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Hillrom P005856A, Инструкция по эксплуатации

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Page ii

187692(10) -  EN - P280 Mattress Instructions for Use

Low Pressure Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  26
Malfunction Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  26

Section 4: Moving the Device

Moving the Patient on the Bed in Transport Mode . . . . . . . . . . . . . . . . . . . . . .  27
Transferring the Device from One Bed to Another . . . . . . . . . . . . . . . . . . . . . .  29
Storing the Device  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  30

Section 5: Disinfecting and Servicing

Cleaning and Disinfecting the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  31

Complying with Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  31
Controlling Infection  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  31
Complying with Hill-Rom Recommendations  . . . . . . . . . . . . . . . . . . . . . . .  32
Frequency of Cleaning and Disinfection of Different Parts of the Mattress.  33
Cleaning and Disinfecting after the Departure of a Patient or when Changing 
the Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  33
Cleaning and Disinfecting at Regular Intervals or in the Event of High Risk of 
Contamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  34
Performing the Final Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  35

Servicing of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  36

Complying with Safety Recommendations . . . . . . . . . . . . . . . . . . . . . . . . .  36
Performing Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  36
Troubleshooting  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  37
Complying with Warranty Conditions  . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  38
De-commissioning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  38

Section 6: Accessories and additional parts

Recommended accessories**. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  39
Recommended additional parts  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  39
MRS Foam Base  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  39
Reflex

™

 Seat Cushion (M04177)**  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  39

Symbols on the upper cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  40
Locate the seat cushion labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  40
Installing the Seat Cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  41
Deflating and Packing the Seat Cushion. . . . . . . . . . . . . . . . . . . . . . . . . . .  42
Cleaning and Disinfecting the Seat Cushion. . . . . . . . . . . . . . . . . . . . . . . .  42

Transport Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  42

Section 7: Compliance 
Electromagnetic Compatibility

Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  43

CE conformity mark. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  43
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  43

Electromagnetic Emissions Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  44
Electromagnetic Immunity Compliance  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  44

Содержание P005856A

Страница 1: ... 187692 EN 187692 Rev 010 P280 Mattress Instructions for Use P005856A P005858A P005987A P006052A P006172A P006173A ...

Страница 2: ...ervices Inc Velcro is a registered trademark of Velcro Industries BV Terralin is a registered trademark of Schülke Mayr GmbH Dismozon is a registered trademark of Bode Chemie GmbH Sanivap is a registered trademark of Sanivap S A Hill Rom reserves the right to make changes to the design characteristics and models without prior notice The only warranty Hill Rom makes is the express written warranty ...

Страница 3: ...s of the device 8 Mattress Topper and Mattress 8 Control Unit 9 Viewing the Whole Device 10 11 Understanding the Symbols on the Device 12 Symbols on the Upper Cover 12 Symbols on the Control Unit 13 Symbols on the Labels 14 Locating the Labels on the Device 15 Labels on the Control Unit 15 Accessing to the Upper and Bottom Covers Identification Labels 16 Serial number of the mattress 17 Checking t...

Страница 4: ... Disinfecting at Regular Intervals or in the Event of High Risk of Contamination 34 Performing the Final Steps 35 Servicing of the Device 36 Complying with Safety Recommendations 36 Performing Preventive Maintenance 36 Troubleshooting 37 Complying with Warranty Conditions 38 De commissioning 38 Section 6 Accessories and additional parts Recommended accessories 39 Recommended additional parts 39 MR...

Страница 5: ...ecifications Installing the Patientt Mobilizing the Patient Moving the Device Disinfection Servicing Accesssories Standards 187692 10 EN P280 Mattress Instructions for Use Page iii Recommended Separation Distances 46 ...

Страница 6: ...Page iv 187692 10 EN P280 Mattress Instructions for Use ...

Страница 7: ...bols Definition For every type of use Hillrom mattresses provide patients with optimal comfort and greater independence for a feeling of well being that is conducive to a swift recovery They are also easy to use for caregivers PATIENT CAREGIVER EASE OF USE INDEPENDENCE WELL BEING COMFORT SAFETY INSTALLATION MOBILIZATION HELP WITH CARE MOVEMENT ...

Страница 8: ...ates that the failure to follow the associated recommendation can put the patient or the user in danger or damage the equipment CAUTION This symbol indicates that the failure to follow the associated recommendation can result in damage to the equipment Tip Risk of Falling Entrapment Hazard Warning Risk of Crushing an Upper Limb Chemical Hazard Warning Electric Shock Hazard Biological Danger ...

Страница 9: ...n hospitals or other medical establishments Application Environment 3 long term care in medical establishments Application Environment 5 outpatient or ambulatory care This device is not designed to come into direct contact with damaged skin and must to be used with a sheet between the patient s skin and the surface of the mattress In accordance with the NPUAP EPUAP directives 1 Hill Rom recommends...

Страница 10: ...n and Maximum Inflation Pmax The P280 Overlay model must be installed on a standard foam mattress or on the MRS foam base The MRS foam base can be ordered separately See MRS Foam Base on page 39 to upgrade P280 Overlay into P280 MRS Configuration of the P280 MRS Intended Users The P280 mattresses are designed to be used by Qualified Staff for patient care and from several care application environm...

Страница 11: ...are met Before using the mattress for the first time or when removing from storage Check the condition and conformity of the electrical system with the applicable safety standards Connect the control unit of the device to the mains power supply See Complying with Electrical Safety Standards on page 6 Allow access to the wall outlet to disconnect the mattress when needed Make sure that all the func...

Страница 12: ...nitoring or constraint It is imperative to observe the practices relating to the safety of caregivers Special attention must be taken when redistributing the load application points since there is a danger that the bed will tip when the frame is moved Surface impermeability and therapy capabilities could be affected by needle sticks or other mattress bladder punctures Caregivers should be instruct...

Страница 13: ... the patient or any other person When intravascular or intracardiac connections are in use the electric potentials of all the unprotected metal parts of the appliance and the bed need to be equalized This label indicates that oxygen tents must never be used and that only the use of nasal tubes and oxygen masks is authorized For reasons of safety masks and tubes should always be kept at a higher le...

Страница 14: ...eight 6 1 kg 13 4 lb 12 kg 26 5 lb 7 5 kg 16 5 Ib Range in transport mode 2 hours Upper cover applied part of the device Polyurethane coating on polyester material low fric tion stretchable in both directions breathing bacte riostatic fungistatic and antimicrobial can be wiped and washed Bladders Polyurethane Safe working load including the total weight of the patient accessories if they are suppo...

Страница 15: ... Vac 0 17 A 120 Vac Maximum energy consumed 5 2 Wh Operation of the device Continuous Sleeve material ABS PC Device sound pressure level sound power ISO 3744 45 dB A 61 dB A Fuses T1AL 250V Compression 0 10 5 kPa Compressor flow rate 10 l min IEC 60601 1 Classification Classe II Degree of protection provided by the cover IEC 60529 IP41 Protected against access to hazardous parts with a wire and ag...

Страница 16: ... Device Item Name P280 MRS A Control Unit B Detachable Upper Cover C Pneumatic Mattress D Heel Zone Foam E Bottom Cover F Power Cord G Hose H MRS Foam Base P280 MRS Mattress Configuration only I Mattress P280 MRS or Mattress Topper P280 Overlay Bottom Cover B F A G D E C H I ...

Страница 17: ...N P280 Mattress Instructions for Use Page 11 Destination Specifications Item Name P280 Air A Control Unit B Detachable Upper Cover C Pneumatic Upper Mattress D Pneumatic Lower Mattress E Bottom Cover F Power Cord ...

Страница 18: ... Use Understanding the Symbols on the Device Symbols on the Upper Cover Do not walk on or run over the power cord Foot End Zone for Notes Top of the Mattress Install on a standard foam type mattress P280 Overlay only Adjust the head and foot end straps ...

Страница 19: ...ting Pressure Cycles every 5 minutes 1 Maximum Inflation P max B Comfort Setting Reduce the Pressure 2 Alternating Low Pressure Mode C Comfort Setting Increase the Pressure 3 Continuous Low Pressure Mode D Selection of the Operating Mode 4 Over Inflation E Security Lock 5 Mains Power Fault Indicator F On Off 6 Low Pressure Indicator G Audible Indicator Silence 7 Malfunction Indicator A B D E F C G...

Страница 20: ...drops Device Referencea IP24 Cover protected against access to hazardous parts with a finger and against splashing water Serial Number Type BF Applied Part Fuse Class II Device CAUTION read the Safety Instructions Carefully Medical Device conformity mark Refer to the User Manual Alternating Current DO NOT DISCARD Obey Local Recycling Rules Temperature Limits Interior Use Atmospheric Pressure Limit...

Страница 21: ... the conditions of use and the specifications of the device A B are located on the rear of the control unit A Conditions of Use and Specifications of the Device B Serial Number C Mandatory Certification only for specific countries See Symbols on the Labels on page 14 P005856A P005987A P006172A P005858A P006052A P006173A P005856A P005987A P006172A P005858A P006052A P006173A C A B ...

Страница 22: ...N P280 Mattress Instructions for Use Accessing to the Upper and Bottom Covers Identification Labels Open the zip fastener on the mattress Upper Cover P280 Upper Cover P280 MRS Fire Bottom Cover P280 Bottom Cover P280 MRS ...

Страница 23: ...e 17 Destination Specifications See details of the symbols for cleaning and disinfection in section Disinfecting and Servicing on page 31 Serial number of the mattress Bottom Cover P280 MRS FIRE Bottom Cover P280 Air P005856A P005858A P005987A P006052A ...

Страница 24: ...Page 18 187692 10 EN P280 Mattress Instructions for Use Checking the Model of the Device on the Packaging Label P006172A P006173A P005856A P005858A P005987A P006052A P006173A P006172A ...

Страница 25: ...ng ability Persons lacking the mental capacity to recognize unsafe actions Unauthorized persons Install and use for the first time must be done in accordance with these instructions Checking the Compatibility of Bed Frame and Mattresses The bed mattress siderails combination and in particular their respective dimensions must be examined in order to make sure that it meets the requirements of the I...

Страница 26: ...l it 4 Check that the symbol on the cover is at the foot of the bed The P280 Overlay delivered without foam base is designed to be used in combination with a foam mattress below Take care not to use it directly on the mattress support platform The P280 MRS mattress delivered with a foam basis and the P280 Air mattress are conceived to be used directly on a sleep deck Be careful to remove the foam ...

Страница 27: ...ving parts of the mattress support platform such as actuators CPR handles etc With articulated frames make sure that the straps of the mattress are only attached to the mobile head and foot sections and NOT to the main frame 9 Attach the control unit to the footboard of the bed using the handle aAttachment 10 Connect the hose to the control unit The connector clicks when correctly in position 11 M...

Страница 28: ...ht of the control unit 17 Press to start the device The corresponding indicator light comes on When connected to the mains power for the first time the device will automatically inflate to maximum inflation P max to fully expand the air bladders It then automatically returns to the default mode Comfort Setting 5 Alternating Low Pressure Mode 10 minute cycle Do not place the patient on the mattress...

Страница 29: ...the internal pressure of the different zones of the device varies creating zones of high and low pressure under the patient s body When this operating mode is selected the indicator light near the symbol comes on Press to select an alternating low pressure cycle Select a 10 15 20 or 25 minute cycle for optimal patient comfort and according to the required result Continuous Low Pressure In Continuo...

Страница 30: ...0 kg and level 10 corresponds to 140 kg Over Inflation In order to provide added support for the patient when seated the pressure can be increased slightly above the selected level in the alternating low pressure and continuous low pressure modes The indicator light near the symbol comes on in addition to the light of the selected operating mode Maximum Inflation P Max When connected to the mains ...

Страница 31: ...the hose connector from the control unit The device takes approximately 15 seconds to deflate 2 If necessary lower the siderails and the head section of the bed or place the bed frame in CPR position before using the emergency flat return refer to the instructions of the bed manufacturer 3 Place a CPR panel under the patient or follow the CPR function protocols Canceling the CPR 1 Connect the hose...

Страница 32: ...unding press If the problem continues the audible indicator sounds again after 3 minutes Mains Power Fault Indicator If the P280 is disconnected or if there is a mains power failure an audible indicator sounds and the light near the symbol comes on The audible and light indicators are active when the P280 is being transported See Moving the Patient on the Bed in Transport Mode page 27 Low Pressure...

Страница 33: ...t audible indicator sounds and the indicator light comes on The others indicator lights are off If an electronic module is disconnected when the device is switched on the module may be destroyed 4 Deactivate the Mains power fault audible indicator by pressing See Audible Indicator Silence page 26 5 Disconnect the device from the wall outlet The device automatically switches to transport mode and r...

Страница 34: ...nto place The device remains inflated for 2 hours when the transport cap is in place 8 Reconnect the device as soon as the destination is reached The device automatically returns to the previous operating mode Make sure that the device does not remain disconnected from the mains for more than 2 hours when a patient is installed The CPR function remains available in transport mode If the hose is co...

Страница 35: ...anport Mode procedure page 27 3 If necessary detach the Velcro straps securing the power cord to the bed frame 4 Undo the two straps securing the mattress to the bed at the head and foot ends 5 Place the control unit on the mattress to prevent it from being damaged 6 Transfer the mattress on to the other bed In the case of P280 Overlay model if there is no mattress on the other bed transfer the ba...

Страница 36: ... and the indicator light near symbol comes on the other lights are off 5 Deactivate the Mains fault audible indicator by pressing See Audible Indicator Silence page 26 6 Detach the Velcro straps securing the power cord to bed 7 Remove the cord from the retaining loops of the straps 8 Undo the two straps securing the mattress to the bed at the head and foot ends 9 Starting at the head end slowly ro...

Страница 37: ...disinfecting of the product provided by the manufacturer Thoroughly dry the device before reusing it Suitable individual protective equipment must be worn during the steps of the cleaning operation blouse gloves eye protection etc Failure to implement one or more of these recommendations may lead to damage or deterioration preventing use of the device and rendering the warranty void Controlling In...

Страница 38: ...Hill Rom can compromise the conformity of the device and patient safety and render the warranty null and void Hill Rom recommends that the device should be disinfected before scrapping in accordance with applicable local regulations Cleaning and disinfecting are two separate procedures Products to Be Avoided Never use cleaning agents detergents degreasing agents or industrial solvents containing a...

Страница 39: ...ipe away any traces of pharmaceutical solutions used for the patients to avoid permanent damage to the surface Remove tough stains with a soft brush and neutral detergents or a chlorine based solution with a concentration less than or equal to 1 000 ppm To eliminate hardened stains excreta other forms of soiling soften them by soaking and take care to thoroughly dry the cover before putting it bac...

Страница 40: ...s Anioxy Spray WS Anios Ready to use contact time 30 min Dry Steam Cleaning the Mattress Dry steam or superheated steam contains no more than 6 of water in suspension and avoids the effects of condensation To avoid damage due to high pressure or an abnormal surface temperature take the following precautions Use low pressure steam on the electric parts Do not use accessories such as high pressure h...

Страница 41: ...e Seat Cushion Do not always machine wash as doing so will reduce the lifetime of the components Machine wash only if particular risks of infection occur Proceed with the following final steps before reusing the cleaned and disinfected device Performing the Final Steps Always remove all traces of the products used when washing or disinfecting the device Make sure that all the parts of the device a...

Страница 42: ...scriptions and calibration instructions can be obtained upon request from Hill Rom After Sales The frequency of inspections must be adapted to the general condition of the product and its use for example if the device is used by heavy patients It is the responsibility of the facility to implement a preventive maintenance program for the device according to its conditions of use The device and acce...

Страница 43: ...ailed troubleshooting instructions Replacing the Fuse 1 Remove the cover of the fuse box on the rear of the control unit using a small screwdriver 2 Check that the characteristics of the new fuse matches the characteristics of the label and meets the IEC 60269 1 standard 3 Replace the faulty fuse 4 Securely close the fuse box Cleaning and Replacing the Air Filter 1 Remove the air filter cover on t...

Страница 44: ...omers should adhere to all federal state regional and or local laws and regulations as it pertains to the safe disposal of medical devices and accessories If in doubt the user of the device shall first contact Hill Rom Technical Support for guidance on safe disposal protocols Do not dispose of electric and electronic equipment in the waste bin per directive 2012 19 EU Never discard the device s ba...

Страница 45: ...ion is an accessory that can be inflated using the P280 Reflex adaptor In combination with the air mattresses the ReFlex seat cushion provide 24 hour pressure relieving care and help to prevent pressure ulcers for semi mobile patients up to high For more information refer to the P280 Spare Parts List The device is intended to be used with a sheet between the patient s skin and the surface of the s...

Страница 46: ... model low friction stretchable in both directions breathing bacteriostatic fungistatic and antimicrobial Can be wiped and washed Cushion Polyurethane Safe working load including the sum total of the patient s weight The safe working load is the technical patient weight limit that can be applied above which the seat cushion may be damaged Medical Device conformity mark Medical Device Cushion Infla...

Страница 47: ... bed 3 Open the flap A on the seat cushion disconnect and stretch the spiral hose B 4 Connect the adaptor C between the spiral hose and the control unit A click confirms the connection 5 Connect the control unit to the mains The device automatically inflates to the maximum P max so as to fully develop the air cushions When he returns to the default mode Alternating Pressure Low the cushion is read...

Страница 48: ...on the side opposite the valve fold the cushion in order to expel the air 4 Close the plug and fold the flap over the hose 5 Store the seat cushion 6 The device must be stored in its original packaging Protected against light and damp At least 10 cm above floor level to prevent fluid ingress Protected against dust Outside passageways Cleaning and Disinfecting the Seat Cushion When cleaning always ...

Страница 49: ...Devices was applied to the P280 mattress for the first time in 2011 Standards Name EN 60601 1 2006 A1 2013 IEC 60601 1 2005 A1 2012 Edition 3 CORR1 CORR2 EN 60601 1 2 2015 IEC 60601 1 2 2014 EN 60601 1 6 2010 IEC 60601 1 6 2010 EN 60601 1 8 2007 IEC 60601 1 8 2007 EN ISO 14971 2012 EN ISO 10993 1 2009 AC 2010 EN ISO 10993 5 2009 EN ISO 10993 10 2010 EN ISO 15223 1 2016 EN 1041 2008 ...

Страница 50: ...pecified below The customer or the user of the P280 Mattress should make sure it is used in such an environment Immunity Test Test Level IEC 60601 Compliance Electromagnetic Environment Recommendations Electrostatic discharge ESD IEC 61000 4 2 8 kV on contact 2 kV 4 kV 8 kV and 15 kV in the air 8 kV on contact 2 kV 4 kV 8 kV and 15 kV in the air The relative humidity must be at least 5 Electric fa...

Страница 51: ...mitted by fixed RF transmitters as determined by an electromagnetic measurement of the sitea must be below the level of compliance in each frequency band b Interference may occur close to devices identified with the following symbol a The field levels of fixed transmitters such as radio telephone bases cell wireless and terrestrial mobile radios amateur radios and AM FM and TV communication radios...

Страница 52: ...e degradation of the performance of this equipment could occur Wireless communication system Separation distance m TETRA 400 limited to 10 W ERP 0 3 Public safety 460 470 MHz GMRS 460 limited to 5 W ERP 0 2 GMRS 460 limitede to 2 W ERP 0 1 GSM 850 GSM 900 RFID 868 MHz TETRA 800 limited to 2 W ERP 0 3 GSM 1900 limited to 1 W ERP 0 2 WLAN 802 11a 5 GHz limited to 1W ERP 0 7 iDEN 820 CDMA 850 GSM 180...

Страница 53: ...tput of the communication equipment Maximum transmitting power of the transmitter W Separation distance versus the frequency of the transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 39 100 11 67 11 67 23 33 For transmitters with a maximum transmitting power not given above the recommended separation distance ...

Страница 54: ...Page 48 187692 10 EN P280 Mattress Instructions for Use ...

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