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Augustine Surgical HotDog WC7 Series, User And Technical Manual

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Augustine Surgical HotDog WC7 Series User And Technical Manual Download Page 17

User and Technical Manual: HotDog Temperature Management Controller 

Page 17 

 

 

TECHNICAL MANUAL 

Read Before Servicing Equipment 

Repair, preventive maintenance, safety testing, and servicing of the System require the skill of qualified medical-

equipment service technicians, who are familiar with good practice for medical device repair. Do not open the 

Controller. There are no user-serviceable parts. If service is required, contact Technical Support. Perform all 

maintenance activities in accordance with the instructions in this technical manual. Approved personnel: unplug 

the Warming Device before servicing internal components. 

MAINTENANCE & TESTING 

Electrical Safety Checks and Functional Testing  

Frequency 

These tests should be completed once every 24 months (or more frequently if required by hospital guidelines). 

Tools/Equipment 

•

 

Warming Device Cable (A101 or A102, A112) 

•

 

Ground continuity tester  

•

 

Leakage current tester 

•

 

Calibrated, fast-reacting thermocouple and meter  

•

 

HotDog Warming Blanket or Warming Mattress (optional) 

Method 

1.

 

Insert the 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. 

WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with 

protective earth ground. 

Note: The Controller is grounded and should not be attached to un-grounded tables intended for use with a 
hyfrecator or equivalent devices. 

2.

 

Perform the following tests on the Controller per standard institutional protocol: 

A.

 

Ground continuity 

B.

 

Connect a Warming Blanket to the Controller and test leakage current to ensure the maximum leakage 
current does not exceed the requirements in 

Table 3

.  

 

Note: The equipotential stud on the back of the Controller 
may be used as a grounding point for these tests. 
Equipotential stud is for ease of attaining ground connection 
during electrical safety testing. Clip to stud during test. 
Reference 60601-1 8.6.7 

 

Table 3: Maximum Allowable Leakage Current 

Polarity 

Condition 

Current (mA) 

Normal / 
Reversed 

Normal 

0.1 

Open Ground 

0.5 

Open Neutral 

0.5 

Open Ground & Open Neutral 

0.5 

Summary of Contents for HotDog WC7 Series

Page 1: ...X WC71 Single Port Controller WC77 Multiport Controller Manufactured by EU Authorized Representative Augustine Temperature Management 6581 City West Parkway Eden Prairie MN 55344 USA TEL 952 465 3500 FAX 952 465 3501 EMAIL cs augsurg com www hotdogwarming com TEL 31 0 70 345 8570 FAX 31 0 70 346 7299 ...

Page 2: ...se 6 Temperature Monitoring and Auto Mode Guide 8 Control Screen Overview 10 Alarms and Alerts 11 Cleaning the Controller 12 Cleaning Warming Blankets and Mattresses 12 Frequently Asked Questions 13 Accessories 14 Definition of Product Symbols 16 Technical Manual 17 Read Before Servicing Equipment 17 Maintenance Testing 17 Electrical Safety Checks and Functional Testing 17 Specifications 20 Electr...

Page 3: ...ry rooms emergency rooms burn units and on other medical surgical floors Core Temperature Monitoring Auto Mode Indications for Use The Controller WC7X is intended to measure patient core temperature from probes and function on AUTO mode whereby the Controller self adjusts warming temperature settings based on the patient s core temperature The System monitors the YSI 400 compatible temperature pro...

Page 4: ...on instructions for use are followed Only plug an approved 3 5mm jack into Tout for the purposes of porting patient temperature data to the patient monitor Dispose of the Controller per local regulations Follow Warming Blanket and Mattress User Manuals for proper disposal The Controller is designed to accept approved YSI 400 compatible temperature probes The temperature display range is 31C 43C Re...

Page 5: ...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 cause the IV pole to tip possibly resulting in injury Figure 1 Controller Mounted on an IV Pole Line up the mounting clamp with the bottom two sets of screw holes IMPORTANT The clamp will not fit on the top two sets of screw holes Ensure the power ca...

Page 6: ...Warming Blanket Warming Mattress following instructions in the User Manual for each device 3 Insert the device s connecting cable into the proper port on the Controller Table 1 WC77 Multi Port WC71 Single Port Port Color Device A B C D A Yellow Warming Blanket Clinician Vest M Blue Warming Mattress Tprobe In Tprobe In Silver Patient Temperature Probe 3 5mm TSR jack Tout Tout Silver 3 5mm TR Jack Y...

Page 7: ...e currently selected Device To select its temperature use the thermometer to increase the temperature or the thermometer to decrease the temperature Turn off the highlighted port at the red power icon Each connected Warming Device can be adjusted separately Other icons to the right adjust all port temperatures simultaneously All High All Medium All Low All Off 5 If using a temperature probe and yo...

Page 8: ...ed 31 43 C 1 C change minute the patient temperature will be displayed 4 AUTO mode is available if Warming Devices are placed on the patient and plugged in and a valid human temperature is measured AUTO mode automatically adjusts the Warming Device temperature settings based on a user selectable Normothermia Zone in increments described in Table 2 The upper and lower limits of the Normothermia Zon...

Page 9: ... of AUTO is logged as T 0 for the duration of the case Device warming settings are not logged d When the predetermined level of patient normothermia is achieved the Device s temperature settings are automatically adjusted downward in increments based on the percentage of the normothermia zone See Table 2 on page 8 for an example e Device remains in AUTO mode until the AUTO mode icon is deselected ...

Page 10: ...h Temperature 5 Set All Devices to Medium Temperature 6 Set All Devices to Low Temperature 7 Turn Off All Devices 8 View Selected Device Info 9 Turn off Selected Device 1 Zoom Out 2 Zoom In 3 Auto Mode switch On Off 4 Patient Temperature T TruCore NA or Probe 5 Patient Temperature Graph 6 Scroll Right 7 Graph Overview 8 Scroll Left Display Tips A Do not press down hard This is not needed B An over...

Page 11: ... the Controller loses communication with the sensor in the Warming Device an Alarm sounds and power is removed from the Device This may be caused by an electrical problem in the Device or Controller Swap the cables and Device with known good product to isolate the problem if possible If the problem continues stop using the Device or cable and contact technical support E5 Device Fold Detection In W...

Page 12: ...r use in the operating room and in pre and post operative areas in healthcare facilities Clean and disinfect Mattresses and Blankets between patient uses if they appear visibly soiled If Mattresses and Blankets are not visibly soiled disinfection at the end of the operating day is recommended Cautions Do not immerse Blankets or Mattresses in water Do not use high level disinfectants to clean Blank...

Page 13: ...aning The non porous outer shell contains an anti microbial and the edges are heat sealed to eliminate crevices The CDC says noncritical items like HotDog Blankets and Mattresses are safe and present virtually no risk of cross contamination 4 Is there a greater risk of cross contamination with reusable HotDog Blankets and Mattresses than with disposable FAW No The Warming Devices are considered no...

Page 14: ...nutes to reach the set temperature We have no data to support the use of the Devices beyond 30 months ACCESSORIES Part Number Description B103 Lower Body Warming Blanket B104 Full Body Warming Blanket B105 Multi position Warming Blanket B107 Head Warming Blanket B110 Chest and Torso Warming Blanket B500 Universal Warming Blanket B502 Warming Blanket Heated Arm Protection B503 HotDog Lower Body Bla...

Page 15: ...utput 3 5mm TSF headphone YSI 400 Series 1 4 in Phono A401 PH 2 Adapter Output 3 5mm TSF headphone Philips 2 pin A402 SPLAB Adapter Output 3 5mm TSF headphone Spacelabs A403 DRAE Adapter Output 3 5mm TSF headphone Draeger A404 MRY DAT Adapter Output 3 5mm TSF headphone Mindray Datascope A405 GE MARQ Adapter Output 3 5mm TSF headphone GE Marquette Adapter A410 OUT Cable Output 3 5mm TSM TSM headpho...

Page 16: ...age Graph Scroll Left Right Confirm Yes Button Cancel No Button Increase Setting Button Volume Brightness Etc Decrease Setting Button Volume Brightness Etc Graph Zoom in Button Graph Zoom out Button Slideshow Play Pause Button Outline indicates pause Slideshow Volume Button Alarm Mute Button X indicates alarm is muted Conforms to Medical Device Regulation OJ No L 117 1 of 2017 05 05 See IFU for Wa...

Page 17: ...HotDog Warming Blanket or Warming Mattress optional Method 1 Insert the 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 WARNING To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth ground Note The Controller is grounded and should not be a...

Page 18: ...ed during any of these steps repeat testing using a different Warming Blanket or Mattress If failure is observed with the second Warming Blanket or Mattress contact Customer Service 1 Tape a calibrated fast reacting temperature sensor to the patient facing surface of the Warming Blanket or Mattress directly over the sensor marking 2 Fold the Warming Blanket or Mattress back on itself black face to...

Page 19: ...l remain on the display until the condition is resolved If multiple Alarm or Alert conditions occur sequentially the code associated with the highest priority Alert condition will be displayed first followed by the next highest priority alarm or alert condition until all Alarm or Alert conditions have been displayed to the user Once all Alarm or Alert conditions have been displayed the display wil...

Page 20: ...8 75 wide Weight 2 8 3 2 kg 6 25 7 15 lbs without the clamp Mounting Can be placed on a horizontal flat surface i e table top clamped to an IV pole or hung using a VESA mount of either FDMI MIS C 35 75 mm or FDMI MIS D 75 75 mm specifications Temperature Characteristics Temperature Control Micro processor Operating Temperatures Blanket Ports A B C and D adjustable in 1oC increments 37 to 43 1 0 C ...

Page 21: ...f PCLCS physiologic closed loop control system AUTO mode per IEC 60601 1 10 ed 1 1 Accompanying Information From Table C 3 Details necessary for the safe use of a DISTRIBUTED PCLCS 6 4 NA Not a distributed PCLCS Summary of the PCLC modes of operation and specification of PCLCS responses 8 2 2 6 See Table 2 in IFU Means to check responses of the PCLCS 8 2 2 6 If patient temperature is outside a nor...

Page 22: ...in temperature above 43 C If skin temperatures exceed 43 C they will stay within the following time temperature limits Time s Temperature C 10000 43 5 6000 44 3300 44 5 1990 45 1000 45 5 600 46 350 46 5 225 47 110 47 5 80 48 60 48 5 38 49 28 49 5 22 50 17 50 5 ELECTROMAGNETIC COMPATIBILITY EMC The System requires special precautions regarding EMC and must be installed and put into service accordin...

Page 23: ... 2 4 8 kV contact 2 4 8 15 kV air 2 4 8 kV contact 2 4 8 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of ...

Page 24: ...rom fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HotDo...

Page 25: ...2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Customer Service Contact Phone 1 952 465 3500 Email CS AugSurg com HotDog is a trademark of Augustine Temperature Management registered in the U S Patent Trademark Office Devices are protected by some or all of the following patents US Patents 7...

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