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User Manual: HotDogTM Patient Warming System Controller Page 2
Contents
Introduction.......................................................................................................................................3
Device Description........................................................................................................................3
Indications for Use ........................................................................................................................3
Contraindications ..........................................................................................................................3
Warnings...........................................................................................................................................4
Cautions ............................................................................................................................................4
Precautions........................................................................................................................................4
Proper Use and Maintenance ............................................................................................................6
Initial Setup & Assembly..................................................................................................................6
Contents.........................................................................................................................................6
Mounting the HotDog Controller to an IV Pole............................................................................7
Control Panel Features & Operating Modes .................................................................................8
Alarms .........................................................................................................................................10
Error Codes .................................................................................................................................10
Instructions for Use.........................................................................................................................11
Maintenance & Cleaning ................................................................................................................12
Testing of Indicator Light Function ............................................................................................12
Cleaning—General......................................................................................................................12
Cleaning—Controller..................................................................................................................13
Cleaning—Warming Devices .....................................................................................................13
Technical Support & Customer Service .........................................................................................16
Definition of Product Symbols .......................................................................................................17
Accessory Part Numbers.................................................................................................................17
Specifications..................................................................................................................................18
Electromagnetic Compatibility (EMC)...........................................................................................20
User Manual: HotDogTM Patient Warming System Controller Page 3
INTRODUCTION
Device Description
The HotDog Patient Warming System consists of the HotDog Controller, reusable warming
devices (e.g., Warming Blankets, Warming Mattresses) and accessories. This manual includes
use and maintenance instructions and specifications for the HotDog Controller Model WC5X.
For information about HotDog warming devices and accessories, refer to the User Manual
provided with each device/accessory.
The HotDog Controller is designed to help maintain normothermia in patients before, during
and after surgical procedures and to help prevent unintended hypothermia. The system is
powered and controlled by an electronic control unit. Warming devices are powered at low
voltage, ensuring safety for patients and operators. Warming temperatures are controlled
automatically to user-selected levels, and over-temperature safety shut-offs are integrated into
the controller as well as into each warming device.
The HotDog Controller can be placed on a flat surface, mounted on an IV pole or suspended
from the OR table/gurney rail using optional hooks. The HotDog Patient Warming System can
be operated continuously to maintain uniform heat under or over the patient, depending on
which warming device/accessory is selected. It is the responsibility of the user to determine
whether warming is appropriate for each individual patient. The HotDog Patient Warming
System should not be used when clinical considerations indicate that warming of the patient is
not advisable.
Indications for Use
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to
provide warmth to patients. The HotDog Patient Warming System should be used in
circumstances in which patients may not maintain a state of normothermia. The System is
intended primarily for use in hospitals and surgical centers including, without limitation,
operating, recovery, and emergency rooms and on medical/surgical floors.
Contraindications
DO NOT warm ischemic or non-perfused tissue; thermal injury may result. Examples
include tissue distal to aortic cross clamping, or when vasoconstrictive drugs would lead to
severe, prolonged vasoconstriction.
DO NOT warm patients receiving transdermal medication; increased drug delivery may
occur.
User Manual: HotDogTM Patient Warming System Controller Page 4
WARNINGS
General
EXPLOSION HAZARD – DO NOT use the HotDog Patient Warming System in the
presence of flammable anesthetics or highly oxygen-enriched environments such as
hyperbaric chambers, oxygen tents, etc.
Inspect HotDog components prior to use for signs of damage or excessive wear such as
cuts, holes or loose electrical connections. If signs of wear are evident, do not use the
product until it is inspected by technical staff.
DO NOT continue to use the HotDog Patient Warming System if the over temperature
indicator and/or alarm continue to sound after reset. Refer to the “Alarm” section of this
manual for more information.
Warming Blanket
DO NOT place HotDog Warming Blankets under the patient. The Warming Mattress and
Disposable Sheets are the only accessories designed for use under the patient.
Warming Mattress
The Warming Mattress is not sterile. Take appropriate precautions, as necessary, to protect
the sterile field.
Accessories and Other Equipment
Accessories and cables other than those specified in HotDog User Manuals may result in
increased emissions or decreased immunity of the HotDog Patient Warming system.
The HotDog Patient Warming System should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, carefully observe the HotDog Patient
Warming System to verify that it operates normally in this non-recommended
configuration.
CAUTIONS
Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare
professional.
PRECAUTIONS
General
Use under the direct supervision of a clinician.
Monitor the patient’s vital signs regularly during warming according to institutional
protocol. If vital sign instability occurs, notify the clinician.
Care should be taken when using multiple warming methods.
User Manual: HotDogTM Patient Warming System Controller Page 5
Dispose of the Controller per local regulations. Follow Warming Blanket and Mattress
User Manuals for proper disposal.
The risk of skin irritation caused by pooling of surgical prep solutions under the patient
may increase with warming; ensure that surgical prep solution instructions for use are
followed.
Warming Mattress
Ensure that the Warming Mattress is securely fastened to the table.
The use of gel pads between the Warming Mattress and the patient is not recommended;
gel pads may cause a loss of warming performance.
Always use a thin patient barrier between the patient and the Warming Mattress.
Maintain contact between the patient and the labeled sensor on the Warming Mattress.
DO NOT use operating table clamps or similar devices on the Warming Mattress as they
may cause damage to the product and result in loss of the heating function and/or localized
heat build-up in the damaged area.
DO NOT place the Warming Mattress over a table joint that will move during surgery.
DO NOT use the Warming Mattress as a stand-alone patient pressure relief system.
DO NOT place any hard objects (e.g., mattress cables, EKG cables, hard cautery return
pads, patient fluid lines, etc.) between the Warming Mattress and patient’s body.
DO NOT fold or wrinkle the Warming Mattress during use as localized heat build-up may
occur in the overlapped area.
DO NOT use the Warming Mattress when the risk of pressure injury cannot be mitigated
Adjust placement of the Warming Mattress during X-rays as the internal wiring, located
primarily along the edges of the device, and the sensor with associated wire may appear in
the images.
DO NOT allow patient fluid lines to be placed between the Warming Mattress and
Warming Blanket or other warming equipment.
DO NOT position the patient’s head directly on the Warming Mattress.
User Manual: HotDogTM Patient Warming System Controller Page 6
PROPER USE AND MAINTENANCE
DO NOT continue to use the HotDog Patient Warming Blanket beyond the labeled
expiration date
DO NOT continue to use the HotDog Patient Warming Mattress beyond the labeled
expiration date
Do not open the HotDog Controller. There are no user serviceable parts. If service is required,
contact Technical Support (see page 17). The manufacturer assumes no responsibility for the
reliability, performance, or safety of the HotDog Patient Warming System if the following
events occur:
The Controller is disassembled or serviced by an unauthorized person.
The Patient Warming System components are used in a manner other than described in the
User Manuals.
The Controller is installed in an environment that does not meet the appropriate electrical
and grounding requirements.
The Controller is grounded and should not be attached to an un-grounded table intended for
use with a hyfrecator or equivalent devices.
INITIAL SETUP & ASSEMBLY
Contents
The following components are included in the HotDog Controller box:
1—HotDog Controller Model WC5X
1—IV pole adapter and mounting hardware
1—Mains power cord
1—CD containing User Manual and Service Manual
1—HotDog Warming Blanket Cable (P/N A101)
Reusable HotDog accessories (e.g., Warming Blankets, Warming Mattresses, connecting
cables, OR table/gurney rail hooks) and HotDog Disposable Sheets are sold separately.
User Manual: HotDogTM Patient Warming System Controller Page 7
Mounting the HotDog Controller to an IV Pole
To mount the HotDog Controller to an IV pole, place the Controller IV pole adapter around the
IV pole and turn the clamp handle clockwise until securely tightened (Figure 1). To remove the
Controller from the IV pole, turn the clamp handle counterclockwise until the unit releases.
Caution
To prevent the IV pole from tipping, the Controller must be attached at a height that provides
stability. It is recommended to use an IV pole with a minimum wheelbase radius of 35.6 cm (14
in) and to mount the Controller no higher than 112 cm (44 in) from the floor. Failure to
properly mount the Controller may result in IV pole tipping, catheter site trauma and patient
injury.
Figure 1: HotDog Controller Mounted on an IV Pole
The Controller may also be suspended from the OR table/gurney rail using optional hooks
(Figure 2).
Figure 2: Optional OR Table/Gurney Rail Hooks
User Manual: HotDogTM Patient Warming System Controller Page 8
Control Panel Features & Operating Modes
Figure 3: HotDog Model WC5X Controls
Figure 4: HotDog Ports
Mains Power Switch / ON Power Indicator
When the HotDog Controller is plugged into an electrical outlet and the Mains Power Switch
on the back of the Controller is turned ON, all displays will illuminate briefly and the
User Manual: HotDogTM Patient Warming System Controller Page 9
Controller will beep. Afterwards, the software version is displayed for approximately 2
seconds. The Mains Power ON Light will illuminate and the Controller will remain idle until a
warming device is plugged in. When the unit is ON and idle (i.e., no Temperature Setting
Lights are illuminated), no power is applied to the warming device and no alarm conditions are
indicated.
Temperature Adjust Button / Temperature Setting Display
When a warming device is plugged into a port, an audible beep will sound and the display will
show two dashes. Press the Temperature Adjust Button for the desired port until the desired
temperature is displayed. The temperature can be selected in one degree increments from 37-
43°C for Ports A and B (Warming Blankets) and 35-39°C for Port C (Warming Mattresses).
The designated warming temperature will flash until the selected temperature is achieved, at
which time the selected temperature will steadily display.
Port A, B and C
Ports A and B are used only for HotDog Warming Blankets, and Port C is used only for
HotDog Warming Mattresses. When a warming device is plugged into the Controller, an
audible beep indicates that the control and over temperature sensors are present and functioning
properly.
Port D and E
Ports D and E supply a 48V output for future approved HotDog accessories; at this time there
are no accessories manufactured for use on these ports.
User Manual: HotDogTM Patient Warming System Controller Page 10
Alarms
Alarm: Port A, B and C
If the warming device sensor temperature exceeds one degree above set point or other fault
conditions exist, an audible alarm sounds and the Alarm Light for the affected port illuminates
Yellow. The Controller will automatically turn off power to that warming device. If the Alarm
Light stays illuminated and the alarm continues to sound, disconnect the warming device from
the Controller to silence the alarm. If the controller alarms again after a reset was performed,
discontinue use and refer the Controller to biomedical engineering for evaluation.
Error Codes
The Controller displays the following error codes on the Temperature Display for specific
alarm conditions. Refer to Troubleshooting and Error Codes sections for more details.
Error Code
Alarm Condition
E1 on affected port
Over-temperature alarm – Temperature of sensor
has exceeded 1 degree above set-point
E2 on affected port
Time-to-temperature alarm – device has not reached
selected set point within ten minutes
E3 on affected port
Over-current condition
E3 on all ports
System over-current condition
E4 on affected port
Primary or secondary broken sensor alarm
E5 on affected port
Over-temperature array alarm
E8 on affected port
Over temperature – Secondary – Temperature of
sensor has exceeded 46C for blankets and 41.5 C for
mattresses (on controllers with software version 1.06
and lower, this alarm displays as E1 and not E8)
Six hour timer
If a warming device is left on with no adjustment to
temperature settings for six hours the controller will
turn off power to warming device.
EA, EC, EE, EF, EH, EP on
all ports
System failure, refer controller to biomedical
engineering department.
Indice
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