background image

0940-001-025 Rev-L

EN

www.stryker.com

13

Guidance and manufacturer’s declaration - electromagnetic immunity

The Cast Cutter (REF 0941-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Cast Cutter (REF 

0941-000-000) should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - 

guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±2, ±4, ±6 kV contact

±2, ±4, ±8 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 a typical commercial or hospital 

environment.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode

Mains power quality should be that 

of a typical commercial or hospital 

environment.

Voltage dips, short interruptions and 

voltage variations on power supply 

input lines

IEC 61000-4-11

<5% 

U

T

 

(>95% dip in 

U

T

for 0,5 cycle

40% 

U

T

 

(60% dip in 

U

T

for 5 cycles

70% 

U

T

  

(30% dip in 

U

T

for 25 cycles

<5% 

U

T

 

(>95% dip in 

U

T

for 5 sec

 

95% Reduction (10ms) 

 

60% Reduction (100ms) 

 

30% Reduction (500ms) 

 

95% Reduction (5s)

Mains power quality should be that 

of a typical commercial or hospital 

environment. If the user of the Cast 

Cutter (REF 0941-000-000) requires 

continued operation during power 

mains interruptions, it is recommended 

that the Cast Cutter (REF 0941-

000-000) be powered from an 

uninterruptible power supply or a 

battery.

Power frequency (50/60 Hz)  

magnetic field

IEC 61000-4-8

3 A/m

3 A/m 

@ 50Hz 

CRT 1A/m

Power frequency magnetic fields 

should be at levels characteristics of a 
typical location in a typical commercial 

or hospital environment.

NOTE:

 

U

T

 is the alternating current mains voltage prior to application of the test level.

Recommended separation distances between portable and mobile RF communications equipment and the Cast Cutter (REF 0941-000-000)

The Cast Cutter (REF 0941-000-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or 

the user of the Cast Cutter (REF 0941-000-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile 

RF communications equipment (transmitters) and the Cast Cutter (REF 0941-000-000) as recommended below, according to the maximum output power of the 

communications equipment.

Rated maximum output  

power of transmitter

W

Separation distance according to frequency of transmitter

150 kHz to 80 MHz 

d

=1.2√

P

80 MHz to 800 MHz 

d

=1.2√

P

800 MHz to 2.5 GHz 

d

=2.3√

P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

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.

Summary of Contents for 0940-000-000

Page 1: ...he document should not appear on produced Labels or IFUs Description Type Stryker Instruments 269 323 7700 800 253 3210 Part Number Rev 6FRSH 2 5 635 3URFHVV 2ZQHU 7HFK 3XEV 0DQDJHU N A 8 5 inch width...

Page 2: ...2016 10 0940 001 025 Rev L www stryker com Cast Cutter 0940 000 000 0941 000 000 Instructions For Use ENGLISH EN...

Page 3: ...aster Stainless Steel 0940 025 000 Synthetic Titanium Nitrided 0940 035 000 User Patient Safety WARNINGS Before using any system component or any component compatible with this system read and underst...

Page 4: ...000 to Stryker PlasterVac REF 0886 000 000 0940 886 000 Adaptor Hose with Cord to connect Cast Cutter REF 0940 000 000 to Stryker PlasterVac REF 0846 000 000 or 0856 000 000 0940 855 000 Adaptor Hose...

Page 5: ...ly J Power Cord Plug Model REF 0941 000 000 Only K Power Source Cord Plug L Power Source Cord M Appliance Inlet Connector Plug N Appliance Inlet Connector Function Switch High Speed Mode The Cast Cutt...

Page 6: ...de is securely installed and the blade retention screw is tight against the blade To Connect the Cast Cutter to a Power Source WARNING ALWAYS set the function switch to the standby mode position befor...

Page 7: ...e direction of the cut 5 Repeat this motion of alternating pressure along the direction of the cut until the cut is complete NOTE Use a cast spreader to remove the cast if necessary 6 Upon completion...

Page 8: ...duals trained and experienced in the maintenance of reusable medical devices should inspect test and maintain this equipment DO NOT disassemble or service this equipment unless otherwise specified Fai...

Page 9: ...e the spring onto the brush CAUTION During installation DO NOT overtighten the brush cap 7 Install and carefully tighten the brush cap to 0 45 0 90 N m 4 8 lb in 8 Repeat the steps to replace the othe...

Page 10: ...nstalled in the wrong orientation Remove and install the motor brushes See the Inspection Testing and Maintenance section The Cast Cutter does not operate smoothly or operates with excessive noise The...

Page 11: ...ith Intermittent Loading Duty Cycle 15 minutes on 1 time 15 minutes on 1 time Rest Between Cycles 20 minutes 20 minutes Maximum Temperature of Applied Part Less than 48 C 118 F Maximum surface tempera...

Page 12: ...NELEC EN 60601 1 1990 Medical Electrical Equipment Part 1 General Requirements for Safety Amendment 1 1993 Amendment 11 1993 Amendment 12 1993 Amendment 2 1995 Amendment 13 1996 International Electrot...

Page 13: ...ding cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P 150 kHz to 80 MHz d 1 2 P 80 MH...

Page 14: ...000 000 be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m 50Hz CRT 1A m Power frequency magnetic fields should be at levels...

Page 15: ......

Page 16: ......

Page 17: ...25 Rev L www stryker com Manufactured for Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 ES DE FR IT NL EL 0940 001 715 JA ZH KO 0940 001 725 SV DA FI PT...

Reviews: