Burke TRI-FLEX II Скачать руководство пользователя страница 10 | Manualshive

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Burke TRI-FLEX II Скачать руководство пользователя страница 10

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SAFETY AGENCY APPROVALS

ETL Listed:

To standard for safety of Medical Electrical Equipment

Conforms To: UL STD 60601-1 with respect to

Electrical Shock, Fire and Mechanical Hazards

Flame

Resistance:

Unit components meet UL 94V-0.

Mattress components pass

Standard for California117.

FDA REGISTRATION

The Manufacturer is an FDA registered company as a manufacturer and as a contract

manufacturer whose quality system meets the requirements of FDA 21 CFR, PART

820-Good Manufacturing practices for medical devices and ISO 9001.

Products are FDA listed.

PATENTS

US & INTL.:

Patent Pending

Complies with Medical Device Directive

93 / 42 / EEC

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Содержание TRI-FLEX II

Страница 1: ...Alternating Pressure System With Width Expansion Using Real Time Pressure Monitoring RTPM Sensor Technology US INTERNATIONAL PATENTS PENDING An FDA Registered Company Products are FDA listed 1800 Merriam Lane Kansas City KS 66106 1 913 722 5658 Email burkebariatric burkebariatric com www burkebariatric com MADE IN USA ...

Страница 2: ...Burke Inc 1800 Merriam Lane Kansas City KS 66106 USA www burkebariatric com 1 913 722 5658 pn 63568 rev 0117 ...

Страница 3: ...t Up 14 Operating Instructions 16 CPR Function 21 Patient Transportation 21 Cleaning Procedure 22 Care and Storage 23 Troubleshooting Guide 24 Warranty Information 25 SECTION PAGE DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS OR AN OXYGEN TENT AROUND THE CONTROL UNIT Symbol used in the manual apply to hazards or unsafe practices which could result in personal injury or property damage Do not...

Страница 4: ...t provided and in no event shall BURKE INC S liability exceed the purchase price paid by the customer for the product Under no circumstances shall BURKE INC be liable for any loss direct indirect incidental or special damages arising out of or in connection with the use of this product INFORMATION CONTAINED IN THIS OPERATING INSTRUCTION MANU AL IS SUBJECT TO CHANGE WITHOUT ANY PRIOR NOTICE Never d...

Страница 5: ...int of attachment of the equipment to earth Grounding Point Mutes audio alarm In the event of power failure or if the hose is disconnected an audio visual alarm will sound Locks out all control unit functions to prevent patient settings tampering Boosts air pressures in the mattress to avoid patient bottoming out Sets Alternating Pressure Therapy times 5 10 15 20 minutes Selects Static Alternating...

Страница 6: ...traps F in several areas so it can be easily fastened to any size hospital bed Ties straps for moving the mattress are mounted inboard The mattress has a side air bolster on each side of the mattress These bolsters when in use to provide additional width to the bed are always maintained at a constant pressure via a separate line with sensor feedback CONTROL UNIT A Figures on page 15 Medium flow 42...

Страница 7: ...patient procedures Detachable zippered highly breathable urethane coated 70 Denier nylon flame retardant water repellent highly vapor permeable anti microbial low friction and low shear quilted reusable top covers a Special multi chambered air distribution layered low air loss top sheet E which administers low air loss relief directly underneath the patient 1 3cm convoluted safety foam enclosed in...

Страница 8: ...S INTL Pressure Zone 2 Max Flow 42 52 LPM Max Flow Pressure 35 6 mmHg Max Flow Timer 30 minutes Support Surface Inflation Time 2 5 minutes Patient Comfort Control Pressures Soft Pressure 7 4 mmHg Firm Pressure 32 6 mmHg Bolster Pressure 55 20 mmHg Cycle Time 5 10 15 20 Min Patient Contact Control unit and mattress have Latex Free components MECHANICAL SPECIFICATIONS Control Unit A Dimensions LxWxH...

Страница 9: ...218x99x13cm 3 Kg Mattress 86 x39 x7 high 23 lb 218x99x18 cm 10 Kg Side Bolsters 86 x4 x7 high 2 per 218x5x18 cm Packaging 1 Piece per Box ENVIRONMENTAL SPECIFICATIONS Operating Conditions Ambient Temperature 40o 104o F 10o 40o C Relative Humidity 30 75 Non Condensing Atmospheric Pressure 700 hPa to 1060 hPa Storage And Shipping Conditions Ambient Temperature 40o 158o F 40o 70o C Relative Humidity ...

Страница 10: ...s meet UL 94V 0 Mattress components pass Standard for California117 FDA REGISTRATION The Manufacturer is an FDA registered company as a manufacturer and as a contract manufacturer whose quality system meets the requirements of FDA 21 CFR PART 820 Good Manufacturing practices for medical devices and ISO 9001 Products are FDA listed PATENTS US INTL Patent Pending Complies with Medical Device Directi...

Страница 11: ...rames are not obstructed by the Burke Low Air Loss Support System control unit Care should be taken such that the control unit A is not blocked and kept away from any heat sources or radiators during the operation of the unit Care should be taken such that the power cord Q of the control unit is not pinched or has any objects placed on it and also ensure it is not located where it can be stepped o...

Страница 12: ... Box 1 Mattress Control Unit Box 1 Control Unit 1 Operating Instructions Manual 1 Power Cord Unpacking and Inspection Before accepting and signing for the box or boxes please inspect the box or boxes for external and internal damages Verify that the number of boxes listed on the packing list matches the number boxes received Also verify that no components are damaged or missing Report any missing ...

Страница 13: ...P therapy mode Static mode or Upright mode Press MD to activate LED M for Static mode or LED AP for AP or LED U for Upright mode ALTERNATING PRESSURE N Press Therapy MD and activate AP mode AP Press Time APT and activate one of the 4 AP Alternating Pressure times AP mode is activated MODE FN Press FN key to select Max Inflate W mode or Low Air Loss AL MAX INFLATE W Rapid inflation of mattress to m...

Страница 14: ...ding power switch ALARM SILENCE AS To mute audio alarm UPRIGHT U Activates patient fowler boost mode In patient fowler position the control unit boosts pressure in the mattress to avoid patient bottoming out POWER FAIL PF Audiovisual alarm in the event of power outage Has internal memory will retain previous settings during power outage LOW PRESSURE LP Audiovisual alarm in the event of mattress ho...

Страница 15: ...me simply press Time TT key to light up appropriate AP time LED In this mode every other air cell in the mattress will change pressures form high to low or low to high 5 To set THERAPY STATIC M mode press Therapy MD key until THERAPY LED lights up In this mode constant pressures are maintained in the mattress 6 To set UPRIGHT mode manually press Therapy key MD to light up Upright LED U patient s f...

Страница 16: ...E System must be installed on bed frames that are equipped with side rails Please raise side rails on the bed and lock them in position after the patient is on the mattress NEVER LEAVE PATIENT UNATTENDED ON MATTRESS SYSTEM WITH BED SIDE RAILS IN THE DOWN POSITION CONTROL UNIT SET UP Figure 2 ...

Страница 17: ... the foot of the mattress and 2 in the middle one on the each side of the mat tress as shown Loop each strap around the bed frame and fasten it securely to the bed frame using the buckle 4 Unroll the Burke Low Air Loss Support System Re placement Mattress and place it on the bed frame BF Verify that the hose end of the mattress is to wards the foot of the bed Figure 4 CONTROL UNIT REAR 5 Open the ...

Страница 18: ...nd lock it in place page 22 Also make sure the Side Bolster CT insert connector is securely connected into the mattress manifold body connector on the end of the mattress Make sure the connectors have a good connection by gently tugging on the hoses Also care should be taken such that the mattress hose is freely suspended without being pinched or kinked OPERATING INSTRUCTIONS 1 Make sure the mattr...

Страница 19: ...ff and the unit will default to previous setting In this mode the entire mattress will be pressurized to 32 6 mmHg 2 The mattress B will inflate to its normal size in 2 5 minutes Inflation time depends on the size of the mattress THERAPY STATIC M 1 To set STATIC mode M press MD key to STATIC position green LED M lights up 2 In STATIC mode all the air cushions in the mattress will be maintained at ...

Страница 20: ...rt control to 20 more than the set pressure level Figure 6 PATIENT COMFORT CONTROL LEVEL CC The Burke Low Air Loss Support System is designed for patients weighting between 50 1000 lbs 22 Kg 455 Kg Pressing the comfort control buttons increases or decreas es the pressure a Pressing the SOFT key K towards the LED 0 position reduces the pressure setting pressing the FIRM key K towards the LED 9 posi...

Страница 21: ...ess to avoid patient bottoming out when the mattress head is elevated to 30 de grees or more LOCK OUT LO Control unit functions including power can be completely locked out from being tampered with by simply pressing and holding the lock key until the light comes on ap proximately 3 5 seconds ALARM SILENCE AS An audio visual alarm is sounded in the event of power failure if the unit is on or when ...

Страница 22: ...s is deflated Transport function The advantage of the mattress is that the patient need never be disturbed in order to move for tests or other procedures The patient may remain in position and the side bolsters can be deflated in order to narrow the width of the Burke Bed to fit through doors To narrow the bed Make sure the switch marked Width Expansion is off light out Remove the wide Expansion p...

Страница 23: ...eet straps from the side of the mattress Disconnect a few air cushions which are directly below the patient s chest from the mattress by pressing the quick release button on the connector with one hand and pulling the air cushion connector with the other PATIENT TRANSPORTATION PT 1 To transport a patient without removing the patient of the bed press mode key to set unit in STATIC mode wait a few m...

Страница 24: ...tergent solution 4 Pour required amount of the germicidal solution into a spray bottle 5 Using a brush or a cloth wipe off dust If necessary spray the exterior of the front and back of control unit power cord and the cord plug with the prepared disinfectant detergent solution Using a damp cloth wipe down the sprayed surface cleanly Note Do not spray excess amount of solution on the control unit 6 ...

Страница 25: ... the washing cycle is complete make sure excess water from inside the air cushions is completely removed Set the dryer to lowest heat settings and operate the dryer until the air cushions or the top sheets are completely dry 6 Leave the mattress to dry in a cool dry area for an hour before using If the mattress is not used immediately roll the mattress and insert it into a plastic bag and store it...

Страница 26: ... Control Unit OFF 2 Power cord disconnected 3 No power in the power source 4 Power outage 5 Blown fuse 1 Check power source and turn on unit 2 Connect power cord to the pwr source 3 Check power source has power and turn it ON 4 Wait till the power source has power 5 Replace blown fuse with an equivalent fuse See page 15 Fig 3 Note To place an order or if you have any questions regarding the Burke ...

Страница 27: ... INC be liable for any loss direct indirect incidental or special damages arising out of or in connection with the use of this product The control unit warranty does not cover normal maintenance such as cleaning periodic electrical tests performance tests and updating of equipment or parts thereof This warranty shall be void and not apply if the control unit including any of it s parts is modified...

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