Operators & Technical Manual: Stille Medstone Urology Imaging Table

OPERATORS & TECHNICAL
MANUAL
STILLETM MEDSTONE
Urology Imaging Table
STILLE MEDSTONE™ Technical manual page 1

Copyright © 2017-11-24 STILLE AB. All rights reserved.
The contents of this manual are the property of STILLE AB. Any reproduction in whole or in part is strictly
prohibited.
At the time of printing, this manual correctly described the device and its functions. However, as
modifications may have been carried out since the production of this manual, the system package may
contain one or more amendments to the manual. This manual including any such amendments must be
thoroughly read, before using the device. Images in the manual are for informational use and may differ
from actual product and/or model.
The English version of the User Manual and Technical Manual is the original instructions. Manuals in other
languages are a translation of the original instructions.
The following MEDSTONE™ models are covered by this manual MEDSTONE URO and GYN with 1-5
motors.
The STILLE MEDSTONE™ Mobile C-Arm Imaging Tables are CE marked in conformity with the essential
requirements, according to annex I, and classified, according to annex IX, as Class I (rule 12) of the
Medical Device Directive 93/42/EEC.
We declare the compliance of the medical device concerned with the Swedish Medical Devices Act
(1993:584) and the regulation LVFS 2003:11 of the Medical Products Agency. Hereby, the medical device
complies with the requirements of the Medical Device Directive 93/42/EEC, the amending Directive
2007/47/EC. The directive 2011/65/EU (RoHs2) and applicable harmonized standards.
The device does also comply with the International standards, IEC 60601-1, IEC/EN. CAN/CSA C22.2
#601601-1. Any modification to the device, not authorized by us, will invalidate this declaration.
The original signed CE declaration of conformity is a separate document can be obtained upon request.
Classifications
CE Medical device classification: Class 1
GMDN code: 40658
FDA Regulation Status: Class II Exempt 892.1980 (IXR)
FDA List No.: D291538
Warranty terms for MEDSTONETM table:

To be able to benefit the full warranty terms of the Medstone tables, the installation report that comes
enclosed ( http://www.stille.se/iq2registration/ ) with the documentation must be filled in at installation and
returned to QA@STILLE.SE, or be completed online
Information regarding STILLE Warranty Provisions can be found on STILLEs website, http://www.stille.se.
If you do not find the installation report please do contact QA@STILLE.SE for a copy.
It is recommended that all repairs and modifications are carry out by authorized personnel.
Manufacturer:
STILLE AB
Ekbacken 11
SE-644 30, Torshälla
Sweden

Contents
Contents
Contents………………………………...…A
Introduction……………………………….A-1
Important note……………………………………A-1
System modes of operation………………A-2

General……………………………………………A-2
Range of application……...……………………..A-2
Safety……..………………..………………….A-3
General…..………………………………………A-3
Safety continued…..……..………………A-4
Maintenance……………………………………A-4
Checks, test……………………………………… A-4
Installation, repair……………………………… A-4
Cleaning………………………………… A-5
Function and safety checks…….…... A-6

Daily checks……………………….…………… A-6
Monthly checks………………………………… A-6
Annual maintenance……………..…………… A-6
Operating the table………………….… A-7

General…………………………………………… A-7
Controlling the table…………………………… A-7
Protective measures…………………... A-8

Mechanical safety…………………………...… A-8
Preventive maintenance ……………... A-9

Safety-relevant parts subject to wear……..… A-9
Waste disposal………………………..………… A-9
Location of Identification label.………. A-10
Technical Specifications..…………… A-11

General…..……………………………….… A-11
Operating environment…….……………………. A-12
Classifications….………………………………. A-12
How to use the wrench……….…..………A-13
Spare parts………………….……………………. A-14
Electrical schematics.….……………… A-15 & 16
Parts List…………….…………… A-17

Contents
Unpacking and installation
Packaging Labels
10 %
The table is shipped in a heavy duty crate. Upon delivery please inspect for any sign of external damage.
Procedure for removing table from the shipping crate.

1. Remove the spring tension klemps holding the top cover and remove, remove the support brace
which is held in place with wood screws on each side and any side packing material
2. Remove the four (4) spring cover (Heavy END) and wood screws on the bottom of the crate and
use the end cover as a ramp.
3. Remove any further packing material and accessories and roll the table out of the crate using the
end cover as a ramp.
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
A-1

Introduction
Introduction
Important note
Using the STILLE Medstone Tables presupposes that the operating personnel is thoroughly familiar
with the operating instructions.
• Safety (A-3)
• Function and safety checks (A-6)
• Protective measures (A-8)
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.
Text emphasis
WARNING!
All text labeled “WARNING” calls attention to potential risk to health or life
A-1

System modes of operation
System modes of operation

General
0047-Series mobile tables are used for imaging applications. The tables, depending on your option are
provided with several actuators and motorized column giving the tables good movement range.
F
C
Figure 1. 0047-TM5 (shown)
A Table Top D Column
B Table Pad E Knee Crutches (Standard)

Foot & Ankle Stirrups (Optional)
C Actuator F Flexible Drain Bag Holder
Shown without covers
Range of application
The intended use of the table is for examinations and imaging (‘C; Arm required)only. Medical staff
must supervise the equipment when it is in use near the patient.
A-2

Safety
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.
A-3

A-3

Safety
Safety
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
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.
Checks, test
Checks and tests that shall be performed with specified intervals are described in Function and
safety checks (A-6)
Installation, repair
Modifications of, or additions to the product must be made in accordance with the legal
regulations and generally accepted engineering standards.
The supplier cannot assume responsibility for the safety features and for the reliability and
performance of the equipment, if:
• installation, equipment expansions or modifications are not carried out by persons

authorized by us.
• components affecting safe operation of the unit are not replaced by original spare parts in
case of a malfunction.
• the product is not used in accordance with the operating instructions.
On request, we will make technical documents for the product available to you at a charge that
will be invoiced. This does not imply an authorization to undertake repairs. We accept no
responsibility for repairs performed without our expressed written approval.
We suggest that you obtain a report indicating the nature and extent of the work performed
from the persons carrying out such work, and specify that the report shows any changes in
rated parameters or operating ranges, as well as date, the name of the firm and a signature.
A-4

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, Moontvale, New Jersey, per manufacturer’s instructions
Reference: National Labortories 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
A-5

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 (A-5).
Monthly checks
• Check the legibility of the label according to section Location of Identification label (page
11). If any label must be replaced, please notify the supplier customer service.
• Power up the stand and check all functions according to Technical Specifications (page
12).
Annual maintenance
The following maintenance is necessary to perform every 12 months to keep the equipment
safe and operational.
• Power up the stand and check all functions according to Technical Specifications (page
12).
• Check parts according to Safety-relevant parts subject to wear (A-9).
A-6

Operating the table
Operating the table

General
CAUTION ! Make sure that all wheels are locked before the patient is placed on the
table. USE OF PATIENT RESTRAINT IS REQUIRED DURING USE.
Controlling the table

The table movement is controlled with the hand switch in accordance with the following figures.
Figure 2
LONGITUDINAL
TRAVEL
TRENDELENBURG
TILT
LIFT
LATERAL TRAVEL
4 Motor hand control
REMOTE HAND CONTROL AND FOOT SWITCH (OPTIONS ARE AVAIABLE)

A-7

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.
Figure 3. Possible Hazard Areas
A-8

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 6 Ft Lbs
M8 16 Ft Lbs
M12 60 Ft 30 Ft Lbs - Table Top
M4 21 In Lbs
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.
A-9

Location of Identification label
Location of Identification label
Location of Certification and

Serial Number Label
Figure 4. Location of Identification label
A-10

Technical specifications
General
Table top size 24” (559 mm) x 48” (2083 mm)

Table Top Extension 24” (559 mm) x 28” (710 mm)
Model number 0047-BT3 0047-BT4 0047-BT5
Table top movement, Lateral tilt ± 15°, ± 15°, ± 15°,
Table top movement, Elevation 300mm 300mm 300mm
Table top movement, Trendelenburg +15°/-15º +15°/-15º +15°/-15º
Travel Longitudinal N/A 400mm 400mm
Travel Lateral N/A N/A 150mm
Weight 600 lbs 650 lbs 600 lbs
273 kg 295 kg 295 kg
400mm
Travel
150mm
Travel
± 15o
o
± 15
300mm
Travel
Figure 5. Table Movement Range
A-11

External power supply
Power supply 120 VAC, 50 – 60 Hz or 230VAC, 50 Hz

Power consumption 9 Amps, 5 Amps
Operating environment
Operating temperature +10° - +30° C

Storing temperature -20° - +40° C
Operating and storing humidity 30 – 80 % relative humidity, non
condensing
Patient weight limit 500 lbs, (227 kg) evenly distributed
Classifications
Protection against electrical shock Type B according to degree of protection

(IEC 601-1)
Class 1 according to type of protection
(IEC 601-1)
EMC-disturbances can appear even if
the product complies with the EMC
demands
Duty factor 15%
Mode of operation Continuous operation with intermittent
loading
Degree of safety of apllication in the Not suitable for use in the presence of
presence of flammable anaesthetic mixture flammable anaesthetic mixtures.
with air or nitrous oxygen
A-12

How to use the wrench
A-13

Recommended Spare Parts
ITEM NO. QTY. PART NO. DESCRIPTION

1 1 29-101 TABLE-PAD
2 4 50-253 TENTE CASTER -5” (125MM)
3 1 06-275/277 SWITCH – EMERGENCY STOP
4 1 0047-810-205 HAND SWITCH
5 1 50-253 POWER CABLE (110 VAC)
6 1 50-253 POWER CABLE (230 VAC) SCHUKO
7 1 50-146 POWER CABLE (230 VAC)- UK
A-14

REVISIONS
REV DESCRIPTION
A-15
NC NEW RELEASE
Lat Lat
Lat Lat Trav
Tren Elev Tren Elev Elev Tren Elev Tren Lat Tilt Lat Tilt Long Long Trav
Trav Trav Long Long Lat Tilt Lat Tilt
up Up Down Down Up up left Right Head Foot left Right
Right left Foot Head Right left Down Down
1 1
2 2
3 3
4 4
5 5
6 6
7 7
8 8
9 9
10 10 SCU Footswitch
Hand Control Pandent 50-186, EHA35-23N50N-000 (OPTIONAL) Control
Longitudinal Travel
10 9 8 6 50-191, 400mm Actuator
Head-Foot
OPERATIONAL UNITS Trendelenburg

5 50-185, 100mm Actuator
HAND & FOOT CONTROLS Head down - Head up
Elevation
4 Down - up
50-184, SCU58-003230-000 50-192, Lift Drive
Motor Control Box Elevation
3 Down - up
2 Lateral Tilt 50-188, 70mm Actuator

BATTERY
ACTUATOR MOTOR PLUGS
NOT Cross Table Drive 50-189, 150mm Actuator
COMUNICATIONS 12 13 14 1 Left - Right
USED
E-STOP
120VAC
0
INCOMING
POWER
11 GND
Earth Ground lug

on chassis
DASH NO. -0009 120 VAC Operation

APPROVALS DATE TITLE ELECTRICAL SCHEMATIC
DRAWN BY BWG 5/1/13 0047-TM5(H)SCU
CHECK BY SIZE DRAWING NO. REV
APPROVED A 0047-010-0009 NC
CONFIDENTIAL AND PROPRIETARY INFORMATION
The document contains Confidential and Proprietary information
of Arcoma-na inc., and all design, manufacturing, reproduction, SCALE NONE SHEET 2 OF 2
use, and sale rights in such information are expessly reserved.

REVISIONS
REV DESCRIPTION
NC NEW RELEASE
Lat Lat Lat Lat

Trav Trav Long Long Lat Tilt Lat Tilt Tren Elev Tren Elev Elev Tren Elev Tren Lat Tilt Lat Tilt Long Long Trav Trav
Right left Foot Head Right left up Up Down Down Down Down Up up left Right Head Foot left Right
1 1
2 2
3 3
4 4
5 5
6 6
7 7
8 8
9 9
10 10 SCU Footswitch
Hand Control Pandent 50-186, EHA35-23N50N-000 (OPTIONAL) Control
Longitudinal Travel
10 9 8 6 50-191, 400mm Actuator
Head-Foot
OPERATIONAL UNITS Trendelenburg

5 50-185, 100mm Actuator
HAND & FOOT CONTROLS Head down - Head up
Elevation
4 Down - up
50-195, SCU96-003230-000 50-192, Lift Drive
Elevation
Motor Control Box 3 Down - up
2 Lateral Tilt 50-188, 70mm Actuator

BATTERY ACTUATOR MOTOR PLUGS
NOT Cross Table Drive
COMUNICATIONS 12 13 14 1 50-189, 150mm Actuator
USED Left - Right
E-STOP
120VAC
INCOMING 0
POWER
11 GND
Earth Ground lug

on chassis
(European use only – Green/Yellow Ground/Earth)
DASH NO. -0009 230 VAC Operation

APPROVALS DATE TITLE ELECTRICAL SCHEMATIC
DRAWN BY BWG 5/1/13
0047-TM5(H)SCU
CHECK BY SIZE DRAWING NO. REV
A-16
CONFIDENTIAL AND PROPRIETARY INFORMATION APPROVED A 0047-010-0009 NC
The document contains Confidential and Proprietary information
of Arcoma-na inc., and all design, manufacturing, reproduction,
use, and sale rights in such information are expessly reserved. SCALE NONE SHEET 2 OF 2

A-17

Technical Manual NOTES

STILLE - Service Centers
Customer Service International Customer Service USA
Phone: +46 (8) 588 58 011 Phone: +1 (800) 665-1614
E-mail: imagiQ2@stille.se E-mail: imagiQ2@stille.se
Technical Service International Technical Service USA

Phone:+46 (8) 588 58 030 Phone: +1 (800) 665-1614 ext. 105
E-mail: service@stille.se E-mail: service.us@stille.se
HQ SWEDEN USA
STILLE AB STILLE Surgical Inc.
Ekbacken 11 915 Parkview Blvd
SE- 644 30 Torshälla Lombard, IL 60148
Sweden United States
Phone: +46 8 588 580 00 Phone: 1.800.6651614
Fax: +46 8 588 580 05 General enquiries US office: sales.us@stille.se
sales@stille.se
Art. no: 950-500-00015-EN © Revision 1, 2017-11-24 STILLE. All rights reserved.

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OPERATORS & TECHNICAL

STILLE MEDSTONE™ Technical manual page 1

Warranty terms for MEDSTONETM table:

STILLE MEDSTONE™ Technical manual page 2

System modes of operation………………A-2

Function and safety checks…….…... A-6

Operating the table………………….… A-7

Protective measures…………………... A-8

Preventive maintenance ……………... A-9

Location of Identification label.………. A-10

Technical Specifications..…………… A-11

Parts List…………….…………… A-17

STILLE MEDSTONE™ Technical manual page 3

Procedure for removing table from the shipping crate.

EMERGENCY STOP SWITCH

Location of Emergency “STOP” Switch

STILLE MEDSTONE™ Technical manual page 4

• Function and safety checks (A-6)

• Protective measures (A-8)

STILLE MEDSTONE™ Technical manual page 5

System modes of operation

Figure 1. 0047-TM5 (shown)

A Table Top D Column

B Table Pad E Knee Crutches (Standard)

C Actuator F Flexible Drain Bag Holder

Shown without covers

STILLE MEDSTONE™ Technical manual page 6

STILLE MEDSTONE™ Technical manual page 7

STILLE MEDSTONE™ Technical manual page 8

At no time should the mobile imaging table be moved with a patient on it

• installation, equipment expansions or modifications are not carried out by persons

• the product is not used in accordance with the operating instructions.

STILLE MEDSTONE™ Technical manual page 9

CLEANING OF SOILS & STAINS

DO NOT APPLY TAPE TO ANY PAD

• Steris Coverage Plus wipes 1608-WC, 1608-GS and 1608-G4

STILLE MEDSTONE™ Technical manual page 10

Function and safety checks

• Check parts according to Safety-relevant parts subject to wear (A-9).

STILLE MEDSTONE™ Technical manual page 11

Operating the table

Controlling the table

4 Motor hand control

REMOTE HAND CONTROL AND FOOT SWITCH (OPTIONS ARE AVAIABLE)

STILLE MEDSTONE™ Technical manual page 12

possible hazard areas are indicated in the figure below.

Figure 3. Possible Hazard Areas

STILLE MEDSTONE™ Technical manual page 13

2. Table-top mounting bolts, check to make sure they are tight

Safety-relevant parts subject to wear

Bolt Size Torque Tightness

Waste and Disposal

STILLE MEDSTONE™ Technical manual page 14

Location of Identification label

Location of Certification and

Figure 4. Location of Identification label

STILLE MEDSTONE™ Technical manual page 15

Table top size 24” (559 mm) x 48” (2083 mm)

Figure 5. Table Movement Range

STILLE MEDSTONE™ Technical manual page 16

Power supply 120 VAC, 50 – 60 Hz or 230VAC, 50 Hz

Operating temperature +10° - +30° C

Protection against electrical shock Type B according to degree of protection