HotDog WC5 Series User manual
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.
User Manual: HotDogTM Patient Warming System Controller Page 11
INSTRUCTIONS FOR USE
The instructions below describe how to operate the Model WC5X Controller. For information
about HotDog warming devices and accessories, refer to the User Manual provided with each
device/accessory.
1. Mount the HotDog Controller on an IV pole or the OR table/gurney rail (refer to page 7),
or place the device on a flat, horizontal surface.
2. Insert the HotDog Controller power plug into a properly grounded hospital grade electrical
outlet.
WARNING: To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth grounding.
Note: The Controller is grounded and should not be attached to un-grounded tables
intended for use with a hyfrecator or equivalent devices.
3. After the lights illuminate in sequence, the unit will emit an audible tone and display the
software revision on the Temp Setting Display for approximately 2 seconds.
4. Position and secure the HotDog warming device (e.g., Warming Blanket, Warming
Mattress) following instructions in the User Manual provided with the device.
5. Insert the warming device connecting cable into the proper port on the Controller.
Controller Port
Warming Device
A and B
Warming Blanket
C
Warming Mattress
D and E
Future approved HotDog accessories
Note: When the connecting cable is inserted into the Controller, an audible beep indicates
that the control sensor and over temperature thermistor are present and functioning
properly.
6. Press the Temp Adjust Button that corresponds with the port being used until the desired
temperature is set, as indicated by the Temp Setting Display. The display will flash until
the temperature has been reached.
7. Monitor the patient’s temperature regularly. Adjust the temperature setting of the HotDog
Controller as necessary to maintain the desired patient temperature.
8. When patient warming therapy is complete, turn the Mains Power Switch to OFF.
9. After use, disconnect the HotDog Controller from the electrical outlet.
10. Discard disposable accessories following standard hospital procedure. Clean the reusable
warming device as instructed in the User Manual provided with the device.
User Manual: HotDogTM Patient Warming System Controller Page 12
MAINTENANCE & CLEANING
Testing of Indicator Light Function
Frequency
This test should be completed upon initial equipment check-in and once every 12 months (or
more frequently if required by hospital guidelines).
Method
1. Insert the HotDog Controller power plug into a properly grounded hospital grade electrical
outlet and confirm that NO cables or devices are connected to any of the ports.
2. Turn the Mains Power Switch to ON and observe for the following proper start-up
sequence:
a. Individual Alarm lights power up sequentially
b. Segmented displays power up as individual units (sequentially, left to right)
3. After the lights illuminate in sequence, the software version is displayed for approximately
2 seconds.
4. After the sequence completes, only the Mains Power ON Light remains illuminated.
5. If this sequence varies or is incomplete, contact Technical Support (see page 17).
Cleaning—General
Warnings
DO NOT use a dripping wet cloth and DO NOT immerse HotDog components in liquid.
Moisture will damage the components, and thermal injury may result.
Precautions
DO NOT use pure harsh solvents (e.g., MEK, acetone, etc.) to clean HotDog components.
Solvents may damage plastic parts, labeling and product finish.
DO NOT use high-level disinfectants (e.g., gluteraldehyde, peracetic acid or hydrogen
peroxide-based solutions). The U.S. Centers for Disease Control (CDC) recommends
against the use of high level disinfectants for cleaning environmental surfaces that may
contact the patient since the chemicals are highly toxic.
DO NOT spray cleaning solutions into electrical connectors.
Recommended cleaners
Alcohol-based disinfectants are easiest to use since they are fast-acting and can be either
sprayed or wiped on. The following list of alcohol-based cleaners is provided for reference only
and is not an endorsement of the manufacturers or their cleaning products: Ecolab (Incidin
Liquid, Incides N, Incidin Foam, Incidin Sun, Mikro-Bak III), Merz (Pursept-A Xpress, Pursept
Foam, Mucocit-A Economy) and Lysoform (Aerodesin 2000, Lysoform Spray).
Other cleaners that have been tested and are compatible with the outer surfaces of HotDog
components include sodium hypochlorite (diluted bleach), phenolic germicidal detergent
quaternary ammonium detergent.
User Manual: HotDogTM Patient Warming System Controller Page 13
Cleaners that contain iodine may cause surface discoloration and are therefore NOT
recommended for routine cleaning.
Cleaning—Controller
Frequency
As needed
Tools/Equipment
Sponge or soft cloth
Mild detergent or anti-microbial spray
Dry soft cloth
Method
1. Disconnect the Controller from the power source before cleaning.
2. Wipe unit with moistened sponge or soft cloth; avoid pushing fluids into any openings.
3. Dry with a separate soft cloth.
Cleaning—Warming Devices
Frequency
Clean between patient use and when the warming device appears soiled.
Method
Clean the warming devices following protocols for non-critical medical devices that may
contact intact skin. Examples of similar devices are blood pressure cuffs, exam table covers,
operating room table pads and surgical supports. Cleaning steps are described in the User
Manual provided with the warming device. Note that the cleaning instructions are general
recommendations and are not meant to replace hospital-specific cleaning protocols.
User Manual: HotDogTM Patient Warming System Controller Page 14
TROUBLESHOOTING/ERROR CODES
Alarm lights and error code display
Alarm lights and an audible alarm turn on when an error condition occurs. The associated error code will remain on the
display until the condition is cleared. If multiple alarm conditions occur sequentially, the code associated with the initial
alarm condition will be displayed. In all cases, the heater is turned off when an alarm occurs.
Alarm Error Condition
Error Code
Displayed
Description
Over-temperature (primary)
E1 (for each port)
When the temperature exceeds one degree above set point, audible and
visual alarms are initiated, and power is removed from the output. The alarm
will reset when:
Temperature is within acceptable limits (+ 1°C), or
Cable connecting warming device to Controller is disconnected, or
power is turned off at mains switch.
Heater Time Out
E2 (for each port)
Failure to reach temp
(Time to Temperature): When the system does not achieve the set-point
within 10 minutes, audible and visual alarms are initiated. The alarm will
reset when the device is unplugged or power is turned off at mains switch.
Overcurrent (Port)
E3 (for each port)
When port current draw exceeds a predetermined level, audible and visual
alarms are initiated. The alarm will reset when the device is unplugged or
power is turned off at mains switch.
Primary or Secondary sensor
failure
E4 (for each port)
Sensor are reading outside of the useful range
Fold detection alarm
E5 (for each port)
In warming devices equipped with an over-temperature array, local
overheating caused by folding of the warming blanket will initiate visual
and audible alarms. The alarm will reset when the device is unplugged or
power is turned off at mains switch.
Over-temperature (secondary)
E8 (for each port)
for software
versions >=1.07
E1 for software
version <=1.06
When the temperature exceeds 46°C on port A and B or 41.5 on Port C,
audible and visual alarms are initiated. The alarm will reset when the device
is unplugged or power is turned off at mains switch.
Temperature control timeout
-- (for each port)
If a warming device is left operating for 6 hours with no changes to set
point, power will be removed, three short audible chirps will sound, and the
visual alarm indicators will flash continuously. Pressing the temperature
select button will clear the alarm and re-start normal operation.
Overcurrent (System)
E3, E3, E3
Too many large heating devices in use. Power system down (remove from
mains or cycle power switch). Remove one device and re-start. If problem
continues call customer service
Calibration failure
EA, EA, EA
System failure. If this occurs, call customer service for technical support
Hardware CPLD failure
EC, EC, EC
System failure. If this occurs, call customer service for technical support
User Manual: HotDogTM Patient Warming System Controller Page 15
System Failure (FET Failure)
EF, EF, EF
System failure. If this occurs, call customer service for technical support
Hardware I2C failure
EH, EH, EH
System failure. If this occurs, call customer service for technical support
Hardware power supply failure
EP, EP, EP
System failure. If this occurs, call customer service for technical support
General System Failure
EE, EE, EE
(software version
1.06 or lower only)
System failure. If this occurs, call customer service for technical support
User Manual: HotDogTM Patient Warming System Controller Page 16
TECHNICAL SUPPORT & CUSTOMER SERVICE
Please have the serial number of your HotDog Controller when you call for technical support. The serial number is
located on the back of the Controller. If it is necessary to return the Controller for service or repair, contact your
local supplier or sales representative.
Augustine Temperature Management
6581 City West Parkway
Eden Prairie, MN 55344 USA
TEL 952.465.3500
FAX 952.465.3501
www.hotdogwarming.com
User Manual: HotDogTM Patient Warming System Controller Page 17
DEFINITION OF PRODUCT SYMBOLS
Do Not Place Under
Patient
This Side Up
Mains Power On Indicator
This Side Down
Heating Area
Alarm
Attention, consult
accompanying documents
Reference Number
Lot Number
BF Patient Applied Part
according to IEC60601-1.
Serial Number
Manufacture Date
Temperature in Range
Transport and storage
temperature range
Temperature Adjustment
Keep Dry
Transport and storage
humidity range
Fuse
Equipotential
Medical Device restricted to sale
by or on the order of a physician
Return to Authorized
Representative
Temperature Sensor
Do not use after
YYYY-MM-DD
Manufacturer
See IFU for Warnings
Medical Device
See electronic IFU on
website at URL provided
EU Authorized
Representative
IPX2
Protected against dripping water when tilted up to 15°; Vertically dripping water shall have no harmful effect when
the enclosure is tilted at an angle up to 15° from its normal position.
Conforms to European Medical Device Directive 93/42/EEC
Medical Equipment Classified by Intertek Testing Services NA Inc. with respect to electric shock, fire, and mechanical hazards
only, in accordance with UL 60601-1. Classified under the Medical Device Directive (93/42/EEC) as a Class IIb device.
ACCESSORY PART NUMBERS
The following cable part numbers are used with the HotDog Patient Warming System:
Part Number
Description
A101
HotDog Warming Blanket Cable, 4m (13ft)
A112
HotDog Mattress Cable, 4m (13ft)
User Manual: HotDogTM Patient Warming System Controller Page 18
SPECIFICATIONS
Physical Characteristics
Dimensions
33 cm high x 14.0 cm deep x 19.7 cm wide13” high x 5.5” deep x 7.75” wide
Weight
5 kg (11 lbs)
Mounting
Can be placed on a horizontal flat surface (i.e. table top), clamped to an IV pole
or hung on a OR/gurney rail using optional hanging hooks
Temperature Characteristics
Temperature Control
Micro-processor
Blanket Ports A and B adjustable in 1oC increments
37° to 43° ± 1.0°C
98.6° to 109.4° ± 1.8°F
Operating Temperatures
Mattress Port C adjustable in 1oC increments
35° to 39° ± 1.0°C
95° to 102.2° ± 1.8°F
Safety System
All alarm conditions are classified as Medium Priority Technical Alarms
Auditory Alarms
Minimum SPL of 65 dB(A) at 3m (from front of controller) with a back ground
SPL not to exceed 55dB(A)
Ports A and B (Warming Blanket)
Alarm sounds when temperature sensor is at set point + 1°C
Primary Over-temp Alarm
Port C (Warming Mattress)
Alarm sounds when temperature sensor at set point + 1°C
Secondary Over-temp Alarm
Ports A and B (Warming Blanket)
Independent electronic circuit shuts the heater off if the Warming Blanket
temperature sensor reaches set point + 3°C. (46°C)
Port C (Warming Mattress)
Independent electronic circuit shuts the heater off if the Warming Mattress
temperature sensor reaches set point ± 2.5°C (41.5°C)
Time to reach temperature
from 23 C +/-2 C
Less than 10 minutes
Time out timer
If warming device does not reach set temperature within 10 minutes the
controller will alarm
Six hour timer
If a warming device is left at a steady setting for six hours the controller will
discontinue power to warming device.
Over-current limits
Port A
10 amps max
Port B
10 amps max
Port C
5 amps
System
14.6 amps
System Over-current Protection
Dual input fused lines.
Electrical Characteristics
Leakage Current
Meets UL 60601-1 and IEC 60601-1 requirements for Class I, Type BF
equipment.
Power Consumption
850W maximum
User Manual: HotDogTM Patient Warming System Controller Page 19
Power Cord
4.6 m (15 ft) - May vary by country and region per local requirements and
regulations.
Device Ratings
Input: 100-240 VAC, 50/60 Hz, 850VA
Output A & B: 48 VDC, 480 VA Max each
Output C: 240 VA Max
Output D & E: 48 VDC, 144 VA Max each
Fuses
T10AL250V (2 x 5x20mm)
Environmental Conditions
Environmental Conditions for Transport
and Storage
Temperature: -20°C to 60°C
Humidity: 20% to 80%
Keep Dry
Environmental Conditions for Use
Temperature: 15°C to 25°C
Humidity: 20% to 80%
Classification and Standards
Certifications
IEC 60601-1; EN 60601-1-2; UL 60601-1; CAN/CSA-C22.2, No. 601.1, EN 55011
Classification
Classified under IEC 60601-1 Guidelines (and other national versions of the
Guidelines) as Class I, Type BF, Ordinary equipment, Continuous operation. Not
suitable for use in presence of flammable anesthetic mixtures with air or with
oxygen or nitrous oxide. Classified by Intertek Testing Services NA Inc. with
respect to electric shock, fire, and mechanical hazards only, in accordance with
UL 60601-1. Classified under the Medical Device Directive (93/42/EEC) as a Class
IIb device. Classified under the Canadian Medical Device Regulation as Class II.
Diagnostics
A qualified technician can perform general system testing. The Controller has no
user serviceable parts.
Important Information
This device complies with the EMC requirements according to IEC 60601-1-2.
Radio transmitting equipment, cellular phones, etc. shall not be used in the
close proximity of the device since this could influence the performances of the
device. Particular precaution must be considered during use of strong emission
sources such as High Frequency surgical equipment and similar so that, e.g., the
HF-cables are not routed on or near the device. If in doubt, contact a qualified
technician or your local representative.
User Manual: HotDogTM Patient Warming System Controller Page 20
ELECTROMAGNETIC COMPATIBILITY (EMC)
The HotDog Patient Warming System requires special precautions regarding EMC and must be
installed and put into service according to the EMC information provided in this User Manual.
Warning
Use of accessories and cables other than those specified 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
configuration.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The HotDog™ Patient Warming System is intended for use in the electromagnetic environment specified below. The
customer or user of the HotDog Patient Warming System should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic Environment – Guidance
RF emissions, CISPR 11
Group 1
The HotDog Patient Warming System uses RF energy only
for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions, CISPR 11
Class A
Harmonic emissions, IEC 61000-3-2
Class A
Voltage fluctuations/ flicker
emissions, IEC 61000-3-3
Complies
The HotDog Patient Warming System is suitable for use in
all establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
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