background image

13

1.3 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 4:

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The 

A

RCTIC

 S

UN

®

  5000 Temperature Management System unit is intended for use in the elec-

tromagnetic environment specified below. The customer or the end user of the 

A

RCTIC

 S

UN

®

  

5000 Temperature Management System unit should assure it is used in such an environment.

Immunity 
Test

IEC60601 
test level

Compli-
ance Level

Intended Electromagnetic Environment

Conducted 
RF 
IEC 61000-
4-6
Radiated 
RF
IEC 61000-
4-3

3Vrms
150kHz to 
80MHz
3V/m
80MHz to 
2.5GHz

3Vrms
150kHz to 
80MHz
3V/m
80MHz to 
2.5GHz

Portable and mobile RF communications equip-
ment should be used no closer to any part of the 

A

RCTIC

 S

UN

®

  5000 Temperature Management Sys-

tem unit, including cables, than the recommended 
separation distance calculated from the equation 
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P      80MHz to 800 MHz
d = 2.3√P      800MHz to 2.5GHz
where P is the maximum output power rating 
of the transmitter in watts (W) according to the 
transmitter manufacturer and d is the recom-
mended minimum separation distance in meters 
(m).
Field strengths from fixed RF transmitters, as 
determined by an electromagnetic site survey

a

should be less than the compliance level in each 
frequency range.

b

Interference may occur in the vicinity of equip-
ment marked with the following symbol:

NOTE 1   At 80MHz and 800MHz, the higher frequency range applies
NOTE 2  These guidelines may not apply in all situations. Electromagnetic propagation is 
affected by absorption and reflection from objects, structures and people.

a

 Field strengths from 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 consid-
ered. If the measured field strength in the location in which the 

A

RCTIC

 S

UN

®

 5000 Temperature 

Management System unit is used exceeds the applicable RF compliance level above, the 

A

RCTIC

 S

UN

®

 5000 Temperature Management System unit should be observed to verify normal 

operation. If abnormal performance is observed, additional measures may be necessary, 
such as re-orienting or relocating the 

A

RCTIC

 S

UN

®

 5000 Temperature Management System 

unit.

b

 Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

1.4 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 6: 

Recommended separation distances between portable and mobile RF communications 
equipment and the 

A

RCTIC

 S

UN

®

  5000 Temperature Management System unit

RF communications equipment can effect medical electrical equipment. The 

A

RCTIC

 S

UN

®

  5000 

Temperature Management System unit is intended for use in an electromagnetic environment 
in which radiated RF disturbances are controlled. The customer or the user of the 

A

RCTIC

 S

UN

®

  

5000 Temperature Management System unit can help prevent electromagnetic interference 
by maintaining a minimum distance between the portable and mobile RF communications 
equipment (transmitters) and the 

A

RCTIC

 S

UN

®

  5000 Temperature Management System unit 

as recommended below, according to the maximum output power of the communications 
equipment.

Rated maximum 
output power of 
transmitter in watts 
(W)

Separation distance according to frequency of transmitter in meters 
(m)

150kHz to 80MHz
d = 1.2√P

80MHz to 800MHz
d = 1.2√P

800MHz to 2.5GHz
d = 2.3√P

0.01

0.12

0.12

0.23

0.1

.38

.38

.73

1.0

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended 
separation distance d in meters (m) can be estimated using the equation applicable to the 
frequency of the transmitter, where P is the maximum output power rating of the transmitter 
in watts (W) according to the transmitter manufacturer.
NOTE 1    At 80 MHz and 800 MHz, the separation distance for the higher frequency range 
applies.
NOTE 2   These guidelines may not apply in all situations. Electromagnetic propagation is 
affected by absorption and reflection from structures, objects and people.

E N G L I S H

Содержание ARCTIC SUN 5000

Страница 1: ...O P E R AT O R S M A N U A L ...

Страница 2: ...Hypothermia Cool Patient and Rewarm Patient 5 End Therapy 6 Chapter 3 Normothermia Settings 6 Normothermia Settings 6 Chapter 4 Hypothermia Settings 7 Hypothermia Settings 7 Chapter 5 Advanced Setup 7 Chapter 6 Alarms and Alerts 8 Alarms 8 Main Safety Alarms 8 Non Recoverable Alarms 8 Recoverable Alarms 8 Alerts 8 Chapter 7 Maintenance and Service 8 Cleaning and Maintenance 8 Software Update 9 Ser...

Страница 3: ...ne check connections If needed replace the leaking pad Leakage may result in lower flow rates and potentially decrease the performance of the system The ARCTIC SUN Temperature Management System is for use only with the ARCTICGEL Pads The ARCTICGEL Pads are only for use with the ARCTIC SUN Temperature Management Systems The ARCTICGEL Pads are non sterile for single patient use Do not reprocess or st...

Страница 4: ...Fluid Delivery Line Patient Temp 1 cable Patient Temp 2 cable optional and Fill Tube to the back of the control module 2 Plug the Power Cord into the wall outlet Position ARCTIC SUN Temperature Man agement System so that access to the power cord is not restricted Power On 1 Turn the power ON by activating the Power Switch 2 The control module will automatically go through a brief self test of the ...

Страница 5: ...ry Line While holding the pad line tubing insert the clear pad line connector into the Fluid Delivery Line manifold Do not press or squeeze the wings when connecting The connector will click into place Temperature Probe Placement Patient temperature control with the ARCTIC SUN Temperature Management System requires patient temperature feedback provided by an indwelling patient temperature probe co...

Страница 6: ...ol Patient window in the Normothermia therapy screen The Control Patient window displays the patient target temperature and the duration since the initiation of normothermia therapy To initiate Normothermia therapy 1 From the Patient Therapy Selection screen press the Normothermia button to display the Normothermia therapy screen 2 The default patient target temperature will display in the Control...

Страница 7: ...cooling duration to cool the patient before rewarming begins Press the Save button to save the new settings and close the Cool Patient Adjust window 2 Rewarm Patient Settings The default patient target temperature and duration will display in the Rewarm Patient window To change the rewarming phase patient target temperature and rewarming rate press the Adjust button in the Rewarm Patient window to...

Страница 8: ...apy screen press the Stop button to terminate water circulation to the pads Press the Empty Pads button and follow the instructions to purge the pads of water Disconnect the pads from the Fluid Delivery Line Slowly and carefully remove pads from the patient skin Discard the used pads in accordance with hospital procedures for medical waste Press the power switch Off If power is lost while the powe...

Страница 9: ...rapy settings press the Close button For instructions on saving the settings as the system defaults see Advanced Setup Chapter 5 Advanced Setup Use the Advanced Setup screen to view the current settings and modify the settings for the following parameters To modify any parameter setting press the Adjust button to the right of the parameter Location Time Settings Language Number Format Current Time...

Страница 10: ...ype of Alarm is known as Non Recoverable If this situation occurs cycle the device power turn device Off then On If the alarm recurs contact Medivance Customer Support Recoverable Alarms Other Alarms that temporarily Stop the device until the user is able to correct the cause and clear the Alarm are classified as Recoverable If the condition that initiated the alarm is not addressed and problem per...

Страница 11: ...Customer Support for technical support and customer service instructions to enable appropriately qualified technical personnel to repair those parts of the equipment that Medivance considers repairable Calibration See ARCTIC SUN 5000 Temperature Management System Service Manual for calibration requirements and instructions Appendix A Product Specifications Technical Description The ARCTIC SUN Temper...

Страница 12: ...d from testing in simulated use Patient Temperature Control Range 32 C to 38 5 C 89 6 F to 101 3 F 0 1 C F increments Water Temperature Display Range 3 C to 45 C 37 4 F to 113 0 F 0 1 C F increments Water Temperature Control Range Manual 4 C to 42 C 39 2 F to 107 6 F 1 C F increments High Water Temperature Limit 36 C to 42 C 96 8 F to 107 6 F 1 C F increments Low Water Temperature Limit 4 C to 25 ...

Страница 13: ...with CAN CSA C22 2 STD 601 1 M90 and UL STD 6060 1 Indicates high temperature part or component Indicates that only sterile or distilled water should be used when filling the ARCTIC SUN Temperature Management System Control Module Identifies Patient Temperature 1 the patient temperature probe input for monitoring and control Identifies Patient Temperature 2 the patient temperature probe input for mon...

Страница 14: ...er emissions IEC 61000 3 3 Complies 1 2 EN IEC 60601 1 2 Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The ARCTIC SUN 5000 Temperature Management System unit is intended for use in the electromagnetic environment specified below The customer or the end user of the ARCTIC SUN 5000 Temperature Management System unit should assure it is used only in such an environment Immun...

Страница 15: ... If the measured field strength in the location in which the ARCTIC SUN 5000 Temperature Management System unit is used exceeds the applicable RF compliance level above the ARCTIC SUN 5000 Temperature Management System unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ARCTIC SUN 5000 Tem...

Отзывы: