CARITAL OptimaCot User Manual Download

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KOHJ-H-15-EN1-1.0-15102021

Design standards

IEC 60601-1:2005 & IEC 60601-1:2005/AMD1:2012 except for

clause 11.7

IEC 60601-2:2014

IEC 60601-1-6:2010 & IEC 60601-1-6:2010/AMD1:2013

IEC 60601-1-11:2015

IEC 62304:2006 & IEC 62304:2006/AMD1:2015

IEC 62366:2007 & IEC 62366:2007/AMD1:2014

IEC 60601-2-52:2009 subclause 201.9.101

EN ISO 13485:2016

EN ISO 14971:2019

EN ISO 10993-1:2018

EN ISO 15223-1:2016

EN ISO 3758:2012

EN 597-1:2015 & EN 597-2:2015

EN 12182:2012

Summary of Contents for OptimaCot

Page 1: ...1 KOHJ H 15 EN1 1 0 15102021 User s guide OptimaCot...

Page 2: ...dd on for the Medicase hygiene cover 12 3 3 Taking off the cover 12 3 4 Putting on the cover 13 4 Commissioning 16 4 1 Components of the mattress system 16 4 2 Connecting the mattress system to the be...

Page 3: ...e and storage 38 7 1 Cleaning 38 7 1 1 Controller and tube system 38 7 1 2 Cells 38 7 1 3 Medicase cover 38 7 1 4 Comfort add on for the cover 39 7 1 5 Foam inserts for the cover 39 7 2 Checking the o...

Page 4: ...745 MDR Main fuse infor mation Keep protected from rain Fragile handle with care Do not use if the packaging is damaged or has been opened Store away from heat See user s guide Type BF device Permitte...

Page 5: ...signals and the adjustment of different adjustment regions Operating modes Normal operation Sitting operation Other NFC tag location in device note this feature is not yet implemented Keypad lock Bat...

Page 6: ...ed with patients with lower ex tremities amputated from the midline of the legs upwards 2 5 System description The Carital OptimaCot mattress system has a double cell structure where the tun nel shape...

Page 7: ...umber beginning with the PC iden tifier Only healthcare professionals can assess the need for and suitability of a mattress system in the treatment situation Any serious incident that has occurred in...

Page 8: ...ead may result in suffocation Make sure that the air tubes and the controller s power cable cannot twist around the head or neck Place the controller s power cable in such a way that it cannot be clam...

Page 9: ...reduction capacity is reduced Supine operation is used only for the treatment of immobile patients on horizontal position lying on their backs Selecting Supine operation in other treatment posi tions...

Page 10: ...tenna cables and external antennas to the controller and its cables should be at least 30 cm so as to ensure the performance specified in the technical files of the controller The controller is intend...

Page 11: ...se hygiene cover The Medicase hygiene cover protects the mattress system s cells from liquids and body fluids The surface of the cover is polyurethane and the lower layer is polyester The cover can be...

Page 12: ...s from the controller 2 Pull down the tube sleeve to expose the by disconnecting the air tube system and air tube connectors Disconnect the air power cable Disconnect the power cable tubing from the c...

Page 13: ...cover 3 4 Putting on the cover 1 If the cover has foam inserts place them 2 Insert the foam inserts into their desig on top of the cover Ensure that the label nated compartments in the cover Close in...

Page 14: ...ide the upper cells first cell fastener adapter 7 Pass the strap through the lock and close 8 Pass the strap through its hole under the the lock foam insert 9 Pass the strap through the hole in the 10...

Page 15: ...cord through the con duit in the cover 15 Pass the air tubing through its own tube sleeve Attach the air tubing to the cell s air tube system 12 Pass the tube sleeve over the air tubing 14 Pull the po...

Page 16: ...e mattress system Controller Controller Type plate stickers on the side and at the bot tom of the controller contain the device iden tification information The lockable power cable 5 m The power cable...

Page 17: ...es an example of troubleshooting The double sided quick guide is found on the back of the controller and is released for viewing by raising it upwards Be sure to put the quick guide caddy back in plac...

Page 18: ...e gaps in the lying surface an extra bottom support foam optional accessory can be used inside the cover underneath the cells The support surface should fit the bed so that it does not extend over the...

Page 19: ...o the moving back part of the lying surface not to the fixed part of the bed body Do not use extra bed sheets pillows or heavy positioning pillows on the mattress If side rails are used with the Carit...

Page 20: ...ctive tube sleeve as far up as possible towards the controller 1 Suspend the controller at the end of the bed in as central position as possible 3 Make sure that the tube sleeve and power cord are as...

Page 21: ...r As a general rule lift and handle the controller using two hands on both sides of the body or according to the instructions with the attached suspender 7 Plug the power cable into an electrical outl...

Page 22: ...ube sleeve has been routed in the bed structure in such a way that it cannot be clamped by the folding parts of the bed Ensure that the label indicating the correct direction of installation of the ma...

Page 23: ...size of the patient such that the pressure in all the adjustment sections are optimally placed to be regulated by the controller in correspond ence to the patient s body parts Make sure that the cont...

Page 24: ...f the controller To turn off the controller in any operating mode press the device s standby button The controller can be turned off in any operating mode by pressing the de vice s standby button The...

Page 25: ...tch to Sitting oper ation The device will first adjust the torso then the foot region and finally the head The Sitting operation LED is lit and the cell LEDs will move up or down The device has activa...

Page 26: ...hanged This allows the controller to monitor the pressure in the torso cells If the pressure values of the torso cells are continuously outside the permissible limit values for 45 minutes the device w...

Page 27: ...s function With the device in operation press the Supine operation button to activate the function The device activates Supine operation The device will first adjust the torso then the foot region and...

Page 28: ...Once the patient transport is finished connect the controller back to the mains by connecting the power cable to an electrical outlet The cells will not deflate during transport The controller must be...

Page 29: ...he cell s tube system and the power cable from the controller turn off the controller and contact Carital service 6 Information signals If the controller detects a failure or wishes to inform the user...

Page 30: ...nowledge the failure indication signal press the information signal re set button Only the audible part of the information signal is acknowledged The visual information signals will remain on and the...

Page 31: ...er 6 3 Check the air tubes leak in tube or inner cells The information signal reset button blinks and the display reads Check the air tubes See the removable quick guide This information signal is dis...

Page 32: ...e Close the tube sleeve When you have checked the above ac knowledge the information signal by pressing and holding down the informa tion signal reset button for three sec onds If the information sign...

Page 33: ...limit for scheduled maintenance is approaching prepare for maintenance Prepare to send the controller in for scheduled maintenance after one 1 month After this the device will display a re minder for...

Page 34: ...hown in an illogical way Turn the controller off and on with the standby button shown in the figure The device will resume Normal operation af ter restarting If the device does not resume Normal op er...

Page 35: ...t resume previous operation Immediately contact Carital service 6 9 Battery charge falls low When the charge of the internal battery falls to a very low level 7 2V 7 0V the controller will provide an...

Page 36: ...isconnected from the mains before an ade quate charge level has been reached the device will shut down itself after 5 seconds after booting To maintain battery performance connect the controller to AC...

Page 37: ...t by a party other than Carital service If the mattress system behaves contrary to the functions and situa tions described in this user s guide disconnect the air tubing from the cell s tube system an...

Page 38: ...ediately if exposed to urea 7 1 1 Controller and tube system Disinfect by wiping using regular cleaning and disinfection agents including ethanol solu tions 60 80 chlorine solutions max 1 000 ppm Dry...

Page 39: ...umble dry Do not iron Do not dry wash Do not use conditioners Ensure that the cover is entirely dry before commissioning it 7 1 5 Foam inserts for the cover Remove the integrated foam inserts from the...

Page 40: ...e 7 2 3 Cells The condition of cells must be inspected When cleaning If you suspect that the cover is broken or the interior is contaminated When the patient changes or weekly in long term care Strip...

Page 41: ...is used in violation of the instructions specified in the user s guide or it is not cleaned of body secretions containing urea in particular or the mattress system is used by a prominently sweating or...

Page 42: ...Service To change from one tab to another in the maintenance view press the information signal reset button To return from the maintenance view to the normal operating mode press and hold down the in...

Page 43: ...o 50 C 35 C to 70 C with vapour pressure 50 hPa Air humidity max 90 Store in a clean and dry place The cells and the cover can be rolled up for storage using for example the trans port bag accessory A...

Page 44: ...an be recycled with cardboard The styrofoam packaging supports and packaging plastic can be recycled with plastic packaging 9 Warranty The Carital OptimaCot mattress system has three year warranty 36...

Page 45: ...e Lithium ion 7 26V capacity 2 650mAh manufacturer Cell tech Oy Varta Storage GmbH Non rechargeable battery type CR2032 lithium ion 3 0V capacity 230mAh manufacturer Varta Microbattery GmbH Fuses F1 F...

Page 46: ...014 IEC 60601 1 6 2010 IEC 60601 1 6 2010 AMD1 2013 IEC 60601 1 11 2015 IEC 62304 2006 IEC 62304 2006 AMD1 2015 IEC 62366 2007 IEC 62366 2007 AMD1 2014 IEC 60601 2 52 2009 subclause 201 9 101 EN ISO 1...

Page 47: ...5 EN1 1 0 15102021 11 Contact details of the manufacturer and service Manufactured by MediMattress Ltd Haukilahdenkatu 4 FI 00550 HELSINKI tel 358 306 40 40 40 info medimattress fi Service add local s...

Page 48: ...phase at 0 0 UT 250 300 cycle 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle 70 UT 25 30 cycles Single phase at 0 0 UT 250 300 cycle Mains power quality should be that of a typical com...

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