0047 Elite Series Mobile C-Arm Imaging Tables Operators Manual Series A Jan 2016

Contents

Contents Index……………………….…………………A-1 Document Information…………..…..……A-2 Operational Service Checks……………..…1 Oeratinal warning, Grounding (Earth) Emergency “Stop Switch” Tables covered by this document

System modes of operation…………..…….2 General Patient restraints Maintenance Waste & Despoosal

Functional & Safety Checks..………….……3 Service checks General Information

Table Operation…..……..………….4, 5, 6 & 7 Table hand control movements 0047-TE1, 0047-TT2 0047-TL2, 0047-TM2ER 0047-TM3MP 0047-TM4ER,

Cleaning………………………………...………8 Table top pad cleaning instructions

Protective Measures …………….……...……9 Pinch point label and location Monthly checks

Preventative Maintenance Procedures...10 Preventative maintenance

Location of Indentification Lable………...11 Technical Specifications……..….12, 13 & 14 General specifications Power supples How to use the SKF plug connection wrench to exchange hand control a& optional foot control

Recommended Replacement Parts…...15

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Content Document Information It is important that this document kept for the life of the equipment and transferred to any subsequent holder or user of the equipment. Document producer This document has been produced by: Arcoma North America, Inc. 23112 Alcalde Drive, Suite A Laguna Hills, California USA 92653 Tel: 949-457-1231

Copyright © 2016 ARCOMA North America, Inc. The reproduction, transmission or use of this document or its content is not permitted without expressed written consent. Offender will be liable for damages. All rights, including rights crated by patent grant or registration of a utility model or design are reserved It is important that this document kept for the life of the equipment and transferred to any subsequent holder or user of the equipment. All rights, including rights crated by patent grant or registration of a utility model or design are reserved

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Contents Operational Warning

!

WARNING: To avoid risk of electrical shock, this equipment must only be connected to a supply main’s (outlet) with a protective ground (earth)

Before using the table for the first time, please make sure that the emergency stop switch has not been pushed in during transportation or uncrating. If the table movements do not function twist the emergency switch clockwise as indicated on the switch the table movements should then function correctly

EMERGENCY STOP SWITCH Location of Emergency “STOP” Switch

Figure’s 1

The table is designed and shipped ready to be used. Make sure that the power cable supplied is plugged into the computer type socket on the side of the table just below the emergency switch, then plug in the power cable supplied in to a standard 15 amp convenience wall outlet. Using the Arcoma “Medstone-Elite” Tables presupposes that the operating personnel is thoroughly familiar with the operating instructions, in particular there are many different versions ranging from a single movement to five movements. This manual covers all Medstone “Elite” tables 0047-TE1, Rlevation (Lift) only, 0047-TT2, Elevation & Trendelenburg Tilt, 0047-TL2, Elevation & Lateral Tilt, 0047-TM2ER, Elevation & Extend-Retract, (Longitusinal Travel) 0047-TM3MP, Elevation, Trendelenburg & Lateral Tilt, 0047-TM3ER, Elevation & Extend-Retract, (Longitusinal Travel) & Trendelenburg Tilt 0047-TM4ER, Elevation & Extend-Retract, (Longitusinal Travel) Trendelenburg & Lateral Tilt 120 & 230VAC operation

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Safety modes of operation

Safety General CAUTION! This device is restricted to use by or on the order of a physician. The device is intended for use in radiographic examinations under the guidance of trained health care professionals. Operating personnel must be familiar with the equipment and the instructions given in this manual before using it.

Warning At no time should the mobile imaging table be moved with a patient on it or should a patient be left unattended while on the table CAUTION ! Make sure that all wheels are locked before the patient is placed on the table. USE OF PATIENT RESTRAINT IS REQUIRED DURING USE.

Figure 2 Use three (3) patient restraints to protect patient from injury

Maintenance To ensure the safety of the patients, the operators, and third parties, the equipment must be checked every 12 months to maintain its reliability and serviceability.

Waste and Disposal All “Equipment and Accessories” parts are recyclable and should be disposed of in a safe manner at end of their expected life cycle.

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Function and safety checks

Function and safety checks If any malfunction is detected, the entire equipment must be taken out of use until a service engineer from the supplier eliminates the malfunction or by local technical staff trained by the supplier.

Daily checks When necessary, clean according to cleaning (page 4).

Monthly checks •

Check the legibility of the label according to section Location of Identification label If any label must be replaced, please notify the supplier customer service.

•

Power up the stand and check all functions according to Technical Specifications

General 0047-“Elite”Series mobile tables are used for imaging applications. The tables, depending on your option are provided with several actuators and motorized column giving the table’s good movement range

B A

A A

C

D A Table Top

C Actuator

B Table Pad

D Column

Range of application The intended use of the table is for examinations with a mobile C-Arm image intensifier. Medical staff must supervise the equipment when it is in use near the pat

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Operating the table

Operating the table Controlling the table The table movement is controlled with the hand switch in accordance with the following figures. Figure 3

UP/DOWN ELEVATION

LIFT

PL10-0001-001 NC

TREN'BURG TILT

TRENDELENBURG

UP/DOWN ELEVATION

LIFT

PL10-0001-002 NC

0047-TE1

0047-TT2

Figure 3

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Operating the table

Controlling the table The table movement is controlled with the hand switch in accordance with the following figures. Figure 3

LONGITUDINAL DRIVE

TREN'BURG TILT

UP/DOWN ELEVATION

LATERAL TILT

TRENDELEN BURG

UP/DOWN ELEVATION

LIFT

LIFT

LATERAL TILT

PL10-0001-003 NC

0047-TM3MP

LONGITUDINAL TRAVEL

PL10-0001-004 NC

0047-TM2ER

Figure 4

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Operating the table Controlling the table The table movement is controlled with the hand switch in accordance with the following figures. Figure 3

LONGITUDINAL DRIVE

TREN'BURG TILT

UP/DOWN ELEVATION

LATERAL TILT

TRENDELENBURG

UP/DOWN ELEVATION

LIFT

LIFT

LATERAL TILT

PL10-0001-003 NC

0047-TM3MP

LONGITUDINAL TRAVEL

PL10-0001-004 NC

0047-TM2ER

Figure 5

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Operating the table Controlling the table The table movement is controlled with the hand switch in accordance with the following figures. Figure 3

LONGITUDINAL DRIVE

LONGITUDINAL TRAVEL

LONGITUDINAL DRIVE

LONGITUDINAL TRAVEL

TREN'BURG TILT

TRENDELENBURG TILT

TREN'BURG TILT

TRENDELENBURG TILT

UP/DOWN ELEVATION

LIFT

UP/DOWN ELEVATION

LIFT

LATERAL TILT

PL10-0001-003 NC

0047-TM3ER

LATERAL TILT

PL10-0001-004 NC

0047-TM4ER Figure 6

REMOTE HAND CONTROL AND FOOT SWITCH OPTIONS ARE AVAIABLE 0047 TABLES +

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Cleaning

Cleaning CAUTION! Surfaces that are in contact with the patient shall be cleaned with a lint free cloth dampened with a small amount of soapy water or cleaning solution.

Approved products and methods for cleaning and disinfecting of table and stretcher pads CLEANING OF SOILS & STAINS Wash with generous application of neutral soap suds and lukewarm water. Rinse with water and dry. Do not immerse. Or Use a diluted bleach solution of 10-parts water to1-part bleach. Wipe dry with clean cloth. Do not immerse. Bleach must be diluted to the 10:0 ratio.

DISINFECTING Use Lysol I.C. Disinfectant Spray by National Laboratories, Mountvale, New Jersey, per manufacturer’s instructions Reference: National Laboratories Item # 95029-000 Or

Use a diluted bleach solution of 10-parts water to1-part bleach. Wipe dry with clean cloth. Do not immerse. Bleach must be diluted to the 10:0 ratio.

DO NOT APPLY TAPE TO ANY PAD The following Steris products are also approved for use in cleaning and disinfecting our pads: • • •

Steris Coverage Plus wipes 1608-WC, 1608-GS and 1608-G4 Steris Coverage Spray HB Plus 1624-77 Steris Coverage Spray TB Plus 1629-B4 and 1629-08

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Protective Measures

Protective measures Mechanical safety It is the operator’s duty to ensure that any danger to the patient or third parties is precluded before movements are released. Possible hazard areas are indicated in the figure below.

Pinch points (Label Indication)

Figure 4. Possible Hazard Areas

Figure 7

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Preventative Maintenance Procedures Preventative Maintenance 1. Preventative maintenance should be performed every six (6) months, checking the following items: 2. Table-top mounting bolts, check to make sure they are tight 3. Actuator mounting bracket bolts are tight and that the actuator pin(s) retention spring clips are securely in position 4. Test movements of all Actuators and Elevation Lifts to insure that they are moving freely and smoothly 5. On all table that have longitudinal travel (extend and retract) check that the Rollon bearing slides are moving freely and smoothly 6. On 004-TM5 (5-movement) model versions, check to make sure that the lateral movement linear slide bearing rails are clean and that the cross table movement is moving freely and smoothly 7. “Emergency Stop Switch”, check that it is functioning correctly, that all movements are disabled when pressed 8. Hand Control, check that all push button movements are functioning correctly 9. (Optional) Foot Control Switch, check that all movements are functioning correctly and that the spring loaded switches are not sticking in the “ON” positions

Safety-relevant parts subject to wear This unit contains the following safety-relevant parts, which should be checked by service personnel according to the following: •

Tightening of bolts: Bolt Size

Torque Tightness

M6 M8 M12 M4

6 Ft Lbs 16 Ft Lbs 60 Ft 30 Ft Lbs - Table Top 21 In Lbs

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Location of Identification label

Location of Identification label Manufactured for: ARCOMA AB Annavagen 1, 352 46 Vaxjo, Sweden By: ARCOMA North America, Inc. 23112 Alcalde Drive, Suite A Laguna Hills, Californa 92653, USA

0047 0413 THIS PRODUCT COMPLIES WITH ALL APPLICABLE STANDARDS UNDER 21 CFR SUB CHAPTER J. DHHS/FDA RADIATION CONTROL FOR HEALTH AND SAFETY ACT OF 1968 (HEALTH CANADA #4543) ETL Classified CONFORMS TO UL Standard 60601-2-43 CERTIFIED TO CAN / CSA STD C 22.2 NO 601.1

Type: Serial Number: Date of Manufacture:

0047-TM3CV 15-2754 JANUARY 2015

Incoming Power Rating: Voltage: 120 VAC Amperage: 9 Amps Frequency: 50/60 Hz Operating Power:

Voltage: 24 VDC

Aluminium Equivalence: <= 1.0mm Maximum Patient Weight Evenly Distributed: 227kg – 500lbs Intermittent Operation:

20% 1 min. ON / 4 min. OFF

LOCATION OF IDENTIFICATION LABEL

Figure 8. Location of Identification label

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Technical specifications

Technical specifications General Table top size

22” (559 mm) x82” (2083 mm)

Model number

0047-TE

0047-TT

0047-TL

Table top lateral tilt Table top movement, vertical Table top movement, Trendelenburg Travel Longitudinal Travel Lateral Weight

N/A 400mm N/A N/A N/A 500 lbs 227 kg

N/A 400mm +15°/-15º N/A N/A 550 lbs 250 kg

± 15°, 400mm N/A N/A N/A 550 lbs 250 kg

0047TM3MP ± 15°, 300mm +15°/-15º N/A N/A 600 lbs 273 kg

0047TM3ER N/A 300mm +15°/-15º 400mm N/A 650 lbs 295 kg

0047TM4ER ± 15°, 300mm +15°/-15º 400mm N/A 650 lbs 295 kg

400mm Travel

200mm Travel

 15o  15o

300mm Travel

Figure 5. Table Movement Range

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Technical specifications

Technical specifications External power supply Power supply Power consumption

120 VAC, 50 – 60 Hz or 230VAC, 50 Hz 9 Amps, 4.5 Amps

Operating environment Operating temperature Storing temperature Operating and storing humidity Patient weight limit

+10° - +30° C -20° - +40° C 30 – 80 % relative humidity, non condensing 500 lbs, (227 kg) evenly distributed

Classifications Protection against electrical shock

Duty factor Mode of operation Degree of safety of application in the presence of flammable anaesthetic mixture with air or nitrous oxygen

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Type B according to degree of protection rd (IEC 60601-1 3 Edition) Class 1 according to type of protection rd (IEC 60601-1 3 Edition) EMC-disturbances can appear even if the product complies with the EMC demands 15% Continuous operation with intermittent loading Not suitable for use in the presence of flammable anaesthetic mixtures.

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Technical specifications Removable of of hand control and Optional Wireless Detector & Foot Control Tool and Instructions

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Recommended Spare Parts ITEM NO.

QTY.

PART NO.

DESCRIPTION

1

1

2

4

29-101W 52-251 52-253

TABLE PAD WITH HEAD CONTOUR & FACIAL CUTOUT TENTE CASTER 4”(100mm) 0047-TM3, 0047-TM4 & TM5 TABLES TENTE CASTER 5”(125mm) 0047-1TE, 0047-TL & 00472-TT TABLES

3

1

06-274

STI, EMERGENCY STOP SWITCH KIT

4

1

0047-810-20X

HAND CONTROL SWITCH, “X” SPECIFY TABLE MODEL

5

1

AS PER TYPE

LABEL- HAND SWITCH, INCLUDED WITH HAND CONTROL

6

1

7

1

06-153 50-146 50-148

POWER CABLE (110 VAC) NORTH AMERICA POWER CABLE (230 VAC)- UK FUSED PLUG POWER CABLE (230 VAC)- SCHUKO EU PLUG

0047-810-201

Hand Control for 0047-TE1 Table

0047-810-202

Hand Control for 0047-TT2 Table

0047-810-203

Hand Control for 0047-TM3MP Table

0047-810-204

Hand Control for 0047-BT & TM4ER Tables

0047-810-205

Hand Control for 0047-BT & TM5ER Tables

0047-810-206

Hand Control for 0047-TL2 Table

0047-810-207

Hand Control for 0047-BT & TM2ER Tables

0047-810-208

Hand Control for 0047-TM3ER Table

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Arcoma-Elite Version 2011.01

Pro2000 (0047)-Series. A