Mizuho Osi 6850 User manual

MODEL 6850 ORTHOPEDIC SURGERY TABLE
PROfx
MAINTENANCE and REPAIR MANUAL
 OSI 2003
®
30031 Ahern Avenue
Union City, CA 94587-1234
Bus: 510-429-1500 Toll Free: 800-777-4674 Fax: 510-429-8500
NW0424 Rev A
TABLE OF CONTENTS
1.0 INTRODUCTION .................................................................................................................................................4
1.1 General Description .............................................................................................................................................4
1.2 Specifications.......................................................................................................................................................4
1.3 Shipping...............................................................................................................................................................4
1.4 Storage .................................................................................................................................................................5
2.0 CONTROLS IDENTIFICATION........................................................................................................................6
2.1 Table Orientation .................................................................................................................................................6
2.2 Major Controls Location......................................................................................................................................6
2.3 Control Panel Identification.................................................................................................................................7
3.0 INSPECTION ........................................................................................................................................................8
3.1 Acceptance and Transfer .....................................................................................................................................8
3.2 Preoperative .........................................................................................................................................................8
3.3 Postoperative .......................................................................................................................................................8
3.4 Annually ..............................................................................................................................................................8
4.0 PRE-OPERATIONAL FUNCTION CHECK ....................................................................................................9
5.0 BASIC OPERATION ..........................................................................................................................................11
5.1 Control Operation ..............................................................................................................................................11
5.2 Floor Lock .........................................................................................................................................................11
5.3 Moving the Table...............................................................................................................................................11
5.4 Hand Pendant Control........................................................................................................................................11
5.5 Leg Spars: ..........................................................................................................................................................12
6.0 THE ELECTRICAL SYSTEM ..........................................................................................................................13
6.1 Description.........................................................................................................................................................13
6.2 On/Off Power Switch ........................................................................................................................................13
6.3 Component Circuit Breaker ...............................................................................................................................13
6.4 Power Cord ........................................................................................................................................................13
6.5 Leakage Current ................................................................................................................................................13
6.6 Floor Lock System.............................................................................................................................................14
6.7 Emergency Backup Battery System...................................................................................................................15
6.8 Troubleshooting .................................................................................................................................................15
7.0 CLEANING and MAINTENANCE...................................................................................................................16
7.1 Cleaning and Disinfecting .................................................................................................................................16
7.2 Maintenance.......................................................................................................................................................16
8.0 REMOVAL and REPLACEMENT of COMPONENTS .................................................................................17
8.1 Floor-lock Actuator ...........................................................................................................................................17
8.2 Floor-lock Pad ...................................................................................................................................................18
8.3 Emergency Backup Battery ...............................................................................................................................19
8.4 10 Amp Motor-control PCB ..............................................................................................................................20
8.5 Power Supply Tray ............................................................................................................................................21
8.6 Stepper-controller Tray......................................................................................................................................22
8.7 Tilt Sensor-Actuator ..........................................................................................................................................23
9.0 TECHNICAL DRAWINGS and PARTS LISTS ..............................................................................................25
9.1 Interconnect Diagram, 110VAC ........................................................................................................................25
9.2 Interconnect Diagram, 220VAC ........................................................................................................................26
9.3 Table Assembly Bill of Materials ......................................................................................................................27
9.4 Replacement / Spare Parts List ..........................................................................................................................27
9.5 Table Assembly Exploded View .......................................................................................................................28
9.6 Base Cover Assembly, Exploded View .............................................................................................................29
9.7 Base Assembly, Exploded View........................................................................................................................30
9.8 X-Ring Assembly Exploded View ....................................................................................................................31
10.0 GLOSSARY OF TERMS..................................................................................................................................32
11.0 OSI TECHNICAL SERVICE...........................................................................................................................33
11.1 Contact for Parts and Service: .........................................................................................................................33
6850 PROfx Maint. & Repair Manual NW0424 Rev. A
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IMPORTANT NOTICES
CAUTION:
To ensure safe operation of the equipment, please READ THESE INSTRUCTIONS COMPLETELY and keep this manual readily available to OR personnel for future reference.
Carefully observe and comply with all warnings, cautions and instructions placed on the equipment or described in this manual.
In this manual, the WARNING symbol is intended to alert the user to the presence of important operation, maintenance, or safety instructions.
Dans ce manuel, le symbole AVERTISSANT est projeté d'alerter l'utilisateur à la présence d'opération importante, l'entretien, ou les instructions de sûreté.
WARNING Proper preoperative and intra-operative procedures must be followed to prevent venous stasis and pooling, pressure sore development, neuropathy, improper electro surgical tissue grounding, hypertension and hypothermia.
AVERTISSANT Preoperative propre et les procédures dans opératifs doivent être suivis pour empêcher venous stasis et pooling, la pression développement endolori, la neuropathie, electro déplacé mettre à terre de tissu chirurgical, l'hypertension et hypothermia.
NOTE: The application techniques outlined in these instructions are the manufacturer’s suggested techniques. The final disposition of each patient’s care as related to the use of this equipment rests with the attending physician.
This device is to be used by trained professional personnel only.
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Classification and Table Rating
The tables listed above are considered Class I Exempt and has a rating of IPX-0.
PROTECTION AGAINST ELECTRICAL SHOCK HAZARD:
This symbol indicates this equipment is an applied part TYPE B and is generally suitable for applications involving external or internal contact with the patient, excluding the heart. The patient circuit is connected to protective earth and this equipment should be connected only to outlets with a protective earth ground.
LA PROTECTION CONTRE LE DANGER DE CHOC ELECTRIQUE:
Ce symbole indique que cet équipement est un B DE TYPE de partie appliqué et est généralement convenable pour les applications contact impliquant, externes ou internes avec le malade, excluant le coeur. Le circuit patient est connecté à la terre protective et cet équipement devrait être seulement connecté aux sorties avec un sol de terre protectif.
WARNING: If the integrity of the external protective earth conductor is in doubt, the equipment shall be operated from its internal electrical power source (battery).
AVERTISSANT: Si l'intégrité de l'externe protectif terre est en doute, l'équipement sera opéré de son interne électrique pouvoir (pile).
This symbol
indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground outlet in your operating room or facility.
To protect the patient, hospital staff and the table from any possible hazards, an external ground wire connection is required between the external ground stud and protective earth ground.
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1.0 INTRODUCTION
1.1 General Description
The model 6850 PROfx Pelvic Reconstruction Orthopedic Trauma Table (6850 Table) is designed to safely hold a patient in the proper position undergoing orthopedic or surgical procedures.
It is a stand-alone, single-pedestal electrically operated table designed to position a patient in a prone, lateral or supine position during surgical procedures. The table has three primary electrically powered functions. Up/down, left/right lateral roll, Trendelenburg/Reverse Trendelenburg tilt. Electromechanical actuator-motors perform these motions.
The table is controlled by means of a hand pendant control with functions clearly labeled. Positive floor locks are employed to stabilize the table in the operating location.
Figure 1: 6850 Table, right-side view.
1.2 Specifications
The table is designed to safely hold up to a 450-pound patient in the proper procedural position at any point within its physical range. The table has a height range of 30 to 40 inches. The width of the tabletop is 21 inches. The length of the tabletop is 62 inches. With leg spars is 125 inches. The lateral roll range is +/- 20 degrees and the Trendelenburg range is +/- 15 degrees. The maximum deflection of the tabletop under full load is less than 1 inch at the cantilever end. The tabletop has a radiolucent equivalency of less that 1-mm of aluminum. The input power requirement is 110 VAC, 60Hz or 230 VAC AC 50 Hz as indicated on the table label. This is a Class 1 exempt type B Medical Device with an IPX-0 rating, 10% duty cycle or 6 minutes per hour.
1.3 Shipping
The 6850 Table must be shipped using appropriate Shipping Crate (OSI part number [p/n] 6800-
400) and Shipping Instructions (p/n NW0408). During shipment the 9650 Table is to be kept in an environment within the following limits:
1. Ambient temperature -20 degrees C to + 50 degrees C
2. Relative humidity from 10% to 100%, including condensation
3. Atmospheric pressure from 50 to 110 kPa
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1.4 Storage
When not in use the table should be stored in a clean dry environment with temperature between 32°F & 120°F.
To insure the battery is always fully charged and ready for use. The table should be stored with the power plug inserted and attached to an appropriate power source (110VAC or 220VAC) and the Power Switch turned “ON”.
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2.0 CONTROLS IDENTIFICATION
Illuminated Circuit Breaker
2.1 Table Orientation
The major components of the 6850 Table are identified below. The table is described as having a "head end" and a "foot end". The On/Off Switch, Floor Lock buttons and the Power Cord are located at the "head end" of the table.
Head-end
Hand Control
Foot-end
Leg Spars
Figure 2: Right-side View with Patient
2.2 Major Controls Location
The Control Panel, On-Off Power Switch, Power Cord receptacle and Model Number/Serial Number identification label are located at the head-end of the table.
Control Panel
"ON / OFF" Power Switch and
Power Cord Receptacle
Floor Lock Override (under panel)
6850 PROfx Maint. & Repair Manual NW0424 Rev. A
Model and Serial Number Identification
Figure 3: Head-end, Base and Control Panel
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Floor Lock Access (1 of 4)
2.3 Control Panel Identification
“DOWN TO LOCK”
Figure 4: Control Panel and Floor Lock Controls
“ UP TO UNLOCK” Button
Button
“LOCKED WHEN LIT” Light
“STOWED WHEN LIT” Light
Hand Control Receptacle
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3.0 INSPECTION
3.1 Acceptance and Transfer
1. Upon receipt of your 6850 Table, remove any protective wrapping or packaging. Visually
inspect all surfaces for freight damage. Check each caster for proper rolling operation.
NOTE: Any freight damage must be reported to the freight carrier immediately upon delivery.
It is the responsibility of the recipient to make freight damage claims.
2. Read the Model/Serial Number Identification Label found at the head end of the base to
confirm the serial number and the input power requirements.
3. Place the 6850 Table, with leg spars attached, in an area with at least 4 feet of clearance on
all sides.
4. Perform Pre-Operational function check.
3.2 Preoperative
Perform Pre-Operational function check.
3.3 Postoperative
Perform Pre-Operational function check.
3.4 Annually
Inspect and test the 6850 Table as described Pre-Operational function check. Thoroughly
clean the table as described in the CLEANING and MAINTENANCE section of this manual. Pay special attention to the cleanliness of the controls as excessive soil could affect function.
Inspect for cuts in the insulation or damage to the connector or power cord.
On a smooth surface, floor locks engaged, push with minimum of 100lbs force. Table should
not move.
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4.0 PRE-OPERATIONAL FUNCTION CHECK
Perform all steps in this procedure. For a complete definition of reference terms used in this procedure, please refer to the “Glossary of Terms”.
CAUTION: Leg Spars can be damaged if allowed contact with floor. Verify Leg Spars are
raised to maximum, are spread beyond parallel, and all lock handles are secured.
LA PRUDENCE: les Perches de Jambe peuvent être endommagées si a permis le contact
avec le plancher. Vérifier les Perches de Jambe sont élevées au maximum, sont étalé au delà de parallèle, et toutes poignées de serrure sont obtenues.
1. Plug in the Hand Control cable-connector into the "HAND PENDANT" port on the Control
Panel.
2. Plug the power cord into a “hospital grade” power outlet and flip the main “ON/OFF” power
switch to "ON". Verify the switch illuminates; this indicates power is applied to the table.
3. Lockout mode:
3.1. Table is operational when the green “LOCKED WHEN LIT” indicator light, located on
the Control Panel is illuminated and the “FLOOR LOCK STATUS ON” indicator light, located on the Hand Control, is illuminated.
3.2. With Floor Locks raised, verify that the amber "STOWED WHEN LIT" indicator light
on the Control panel is illuminated and the “FLOOR LOCK STATUS STOWED” indicator on the Hand Control is illuminated.
3.3. Verify only
the Hand Control operates the Floor Locks when Floor Locks are stowed.
4. Floor lock check using the Control Panel:
4.1. Press and hold “DOWN TO LOCK” button until green “LOCKED WHEN LIT” light is
illuminated. Verify table cannot move on its wheels.
4.2. Press and hold “UP TO UNLOCK” button until amber "STOWED WHEN LIT" light is
illuminated. Verify table is moveable on its wheels.
5. “FLOOR LOCK OVERRIDE" button check:
5.1. Press and hold "FLOOR LOCK OVERRIDE" button located under Control Panel, press
each Hand Control button; Up, Down, Tilt, and Trendelenburg to verify that each function works without Floor Locks engaged (table locked to the floor).
6. Hand Control check; Cycle all button functions below, to their limits.
6.1. Press and hold "FLOOR LOCK" button. Verify all four locking feet move down and
contact the floor and the green "LOCKED WHEN LIT" light illuminates.
6.2. Press and hold "FLOOR UNLOCK" button. Verify all four locking feet move up and
amber "STOWED WHEN LIT" light illuminates.
6.3. Press and hold "FLOOR LOCK" button to relock table to floor. Verify all four locking
feet move down and contact the floor and the green "LOCKED WHEN LIT" light illuminates.
6.4. Press and hold "HEIGHT UP" button. Verify Tabletop moves up.
6.5. Press and hold “HEIGHT DOWN" button. Verify Tabletop moves down.
6.6. Press and hold "REV. TREN" button. Verify head-end of tabletop moves up, foot-end
moves down.
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6.7. Press and hold "TREN" button. Verify head-end of tabletop moves down, foot-end
moves up.
6.8. Press and hold "LEFT LATERAL ROLL" button. Verify Tabletop rolls to the left.
6.9. Press and hold "RIGHT LATERAL ROLL" button. Verify Tabletop rolls to the right.
6.10. Disorient tabletop by raising height minimum six inches, Left or Right Lateral
Roll the tabletop and Trendelenburg a minimum of five degrees. Press and hold the "RETURN TO LEVEL" button. Verify Tabletop first levels laterally, levels Trendelenburg, then after a three-second delay, the tabletop moves down.
6850 PROfx Maint. & Repair Manual NW0424 Rev. A
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