Kimberly-Clark M1000 User manual

Kimberly-ClarK*
Patient Warming System .
M1000 Control Unit
Operator’s Manual: U.S.

1
Preface
Customer Information & Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
chaPter One
1.1 Introduction........................................................ 4
1.2 SymbolsandStandards.............................................. 4
1.3 EnvironmentalConditions............................................ 6
1.4 IndicationsforUse.................................................. 6
1.5 ContraindicationsforUse............................................ 6
1.6 GeneralWarnings................................................... 6
1.7 Cautions........................................................... 7
chaPter twO
2.1 KIMBERLY-CLARK*
Patient Warming System M1000 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 System Diagram of the Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3 KIMBERLY-CLARK* Patient Warming System M1000
Control Unit User InterfacesControl Unit User Interfaces . . . . . . . . . . . . . . . 11
2.4 ModesofOperation................................................ 11
2.5 CustomMenuKeys ................................................ 12
2.6 Patient Temperature Trend Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.7 Patient Temperature Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.8 FluidDeliveryLines ................................................ 13
2.9 PatientTemperatureProbes......................................... 14
2.10 Patient Temperature Output (Echo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
chaPter three
3.1 OperatingInstructions.............................................. 15
3.2 StartUp........................................................... 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 SettingCustomParametres......................................... 17
3.6 Pre-warming of the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.7 Connecting the Thermal Pads to the Fluid Delivery Lines. . . . . . . . . . . . . . . . 20
3.8 ThermalPadSelection ............................................. 20
3.9 ThermalPadPlacement ............................................ 21
3.10 Treating a Patient in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.11 Treating a Patient in Manual Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.12 CompletingaProcedure............................................ 26
Table of Contents
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.

2
3.13 Interrupting Treatment for Patient Transport or Relocation . . . . . . . . . . . . . . 26
3.14 Collecting Data from the RS232 Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
chaPter fOur
4.1 Maintenance and Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2 Draining the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.3 Cleaning the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.4 Cleaning/Replacing Fluid Delivery Line Filter . . . . . . . . . . . . . . . . . . . . . . . . . . 29
chaPter five
5.1 AlarmsandAlerts.................................................. 30
5.2 Troubleshooting ................................................... 32
aPPendices
A. Installation&TestProcedure........................................ 35
B. Alarms/Alert: Descriptions and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 38
C. Alarm/AlertTable.................................................. 39
D. SpecificationTable................................................. 47
E. ProductList....................................................... 48
F. DataOutput....................................................... 49
Table of Contents
(continued)
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.

3
Kimberly-clarK* Patient Warming Systems 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 acces-
sories. 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: [phone]
Fax: [phone]
Address: 1400 Holcomb Bridge Road
Roswell, GA 30076
Internet: www.kchealthcare.com
Preface

4
Kimberly-clarK* Patient Warming Systems 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 con-
dition where patient temperature control within the range covering mild hypother-
mia 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.
The KIMBERLY-CLARK* Patient Warming System meets the electrical safety require-
ments 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)
1Schwab S. Schwart S. Spranger M, et al. Moderate Hypothermia in theTreatment of
Patients with Severe Middle Cerebral Artery Infarction. Stroke 1998;29 (12): 2461-6
1.1 Introduction
1.2 Symbols and
Standards

For the safe and effective use of this device, the operator
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,” per standard IEC 60601-1 and affords the
degree of patient protection defined in that standard for this
type of applied part.
The Entela Monogram means that the control unit has
been Certified for Safety by Entela, Inc. against standard IEC
60601 and UL 2601.
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
5
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
Table 1
1.2 Symbols and
Standards
(continued)
2005-01

6
Kimberly-clarK* Patient Warming Systems 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
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.
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.
❚ 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.
1.3 Environmental
Conditions
1.4 Indications
for Use
1.5 Contraindications
for Use
1.6 General Warnings

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Kimberly-clarK* Patient Warming Systems 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 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 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.
1.7 Cautions

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Kimberly-clarK* Patient Warming Systems 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.
1.7 Cautions (continued)

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Kimberly-clarK* Patient Warming Systems 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 classifica-
tion 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 tempera-
ture 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, 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 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.
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.