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D9U003VB3-0101_04

16 Standards and Regulations

Apllied norms are stated on Declaration of Conformity.

The manufacturer adheres to a certified quality management system in compliance with the following standards:

■

ISO 9001

■

ISO 14001

■

ISO 13485

■

MDSAP (Medical Device Single Audit Program)

Содержание Virtuoso 3 Series

Страница 1: ...Virtuoso Air Mattress System SERIES 3 D9U003VB3 0101 Version 04 Publication Date 2020 05 Instructions for Use and Technical Description...

Страница 2: ...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 als...

Страница 3: ...el Zoner Air Alternating Air Base 27 6 6 Mechanical Specifications Virtuoso Pro 27 6 7 Mechanical Specifications Seat cushion 28 6 8 Mechanical Specifications SCU and Accumulator 28 6 9 Electrical Spe...

Страница 4: ...the following 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 Instructions Structure of instructions Perfor...

Страница 5: ...5 65 D9U003VB3 0101_04 1 4 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...

Страница 6: ...CIDENTS DUE TO ELECTRICAL CURRENT TYPE B APPLIED PARTS DOUBLE INSULATION CLASS II EQUIPMENT WARNING CE MARK OF CONFORMITY WITH EU REGULATION SCU MAINS SWITCH ON CONNECTED TO THE MAINS SUPPLY O OFF DIS...

Страница 7: ...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...

Страница 8: ...D9U003VB3 0101_04 8 65 RECYCLING SYMBOL DO NOT POLLUTE THE ENVIRONMENT MANUFACTURER MANUFACTURING DATE REFERENCE NUMBER PRODUCT TYPE DEPENDING ON CONFIGURATION SERIAL NUMBER...

Страница 9: ...just for explanation 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 N...

Страница 10: ...0200127572 1 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 Cod...

Страница 11: ...sconnected from the mains mains switch is turned OFF mains power is not available REPEATED 2 TONE SIGNAL FIRST TONE BEEP lasting 0 5s and SECOND TONE BEEP lasting 0 5s 30s silence accumulator discharg...

Страница 12: ...te 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 100...

Страница 13: ...ot 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 WARNI...

Страница 14: ...el trained and authorized by the manufacturer Do not exceed the maximum patient weight limit see Mechanical Specifications Do not use the SCU near flammable gases This does not apply to oxygen cylinde...

Страница 15: ...6 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...

Страница 16: ...ir Base Virtuoso Pro VIRTUOSO AIR DECKS ALTERNATING LAYERS FOWLERBOOST ZONERS Accumu lator MCM Overlay Air Foam Air Air 1 2 Single point Linear Head Foot Body Virtuoso Overlay a a a optional a Virtuos...

Страница 17: ...verlay Virtuoso Overlay has one layer of air cells 21 transverse air cells 2 longitudinal air filled side formers 3 Static head cells 11 alternating torso and leg cells 7 Foot section cell Fig Mattres...

Страница 18: ...cells and one foam layer 4 2 1 Top Deck 21 transverse air cells 2 longitudinal air filled side formers 3 static head cells 11 alternating torso cells 7 alternating foot section cells 4 2 2 Bottom Dec...

Страница 19: ...has two air layers 4 3 1 Top Deck 21 transverse air cells 2 longitudinal air filled side formers 3 Static head cells 11 alternating torso cells 7 alternating foot section cells 4 3 2 Bottom Deck 3 rib...

Страница 20: ...cells 2 longitudinal air filled side formers 3 static head cells 11 alternating torso cells 7 alternating foot section cells 4 4 2 Bottom Deck 21 transverse air cells 2 longitudinal air filled side f...

Страница 21: ...ot zone cells 4 5 2 Bottom Deck Head section static longitudinal cells Torso section 9 transverse alternating cells Leg section 5 static longitudinal cells 2 static side formers 4 5 3 Valves Head zone...

Страница 22: ...uds fixation toggles and polyurethane loops A two part cover made of polyurethane coated nylon covers both mattress decks The top part of the cover consists of four way stretch material and has High M...

Страница 23: ...ed depending on Heel Zone Valves transverse cells 4 6 2 Bottom Deck The bottom part consists of 5 modules Head section 3 longitudinal cells remains inflated static Heel section 5 cells remains inflate...

Страница 24: ...Base Cover all configurations 4 8 1 Transport Handles Transport Handles are intended for transport of the mattress WARNING Material damage and risk of injury due to incorrect use Transport the mattre...

Страница 25: ...ipped with self retracting bed hanging arms and with mounting feet on base of SCU for floor mounting 5 Control Panel Description The control panel of the SCU serves to control the mattress replacement...

Страница 26: ...d time in Transport mode 12 hours Sound Pressure Level mattress with SCU max 46 dB Dimensions Mattress inflated length x width x height 200 cm x 86 cm x 17 cm 78 7 x 33 9 x 6 7 Weight Mattress inflate...

Страница 27: ...ess inflated length x width x height 200 cm x 90 cm x 23 cm 78 7 x 35 4 x 9 1 Weight Mattress inflated 12 kg 26 5 lbs Cycle Mattress inflated 3 cells 7 5 min Max load Safe Working Load Mattress 254 kg...

Страница 28: ...y voltage Model 230 V with Accumulator back up Accumulator in accumulator pack 220 240 V 50 60Hz 12 V DC 16 V DC when connected to the mains Nominal power Model 230 V with Accumulator back up Accumula...

Страница 29: ...is air mattress system Virtuoso including cables specified by manufacturer Otherwise this could lead to deterioration of functionality of this air mattress sys tem WARNING Do not overload the bed SWL...

Страница 30: ...0 Ut 0 5 cycle At 0 45 90 135 180 225 270 and 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 Ba...

Страница 31: ...s 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 plac...

Страница 32: ...rict the air flow Loosely fasten Mattress Fixing Straps to suitable parts of the bed frame WARNING Risk of injury due to incorrect use When using mattress replacement system make sure to use safe and...

Страница 33: ...ard is not suitable for hanging SCU Put SCU on floor with integrated mounting feet CAUTION Risk of injury when installing SCU Ensure that no body parts are trapped between hook and foot board when usi...

Страница 34: ...se cable routing clips in order to avoid tripping hazards Ensure that it is not possible for the cable to get trapped between any moving parts of the bed frame WARNING Risk of incompatibility due to i...

Страница 35: ...es in seat and back sec tions Fowler Boost automatically at a single point when Backrest is adjusted to 30 degrees Virtuoso Overlay Virtuoso Mattress Replacement Air Foam Base Virtuoso Mattress Replac...

Страница 36: ...f safety straps of mattress cover are too tight and correct if necessary If indicator 7 see Control Panel picture flashes during inflation process and audio alert signal sounds Check if air pipe is co...

Страница 37: ...ccumulator functionality at least once a month in accordance with the user and service manuals and have the accumulator changed if necessary WARNING Risk of injury due to insu cient power supply In ca...

Страница 38: ...of use at the latest To charge the accumulator Connect the SCU with a mattress to the mains Turn on SCU Mains switch Turn on the Accumulator switch While the accumulator is being charged the status i...

Страница 39: ...e mains 1 status of Accumulator Status Indicator no audio alert DISCHARGING 50 25 accumulator is turned on SCU is disconnected from the mains 1 status of Accumulator Status Indicator no audio alert DI...

Страница 40: ...mory is erased when the backup accumulator is not fitted or is switched off loss of mains power when SCU is running from accu mulator if the accumulator is too low to use CHARGE FAULT or Accumulator F...

Страница 41: ...Detection of the correctly inserted accumulator with Mains power switch turned on Accumulator is correctly inserted to SCU when the Accumulator Charge Status Indicator is lit for 2 seconds and the aco...

Страница 42: ...sure that mattress is completely and correctly inflated Ensure all Head Body and Heel valves on the side of the mattress are in an inflate position Ensure that mattress is correctly secured with safet...

Страница 43: ...eflate See chapter 19 for valve operation instructions WARNING Ensure adequate patient support is maintained during normal mattress operation Remember that APT mode alternately deflates cells in a 3 c...

Страница 44: ...ator Indicates that seat cushion is connected Fowler Boost Indicator Indicates if backrest is raised CPR Air Connector Open Indicator Indicates that air pipe is not connected correctly or not at all S...

Страница 45: ...ON 2 statuses of Mains Power Indicator in sequen ce not illuminated Mains Power Indicator for 5 seconds and after there is 20 seconds long blink of the Mains Power Indicator alert after 5 seconds long...

Страница 46: ...ier weight of the intended pati ent During pressure adjustment The section of the pressure control indicator corresponding to the desired pressure flashes green When desired pressure is reached The se...

Страница 47: ...llow If Max Mode is required for less than 30 minutes Set new mode by pressing button 13 If Max Mode is required for more than 30 minutes Press MODE Button once or repeatedly until Max Mode is set aga...

Страница 48: ...activating Fowler Boost Lower backrest When backrest is lowered When the Backrest is lowered the SCU automatically reduces the mattress pressure The Fowler Boost Indicator 6 will extinguish and the pr...

Страница 49: ...ignal synchronized with flash sequence sounds NOTE The number of times that the alert sounds and indicator 8 flashes indicates the type of error The number of flashes will be required when contacting...

Страница 50: ...st compression can start immediately NOTE During this process it is possible that the backrest detector plug is pulled out This does not affect the CPR function 11 7 CPR umbilical disconnected To allo...

Страница 51: ...To activate Active Transport Mode Turn on the Accumulator power switch Disconnect mains plug from wall outlet 11 9 Power Failure In case of a power failure the mattress will remain inflated for at lea...

Страница 52: ...circle indicates default mode of corresponding cell To inflate to a static pressure in the individual cell Turn selector to the position or NOTE Green colour in the circle indicates default mode of c...

Страница 53: ...deflate individual cell Turn selector to the position To inflate individual cell in APT Mode or CLP Mode Turn selector to the position NOTE Green colour in the circle indicates default mode of corresp...

Страница 54: ...ns is the same but the fitting instructions vary 11 12 1 Functioning The seating system provides alternating pressure therapy for patients that are not bed ridden Have seating system used only by or u...

Страница 55: ...the chairs original seating area Ensure the chair supports the weight of the seat cushion and any arm rests are at a suitable height for the patient Ensure that there are no protruding parts or sharp...

Страница 56: ...Cushion Connectors will retain the air present in the cells at the time of disconnection Ensure there is air in both Cushion cell sets prior to disconnection The Cushion Connectors can be joined toge...

Страница 57: ...itch on SCU using power switch on side of SCU Indicator 6 flashes Confirming signal sounds Seat cushion is being inflated During the inflation process Indicator 6 flashes white When the inflation proc...

Страница 58: ...Observe local directives concerning infection control LINET recommends the following cleaning agents 12 1 Cleaning CAUTION Incorrect cleaning disinfection can damage the mattress and SCU Do not use pr...

Страница 59: ...or 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 d...

Страница 60: ...ged into rear of SCU and protective cover is in place Check SCU is plugged into mains outlet that has been switched on If available connect Accumu lator back up pack see 10 2 Accumulator Back up Pack...

Страница 61: ...Backrest is raised to an angle of at least 30 degre es Virtuoso Overlay Virtu oso Mattress Replacement Air Foam Base Virtuoso Mattress Replacement Air Static Air Base Virtuoso Mattress Replacement Ai...

Страница 62: ...ed frame Check mattress securing straps have been attached to bed frame correctly see 4 8 Base Cover all configu rations on page 24 1 Restart unit by turning power off then back on see 9 5 1 Inflation...

Страница 63: ...d 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 di...

Страница 64: ...ng through an authorized company more details on www linet cz 15 2 Disposal The main objective of the obligations arising from the European Directive No 2012 19 EU on Waste Electric and Electro nic Eq...

Страница 65: ...gulations Apllied norms are stated on Declaration of Conformity The manufacturer adheres to a certified quality management system in compliance with the following standards ISO 9001 ISO 14001 ISO 1348...

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