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Operator Manual

Aspect 100-4T and ISR

L100-2843 Rev. E

www.imagediagnostics.com

37

Guidance and Manufacturer’s Declaration Emissions, Equipment and Systems that
are NOT Life-Supporting

Table 3

This equipment is intended for use in the electromagnetic environment specified below.

The customer or user of this equipment should ensure that it is used in such an
environment.

Immunity Test

EN/IEC 60601

Test Level

Compliance

Level

Electromagnetic

Environment

Guidance

Conducted RF
EN/IEC 61000-4-6

Radiated RF
EN/IEC 61000-4-3

AC Mains:
3V, 0.15MHz – 80MHz
6V in ISM band between
0.15MHz and 80MHz
80%AM at 1KHz
[see table 5 of IEC
60601-1-2]

SIP/SOPS:
3V, 0.15MHz – 80MHz
6V in ISM band between
0.15MHz and 80MHz
80%AM at 1kHz
[see table 5 of IEC
60601-1-2]

3V/m
80MHz to 2.7GHz

80%AM at 1kHz

AC Mains:
3V, 0.15MHz – 80MHz
6V in ISM band
between
0.15MHz and 80MHz
80%AM at 1KHz
[see table 5 of IEC
60601-1-2]

SIP/SOPS:
3V, 0.15MHz – 80MHz
6V in ISM band
between
0.15MHz and 80MHz
80%AM at 1kHz
[see table 5 of IEC
60601-1-2]

3V/m

80% AM

Portable and mobile
communications equipment
should be separated from this
equipment by no less than the
distances calculated/listed below:

D=(3.5/3)(Sqrt P)

D=(3.5/3)(Sqrt P)
80 to 800 MHz

D=(7/3)(Sqrt P)
800 MHz to 2.7 GHz

where P is the max power in watts
and D is the recommended
separation distance in meters.

Field strengths from fixed
transmitters, as determined by an
electromagnetic site survey,
should be less than the compliance
levels (V1 and E1).

Interference may occur in the
vicinity of equipment containing a
transmitter.

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Содержание Aspect ISR

Страница 1: ...Made in the USA Aspect 100 4T and ISR Mobile Image Tables Operator Manual ...

Страница 2: ... regulations and standards Consult local state federal and or international agencies regarding specific requirements and regulations applicable to the use of this equipment Image Diagnostics Inc certifies only this equipment Operating practices and safety for this equipment are the sole responsibility of the owner and operators Image Diagnostics Inc assumes no liability or responsibility for perso...

Страница 3: ...FOOT ACTUATED MOTION CONTROLS 19 9 PATIENT PREPARATION 20 9 1 Preparation for Patient Use 20 9 2 Patient Loading 20 9 3 Preparation for Performing CPR 21 10 STANDARD ACCESSORIES 21 10 1 Patient Mattress Pad for Tabletop 21 10 2 Patient Restraint Straps 22 11 ADD ON ACCESSORIES 23 11 1 Clamp on Accessory Rail 23 11 2 Vascular Access Arm Board VAB 23 11 3 Quick Release Rail Mount Arm Board requires ...

Страница 4: ...s com 4 12 GENERAL CLEANING 27 13 MAINTENANCE SERVICE REPAIR 28 13 1 RECOMMENDED PERIODIC PERFORMANCE CHECKS 28 13 2 SERVICE REPAIR STATEMENT 28 14 TROUBLESHOOTING 29 15 DISPOSAL OF COMPONENTS 32 16 PRODUCT DATA 33 17 SPECIFICATIONS 34 18 WARRANTY AND CONTACT INFORMATION 38 ...

Страница 5: ...o the equipment Emergency Stop Pushbutton Electric Shock hazard present Information or instructions shown near this symbol must be adhered to in order to prevent a potentially hazardous situation which if not avoided could result in death personal injury or damage to the equipment Equipotential Terminal of the table which provides for a connection between the table and the equipotential bus bar of...

Страница 6: ...el of Table Serial Number of Table Indication of European Conformity for sale in the European Economic Area EEA Item complying to Type B applied part per IEC 60601 1 Date of manufacture of the device Location where device was manufactured Alternating Current AC CPR Cardiopulmonary resuscitation This symbol denotes that the product contains electronic devices and cannot be disposed of with househol...

Страница 7: ...Rev E www imagediagnostics com 7 Elevate tabletop Lower tabletop Tilt tabletop s imaging end up Trendelenburg Tilt tabletop s imaging end down Trendelenburg Roll tabletop clockwise Roll tabletop counterclockwise Tabletop is centered from side to side ...

Страница 8: ...agnostic therapeutic and surgical applications The device is designed for use as either a fluoroscopic or radiographic table 3 SAFETY INSTRUCTIONS All persons using this equipment must fully understand its operation instructions emergency procedures capabilities including total range of motion and be aware of all potential safety hazards This manual should be accessible to all personnel installing...

Страница 9: ...not been tested for use with high frequency surgical equipment cardiac defibrillators or cardiac defibrillator monitors Use with such equipment may cause patient burns explosion hazards or electrical shock to the patient or operator CAUTION Do not leave patient unattended on table WARNING To avoid electric shock plug the electrical power cord into a properly grounded hospital grade outlet WARNING ...

Страница 10: ...y for the safety of patient and operator CAUTION During operation of the table if any unusual sounds and or erratic movement is observed immediately discontinue use of the table CAUTION Do not use table for patient transport CAUTION Do not place or store any containers or large items underneath the tabletop As the tabletop is descending contact with an obstruction may cause permanent damage to the...

Страница 11: ...e used no closer than 30 cm 12 inches to any part of this equipment including cables connected to the table Otherwise degradation of the performance of this equipment could result NOTE The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required ...

Страница 12: ...al electrical power connection and disconnection is through the AC power cord and outlet The table will operate on 110 V 230 V or on internal battery backup power see section 8 2 When external electrical power is applied to the actuators which control the movement of the tabletop the green LEDs on the Handset Control will illuminate The electrical power outlet used should be visible and accessible...

Страница 13: ...ing charged during normal use when connected to AC power When the table is not in use and not connected to AC power the Emergency Stop Pushbutton must be fully engaged to prevent the batteries from being discharged and to safely power off the equipment This equipment s tabletop braking systems utilize a passive magnetic brake it remains engaged energized in the event of a complete loss of electric...

Страница 14: ...ock Pedal is pushed DOWN The Rear Casters will be totally locked and will not roll in any direction Always lock all casters in this way before loading the patient onto the table The table is in the UNLOCK setting when the Rear Caster Lock Pedal is pushed down on the BOTTOM half until it is fully engaged and when the Front Steer Lock Pedal is pulled UP to disengage the unidirectional wheels and eng...

Страница 15: ...y Stop Pushbutton is engaged 8 3 TABLE MOTION CONTROLS All Aspect ISR Aspect 100 4T tables are equipped with tabletop motion control boxes that allow users to move the tabletop in many different directions PANHANDLE KNOB PLACE PALM ON TOP OF KNOB LIFT LIP UNDERNEATH THE KNOB WITH FINGERTIPS TO FLOAT TABLETOP IN HORIZONTAL DIRECTION LATERALLY CENTERED TABLETOP INDICATOR TABLETOP ELEVATE MOTION SWIT...

Страница 16: ... a level position motion will stop for 1 second When the Rocker Switch is pressed down if the Tabletop is already in a level position it will take 1 second for motion to begin Continually pressing down on the Rocker Switch to the right of this symbol will roll the Tabletop in a clockwise direction if looking down the length of the Table from the pedestal end When the Tabletop reaches a level posit...

Страница 17: ...anually repositioned The Switch Lockout Pushbutton only disables Elevate Trendelenburg and ISO Centric Roll ISR only motions to prevent accidental activation The Tabletop Motion Control Unit clamps onto either the left or right Accessory Rail on the Tabletop and can be moved along the length of the rails by rotating the lever down on the bottom of the Motion Control Unit until the clamp releases t...

Страница 18: ...sition for 1 second before motion begins again When the Table s Trendelenburg tilt position is already level and the Trendelenburg buttons are pressed it will take 1 second before the motion of the Tabletop begins When the ISO Roll function buttons are used ISR only the Tabletop motion will stop at level position When this happens release and repress the button again to continue the motion WARNING...

Страница 19: ...ke 1 second before the motion of the Tabletop begins ISR FOOT SWITCH CONTROL Foot Switch activated control motions for the Aspect ISR table are ISO Roll Trendelenburg down up and elevate lower Safety hood helps avoid accidental motorized Table movement from Foot Switch Control When the Trendelenburg Foot Switch Pedal is used the Tabletop motion will stop at level position for 1 second before motio...

Страница 20: ...t Loading Patients must be loaded from the side of table There is a possibility of tilting instability and or tipping if patient is loaded onto the pedestal end or the imaging end of the table To reduce potential motion during patient transfers with larger patients move the tabletop lateral side to side in the direction the patient will be moving until the limit of the tabletop travel is reached r...

Страница 21: ...ming CPR on a patient 10 STANDARD ACCESSORIES 10 1 Patient Mattress Pad for Tabletop The Patient Mattress Pad is held in place by hook and loop fasteners To remove the pad simply pull pad up gently to remove Replacement pads are supplied with new self adhesive fasteners installed and new adhesive backed mating pieces for the tabletop Peel off old fasteners from tabletop and install new pad Note Pa...

Страница 22: ...r the Tabletop hangs down between the rails and the tabletop and wrapped over the outside of the rails to meet over the top of the table If the strap is to be used along the rest of the tabletop slide the strap over the end of the table with the thin part of the strap over the Tabletop and the thicker part under the tabletop The ends of the strap meet over the top of the table and connect with hoo...

Страница 23: ...ength European version with 10mm x 25mm metric rail is available 11 2 Vascular Access Arm Board VAB One piece extra wide carbon fiber arm board for vascular access and fistula application procedures Mounts to table by laying across the width of the tabletop underneath the Patient Mattress Pad and uses a hook pin to hold in place Includes arm board pad and restraint strap ...

Страница 24: ... Clamp on Accessory Rail Radiolucent materials Includes arm board pad and restraint straps version for 10mm x 25mm metric rail size is available 11 4 Arm Board Shoulder Mount Carbon fiber base Mounts to table by sliding under Patient Mattress Pad Includes padded arm board and restraint strap 11 5 Tabletop Catheter Tray Extensions ...

Страница 25: ...pivoting the extension up or down to angle the patient s head To remove the Articulating Headrest Extension from the Tabletop depress the release levers located on the underside of the extension and pull away from Tabletop as shown below 11 7 Peripheral Headrest Extension Carbon fiber base extends Tabletop 12 Mounts to imaging end of Table onto 5 Mini Accessory Rails Includes Pad WARNING Use of ta...

Страница 26: ...y rail and the tabletop by clamp 11 9 Anesthesia Screen Holder May require a pair of side rail clamps Flexible Hoop If this is to be used in an area of the tabletop that has no side rails then a pair of Clamp on Accessory Side Rails and a pair of Side Rail Clamps are needed The Screen Holder can also be mounted directly to the Headrest Extension if it is used 11 10 Side Rail Clamps Rotating For us...

Страница 27: ...d Power cord Handset Control and Foot Control cords must be plugged in at the table base to protect the inside of the connectors from debris e Remove all pads and accessories f Wipe off any excess fluids with a water dampened cloth or sponge g Clean the Tabletop and accessories using an approved cleaner listed above h Clean all pads according to the instructions attached to the pad i Clean the tab...

Страница 28: ...ser serviceable Replacement must be performed only by a qualified service technician Weekly Check battery operation by disconnecting the AC power and running the tabletop up and down Run the tabletop through its full range of motions to help keep the actuators from sticking or freezing up Semi annually Inspect carbon fiber tabletop 13 2 SERVICE REPAIR STATEMENT Only qualified personnel should perf...

Страница 29: ...er to Section 5 of this manual 7 Reinitialize Actuator Controller with Handset Control 2 Lateral and Longitudinal Brakes stuttering or sticking 1 Table has been dormant for extended length of time 2 Contamination on brake surfaces or improper cleaning or maintenance performed 1 Release brakes using Tabletop Motion Control Panhandle and move tabletop in all directions Working tabletop motions may f...

Страница 30: ... Switches disabled 5 Panhandle Failure 6 Control connection 7 Actuator s uncalibrated 8 Actuator Failure 1 Check electrical outlet 2 Connect to AC Power 3 Reset Emergency Stop Pushbutton 4 Reset Switch Lockout Pushbutton 5 Test motion with Handset Control If Trendelenburg works correctly replace Panhandle Unit 6 Service Control connections 7 Reinitialize Actuator Controller with Handheld Control 8...

Страница 31: ...test response with optional Handset Control or Foot Switch Control if available 9 No response to Handset Control or Foot Switch Control Optional 1 No Power 2 Battery is depleted 3 Emergency Stop Pushbutton engaged 4 Handset Control or Foot Switch Control Cable damaged 5 Actuator s uncalibrated 6 Device Failure 1 Check electrical outlet 2 Connect to AC Power 3 Reset Emergency Stop Pushbutton 4 Test...

Страница 32: ...able Metal Steel and Copper Plastic Copper Control Box PC Board Plastic Housing Cable Transformer Batteries Electronic Plastic Copper Copper Lead Acid Batteries Hand Controls PC Board Housing Cable Electronic Plastic Copper Table Base Frame Casters Covers Metal Steel Plastic and Steel Stainless Steel Electronic waste and batteries Electronic components and devices must be disposed of according to ...

Страница 33: ...roll ISR ONLY Approx 12 with automatic stop at level position Tabletop height range ISR 81 3 cm to 111 3 cm 32 in to 44 in without pad 100 4T 76 2 cm to 109 2 cm 30 in to 43 in without pad Longitudinal travel 81 3 cm 32 in Lateral Cross Travel 20 3 cm 8 in Patient capacity 272 kg 600 lbs without tabletop extensions Automatic locking of longitudinal travel when table Trendelenburg is not level Emer...

Страница 34: ...r 230 5 Vac 50Hz Duty Cycle 10 2 min on 18 min off Current Rating Less than 10 Amps Battery Backup Power Environmental Operating Temperature Range 10 C to 40 C Operating Humidity Range 30 to 75 relative humidity noncondensing Operating Pressure Range 700 hPa to 1060 hPa Transport Storage Temperature Range 40 C to 60 C Transport Storage Humidity Range 30 to 75 relative humidity noncondensing Transp...

Страница 35: ...uld ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 This equipment uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A This equipment is suitable for use in the professional...

Страница 36: ...25 270 and 315 0 UT 1 cycle 70 UT 25 30 cycles for 50 Hz and 60Hz respectively Single phase at 0 0 UT 250 300 cycle for 50 Hz and 60 Hz respectively Single phase at 0 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle 70 UT 25 30 cycles for 50 Hz and 60Hz respectively Single phase at 0 0 UT 250 300 cycle for 50 Hz and 60 Hz respectively Single phase at 0 Main power quality should be th...

Страница 37: ...ISM band between 0 15MHz and 80MHz 80 AM at 1kHz see table 5 of IEC 60601 1 2 3V m 80MHz to 2 7GHz 80 AM at 1kHz AC Mains 3V 0 15MHz 80MHz 6V in ISM band between 0 15MHz and 80MHz 80 AM at 1KHz see table 5 of IEC 60601 1 2 SIP SOPS 3V 0 15MHz 80MHz 6V in ISM band between 0 15MHz and 80MHz 80 AM at 1kHz see table 5 of IEC 60601 1 2 3V m 80 AM Portable and mobile communications equipment should be s...

Страница 38: ...r of the Communications Equipment Table 4 Max Output Power Watts Separation m 150kHz to 80MHz D 3 5 3 Sqrt P Separation m 80 to 800MHz D 3 5 3 Sqrt P Separation m 800MHz to 2 5GHz D 7 3 Sqrt P 0 01 1166 1166 2333 0 1 3689 3689 7378 1 1 1666 1 1666 2 3333 10 3 6893 3 6893 7 3786 100 11 6666 11 6666 23 3333 18 WARRANTY AND CONTACT INFORMATION Warranty details for IDI Products can be obtained directl...

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