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Kimberly-Clark M1000 Скачать руководство пользователя страница 8

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* Patient Warming Systems

M000 Control Unit Operator’s Manual: U .S .

❚

This product is to be used by or under the supervision of trained, qualified medical

personnel .

❚

The operator is responsible for determining the appropriateness of user-settable

parameters .

❚

The KIMBERLY-CLARK*Patient Warming System M000 Control Unit must be used

only with the KIMBERLY-CLARK* Thermal Pads .

❚

The Thermal Pads are non-sterile . If used in a sterile environment, pads should

be placed according to the physician’s request, prior to the sterile preparation or
sterile draping . Thermal Pads should not be placed in a sterile field .

❚

The Control Unit will control and monitor core temperature using an indwelling

temperature probe attached to the system – Kimberly-Clark recommends
the use of a second site to verify core temperature while controlling and
monitoring patient temperature .

❚

It is the sole responsibility of the clinician operator to monitor patient

temperature when in Manual Mode and to adjust the water temperature
target appropriately .

❚

Federal law (USA) restricts this device to sale by or on the order of a physician .

❚

The Control Unit will not control the patient’s temperature in Manual

Mode (Water Temperature Control) . Ensure that the selected target water
temperature is appropriate for the patient’s temperature . Since patient
temperature is not controlled in Manual Mode, patient temperature should be
monitored at regular intervals during prolonged warm water or cold water treat-
ment to minimise over-warming or over-cooling the patient .

❚

Any device connected to the RS232 data port must comply with the applicable

standards for that device .

❚

Patient temperature will not be controlled and alarms are disabled in Stop Mode .

Patient temperature may increase or decrease with the KIMBERLY-CLARK*
Patient Warming System M000 Control Unit in Stop Mode .

❚

Do not place Thermal Pads over an electrosurgical grounding pad . The

combination of heat sources may result in skin injury .

❚

The Thermal Pads must be changed after 24 hours of use . If thermal treatment is

to continue, a new set of pads should replace the old pads .

❚

Do not allow circulating water to contaminate the sterile field if pad lines are

disconnected . The circulating water is non-sterile .

❚

The pads are non-sterile for single patient use . Do not reprocess or sterilize .

❚

Do not puncture the pads with sharp objects . Punctures will result in air

entering the fluid pathway and may reduce performance .

.7 Cautions

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Содержание M1000

Страница 1: ...Kimberly Clark Patient Warming System M1000 Control Unit Operator s Manual U S ...

Страница 2: ...mperature Display 13 2 8 Fluid Delivery Lines 13 2 9 Patient Temperature Probes 14 2 10 Patient Temperature Output Echo 14 Chapter Three 3 1 Operating Instructions 15 3 2 Start Up 15 3 3 Filling the KIMBERLY CLARK Patient Warming System M1000 15 3 4 Placement of the KIMBERLY CLARK Patient Warming System M1000 Control Unit 16 3 5 Setting Custom Parametres 17 3 6 Pre warming of the KIMBERLY CLARK Pa...

Страница 3: ...he KIMBERLY CLARK Patient Warming System M1000 29 4 4 Cleaning Replacing Fluid Delivery Line Filter 29 Chapter Five 5 1 Alarms and Alerts 30 5 2 Troubleshooting 32 Appendices A Installation Test Procedure 35 B Alarms Alert Descriptions and Specifications 38 C Alarm Alert Table 39 D Specification Table 47 E Product List 48 F Data Output 49 Table of Contents continued Kimberly Clark Patient Warming ...

Страница 4: ...ed by or under the supervision of trained qualified medical personnel Customer Information and Technical Support Kimberly Clark hours of operation are 8 am to 5 pm Eastern Standard Time For service please call your sales representative or 1 800 KC HELPS Educational materials such as training programmes for in house staff operator manuals quick reference guides and a bibliography of relevant materi...

Страница 5: ...e time to extubation contribute to coagulopathies increase the chance of infection and increase cardiac demand as a result of shivering 1 The use of the Patient Warming System is designed to be an effective means of counteracting this drop in patient temperature by applying heat to the patient through a set of patented thermally conductive foam pads The KIMBERLY CLARK Patient Warming System meets ...

Страница 6: ...tential terminal s on one or more other types of equipment in close proximity in order to bring all pieces of equipment to the same potential for safety purposes Indicates high temperature part or component Indicates that only sterile or distilled water should be used when filling the Patient Warming System M1000 Control Unit Identifies Patient Temperature 1 the primary patient temperature probe i...

Страница 7: ...perfused or has the appearance of rash While there are no known allergies to the hydrogel materials used in this product caution should be exercised with any patient who has a history of skin allergies or sensitivities CAUTION This product is to be used by or under the supervision of trained qualified medical personnel Do not use the KIMBERLY CLARK Control Unit in the presence of flammable agents ...

Страница 8: ...nit will not control the patient s temperature in Manual Mode Water Temperature Control Ensure that the selected target water temperature is appropriate for the patient s temperature Since patient temperature is not controlled in Manual Mode patient temperature should be monitored at regular intervals during prolonged warm water or cold water treat ment to minimise over warming or over cooling the...

Страница 9: ...al agents to pool underneath the pads Excess antibacterial agents can absorb into the pad adhesive and cause chemical burns and loss of pad adhesion Carefully remove pads from the patient s skin at the completion of use Carefully observe the system for air leaks in the system before and during use If the pads fail to prime or a significant continuous air leak is observed in the pad return line che...

Страница 10: ...be used only with the KIMBERLY CLARK Thermal Pads The pads are thin con formable and anatomically shaped to cover areas of the patient s skin They come in non sterile kits in sizes to cover a broad range of patients fit both males and females and are for single patient use only Each pad has an inlet and an outlet connection that attaches to a fluid delivery line The pads allow water to flow within...

Страница 11: ... 3 Latch Handle 4 Fluid Delivery Line Port Manifold 5 Fill Port 6 Reserved for future use 7 Patient Temperature 1 Input 8 Patient Temperature 2 Input 9 Patient Temperature Output Echo 10 Fill Tube Clip 11 Drain 12 Power Cable Storage 13 Heater Fuse 14 Equipotential Terminal 15 Power Cable Connection Figure 2 2 2 System Diagram of the Controller 2 13 14 15 1 12 11 10 9 8 7 6 4 5 3 Accessories Metre...

Страница 12: ...ve the pre set patient target temperature Patient temperature can be controlled and monitored between 33 C and 37 C 91 4ºF and 98 6ºF NOTE The system will not go into Automatic Mode unless a patient s temperature probe is inserted into a patient and attached to the control unit CAUTION The Control Unit will control and monitor core temperature using an indwelling temperature probe attached to the ...

Страница 13: ... or changes Alarm Key The Alarm Key is illuminated when situations arise that may pose a safety issue for the patient or if the system is not performing to its proper specification To silence or acknowledge an alarm or alert press the Alarm Key Kimberly Clark Purge Mode The Purge Key removes water from the Thermal Pads Water flows from the Thermal Pads back to the reservoir prior to disconnection ...

Страница 14: ...RK Patient Warming System M1000 Control Unit to the thermal pads through the Fluid Delivery Line that connects to the back of the control unit The Fluid Delivery Line is reusable and should only be replaced if defective see Section 5 2 Troubleshooting The Fluid Delivery Line comes in two configurations accepting either 2 pads Part 00834 04 or 4 pads Part 00834 05 Center circle no change or less th...

Страница 15: ... monitoring from a second patient site The adapter is similar to Patient Temperature 1 and is inserted into the appropriately labelled connector directly below the Patient Temperature 1 port NOTE Patient temperature is not controlled from the secondary patient temperature probe The secondary patient temperature probe is a backup patient temperature monitor for increased patient safety in those ins...

Страница 16: ...able agents because an explosion and or fire may result WARNING Power cable has a hospital grade plug Cable grounding reliability can only be achieved when connected to an equivalent receptacle marked hospital use or hospital grade The water level is displayed at a variety of times when the system is powered on after completion of a fill after the pads are emptied or purged and when accessing the ...

Страница 17: ...the filling cycle is stopped prior to completion the reservoir will have a volume less than full and may require more frequent filling The number of proce dures that can be conducted prior to filling depends on the number of pads used and the amount of water remaining in the pads after a Purge cycle is completed To avoid overfilling do not fill the KIMBERLY CLARK Patient Warming System M1000 Contr...

Страница 18: ...r temperature in Manual Mode Shows the level of the water in the reservoir at any given time This reading is updated during purge fill cycle power on Set the maximum water temperature the system will use to control patient temperature in Automatic Mode Set the minimum water temperature the system will use to control patient temperature in Automatic Mode 33 C 37 C 91 4ºF to 98 6ºF 20 C 42 C 68ºF to...

Страница 19: ...rvals to contact Kimberly Clark or authorised biomedical engineer to verify system calibration and operation Press Enter to save all current settings as defaults Enabled Disabled Surgical Reserved ºC Centigrade ºF Fahrenheit English Off Between 5 and 60 seconds 5 second increments Between 1 and 10 minutes 1 minute increments Do not reset until calibration is completed Press Return to Main Menu Key...

Страница 20: ...complished prior to connecting the pads to facilitate efficient operating theatre setup To pre warm the control unit turn the power on by pressing the On Off switch to the On position The control unit then performs the startup self diagnostic check and will eventually show the Main Menu or Home Screen Press the Manual Key to begin warming the water in the unit The control unit will then begin heat...

Страница 21: ...esence of a significant continu ous air leak check connections If this does not correct the problem refer to Section 5 2 Troubleshooting for more information Leakage may result in lower flow rates and potentially decrease the performance of the system If the machine is in Stop Mode press the Manual Key to begin warming Press the Down Arrow Key once to go to the Water Target Temperature set point s...

Страница 22: ...ap across the spine This is normal and acceptable A B Pad Skin Contact After the patient has been transferred to the surgical table and prior to draping pads can be placed on the patient using one of the following methods outlined on the next page Place the pads on healthy skin only Remove any creams or lotions from patient s skin before pad application Remove the release liner from each pad and a...

Страница 23: ...he release liner on a pad 5 Start pad placement by placing the second flap mid axilla and smoothing the pad down the patient s back and towards the spine 6 Repeat on the other side 7 Ensure that manifolds are placed free and clear of pressure areas such as the scapula 8 Adhere pad flaps to the side of the patient Note Make sure to reposition the upper flap after arm tuck Application Methods Univer...

Страница 24: ...th fragile skin or other medical conditions Minimum Water XXºC Automatic Mode Limits the lowest temperature of the water that will flow through the pads The minimum water temperature is 20 C 68ºF This can be increased for patients with fragile skin or other medical conditions CAUTION Check that the patient temperature probe is accurately placed and is functioning prior to initiating the treatment ...

Страница 25: ...ry patient temperature input port Kimberly Clark recommends measuring patient temperature from a second site to verify core temperature while controlling and monitoring patient temperature with the Patient Warming System M1000 CAUTION Manual Mode should only be used when a patient s temperature and condition are continuously monitored Note A second patient temperature probe may be enabled and conn...

Страница 26: ...nt over warming or over cooling the patient CAUTION Manual Mode should only be used when a patient s temperature and condition are continuously monitored To begin treatment pre warm the pads as described above for Automatic Operation Kimberly Clark recommends using a set point of 38ºC to pre warm the pads and during initial pad placement for on pump procedures Once the pads have been placed on the...

Страница 27: ...pletion of use Aggressive removal of the pad or edge tape adhesive from the patient s skin may result in skin tears Adhesive tape is included on certain pad designs CAUTION Do not allow residual water to contaminate the sterile field when patient lines are disconnected It is sometimes necessary to move a patient or continue warming treatment post surgery To minimise water spillage follow the proto...

Страница 28: ...ystem is ON Data cannot be stored or retrieved once an event has occurred Refer to Appendix F for details on the data communication protocol CAUTION Any device connected to the RS232 data port must comply with the applicable IEC electrical safety standards for that device RS232 Data Port 3 14 Collecting Data from the RS232 Port 27 Kimberly Clark Patient Warming Systems M1000 Control Unit Operator ...

Страница 29: ...ths See Section 4 3 on the next page The Patient Warming System M1000 internal fluid filters should be inspected every six weeks or whenever flow is lower than expected for the given Thermal Pad configuration See Section 5 2 Troubleshooting 4 1 Maintenance and Service Information For the purpose of routine maintenance or shipping the Patient Warming System M1000 Control Unit you will need to drain...

Страница 30: ...section 4 2 Replace Filter using procedure below Obtain a liter of cleaning solution from cleaning kit Part 00838 01 Refill the unit using the liter of cleaning solution and two liters of sterile distilled water Place a recirc line on the fluid delivery line Run the control unit in Manual at 30ºC for approximately 10 minutes The M1000 control unit is now ready for normal operation 4 4 Cleaning Rep...

Страница 31: ...ill repeat itself every 10 seconds until cleared If the alarm condition is not addressed and the problem persists the Alarm will recur While there are multiple alarms and safety features in the Patient Warming System M1000 Control Unit there are four main safety alarms that are non changeable Alarm Kimberly Clark High Patient Temperature Alarm In Automatic Mode an alarm condition will occur when t...

Страница 32: ...mperature test fail Control or Alarm 81 Outlet Water over temperature test fail Monitor will be activated Should either an Alarm 80 or 81 appear on the display screen notify Kimberly Clark that this has occurred These alarms are unrecoverable errors and need to be checked by Kimberly Clark personnel For additional information on alarms see Appendices B and C Alerts Alerts are intended to inform th...

Страница 33: ...s are primed approximately 10 minutes assure the flow rate displayed on the control panel is appropriate for the number of pads connected see Table 7 The system will track the initial highest flow rate If flow drops by 50 the system will alert you to check the lines to ensure water is flowing to the patient The following is a list of suggestions for some commonly occurring conditions If there are ...

Страница 34: ...s If operating in Automatic Mode press Stop then using the Up and Down Arrows scroll to the Maximum Water Target Screen and ensure that the temperature is set to the highest possible setting for the patient and procedure Issue When warming in Automatic Mode water temperature begins to decrease prior to reaching the target Action As the patient s temperature increases the control algorithm will dec...

Страница 35: ...cure If the temperature cable is wet replace with a new cable Note If temperature is out of range three dashes will appear on the screen Issue Flow rate is below expected values for the number of pads being used after unit has been run for at least 30 minutes 1 5 liters per minute for 2 pads 2 2 liters per minute for 3 pads Action Check filter Replace if clogged Check to see if any lines are kinke...

Страница 36: ...y lift the control unit such that the clamp fits just on top of the support ledge on the pole Tighten down the pole clamp by turning the pole clamp handle clockwise until just snug Figure 4 Raise top pole and rotate so curve is extended over control unit 8 Remove the fill tube Part 00809 02 from its bag and attach it to the fill tube port located just below the Fluid Delivery Line connection Figur...

Страница 37: ...tterfly nut and clamp find the strain relief kit and connect the port 2 cable to the second threaded bolt next to the power cable Figure 12 17 Remove the Patient Temperature Output Cable Part 00835 52 Nellcor from its bag and attach the black and grey connector to the Temp Out Port on the back of the unit Figure 13 Initial Test 1 Turn the unit on by pressing the On Off switch located above the pow...

Страница 38: ...ure is climbing The water temperature should reach 41 C 105 8ºF within 10 minutes Some overshoot approximately 0 5 C is normal while the unit will eventually settle at the target temperature 0 1 C F 11 Change the water temperature set point to 30 C 86ºF by pressing the Down Arrow Key again until the screen reads Water Temp Target XX press Enter to change Adjust as before and press Enter when compl...

Страница 39: ...led and the condition has not been cleared the alarm will recur If an alert is cancelled and the alert condition has not been cleared the alert will not recur unless the Stop Mode is activated or the KIMBERLY CLARK Patient Warming System M1000 has been turned to the OFF position Appendix B Alarms Alerts Descriptions and Specifications Specifications Alarms and Alerts Parameter Specification Water ...

Страница 40: ...livery line Check connection of fluid delivery lines to the system Make certain all fittings are secure Check to make sure that lines are not kinked or blocked Check Fluid Delivery Line filter and ensure it is not clogged see section 4 4 of manual Listen to hear if pump is running If not contact Kimberly Clark Service If situation is corrected cancel alert Water reservoir level low Alert Reservoir...

Страница 41: ...emperature shut system off and call Kimberly Clark Service Patient Temperature 1 above user defined limit Alert Patient Temperature 1 reading is equal to or greater than the user defined value established in the custom settings menu Current Mode continues Audio alarm half second tone every 2 minutes Alarm Alert indicator flashing Check patient temperature Cancel alert If system stopped alert will ...

Страница 42: ... probe proven good on another Patient Warming System If the new cable performs correctly replace the original cable Unable to obtain stable patient tem perature for Automatic control Alarm Patient tempera ture discontinuity Significant change in patient temperature reading for more than 10 minutes Changes to Stop Mode Audio alarm half second tone every 10 seconds Alarm Alert indica tor flashing Ch...

Страница 43: ... not been dislodged Contact Clinical Biomedical Engineering or Kimberly Clark Service to verify calibration System may be run in Manual Mode but patient temperature will be displayed as three dashes System is cooling and Patient Temperature 2 low Alert Patient Temperature 2 reading is below 32 C 89 6ºF water temperature is below 32 C 89 6ºF and the system is unable to heat in Manual Mode Current M...

Страница 44: ...4ºF and the system is unable to cool in Manual Mode Current Mode continues Audio alarm half second tone every 2 min utes Alarm Alert indicator flashing Check that the vents on the sides of the machine are not blocked Reduce WaterTargetTemperature System is cooling and Patient Temperature 2 low Alert Patient Temperature 2 reading is below 32 C 89 6ºF water temperature is below 32 C 89 6ºF and the s...

Страница 45: ...mberly Clark Service to verify calibration System may be run in Manual Mode but patient temperature will be displayed as three dashes Patient Temperature 2 calibration error Restart system Alarm In Automatic Mode internal temperature calibration from the Patient Temperature 2 probe input is not functioning Changes to Stop Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator fla...

Страница 46: ...it until water cools Restart Automatic Mode or Manual Mode If problem persists contact Kimberly Clark Service Water temperature below safety level Allow system to warm Alarm Water temperature is below 3 5 C 38 3ºF Changes to Stop Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing This alarm may be caused by transient conditions such as a momentary occlusion air bolus...

Страница 47: ...problem continues replace User Interface Contact Kimberly Clark Service User Interface Disconnect Alert User Interface not detected by control system Current Mode con tinues Audio alarm half second tone every 2 minutes Alarm Alert indicator flashing Check user interface cable connections on the user interface module and Kimberly Clark Patient Warming System M1000 Control Unit If the error persists...

Страница 48: ...s 34 C then check connection of patient temperature probe and cable connection If wet replace cable Test the input with a cable and probe proven good on another Patient Warming System If the new cable performs correctly replace the original cable Non recover able system fault Refer to Operator s Manual Alarm System error that cannot be managed with out speaking to Kimberly Clark Changes to Stop Mo...

Страница 49: ...isplay communication fault Changes to Stop Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing Check user interface cable connections on the user interface module and Kimberly Clark Patient Warming System M1000 Control Unit If the error persists replace the User Interface Cable and power up If problem continues replace User Interface Contact Kimberly Clark Service SPI...

Страница 50: ...istor signal out of range high resistance Changes to Stop Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing Contact Kimberly Clark Service Inlet Water Temperature Sensor Shorted Alarm T3Thermistor signal out of range low resistance Changes to Stop Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing Contact Kimberly Clark Service Outlet ...

Страница 51: ...does not communicate Contact Kimberly Clark Service MachineType Fault Alarm Unit has very little or no cleaning solution in the reservoir Turn unit off drain unit fill unit using cleaning kit part 00838 01 See cleaning kit instructions for details Contact Kimberly Clark Service Power Supply Fault Alarm Power supply volt age out of range Contact Kimberly Clark Service Processor Fault Alarm Processo...

Страница 52: ...C 89 6ºF 0 4 C 38 C 100 4ºF to upper boundary includes 0 1 C ºF external probe Patient Temperature Control 33 C to 37 C 91 4ºF to 98 6ºF Range Automatic Mode In 0 1 C ºF increments Water Temperature Display 3 C to 45 C 37 4ºF to 113ºF Range Resolution 1 C ºF Water Temperature Control 20 C to 42 C 68ºF to 107 6ºF Range Manual Mode In 0 1 C F increments Maximum Water Temperature 32 C to 42 C 89 6ºF ...

Страница 53: ...4 6 meter 15 feet 00832 02 Fluid Delivery Line Single 00834 04 Fluid Delivery Line Y 00834 05 Fill Drain Tube 00809 02 Strain Relief Kit 00832 99 Recirculation Line 00809 04 Cart M1000 00830 01 Cleaning Kit 00838 01 Install Kit North America 00839 01 M1000 Control Unit 01000 01 Dimensions Table Parameter Specification Maximum relative humidity operating 70 Maximum relative humidity range storage 5...

Страница 54: ...adjust the desired setting using the Up or Down Arrows Press Enter to set the new value Data Output Parametres Protocol RS 232 Port Configuration 9600 Baud 8 Data Bits No Parity 1 Stop Bit No Handshake Wiring DB 9 connector Pin No Function Pin 2 Receive In Pin 3 Transmit Out Pin 4 5 Earth The RS 232 connector wiring is configured for connection to a Palm PDA Connection directly to a PC may require...

Страница 55: ... Purge 5 Fill 7 Diagnostic Mode 0 Normal Mode 1 Diagnostic Mode 8 Outlet Water C Temperature Monitor 9 Outlet Water Temperature C 10 Inlet Water Temperature C 11 Chiller Temperature C 12 Water Outlet Target Temperature C 13 Temperature Display Mode 0 C 1 14 Communications Output Interval Seconds 15 Current Alarm Number See Alarm Alert list for corresponding numbers 16 Flow Rate Liter minute 17 Res...

Страница 56: ...alth Pain Management Commitment to Excellence If for any reason our products do not meet your expectations please let us know your comments or suggestions for improvement Your input will result in a concerted effort on our part to meet your requirements Our goal is to provide quality products that completely meet your needs time after time For more information please call your Kimberly Clark repre...

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