M1000 Control Unit Operators Manual US

Kimberly-Clark* Patient Warming Systems

Table of Contents (continued)

M1000 Control Unit Operator’s Manual: U.S.

3.13

Interrupting Treatment for Patient Transport or Relocation... 26

3.14

Collecting Data from the RS232 Port... 27

Chapter Four 4.1 4.2 4.3 4.4

Maintenance and Service Information... Draining the KIMBERLY-CLARK* Patient Warming System M1000... Cleaning the KIMBERLY-CLARK* Patient Warming System M1000... Cleaning/Replacing Fluid Delivery Line Filter...

28 28 29 29

Chapter Five 5.1 5.2

Alarms and Alerts... 30 Troubleshooting... 32

Appendices A. B. C. D. E. F.

Installation & Test Procedure... Alarms/Alert: Descriptions and Specifications... Alarm/Alert Table... Specification Table... Product List... Data Output...

35 38 39 47 48 49



Kimberly-Clark* Patient Warming Systems

Preface

M1000 Control Unit Operator’s Manual: U.S.

This Operator’s Manual provides a detailed discussion of the KIMBERLY-CLARK* Patient Warming System M1000 Control Unit, its components, and relevant accessories. The Patient Warming System provides a safe and effective way of modifying patient temperature, providing precise temperature control using a novel approach. The Patient Warming System M1000 Control Unit is equipped with numerous safety features, such as temperature and system alarms and alerts, and programming of maximum or minimum water temperatures. Reading and understanding this Operator’s Manual will help to guide the user to providing the maximum performance of the Patient Warming System in a safe manner. CAUTION: This product is to be used 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 materials are available to all Kimberly-Clark customers through your Kimberly-Clark sales representative. Prior to using the KIMBERLY-CLARK* Patient Warming System M1000, a 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

Phone:

1-800-528-5591

Fax:

1-801-572-6999

Address:

1400 Holcomb Bridge Road

Roswell, GA 30076

Internet:

www.kchealthcare.com



Kimberly-Clark* Patient Warming Systems

1.1 Introduction

M1000 Control Unit Operator’s Manual: U.S.

The KIMBERLY-CLARK* Patient Warming System has been designed to monitor and control patient temperature. The indications for use of the device include any condition where patient temperature control within the range covering mild hypothermia to normothermia is required. The system consists of M1000 Control Unit, Fluid Delivery Line, Thermal Pads and other associated accessories. Using a novel direct heat conduction approach, the Patient Warming System aids in the elimination of unplanned hypothermia. Unplanned hypothermia may occur for a variety of reasons, including exposure to cold environments, brain injury, or complex surgical procedures. During surgery, a patient typically experiences mild hypothermia due to the effect of general anaesthesia on the body’s thermoregulatory system and prolonged exposure of internal organs. Mild hypothermia in the medical or surgical patient has been proven to prolong the 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.

1.2 Symbols and Standards

The KIMBERLY-CLARK* Patient Warming System meets the electrical safety requirements of IEC 60601 and UL 2601, the relevant safety standard for electrical medical devices. The control unit has also been tested to meet both the electromagnetic interference and susceptibility requirements of IEC 60601-1, and is compatible with other equipment that also currently conforms to that standard. There is no known failure mode in the Patient Warming System M1000 Control Unit associated with electromagnetic interference from other devices. The Patient Warming System M1000 Control Unit bears the following symbols affixed to the system. (see Table 1)

Schwab S. Schwart S. Spranger M, et al. Moderate Hypothermia in the Treatment of Patients with Severe Middle Cerebral Artery Infarction. Stroke 1998;29 (12): 2461-6 1



Kimberly-Clark* Patient Warming Systems

1.2 Symbols and Standards

M1000 Control Unit Operator’s Manual: U.S.

Table 1 For the safe and effective use of this device, the operator must consult the accompanying documents prior to use.

(continued)

This symbol adjacent to the patient connections means that the thermal probe connection is a “Defibrillator-Proof, Type BF Applied Part,” per standard IEC 60601-1 and affords the degree of patient protection defined in that standard for this type of applied part. The ETL Certification Mark means that the control unit has been Certified for Safety by Intertek, Inc. against standard IEC 60601 & UL 60601. Identifies the equipotential terminal on the equipment, which is intended to be connected with the equipotential 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 input. Identifies Patient Temperature 2, the secondary patient temperature probe input. Identifies the drain port. Identifies the heater fuse. Identifies the storage relative humidity range. Indicates electrical hazard. Indicates Earth Ground. Indicates sharp object. Manufactured Date 2005-01



Kimberly-Clark* Patient Warming Systems

1.3 Environmental Conditions

M1000 Control Unit Operator’s Manual: U.S.

The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit should be stored and used within the following specific operating conditions:

Ambient Temperature Range: Operating Temperatures: 10ºC to 27ºC (50º to 80ºF) Storage Temperatures: -30ºC to 50ºC (-20º to -120ºF) NOTE: At higher room operating temperatures, the cooling capability is compromised and the ability to cool a patient may be compromised. Therefore, the unit’s cooling capacity is de-rated at an ambient temperature above 27ºC (80ºF).

Ambient Humidity Range: Operating: 5% to 70% relative humidity, non-condensing Storage: 5% to 95% relative humidity, non-condensing

1.4 Indications for Use

The Patient Warming System is intended for monitoring and controlling patient temperature. The indications for use of the device include any condition where patient temperature control within a range covering mild hypothermia to normothermia is required.

1.5 Contraindications for Use

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

1.6 General Warnings

❚ Do not use the KIMBERLY-CLARK* Control Unit in the presence of flammable agents because an explosion and/or fire may result. ❚ Kimberly-Clark will not be responsible for patient safety or equipment performance if the procedure to operate, maintain, modify or service the Control Unit is other than those specified by Kimberly-Clark. Anyone performing the procedures must be appropriately trained and qualified. ❚ There is a risk of electrical shock and hazardous moving parts. Refer servicing to qualified personnel. ❚ Power cable has a hospital grade plug. Grounding reliability can only be achieved when connected to an equivalent receptacle marked “hospital use” or “hospital grade.” ❚ When using the Patient Warming System, note that any other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the Patient Warming System may alter or interfere with patient temperature control. 

Kimberly-Clark* Patient Warming Systems

1.7 Cautions

M1000 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 M1000 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 treatment 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 M1000 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.



Kimberly-Clark* Patient Warming Systems

1.7 Cautions (continued)

M1000 Control Unit Operator’s Manual: U.S.

❚ Use only distilled or sterile water. The use of other fluids may damage the Patient Warming System M1000 Control Unit. ❚ Skin injury may occur as a cumulative result of pressure, time and temperature. Do not place a bean bag or other firm positioning devices under the pads. Do not place positioning devices under the pad manifolds or patient lines. ❚ Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold. Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status, steroid use or high dose vasopressor therapy. ❚ If accessible, examine the patient's skin under the pads often, especially those at higher risk of skin injury. ❚ If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury. ❚ Do not allow antibacterial 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, check connections. If needed, replace the leaking pad. Leakage may result in lower flow rates and potentially decrease the performance of the system. ❚ The top of the controller must be placed at a level15 cm to 90 cm (6 in. to 36 in.) below the patient to ensure proper fluid flow. ❚ Users should not use cleaning or decontamination methods different from those recommended by the manufacturer without first checking with the manufacturer that the proposed methods will not damage the equipment. ❚ It is advisable not to cancel the alarm or alert until the situation is resolved. If an alarm is cancelled 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.



Kimberly-Clark* Patient Warming Systems

2.1 Kimberly-Clark* Patient Warming System M1000 Description

Figure 1 When in use, the display module can be separated from the control module and placed in a convenient position. The display module can also be attached to the handle for easy visibility.

M1000 Control Unit Operator’s Manual: U.S.

The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit is a CLASS I (Type BF, IPX0 and Mode of Operation - Continuous) portable device per classification scheme of IEC 60601 (UL 2601). The Patient Warming System is a thermoregulatory device that monitors and controls patient temperature within a range of 33°C to 37°C (91.4ºF to 98.6ºF). The control unit pulls temperature-controlled water ranging between ambient temperature to 42°C (68ºF to 107.6ºF) through the Thermal Pads at approximately one liter per minute per pad. This results in heat exchange from the water to the patient. The system functions in either Automatic Mode or Manual Mode. In Automatic Mode, a patient temperature probe is connected to the Patient Warming System M1000 Control Unit and provides feedback to an internal control algorithm. This control algorithm then modifies the water temperature (thus pad temperature) to reach a pre-set patient temperature target determined by the clinician. In Manual Mode, the feedback control algorithm is not activated. The operator adjusts the temperature of the water delivered to the pads to achieve the appropriate patient temperature. The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit must be used only with the KIMBERLY-CLARK* Thermal Pads. The pads are thin, conformable, 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 an internal pathway across its surface to provide even, efficient heat transfer between the skin and water. The pads adhere to the patient by the use of a skin compatible hydrogel adhesive which maintains its adhesion level over extended periods. The biocompatible hydrogel material consists of approximately 50% water and is a good thermal conductor. The pads can be removed and replaced on the patient's skin if repositioning is needed. The back of each pad is insulated to minimise heat loss to the environment and condensation when cooling. The Thermal Pads contain no natural rubber latex. The Patient Warming System M1000 Control Unit (Figure 1) can be placed in various locations while being controlled from a remote display panel. The Control Unit is mounted on a four-wheel independent locking action cart with an adjustable height stand.



Kimberly-Clark* Patient Warming Systems

2.2 System Diagram of the Controller

M1000 Control Unit Operator’s Manual: U.S.

Below is a diagram (Figure 2) of the KIMBERLY-CLARK* Patient Warming System M1000 Control Unit showing the connection ports for the associated accessories. 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. The lengths of these accessories are found in Table 2.

Figure 2

3 4

2

1

5 15

6 7

14

8

13

9 12

1

Power Switch

2

RS232 Data Port

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

10

11

Table 2

Accessories

Metres

Feet

Remote Display Cable (standard)

1.1 metres

42 feet

Remote Display Cable (optional)

4.6 metres

15 feet

Power Cable

4.6 metres

15 feet

Water Supply Lines

3.0 metres

10 feet

Temperature Input Cables

3.0 metres

10 feet

Temperature Output Cable (pigtail)

13 centimetres

5 inches

Fill Tube

0.6 metres

24 inches

10

Kimberly-Clark* Patient Warming Systems

M1000 Control Unit Operator’s Manual: U.S.

2.3 Kimberly-Clark* Patient Warming System M1000 Control Unit User Interfaces

The Patient Warming System M1000 Control Unit can be operated from remote locations by attaching the User Interface (Figure 3) to an IV pole or other suitable holder. The User Interface is connected to the Patient Warming System M1000 by a 1.1 metre (42 inch) cable. A 4.6 metre (15 foot) cable is also available.

2.4 Modes of Operation

There are four principle modes of operation. These can be accessed by pressing any of the four keys on the lower right side of the display: Automatic, Manual, Purge, and Stop. Each key represents a unique function of the KIMBERLY-CLARK* Patient Warming System M1000 Control Unit.

Figure 3

Kimberly Clark*

Automatic Mode: The Automatic Mode monitors and controls the patient’s temperature to a set target temperature. Water will be cooled or warmed as needed and pulled through the Thermal Pads to achieve 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 system. Kimberly-Clark recommends the use of a second site to verify core temperature while controlling and monitoring temperature.

Manual Mode: The Manual Mode is functional with or without a patient temperature probe placed. Water temperature is established and managed by the operator. Patient temperature is not controlled in Manual mode. The operator must monitor patient temperature when Manual Mode is active. Water temperature can be modified during the Manual Mode Operation. Note: Manual Mode can be used prior to placement of a temperature probe or transition to Automatic Mode.

11

Kimberly-Clark* Patient Warming Systems

2.4 Modes of Operation (continued)

M1000 Control Unit Operator’s Manual: U.S.

Purge Mode: The Purge Key removes water from the Thermal Pads. Water flows from the Thermal Pads back to the reservoir prior to disconnection, which minimizes leakage and reduces the amount of water remaining in the pads. NOTE: Pads should be emptied prior to a Fill Cycle. Failure to empty pads before filling may result in inadequate emptying of the pads, or overfilling the device.

Stop Mode: The Stop Key halts all modes of operation. During power up and alarm states, the system defaults to a Stop Mode. While in Stop Mode, all of the customisable machine settings can be adjusted. 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 Menu Keys

The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit control settings can be adjusted through a series of menu options displayed on the LCD screen at the top of the user interface.

Kimberly Clark*

The Menu Control Keys are used to scroll through the various menu options and adjust settings.

Down or Up Arrow When in Stop Mode, these keys allow the operator to review custom menu options and display screens. The arrows are also used for adjusting settings for the custom options. During Manual Mode, these arrows provide access to the Water Target Temperature Modification Screen.

Enter Key The Enter Key is used to accept modifications or enter changes to a custom parameter.

Home Key Pressing the Home Key returns the screen to the Main Menu when in any custom display screen. This key does not accept modifications 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. 12

Kimberly-Clark* Patient Warming Systems

2.6 Patient Temperature Trend Indicator

M1000 Control Unit Operator’s Manual: U.S.

The Patient Temperature Trend Indicator reflects the change in the patient’s temperature over the previous five minutes. Flashing Up arrows indicate patient temperature is increasing. Flashing Down arrows indicate patient temperature is decreasing.

• Center circle no change or less than 0.25ºC (0.45ºF) change per hour • One arrow (up or down) – 0.25ºC to 0.5C (0.45ºF to 0.96ºF) change per hour • Two arrows (up or down) – 0.5ºC to 0.75ºC (0.96ºF to 1.35ºF) change per hour • Three arrows (up or down) – 0.75ºC to 2.0ºC (1.35ºF to 3.6ºF) change per hour • Three arrows flashing simultaneously – > 2.0ºC (> 3.6ºF) change per hour Figure 4

2.7 Patient Temperature Display

2.8 Fluid Delivery Lines

Patient Temperature Trend Indicator

The Patient Temperature Display indicates temperature from Patient Temperature 1 in degrees Centigrade (C) or degress Fahrenheit (F). The display units can be changed in the custom parameter menu found under Setup when in Stop Mode. The temperature range that can be displayed is between 10°C and 42°C (50ºF to 108ºF).

Water flows from the KIMBERLY-CLARK* 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).

Fluid Delivery Line Port

13

Kimberly-Clark* Patient Warming Systems

M1000 Control Unit Operator’s Manual: U.S.

2.9 Patient Temperature To run the Patient Warming System M1000 Control Unit in Automatic Mode, an indwelling temperature probe must be placed into the patient and connected to the Probes control unit. The control unit comes with an adapter cable to connect to the patient temperature probe. This temperature probe cable adapter is inserted in the Patient Temperature 1 Input port in the rear of the machine (Figure 2). Two types of adapter cables are available: one for 2-pin connections (Nellcor/SIMS) and one for a single jack connector (Bard). The control unit only works with Yellow Springs Instrument 400 Series (YSI 400) thermistor compatible patient temperature probes. These probes include nasopharyngeal, esophageal, tympanic, rectal, or bladder probes. Refer to the temperature probes’ Manufacturer’s Instructions for Use for the specific indications and placement of these probes. A second patient temperature probe, identified as Patient Temperature 2, may be connected to the Patient Warming System M1000 Control Unit to provide patient temperature 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 instances when patient temperature is not constantly monitored by the clinician. The secondary probe will alarm and shut down the control unit if the primary probe is dislodged or fails.

2.10 Patient Temperature Output (Echo)

The Patient Warming System M1000 will output Patient Temperature 1 (the primary patient temperature) input reading to a YSI 400 compatible hospital monitor using the Patient Temperature Output (Echo). An adapter for use with various temperature probe cables (similar to the patient temperature adapter cables) included with the installation kit, can be inserted into the Patient Temperature Output (Echo) port in the rear of the machine. The temperature displayed on the Patient Warming System M1000 Control Unit and monitor represents the same temperature but may not be identical due to calibration differences between the control unit and the monitor.

14

Kimberly-Clark* Patient Warming Systems

M1000 Control Unit Operator’s Manual: U.S.

3.1 Operating Instructions

The KIMBERLY-CLARK* Patient Warming System offers an easy efficient way of managing patient temperature. The sophisticated control algorithm works to modify patient temperature precisely and accurately. It is essential that the clinician review the patient's medical history, inspect the skin integrity, and determine the adequacy of tissue perfusion prior to treating with the Patient Warming System. The clinician can then adjust the specific parameters prior to cooling or warming the patient.

3.2 Start Up

To begin using the Patient Warming System M1000 Control Unit, press the ON/OFF Switch to the ON position. The system will go through a brief self-diagnostic system check and check the water level in the reservoir. When finished, the display will read “Kimberly-Clark Patient Warming System.” This is the Main Menu or “Home” Screen. When the Patient Warming System M1000 Control Unit is turned to the ON position, a power up test for the independent safety alarm is automatically run. The audio alarm will sound and the alarm indicator will illuminate during setup. The operator must verify that both are operational before operating the system. For additional information on alarms, see Appendices B and C. WARNING: Do not use the Patient Warming System M1000 in the presence of flammable 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."

3.3 Filling the Kimberly-Clark* Patient Warming System M1000

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 Fill Screen from the custom menu. The levels displayed are as follow: Water Level

Action

Full

Do not add water

3/4 Full

Add approximately 0.5 liters

1/2 Full

Add approximately 1.0 liters

Water Level Low

Add approximately 1.5 liters

Water Level Empty

Add approximately 2.0 liters

Initial Installation & refill after cleaning

Use approximately 3 liters

Table 3

The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit can be operated at any level except when reading Water Level Empty. CAUTION: Use only distilled or sterile water. The use of other fluids may damage the Patient Warming System M1000. NOTE: If Alarm 4 or 5 is activated when the unit is turned on, silence the alarm by pressing the flashing alarm button. Perform the following procedure to fill the unit before operating. Additionally, if Alert 3 (Low Fluid Level) sounds, Kimberly-Clark 15 recommends filling the unit as well.

Kimberly-Clark* Patient Warming Systems

3.3 Filling the Kimberly-Clark* Patient Warming System M1000 (continued)

M1000 Control Unit Operator’s Manual: U.S.

To fill the KIMBERLY-CLARK* Patient Warming System M1000, take the following steps: 1. Obtain approximately 2.0 liters of distilled or sterile water. 2. Locate the Fill Tube on the back of the controller and to the lower left of the Fluid Delivery Line (see Appendix E Parts Table for part number for reordering). NOTE: Fluid Delivery Line Port (Figure 2) must have either a fluid delivery line without pads or manifold plug attached in order to properly fill the tank. 3. Press the Home Key. Then press the down arrow until the fill screen appears: “Water Level Empty. Enter to Fill.” Press Enter to proceed. 4. The display screen will read: “Place the Fill Tube in the container of water. Press Enter to fill.” Place the end of the fill tube in the container of water.

Fluid Delivery Line Port

5. Press Enter again and the Patient Warming System M1000 will automatically fill until the reservoir is full. The fill tube may have to be held in the container to ensure adequate suction. 6. The screen will read “Fill Complete.” Press Enter and remove the Fill Tube from the container. Keep the fill tube connected to the Control Unit.

Fill Tube

7. Press Home to return to Main Menu. Note: Pads must not be connected to the fluid delivery line while filling the unit. The filling cycle can be terminated at any point during the filling process by pressing Stop. If 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 procedures 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 Control Unit unless pads have been emptied by pressing the Purge Key. If the reservoir is filled prior to emptying the pads, the reservoir may be full and may not allow a full Purge to occur. An incomplete Purge may result in excess water remaining in the pads. In the event of a power failure or shutdown of the system, the reservoir may read EMPTY if the pads are filled with water. Press Purge to refill the reservoir and then resume treatment.

3.4 Placement of the Kimberly-Clark* Patient Warming System M1000 Control Unit

The control unit has been designed to take up a minimal amount of space and to be easily moved to an appropriate location in the Operating Suite. To ensure proper operation, the top of the unit should be located 15 cm to 90 cm (6 in. to 36 in.) below the patient to ensure proper flow. Maintaining the reservoir lower than the patient also minimises accidental leakage in the event of puncture or disconnection of the fluid delivery lines. CAUTION: The top of the controller must be placed at a level 15 cm to 90 cm below the patient to ensure proper flow. 16

Kimberly-Clark* Patient Warming Systems

3.5 Setting Custom Parameters

M1000 Control Unit Operator’s Manual: U.S.

The Patient Warming System M1000 Control Unit is shipped with default settings (see Tables 4-6 below), which may be modified as needed. Settings can be changed for individual patients or procedures, or permanently changed to create new default settings. Prior to using the Patient Warming System on a patient, it is important to verify that all parameters are appropriately set for the particular patient or procedure, including maximum water temperature in Automatic Mode. Table 4 indicates the parameters, the default settings, the available ranges of settings, and incremental changes. When pressing the Down arrow, the parameters that are displayed are shown in order of their appearance. Table 4

Parameter–Default

Explanation

Range

Patient Target XX°C Automatic Mode/ (Default-37°C) (98.6ºF)

Set desired target patient temperature in Automatic Mode.

33°C-37°C 0.1°C (0.1ºF) (91.4ºF to 98.6ºF) increments

Resolution

Water Target XX°C Manual Mode/ (Default-37°C) (98.6ºF)

Set desired water temperature in Manual Mode.

20°C-42°C (68ºF to 105.8ºF)

1.0°C (1.0ºF) increments

Water Level

Shows the level of the water in the reservoir at any given time. This reading is updated during purge, fill cycle & power on.

Empty to Full

Empty, Low, Full

Maximum Water XX°C Automatic Mode (Default-42°C) (107.6ºF)

Set the maximum water temperature the system will use to control patient temperature in Automatic Mode.

32°C-42°C 1.0°C (1.0ºF) (89.6ºF to 107.6ºF) increments

Minimum Water XX°C Automatic Mode (Default-4°C) (39.3ºF)

Set the minimum water temperature the system will use to control patient temperature in Automatic Mode.

20°C-32°C (68ºF to 89.6ºF)

1.0°C (1.0ºF) increments

Setup provides a second tier of user-defined options that pertain to equipment settings that may require less frequent changes. (See Tables 5 and 6) Table 5

Parameter–Default Explanation Range

Incremental Changes

Patient High Alert XX°C Automatic Mode (Default 42°C) (107.6ºF)

Defines the temperature limit at which the system should issue an alert if the patient temperature exceeds that limit.

10.1°C- 42.0°C 0.1°C (0.1ºF) (50.1ºF to 107.6ºF)

Patient Low Alert XXºC Automatic Mode (Default 10°C) (50ºF)

Defines the temperature limit at which the system should issue an alert if the patient temperature falls below that limit.

10.0°C- 41.9°C (50ºF to 107.5ºF)

0.1°C (0.1ºF)

17

Kimberly-Clark* Patient Warming Systems

3.5 Setting Custom Parameters (continued)

M1000 Control Unit Operator’s Manual: U.S.

Table 6

Parameter–Default

Explanation

Options

Patient Temperature 2(Default-Disabled)

Allows user to enable the system for a second patient temperature probe if a probe is connected to the control module from a secondary site on the patient. The second site is for monitoring, not controlling patient temperature.

Enabled Disabled

Control Strategy (Default: Surgical)

Determines the response of the internal algorithm to anaesthetised patients.

Surgical Reserved

Temperature Mode (Default -°C)

Select temperature units of measure.

ºC (Centigrade) ºF (Fahrenheit)

Note: All custom settings should be verified if changing between °C and °F.

Language (Default-English)

English

Data Output Interval (Default-1 minute)

Data outlet intervals 2000 systems house a 250 power speed when sending real time system information through the RS232 port for data collection.

Off, Between 5 and 60 seconds: 5 second increments; Between 1 and 10 minutes: 1 minute increments

Reset Calibration Alert Timer

Alert will notify user at defined intervals to contact Kimberly-Clark or authorised biomedical engineer to verify system calibration and operation.

Do not reset until calibration is completed.

Save Current Settings as Defaults

Press Enter to save all current settings as defaults.

Press Return to Main Menu Key to return to the main screen.

CAUTION: The operator is responsible to determine the appropriateness of custom parameters for each patient. With the Stop Key lit, press the Down or Up Arrow to access the custom settings menu to verify or modify default parameters. To modify a setting, scroll to the appropriate parameter shown on the display screen. Press the Enter Key. The setting will flash indicating that the setting can be changed. Using the Down or Up Arrows, change the setting. Press Enter to accept the new setting. (See Figure 5 for an overview of the settings.) Note: When the system is powered off, all changes will revert to the default unless the new settings have been established as new defaults.

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Kimberly-Clark* Patient Warming Systems

3.5 Setting Custom Parametres

M1000 Control Unit Operator’s Manual: U.S.

Figure 5 Patient Target - Automatic Mode

(continued)

Water Target - Manual Mode Water Level (Empty, Full) Maximum Water - Automatic Mode

STOP

Minimum Water - Automatic Mode SETUP Patient High Alert-XX-Automatic Mode Patient Low Alert-XX-Automatic Mode Patient Temperature 2 (Enabled/Disabled) Control Strategy (Surgical/Reserved) Temperature Mode (C/F) Language (English) Data Output Interval (Off, 5-55 seconds, 1-10 Minutes) Reset Calibration Alert Timer Save Current Settings as Default

3.6 Pre-warming the Kimberly-Clark* Patient Warming System M1000

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 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 heating the water to the previously saved default water target temperature. To change this temperature, press the Down Arrow Key once until the screen reads “Water Target Temperature XX, Press Enter to Change.” Press “Enter” and adjust the temperature using the Up and Down Arrow Keys. From room temperature (20ºC/68ºF) the control unit will warm the water to the target temperature in approximately 5 to 10 minutes.

CAUTION: The surface of the heating device should be checked for mechanical damage prior to use.

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Kimberly-Clark* Patient Warming Systems

3.7 Connecting the Thermal Pad to the Fluid Delivery Lines

M1000 Control Unit Operator’s Manual: U.S.

To connect the Patient Warming System Thermal Pads to the control unit and prewarm them prior to surgery, begin by placing the correct size and configuration pads (see Section 3.8 below), liner side up on the surgical table. Connect the translucent pad lines to the fluid delivery line by inserting the blue connector into the blue labelled receptacle on the manifold. Similarly, insert the white connectors into the white labelled receptable immediately adjacent. This can be done without stopping the machine if it is already in Manual Mode. CAUTION: Carefully observe the system for air leaks in the system before and during use. If the pads fail to prime or if large air bubbles are observed in the pad return line, indicating the presence of a significant continuous 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 screen. Press Enter to allow adjustment of the target using the Up/Down Arrow Keys. When the desired water target temperature is highlighted, press enter to accept. The pads will be at temperature in approximately 5 minutes. Note: The temperature at the surface of the pad is approximately 1°C less than the water temperature under normal circumstances.

3.8 Thermal Pad Selection

Pad Selection ❚ Each patient should be individually assessed to determine that pads are sized appropriately.

Torso

Universal

Small <5'3" <160cm Medium 5'3" –5'8" 160cm – 173cm Large >5'8" >173cm

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