Kimberly-Clark M1000 Operator's Manual
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Kimberly-Clark M1000 Operator's Manual

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imberly
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Patient Warming System
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M1000 Control Unit
Operator's Manual: U.S.

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Summary of Contents for Kimberly-Clark M1000

  • Page 1 Patient Warming System M1000 Control Unit Operator’s Manual: U.S.

  • Page 2: Table Of Contents

    2 .3 KIMBERLY-CLARK* Patient Warming System M000 Control Unit User InterfacesControl Unit User Interfaces . . . . . . . . . . . . . . .  2 .4...
  • Page 3 4 .2 Draining the KIMBERLY-CLARK* Patient Warming System M000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 4 .3...

  • Page 4: Customer Information & Technical Support

    Kimberly-Clark representative will provide on-site in-services to ensure adequate training has occurred . Additional requests for technical support, information or orders may be placed by mail, fax, or by calling Kimberly-Clark customer service . Model No. KIMBERLY-CLARK* Patient Warming System M1000...

  • Page 5: Introduction

     . Introduction The KIMBERLY-CLARK* Patient Warming System has been designed to monitor and control patient temperature . The indications for use of the device include any con- dition where patient temperature control within the range covering mild hypother- mia to normothermia is required .
  • Page 6 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK Table 1  .2 Symbols and Standards For the safe and effective use of this device, the operator (continued) must consult the accompanying documents prior to use . This symbol adjacent to the patient connections means that the thermal probe connection is a “Defibrillator-Proof, Type BF Applied Part,”...

  • Page 7: Environmental Conditions

     .5 Contraindications There are no known contraindications for the use of a thermoregulatory system . The KIMBERLY-CLARK* Thermal Pads should not be placed on skin that is ulcerated, for Use burned, is poorly perfused or non-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 .

  • Page 8: Cautions

    ❚ 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...
  • Page 9 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK  .7 Cautions ❚ Use only distilled or sterile water . The use of other fluids may damage the Patient (continued) Warming System M000 Control Unit . ❚...

  • Page 10: Kimberly-Clark

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

  • Page 11: System Diagram Of The Controller

    2 .2 System Diagram Below is a diagram (Figure 2) of the KIMBERLY-CLARK* Patient Warming System M000 Control Unit showing the connection ports for the associated accesso- of the Controller ries . The Fluid Delivery Line, Primary and Secondary Patient Temperature Cables, Temperature Output Cable, Remote Display Cable, and the Power Cable are all connected to the rear of the control unit .

  • Page 12: Kimberly-Clark* Patient Warming System M000

    Automatic, Operation Manual, Purge, and Stop . Each key represents a unique function of the KIMBERLY-CLARK* Patient Warming System M000 Control Unit . utOmatic The Automatic Mode monitors and controls the patient’s temperature to a set target temperature .

  • Page 13: Custom Menu Keys

    CAUTION: Patient temperature will not be controlled in Stop Mode. Patient temperature may increase or decrease with the Patient Warming System M1000 in Stop Mode. Alarms are not enabled in the Stop Mode. 2 .5 Custom The KIMBERLY-CLARK* Patient Warming...

  • Page 14: Patient Temperature Trend Indicator

    0°C and 42°C (50ºF to 08ºF) . 2 .8 Fluid Delivery Water flows from the KIMBERLY-CLARK* Patient Warming System M000 Control Lines Unit to the thermal pads through the Fluid Delivery Line that connects to the back of the control unit .

  • Page 15: Patient Temperature Probes

    * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK 2 .9 Patient Temperature To run the Patient Warming System M000 Control Unit in Automatic Mode, an indwelling temperature probe must be placed into the patient and connected to the Probes control unit .

  • Page 16: Operating Instructions

    . When finished, the display will read “Kimberly-Clark Patient Warming System . ” This is the Main Menu or “Home” Screen . When the Patient Warming System M000 Control Unit is turned to the ON position, a power up test for the independent safety alarm is automatically run .
  • Page 17 Purge cycle is completed . To avoid overfilling, do not fill the KIMBERLY-CLARK* Patient Warming System M000 Control Unit unless pads have been emptied by pressing the Purge Key .
  • Page 18 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK 3 .5 Setting Custom The Patient Warming System M000 Control Unit is shipped with default settings (see Tables 4-6 below), which may be modified as needed . Settings can be changed Parameters for individual patients or procedures, or permanently changed to create new default settings .
  • Page 19 1 and 10 minutes: 1 minute increments Reset Calibration Alert will notify user at defined Do not reset until Alert Timer intervals to contact Kimberly-Clark calibration is or authorised biomedical engineer completed. to verify system calibration and operation. Save Current Settings...

  • Page 20: Setting Custom Parametres

    Pre-warming of the Patient Warming System can be accomplished prior to connecting the pads to facilitate efficient operating theatre setup . To pre-warm the KIMBERLY-CLARK* control unit, turn the power on by pressing the On/Off switch to the “On” position .

  • Page 21: Connecting The Thermal Pads To The Fluid Delivery Lines

    * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK 3 .7 Connecting the To connect the Patient Warming System Thermal Pads to the control unit and pre- warm them prior to surgery, begin by placing the correct size and configuration pads Thermal Pad to the (see Section 3 .8 below), liner side up on the surgical table .

  • Page 22: Thermal Pad Placement

    * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK 3 .9 Thermal Pad ertical Or shOulder reference Placement ❚ If patient is sitting upright, place tip of pad 5 cm (2") below C7 . If lying down, place top of pad 2 .5 cm (") below C7 . (Reference A .) xilla Or hOrizOntal reference ❚...
  • Page 23 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK 3 .9 Thermal Pad Placement (continued) PPlicatiOn ethOds OrsO 1. With the patient sitting on the operating theatre table, overlap the inside seam of the pads so the width of the pads between the flap insert is approximately as wide as the patient’s back .

  • Page 24: Treating A Patient In Automatic Mode

    3 .0 Treating a Patient For off-pump cardiac artery bypass procedure and other general surgeries, Kimberly-Clark advises the use of the Automatic Mode of treatment . In this mode, in Automatic the KIMBERLY-CLARK* Patient Warming System M000 Control Unit uses the feed-...

  • Page 25: Treating A Patient In Manual Mode

    CAUTION: The Patient Warming System M1000 will control and monitor core temperature based on the temperature probe attached to the system Patient Temperature 1 (primary patient temperature) input port.
  • Page 26 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 patient, adjust the water target temperature as described below to accomplish the specific control strategy appropriate for the patient and procedure in question .

  • Page 27: Completing A Procedure

    . Note: If power is lost while the power switch is in the On position, the KIMBERLY-CLARK* Patient Warming System M1000 Control Unit will issue an audible warning until the switch is turned off. This alerts the user that treatment has been accidentally stopped.

  • Page 28: Collecting Data From The Rs232 Port

    3 .4 Collecting The KIMBERLY-CLARK* Patient Warming System M000 Control Unit has an RS232 data communication port (refer to Figure below for port location) . Data can be Data from the downloaded real time as the events are happening while the system is ON . Data cannot be stored or retrieved once an event has occurred .

  • Page 29: Maintenance And Service Information

    . Kimberly-Clark offers a one-year warranty on parts and labour, provided the system has been used according to its intended use . Kimberly-Clark accepts responsibility for the safety, reliability, and performance of this equipment only if:  .

  • Page 30: Cleaning The Kimberly-Clark

    Kimberly-Clark recommends cleaning the water reservoir and circuit at least once every 3 months with the KIMBERLY-CLARK* Patient Warming System M000 Cleaning Solution . This cleaning solution is supplied in the cleaning kit (Part #00838-0), which can be purchased from Kimberly-Clark .

  • Page 31: Alarms And Alerts

    5 . Alarms and Alerts The KIMBERLY-CLARK* Patient Warming System M000 Control Unit has safety features to warn the user of certain conditions that may interfere with patient safety, system performance, or patient outcome . There are two types of warning conditions in the Patient Warming System M000 Control Unit - Alarms and Alerts .
  • Page 32 . Should either an Alarm 80 or 8 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 .

  • Page 33: Troubleshooting

    . The following is a list of suggestions for some commonly occurring conditions. If there are any questions, please contact Kimberly-Clark Service. ssue Water flow rate suddenly decreases ctiOn ❚...
  • Page 34 ❚ Check the connection between the patient temperature probe and the temperature cable attached to the KIMBERLY-CLARK* Patient Warming System M000 . ❚ Ensure that the connection between the temperature probe and cable is kept thoroughly dry . If wet, replace the cable .
  • Page 35 Fluid Delivery Line . If air bubbles appear to come from pad, replace pad . If bubbles appear to come from Fluid Delivery Line, then change Fluid Delivery Line . For additional information contact your Kimberly-Clark sales representative or Kimberly-Clark customer service at 1-800-KC-HELPS.

  • Page 36: Installation & Test Procedure

    Appendix A — Tools Needed: 1/8" Hex Wrench Installation & Test Unpack both boxes associated with the KIMBERLY-CLARK* Patient Warming Procedure System M000: the Control Unit (Part # 0000-0) and the Installation Kit (Part # 00839-0) . Insert the Steel Pole into the moulded base of the cart . Align the depressions in...
  • Page 37 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK Appendix A —  . Remove the User Interface (Part # 0083-02) from its box . The clamp on the bot- tom of the User Interface must be rotated 90 degrees before securing it to the Installation &...
  • Page 38 2 . Once the unit has reached 30°C (86ºF), purge the system by pressing the Purge Key . Verify that the water is removed from the recirculating line . 3 . Turn off the KIMBERLY-CLARK* Patient Warming System M000 Control Unit Figure 10 and remove the recirculating line .

  • Page 39: Alarms/Alert: Descriptions And Specifications

    . If the operator cannot troubleshoot the condition, note the alarm or alert number and phone Kimberly-Clark Service . CAUTION: It is advisable not to cancel the alarm or alert until the situation is resolved.

  • Page 40: Alarm/Alert Table

    (see section 4.4 of manual) • Make certain all fittings are secure. • Listen to hear if pump is running. If not, contact Kimberly-Clark Service. • If situation is corrected, cancel alert. Low water Flow to the pads Current Mode •...
  • Page 41 2 min- • May indicate a machine malfunction, contact the purge cycle. utes. Alarm indica- Clinical/Biomedical Engineering or Kimberly-Clark Alarm tor flashing. Service if problem persists and the reservoir is not overfilled. System...
  • Page 42 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK Appendix C — Alarm/Alert Table Alarm/ Message Alarm/Alert Alert Description System Status Action Displayed Patient Patient Current Mode • Check that the vents on the sides of the machine and water Temperature 1 continues.
  • Page 43 1 calibration temperature half-second tone • Contact Clinical/Biomedical Engineering or error. Restart calibration every 10 seconds. Kimberly-Clark Service to verify calibration. system. from Patient Alarm/ Alert • System may be run in Manual Mode, but patient Temperature 1 indicator flashing.
  • Page 44 • If water temperature does not rise in response Alarm 32°C (89.6ºF) and to patient temperature, shut system off and call the system is Kimberly-Clark Service. unable to heat in Automatic Mode. Patient Patient Current Mode con- •...
  • Page 45 • Contact Clinical/Biomedical Engineering or tion. Replace from the Patient every 2 minutes. Kimberly-Clark Service to verify calibration. temperature Temperature 2 Alarm/Alert • System may be run in Manual Mode, but patient probe or probe input is indicator flashing.
  • Page 46 • Wait until water cools. Restart Automatic Mode Alarm or Manual Mode. • If problem persists, contact Kimberly-Clark Service. Water Water temperature Changes to Stop • This alarm may be caused by transient conditions temperature is below 3.5°C...
  • Page 47 Audio alerts before restarting procedure. Save all values. System tings are invalid. alarm half-second • Contact Kimberly-Clark Service if problem persists. default tone every 2 min- settings utes. Alarm/Alert restored. indicator flashing. Alarm User...

  • Page 48: Specification Table

    10 seconds. Manual. Kimberly-Clark. Alarm/Alert indica- tor flashing. Alarm Parameter Control Processor Changes to Stop • Contact Kimberly-Clark Service. Memory parameter Mode. Audio alarm invalid. memory fault. half-second tone (Control) every 10 seconds. Alarm/Alert indica- Alarm tor flashing.
  • Page 49 Mode. Audio alarm user interface module and K Patient imberly larK fault. half-second tone Warming System M1000 Control Unit. Alarm every 10 seconds. • If the error persists, replace the User Interface Alarm/Alert Cable and power up. indicator flashing.
  • Page 50 Message Alarm/Alert Alert Description System Status Action Displayed Primary T2 Thermistor Changes to Stop • Contact Kimberly-Clark Service. Outlet Water signal out of range Mode. Audio alarm Temperature - low resistance. half-second tone Sensor Shorted. every 10 seconds. Alarm/Alert Alarm indicator flashing.
  • Page 51 Appendix C — Alarm/Alert Table Alarm/ Message Alarm/Alert Alert Description System Status Action Displayed A/D Acquisition A/D converter • Contact Kimberly-Clark Service. Fault. fault. Alarm Interprocessor The Monitor • Contact Kimberly-Clark Service. communication Processor does failure (Monitor) not communicate. Alarm...
  • Page 52 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK Appendix D — General Parametre Specification Specification Control Modes Automatic, Manual, Purge, Stop Table Heater Capability 750 W Circulating Fluid Distilled or Sterile Water Reservoir Capacity 3 liters for initial set up Water flow rate (total) 0 .5 - 8 .0 liter/min...

  • Page 53: Product List

    * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK Appendix D — imensiOns able Specification Parameter Specification Maximum relative humidity (operating) Table (continued) Maximum relative humidity range (storage) 5-95% Temperature range (operating) 0°C to 27°C (50ºF to 80ºF) Temperature range (storage) -30°C to 50°C (-20ºF to 20ºF) Height of unit (handle down)

  • Page 54: Data Output

    Appendix F — To collect data from the KIMBERLY-CLARK* Patient Warming System M000 Control Unit use the RS232 Port on the rear of the device . Portable PDAs Data Output (personal data assistants) or computers can be connected to the Patient Warming System M000 Control Unit to download data .
  • Page 55 * Patient Warming Systems M000 Control Unit Operator’s Manual: U .S . imberly larK Appendix F — arametre equence Data Output Sequence (continued) Number Description Values Sequence Start Indicator $(ASCII 36) Serial Sequence Number ,2,3,4,5 . . ., Initialised at power up . Patient Temperature  °C, 0 if probe not connected Patient Temperature 2...
  • Page 56 At Kimberly-Clark, our mission is Healthcare-Associated Infection Solutions to deliver clinical solutions that you can depend on to meet the demands of your fast-paced world. Surgical Solutions Whether your needs involve preventing healthcare-associated infections, surgical and digestive Digestive Health solutions or pain management, with Kimberly-Clark you’ll...

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