User Manual - Elan Medical Supplies
Contents
1. OPERATION MANUAL gt English 1 0 Indications Attention Please read VAN enclosed document thoroughly Declaration of Conformity to Medical Device Directive International Electronics Approval Do not immerse power IPX0 unit in liquid or spray liquids directly on power unit tT Type B Equipment Indications This air alternating mattress system is designed for patients who endure pressure ulcer and potential patients who wish to reduce the likelihood of pressure ulcer This device is intended to treat and prevent pressure ulcers by facilitating blood circulation and decreasing pressure of each tissue s contact area Always consult a physician or health professional before using this 3 AIR ALTERNATING PRESSURE MATTRESS SYSTEM mattress system Contraindications Certain patient conditions are not suitable for using this type of device such as fracture of instable vertebrae and illness of instable vertebrae Always consult a physician or health professional before using this device The use of this system does not replace the regular repositioning monitoring and nursing of the patient 2 0 Safety Precautions 1 To ensure proper operation please inspect and verify all parts are setup properly and anchor securely Do not place anything on top of the power unit Make sure power cord is underneath bed frame and free from hazard 2 It is recommended to limit bed linens to a sing2. Or and Patient leaves a deep dent at the contact area which does not return back to its original shape worn down by the patient Verify if CPR latch is properly inserted Connect CPR latch securely Check if mattress air hose couplings are properly connected to power unit s quick release couplers Secure air hose couplings firmly into place Verify if patient weight setting is correct Increase or decrease weight setting until appropriate pressure is reached Inspect air filter for dust Clean or replace air filter Lift mattress coverlet up to check if air cells are connected correctly Make sure all air cells are properly linked to air supply Lift mattress coverlet up to check if air tubes are kinked or obstructed Check and adjust air tubes positions Check if air cells are cut or cracked Replace with genuine spare parts or contact your local distributor 5 Patient is not getting pressure relief due to system failure reddening of skin Contact your physician and or nursing service immediately Air tube is referring to the mean of directing air flow from the power unit to each individual air cell 9 AIR ALTERNATING PRESSURE MATTRESS SYSTEM 12 0 Returns for Service This device is not self serviceable Service and repair must be performed by an authorized technician or representative All returned device must be cleaned and disinfected prior
3. 0 Program Setting 9 0 Cleaning Instruction Air mattress and power unit must be cleaned thoroughly between patients to avoid cross contamination The following is a suggested guideline but local infection control policies should be followed as well Regular cleaning can be performed at bedside with disinfectant and water followed by drying with a clean dry cloth Use only mild detergents and water to clean the coverlet and the mattress Any appropriate NON PHENOLIC cleaning agent may be used for heavy soiling with urine blood or other body fluids Please ensure air mattress and coverlet are completely dry before letting the patient laying on the surface again The recommended wash temperature is 71 C At 95 C the shrinkage rate is 1 higher and the color might run insignificantly Do not use electric or tumble dryers Do not iron WARNING Always unplug the power unit before cleaning Routine cleaning of power unit can be done by wiping down with damp cloth using disinfectant and water Never spray liquids directly on the unit itself 10 0 Routine Maintenance Remove air filter from the real panel of the power unit by opening up the filter cap to clean or replace the air filter Inspect the filter for dirt or dust and clean it with mild soap and water Reinsert the dried air filter after cleaning and ensure the cap is secure Replace with genuine air filter once a year is recommended and compressor every
4. B double insulated with or without functional ground wire IPX0 do not immerse power unit in any liquid or spray any liquids directly on the power unit This system is not AP APG protected Continuous operation Agency Approval EN60601 1 EN60601 1 2 EN61000 3 2 EN61000 3 3 UL2601 1 Electromagnetic Compatibility EN60601 1 2 1993 Maximum Weight Capacity Coziny 100 3 5 kg Coziny 200 6 kg Coziny 300 25 kg Carilex reserves the right to change prices or design parameters and specifications without incurring any liability in connection with such modifications 15 0 Environmental protection The instructions for use shall identify any RISKS associated with the disposal of waste products residues etc and of the ME EQUIPMENT and ACCESSORIES at the end of their EXPECTED SERVICE LIFE and provide advice on minimizing these RISKS UTDIC SUZRIC ENTERPRISE CO LTD C E EU Declaration of Conformity according to the Medical Device Directive 93 42 EEC Product Coziny 100 200 300 Type Designation Support Surface Model Power Unit SR368 Mattress Coziny 100 MSR215 Coziny 200 MSR216 Coziny 300 MSR217 Classification I For Annex IX MDD We herewith declare that the above mentioned product concerned meet the provisions of the following EC Council Directive and Standards General Applicable Directive Medical Device Directive 93 42 EEC Standards EN 60601 1 EN 60601 1 2 EN 980 ISO 13485 IS
5. Mattr ess Package Mattress unit with coverlet x 5 0 Features Control Panel Features See Figure 5a on page 5 power LED The green power LED will light when the main power rocker switch on the right side panel is turned on alarm LED A This low pressure alert notifies medical staff the mattress has insufficient pressure Audible alarm will sound for 15 seconds at each cycle and the indicator will stay on until the problem has been solved pressure monitoring LED Power unit features an integrated pressure senor which can monitor the mattress internal pressure 24 hour to achieve optimal internal pressure and to ensure maximum pressure relief LED indicates the system is monitoring the mattress internal pressure while the compressor is inflating Comfort Knob Simply turn the knob from min to max to adjust the mattress internal pressure The scale is only an approximation Please adjust the pressure setting if the mattress is too soft or firm to suit each patient s comfort Caregivers should always perform a hand check by placing their hands underneath patient s pelvis area to check if there is sufficient air support to ensure the patient is not bottoming out Control Panel Features Figure 5a Power Receptacle 3 Insert power cord firmly into receptacle Rear Panel Features See Figure 5c Convenient Handle 1 It provides additional gripping surface for user to carry the p
6. Anti Decubitus Air Alternating Pressure Mattress System Operation Manual Coziny 100 200 300 Incubator Baby Cot Baby Crib carilex Carilex Medical GmbH www Carilex de ys Bu3 E carilex Congratulations and thank you for purchasing this Carilex anti decubitus mattress system PLEASE READ THIS OPERATION MANUAL CAREFULLY BEFORE SETTING UP AND USING THE DEVICE Pay special attention to the warnings and other safety information Use genuine Carilex components are essential for optimal performance If you do not fully understand all the instructions safety precautions and warnings do not use this device In case you have questions please contact your local Carilex distributor 1 AIR ALTERNATING PRESSURE MATTRESS SYSTEM Table of Contents Section Lo 2 0 3 0 40 5 0 6 0 7 0 8 0 Description Page Indications 3 Safety Precautions 3 Warnings eee 4 System Package 4 Features 4 Mattress and Power Unit Installations 5 Program Settings 6 Patient Transfer and Transport ssisissasesssscocvesceces 6 COZINY 100 200 300 Section 9 0 10 0 11 120 13 0 140 15 0 Description Page Cleaning Instruction 6 Routine Maintenance 7 Troubleshooting 8 Returns for Service 10 Warranty sssrisirisisisississess 10 Product Specifications 10 Environmental protection 11
7. O 14971 Responsible for making this declaration is x The Manufacturer O The Authorized representative in the EU if applicable Manufacturer s Name Suzric Enterprise Co Ltd Manufacturer s Address No 77 Keji 1 Rd Guishan Township Taoyuan County Taiwan R O C Tel 886 3 3287882 Fax 886 3 3288622 Person responsible for making this declaration Name Surname Suzanne Wang Position Title President Taipei July 28 2011 For Class I Products Only carilex Turmbergstr 9A D 76227 Karlsruhe Germany Tel 49 0 721 16 19 835 Fax 49 0 721 16 19 836 Email info carilex de Website http www carilex de Coziny 100 200 300 U 2EGM11 COZI1
8. eration a reasonable service fee and part cost will be charged The warranty stated above is the only warranty made and is in lieu of all other warranties whether expressed or implied including any warranty of merchantability or fitness for a particular reason Carilex Medical GmbH will not be liable for consequential or incidental damages or any kind 14 0 Product Specifications The Coziny series contains three models for different sleeping surfaces Coziny 100 for incubator Coziny 200 for baby cot and Coziny 300 for baby crib Please use the appropriate model that best suit your need Mattress Dimension MSR215 216 217 Coziny 100 MSR215 68 x 38 x 2 cm Coziny 200 MSR216 75 x 49 x 7 cm Coziny 300 MSR217 140 x 70 x 8 cm OPERATION MANUAL 10 Number of Air Cells Coziny 100 One piece pad with 46 air cells Coziny 200 20 air cells Coziny 300 39 air cells Power Control Unit Dimension SR368 29 5 x 22 5 x 12 0 cm Material Power Unit ABS fire retardant UL Mattress Cell 100 nylon with TPU lamination Coverlet Dartex 100 nylon with PU backing Power Input AC 100 120V 50 60 Hz AC 220 240V 50 Hz Power Consumption Normal Operation Max 10W Power Control Unit Weight 2 5 kg Power Cord H05VV F3x1 00mm Fuse Rating T1A 250V Operating amp Transportation amp Storage Conditions Temperature 5 C 40 C Humidity 15 60 Electrical Classification Class I Type
9. le layer in order to allow the moisture escape efficiently through the coverlet Only breathable incontinent pads are recommended for use with this mattress system 3 Avoid using this device near open flames lighters or cigarettes Flammability hazard exists This device draws air from the surrounding Thus cigarette smoking may damage internal component 4 This system should disinfect thoroughly between patients to avoid cross contamination 5 Verify patient weight does not exceed bed frame bed rails and this mattress system s weight capacity 3 0 Warnings 1 Use this mattress with proper side rails to ensure the gap between the side rail and top of the mattress is small enough to prevent patient from getting his or her head or neck into the gap Fail to do so could result in serious patient injury 2 DO NOT disassemble the power unit if you are not a qualified technician Please contact your local distributor for all service 3 This product is NOT AP APG protected 4 Re position the patient regularly is still necessary when using this mattress 5 Operating transportation and storage conditions Temperature 5 C 40 C Humidity 15 60 CAUTION ENSURE THAT THERE ARE NO PROTRUDING OBJECTS SHARP POINTS OR BED SPRINGS UNDER THE MATTRESS AS THESE COULD PUNCTURE THE AIR CELLS 4 0 System Package Power Unit Package Power unit x 1 Power cord x 1 Operation manual x 1
10. ower unit Hanging Hooks 2 Hanging hooks are designed to hang the power unit on almost any foot board Fuse 3 Fuse holder can be opened for maintenance Air Filter and Filter Cap 4 Carilex recommends that the filter to be clean or replace once a month to ensure optimal performance of the power unit Right Side Panel Features Figures 5c 6 0 Mattress and Power Unit Right Side Panel Features See Figure 5b Installations Rocker Switch 1 1 Place Carilex mattress on top of the Power unit s main power switch original mattress with the logo at foot end Secure the mattress by using Couplers 2 elastic straps for Coziny 200 and 300 Quick release couplers are used to if needed Please verify all bed secure mattress air hoses to power unit O AIR ALTERNATING PRESSURE MATTRESS SYSTEM functions are working properly without interference before proceeding to the next step 2 Secure the power unit onto the foot board using hanging hooks 3 Firmly connect the mattress air hose couplings to the quick release couplers on the power unit s air outlet 4 Plug the power unit into a wall outlet and turn on the main power rocker switch on the right side panel to inflate the mattress system 5 Turn the comfort knob on the power unit s control panel to maximum setting to shorten the initial inflation time if needed 6 Wait for approx 15 minutes or les
11. s for the mattress to inflate fully 7 0 Program Settings 1 Center the patient on the mattress Adjust the mattress internal pressure according to the patient weight by using the comfort knob on the control panel of the power unit If the patient feels the mattress is too soft or firm increases or decreases the mattress internal pressure by fine turning the comfort knob one increment at a time and wait for the system to stabilize before making another change until a comfortable state is achieved 2 Caregivers should always perform a hand check by placing their hands underneath patient s pelvis area to check if there is sufficient air support to ensure the patient is not bottoming out 3 IMPORTANT TUCKING THE SHEET IN TIGHTLY REDUCES THE EFFECTIVENESS OF THE SYSTEM 8 0 Patient Transfer and Transport Transfer It is recommended to have the mattress system at maximum weight setting during transfer Make sure the bed is secured before proceeding Transport If a transport occasion comes up two options are available 1 Detach the mattress air hose couplings from the power unit s quick release couplers and connect the two air hose couplings together to retain air in the mattress and the mattress will stay inflated for approx 2 hours 2 Unplug the power unit s power cord from the wall outlet and the mattress should stay inflated for approx 40 50 minutes To resume normal operation please follow 7
12. to shipping Unsanitary or soiled systems will be returned without servicing 13 0 Warranty Carilex Medical GmbH warrants the product to be free from defects from the date of purchase Please inspect all accessories when you purchase our product If there is any damage or missing accessories when you receive the product please ask for a replacement from your local distributor within three days of purchase The warranty periods for Carilex products are according to the regulations in your country the minimum period is 1 year from date of purchase for the power unit and 1 year for the mattress and the coverlet The warranty coverage of any Carilex product is contingent up on its purchase from an authorized dealer Warranty for any product in the Carilex product line will be honored by the official distributor in your country Warranty coverage will not be extended to any product on which the production lot number has been removed or defaced on which repair has been attempted by any person or agency not authorized by Carilex or if in the sole opinion of Carilex that the system shows evidence of tampering abnormal or unreasonable abuse negligence accident or operation without regard for the restrictions specified in the instructions which accompany the system This warranty does not cover normal maintenance such as cleaning adjustment lubrication and updating of equipment or parts If the damage is result from improper op
13. two year is strongly suggested to prolong system lifetime Only disinfected and dry systems are to be stored Disconnect the air hoses from the power unit Roll up the mattress starting from head end and working down toward the foot end Use the straps to fix it 7 AIR ALTERNATING PRESSURE MATTRESS SYSTEM 11 0 Troubleshooting Problem Inspection Procedure Possible Solutions 1 Power unit does not function Check if power cord is firmly plugged into wall outlet Secure power cord into wall outlet Check if power switch is in ON position Turn power switch to ON position Check if power surge shuts down power unit Make sure there is no power failure A power surge may overload the circuitry temporarily Turn the unit off and check the fuse for damage Turn the unit ON again with normal procedure Power unit does not respond to possible solutions Please contact your authorized local distributor for assistance 2 Low pressure alert does not go out in 30 sec after systems start Possible control failure Please contact your authorized local distributor for assistance 3 alarm LED is lit during operation Check if there is leakage in air tubes or air cells OPERATION MANUAL 8 Please contact your authorized local distributor for assistance 4 Power unit is N working but mattress replacement is not inflating Or and Bottoming out is occurring
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