Augustine Surgical HotDog WC7 Series Скачать руководство пользователя страница 16 | Manualshive

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Augustine Surgical HotDog WC7 Series Скачать руководство пользователя страница 16

User and Technical Manual: HotDog Temperature Management Controller

Page 16

DEFINITION OF PRODUCT SYMBOLS

Do Not Place Under
Patient

This Side Up

This Side Under Patient

This Side Down

Heating Area

Medical Device

Attention; consult
accompanying
documents

Reference Number

Lot Number

BF Patient Applied
Part according to
IEC60601-1.

Serial Number

Manufacture Date

Do not use after
YYYY-MM-DD

Transport and storage
temperature range

Manufacturer

Keep Dry

Transport and storage
humidity range

Fuse

Equipotential

EU Authorized
Representative

Return to Authorized
Representative

Temperature Sensor

Device Temperature
Increase 1°C
(When gray, device is at
maximum temperature.)

Device Temperature
Decrease Button -1°C
(When gray, device is at
minimum temperature.)

Main Menu Button

Back Button

Next/Previous Page
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 Warnings and
Precautions

Medical Device restricted
to sale by or on the order
of a physician

Measured
temperature (invalid
patient temperature)

Valid Patient Temperature
(example)

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.

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.

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Содержание HotDog WC7 Series

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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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