CARITAL NeoICU User Manual Download Page 42

Page: 42 / 44

KOHJ-H-13-EN1-2.0-19042022

Class I medical device under the EU Medical Device Regulation

2017/745 (MDR) (Rule 1 - Non-invasive devices / Rule 13 -

All other active devices).

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

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 NeoICU

Page 1: ...1 KOHJ H 13 EN1 2 0 19042022 User s guide NeoICU NeoIW...

Page 2: ...3 1 NeoICU support surfaces 11 3 1 1 Standard 11 3 1 2 Giraffe 11 3 2 NeoIW support surface 12 3 3 Medicase hygiene cover 13 3 3 1 Removing the cover 13 3 3 2 Putting on the cover 15 4 Commissioning 1...

Page 3: ...t 33 7 Maintenance and storage 35 7 1 Cleaning 35 7 1 1 Controller and tube system 35 7 1 2 Cells 35 7 1 3 Medicase hygiene cover 35 7 1 4 Foam plastic supports 36 7 2 Checking the operability of the...

Page 4: ...745 MDR Main fuse information 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 Allowable...

Page 5: ...icating information signals and the adjustment of different adjustment regions Operating modes 0 3 kg 3 6 kg Other NFC tag location in device note this feature is not yet implemented Information signa...

Page 6: ...atients who undergo extracorporeal membrane oxygenation ECMO or therapeutic hypothermia or who have spinal or other severe or unstable fractures in the treatment of pressure ulcers regardless of the c...

Page 7: ...guide 2 7 Warnings This guide applies only to second generation Carital controllers Asecond generation controller can be identified with its serial number beginning with the PC identifier Only a heal...

Page 8: ...or example because of children or pets If necessary and the operating environment poses a risk of inadvertent changes of control operating modes use the keypad lock in the controller A twisted air tub...

Page 9: ...e support surface holding the cells or the cover Sharp objects may puncture the cells If the cover or cells are exposed to urea sweat and urine for a prolonged period the molecular structure of polyur...

Page 10: ...al regulations pertaining to contaminated healthcare waste If the controller has encountered a significant mechanical strain dropped hard collision or similar check the mechanical condition of the con...

Page 11: ...NeoICU support surfaces 3 1 1 Standard height 40 mm width 350 mm length 650 mm Dimensions of the NeoICU cells 3 1 2 Giraffe The dimensions of the Giraffe support surface are designed to fit the GE Gir...

Page 12: ...mm width 350 mm length 540 mm Dimensions of the NeoICU Giraffe cells 3 2 NeoIW support surface The NeoIW support surface is designed for use in warmers and baby stations height 40 mm width 470 mm leng...

Page 13: ...or the patient to be x rayed on the mattress NeoICU Medicase hygiene cover 3 3 1 Removing the cover The example illustrates the removal of the cover of the NeoICU Giraffe support surface 2 Pull the tu...

Page 14: ...grated into the cover Note NeoICU Giraffe only 6 Pass the air hose through its opening 8 Open the velcro on the womb substitute system Note NeoICU only and carefully remove the cells Repeat for both p...

Page 15: ...oICU Giraffe support surface 1 Check that the necessary components are readily available cover WSS cells and their covers Note NeoICU only foam plastic inserts Note NeoICU Giraffe only air tubes and t...

Page 16: ...the cover zippers 7 Pass the tube sleeve as far up as possi ble towards the white and blue Sixtube connector 4 Pass the cell air tubes out of their opening 6 Insert the womb substitute system Note Ne...

Page 17: ...oller Controller Air tube system between the controller and cells including connectors The air tube sys tem is supplied with the tube sleeve on Type plate stickers on the side and at the bot tom of th...

Page 18: ...s the correct direction of in stallation for the mattress system Ensure that the label indicating the correct direction of installation of the mattress system is located at the foot end and facing upw...

Page 19: ...nto the incubator The air tubes of the cells have been routed out at the left or right corner of the leg part NOTE The outlet of the tubes can be changed according to the incubator NeoICU Giraffe Medi...

Page 20: ...position supports on the mattress system 4 3 Commissioning the controller 1 Suspend the controller firmly on an incu bator structure with at least a 10 kilogram load bearing capacity e g side rail in...

Page 21: ...ive tube sleeve as far up as possible towards the controller 4 Connect the Sixtube connector to the con troller with the blue release button facing up and make sure the connector snaps when locking in...

Page 22: ...ttress system is located at the foot end and fac ing upward Make sure the tube sleeve has been rout ed in such a way that it cannot be clamped by the folding parts of the incubator Ensure that the con...

Page 23: ...er who weigh 3 6 kg Only a healthcare professional can assess the need and suitability of using the mattress system in a treatment situation Before placing the patient on the support surface start the...

Page 24: ...f the cells When the mattress system has success fully activated the selected operation green LED indicators will light up at the centre of the LED light bar 5 2 Turning off the controller To turn off...

Page 25: ...mattress system will then run on the internal battery of the device Under normal operating conditions a fully charge battery will suffice for at least 30 minutes of continuous pumping of the cells The...

Page 26: ...uired for normal operation see section 6 8 Information signals Battery charge level low 5 5 Resuscitation situations IN A RESUSCITATION SITUATION Turn off the device from the standby button and start...

Page 27: ...he LED display and references to more detailed troubleshooting guides 6 1 Pressure sensor function error 6 2 Check the air tubes leak in tube or cell system potential leak in the centre part 6 2 Check...

Page 28: ...reset button blinks and the display reads Check the air tubes See the removable quick guide This information signal is displayed if the device does not achieve the desired op erational setting within...

Page 29: ...tal service 6 3 Pressure target value invalid The LED row will light up as shown in the figure and the display will read Incorrect target pressure value contact service The fault status information si...

Page 30: ...s shown in the figure and the display will read The time limit for scheduled maintenance has passed contact service Immediately contact Carital service and send the controller in for sched uled mainte...

Page 31: ...in Appendix 1 a situation may result where the device s mode of operation will randomly change without user action Move the device further from the source of the electromagnetic interference to elimin...

Page 32: ...ate the decreasing time on the display After 15 minutes the device will turn off completely and indicate this with a sound and on the device screen When the device is connected back to the mains resta...

Page 33: ...one time malfunction failure state can be acknowl edged by pressing the acknowledgement button of the indication signal The indication signal is acknowledged only for sound visual information signals...

Page 34: ...r or modification carried out by a party other than Carital service If the mattress system does not behave in accordance with the func tions and situations described in this manual disconnect the air...

Page 35: ...infect by wiping using regular cleaning and disinfection agents including ethanol solu tions 60 80 chlorine solutions max 1 000 ppm Dry at room temperature Do not immerse the controller in any liquid...

Page 36: ...lows when commissioning the controller when moving the controller when cleaning whenever there is reason to believe the device has been damaged The controller should be visually inspected for the cond...

Page 37: ...e support surface is used in violation of the instructions spec ified in the user s guide and it is not cleaned of body secretions containing urea in particular or the mattress system is used by a pro...

Page 38: ...e 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 i...

Page 39: ...5 o C 70 o C with vapour pressure 50 hPa Air humidity max 90 Store in a clean dry place The cells and the cover can be rolled up for storage using for example the transport bag accessory The cells and...

Page 40: ...rd The styrofoam packaging supports and the plastic packaging can be sorted into plastic pack aging collection 9 Warranty The Carital NeoICU and NeoIW mattress systems have a three year warranty 36 mo...

Page 41: ...6V capacity 2 650mAh manufacturer Celltech Oy Varta Storage GmbH Non rechargeable battery type CR2032 lithium ion 3 0V capacity 230mAh manufacturer Varta Microbattery GmbH Fuses F1 F2 T 2 5A 250V 5X20...

Page 42: ...andards 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...

Page 43: ...00550 Helsinki tel 358 0 306 40 40 40 asiakaspalvelu medimattress fi www medimattress fi Distributor and Service United Kingdom Direct Healthcare Group Ltd Withey Court Western Industrial Estate Caerp...

Page 44: ...se 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 commer...

Search results

Summary of Contents for NeoICU

Reviews:

Related manuals for NeoICU

Brands by name

Popular brands

CARITAL NeoICU, User Manual

Search results

Summary of Contents for NeoICU

Reviews:

Related manuals for NeoICU

Brands by name

Popular brands