labels contain information for claims and ordering replacement par...
Page 39: ...ging through an authorized company more details on www linet cz 12 1 1 Disposal The main objective of the obligations arising from the European Directive No 2012 19 EU on Waste Electric and Electro nic Equipments nationally regulated in Act No 185 2001 Coll as amended On Waste and in Decree of the Ministry of the Environment No 352 2005 Coll as amended is to increase the re use material recovery a...
Page 40: ... material and manu facturing related failures and errors Failures and errors caused by incorrect use and external effects are not covered Justified complaints will be fixed free of charge during the warranty period Proof of purchase with the date of purchase is required for all warranty service Our standard terms and conditions apply 14 Standards and Regulations Apllied norms are stated on Declara...
