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Mediland Enterprise Corporation PA900 Orthopedic Extension

Rev 2 DIRECTION SM-PA900E

LIMITATION OF LIABILITY AND INDEMNITY


Unless otherwise provided in this Limitation of Liability and Indemnity, Mediland
Enterprise Corporation Ltd., its suppliers and the owner of “Mediland” trade mark
SHALL NOT HAVE ANY LIABILITY of any consequential or incidental damages
including, but not limited to, the loss of profits or revenues, loss of use of the product
that has “Mediland” trade mark or its any associated equipment (the Product), loss of
the buyer’s products, cost of capital, cost of substitute products, facilities, services or
replacements, cost of handling the damages, damage of being sued (including
attorney fees), the injuries or death or the death of employees of the buyer or ultimate
user of the Products, for any claim of any person, including but not limited to, for the
breach of contract, warrant, performance of contract, tort (including negligence and
strict liability) or any other legal basis that associates with the Product.

The aforesaid liability against any claim of any person SHALL NOT BE EXCEEDED
THE PRICE OF THE PRODUCT.

The right against the aforesaid liability shall extinguish six months after the date of
installation of the Product or the expiration date of the warranty period of the Product.
The shorter period of the two periods shall be prevailed.

The tort damages in the aforesaid liability shall be limited to the very corporation
which has the gloss negligence or strict liability.

The buyer and ultimate user indemnifies that Mediland Enterprise Corporation Ltd., its
suppliers and the owner of “Mediland” trade mark shall be free from any further liability.

If the buyer transfers the title or leases the Product to any third party, the buyer shall
make the third party to abide to this Limitation of Liability and Indemnity, and the third
party shall have no better right than the buyer.

If there is any dispute related to this Limitation of Liability and Indemnity, Taiwan Taipei
District Court or its branch court shall have the sole jurisdiction. The laws of the
Republic of China, Taiwan shall be the sole applicable laws.

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

REVISON HISTORY

REVISION DATE OF ISSUE REASON FOR CHANGE


1 Jun. 10, 2003 FIRST RELEASE
2 July. 27, 2006 2nd RELEASE

The revision of this manual is shown at the upper left corner of this page.
A revision bar at the left margin highlights changes in a revised page.

LIST OF AFFECTED PAGES

DIRECTION CHAPTER PAGE REVISION


SM-PA900E ALL ALL REV1
SM-PA900E 1,4 1,6 REV2

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

TABLE OF CONTENTS
SECTION PAGES

1 Introduction ...............................……………………................................................…….. 1
1-1 Product Components ……………………………………………………………………. 2-3

2 Products Identification …..…………………………………………………………………….. 4


2-1 Product Identification ..…………………………………………………………………... 4

3 Pinch Point Warning ……………………………………………………………………………. 5

3-1Pinch Point Warning …………………………………………………………………………5

4 Specification …………………………………………………………………………………….. 6
4-1 Maximum Patient Weight ……………………………………………………………….. 6
4-2 Operating Range (Specification) ……………………………………………………….. 6

4-3 The Outline of PA900 Orthopedic Extension …………………………………………..7

5 Installation ……………………………………………………………………………………….. 8
5-1 Compatibility ……….……………………………………………………………………....8
5-2 Positioning of table .……………………………………………………………………… 9
5-3 Attachment to table .………………………………………………………………………10
5-4 Detachment from table ……….…………………………………………………………..11
5-5 Right/Left Pinning Procedure (Unilateral Traction) …………………………………….12
5-6 Right/Left Pinning Procedure (Bi-Lateral Traction) ………………………………….. .13
5-7 Right/Left Tibia/Fibula Procedure ……………………………………………………….14
5-8 Right/Left I.M. Nailing – Supine W/Skeletal Traction ..………………………………. 15
5-9 Right/Left I.M. Nailing Lateral Procedure(Alternate Setup) ..…………………………16
5-10 Myelograms Position ……………………………………..…………..…………………. 17
5-11 Accessories ………………………………………………………………………………. 18-19
5-12 Attachment of Accessories ……………………………………………………………….20

6 Maintenance ………………………………………………………………………………………21
6-1 Maintenance ……….….……………………………………………………………………21
6-2 Service maintenance .……………………………………………………………………..21

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

SECTION 1 INTRODUCTION

The PA900 Orthopedic Extension allows the Amax9000 Electric Hydraulic


Surgical Table to be used for hip and lower extremity procedures such as:
hip pinning, ender pinning, intramedullary nailing of femur, tibia, and fibula
surgery. The extension is a simple and secure attachment to the
Amax9000 Electric Surgical Table with the help of the accessory cart
which enables the user to remove and store the extension and
accessories when not in use. Abductor bars and all needed accessories
are stainless steel design that is resistant to corrosive effects of standard
hospital cleaners and disinfectants.

WARNING ! TIPPING HAZARDED DO NOT USE TABLE UNLESS


THIS EQUIPMENT IS INSTALLED PROPERLY.

WARNING ! TIPPING HAZARDED DO NOT USE TABLE TO


SUPPORT UP TO A PATIENT OVER
400lbs(181.6kgw).

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

1-1 Product Components:


Please refer to Illustration 1-1 and Illustration 1-2.
Illustration 1-1
PA900 Orthopedic Extension

1. Amax9000 Surgical Table 5. Tibia Countraction Support

2. Pelvic Bracket 6. Universal Leg Holder

3. Perineal Post 7. Foot Traction Boot

4. Sacral Rest with Pad 8. Boot Plate

9. Suspension Arm Assembly

4 3 9
1 5 6

2
7 8

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

Illustration 1-2
PA900 Orthopedic Extension

10. Elevator 14. End Stand Support

11. Hip Rest with Pad 15. Patient Transfer Board with Pad

12. Traction Accessory Clamp 16. Storage Trolley

13. Clark Socket 17. Traction Unit Assembly

18. Telescopic Bar

11 10
12 17

13 16
15 18 14

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

SECTION 2 PRODUCTS IDENTIFICATION

This section provides component identification and mounting location of the


identification plate for the PA900 Orthopedic Extension.
Please refer to lllurtration 2-1

lllustration 2-1
Product Identification

Identification Plate

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

SECTION 3 Pinch Point Warning


3-1
There exist some pinch points during extension position adjustment. These points are
identified in Fig 3-1, Fig 3-2 and Fig 3-3.
To prevent damage, all personnel should examine and be aware of these points before
operationing this extension.
Please refer to Fig 3-1, Fig 3-2 and Fig 3-3.

Fig.3-1 Fig.3-1
1. Between Pelvic Bracket and Leg
Section.
2. Around Abductor Bar.
(Inner and Outer)

Fig.3-2 Fig.3-2
1. Between Leg Section and Base
Cover or Floor.
2. Between Headrest and Back

Fig.3-3 Fig.3-3
1. Between Table Frame and
Column Skirt.

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

SECTION 4 SPECIFICATION

4-1 Maximum Patient Loding Capacity


When doing orthopedic operation, do not exceed 400lbs(181.6kgw) maximum patient
weight. If doctor needs to operate Trendelenburg or reverse Trendelenburg motion, do
not exceed 300lbs(136.2kgw) patient weight.If the weight of patient is over 400lbs, please
contact to Mediland or representatives for further information.

4-2 Operating Range(Specification)

Please refer to table 4-1

Table 4-1

Attachment to the pelvic section of the Secure sliding into the side rails of the
Amax9000 Table Table
Remove or store extension and Storage Trolley provides a movable
accessories platform
Indicate Number Plate Design Quick Positioning
Material Composition of Pelvic Bracket Stainless Steel
Operation Temperature 0-40°C
Operation Relative Humidity 30-60 %RH
Extension Section Operating Specification
Abductor Bar(Inner) Ratation Angle:0-90°
Abductor Bar(Outer) Ratation Angle:0-180°
Traction Unit Traction distance:200mm
Traction Unit Height adjustment:400mm
Telescopic Bar Extension distance:540mm

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

4-3 The Outline of the PA900 Orthopedic Extension

Please refer to the Illustration 4-1 for the outline.


lllustration 4-1
PA900 Orthopedic Extensin OutLine Drawingwing

PA900 ORTHOPEDIC EXTENSION WITH AMAX9000 TABLE

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

SECTION 5 INSTALLATION

This section provides PA900 Orthopedic Extension Device installation


information.

▲ WARNING!TIPPING HAZARD: Tipping hazard can cause patient or user injury.


Always check table stability when patient is positioned. Do not use
table unless floor locks are engaged. Do not release floor locks
while patient is on the table.

5-1 Compatibility

This extension is designed to be compatible with Mediland Amax9000 Electric Surgical


Table. Do not use PA900 Orthopedic Extension with any other table than Amax9000
table.

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-2 Positioning of table

Do complete Amax9000 table positioning procedure and make sure floor locks are
engaged prior to each use.

▲ WARNING!Do not use table unless it is installed properly.

Procedure as follows:
1. Place table at the desired location.
2. Make sure floor locks are in LOCK position.
3. Check if table is securely located on the floor.

Note:Table positioning is adjusted horizontally before shipment ; Make necessary


readjustments under the actual conditions during the installation, ensuring table is
securely positioned on the floor.

Please refer to lllustration 5-1


lllustration 5-1
Table positioning

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-3 Attachment To Table


Do complete Amax9000 table attachment installation and ensure Pelvic Bracket is slided
securely into Amax9000 table prior to each use.
▲ WARNING! TIPPING HAZARD: Do not use table and extension unless this
equipment is installed properly.
Procedure as follows:
1. Place the PA900 Orthopedic Extension on the storage trolley with the bars locked at the
four joints in the appropriate positions:(the red points on the bars and number plates should
be met)
2. Make sure that the table’s floor locks are engaged.
3. Lower the powered leg section of table to its extreme.
4. Adjust tabletop to the height of the PA900 Orthopedic Extension.
5. The mounting post of the PA900 Orthopedic Extension should face the table’s pelvic
section.
6. Slide Pelvic Bracket fully into the side rails of the table.
7. Make sure table side rails is firmly hooked in by the safety hook and tighten the locking
knob, which secure the extension to the table.
8. Insert patient transfer board into the Pelvic Bracket.
9. Raise the surgical talbe and remove the storage trolley form the operating area.

Note: To move an abductor bar, loosen the locking knobs below the bar, and then move the bar
to the desired position.
Please refer to lllustration 5-2
lllustration 5-2
Attachment To Table

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-4 Detachment from Table

1. When the operation is finished, thoroughly clear and disinfect the table, orthopedic extension,
sacral rest, and perineal post with mild detergent solution and disinfectant.
2. Raise the tabletop and position the storage trolley under the abductor bars.
3. Lock bars in the appropriate position:(the red points on the bars and number plates should
be met)
4. Loosen the locking knobs on both side of Pelvic Bracket.
5. Pull the PA900 Orthopedic Extension off the table and put it on the storage trolley.

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-5 Right / Left Pinning Procedure (Unilateral Traction)


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check the table
and accessories for damage or wear prior to each use. Do not use
if any damage is apparent or device cannot be securely tightened.

Procedure as follows:
1. Attach PA900 Orthopedic Extension to the table. Refer to the section 5-3.
2. Loosen the locking knob. Then, position and lock abductor bars. Refer to the
Illustration 5-3 for reference.
3. Insert sacral rest into affected side slot of pelvic bracket.
4. Place traction accessory clamp on the affected abductor bar.
5. Insert patient transfer board.
6. Transfer Patient.
7. Add multitask armboard to unaffected side.
8. Insert the perineal post and make sure the patient is snug against it.
9. Place legholder in the traction accessory clamp and position unaffected leg.
10. Position traction unit assembly and secure feet in foot traction boot.
11. Remove the patient transfer board.
12. Raise the table to the proper height for surgeons.
13. Position the C-Arm. Refer to the illustration 5-3.

lllustration 5-3
Right / Left Pinning

Telescopic Bar:1
Sacral Rest with Pad:1
Perineal Post with Pad:1
Traction Unit Assembly:1
Foot Traction Boot:1
Traction Accessory Clamp:1
Legholder(PA08):1
Multitask Armboard(PA14):1
Clark Socket(PA24):2
Screen(PA03):1

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-6 Right / Left Pinning Procedure (Bi-Lateral Traction)


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check the table
and accessories for damage or wear prior to each use. Do not use
if any damage is apparent or device cannot be securely tightened.

Procedure as follows:
1. Attach PA900 Orthopedic Extension. Refer to the section 5-3.
2. Loosen the locking knob. Then, position and lock abductor bars. Refer to the
Illustration 5-4 for reference.
3. Insert sacral rest into affected side slot of pelvic bracket.
4. Place traction accessory clamp on the affected abductor bar.
5. Insert patient transfer board.
6. Transfer Patient.
7. Add armboard to unaffected side.
8. Insert the perineal post and make sure the patient is snug against it.
9. Secure feet in the foot traction boot.
10. Remove the patient transfer board.
11. Raise the table to the proper height for surgeons.
12. Position the C-Arm. Refer to the illustration 5-4.

lllustration 5-4
Right / Left Pinning(Bi-Lateral Traction)

Telescopic Bar:2
Sacral Rest with Pad:1
Perineal Post with Pad:1
Traction Unit Assembly:2
Foot Traction Boot:2
Armboard(PA26):2
Clark Socket(PA24):1
Screen(PA03):1

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-7 Right / Left Tibia / Fibula Procedure


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check the table
and accessories for damage or wear prior to each use. Do not use
if any damage is apparent or device cannot be securely tightened.

Procedure as follows:
1. Attach the PA900 Orthopedic Extension. Refer to the section 5-3.
2. Loosen the locking knob. Then, position and lock abductor bars. Refer to the
Illustration 5-5 for reference.
3. Insert sacral rest into affected side slot of pelvic bracket.
4. Mount tibia countertraction support into traction accessory clamp on abductor bar on
affected side and tighten.
5. Insert patient transfer board.
6. Transfer Patient.
7. Add armboard to the unaffected side.
8. Insert the perineal post and make sure the patient is snug against it.
9. Place universal leg holder into traction accessory clamp and position unaffected leg.
10. Support affected leg, and remove the patient transfer board.
11. Place the affected leg onto tibia countertraction support.
12. Adjust height of the tibia countertraction support to desired height and tighten the
knobs.
13. Secure patient’s foot in traction unit assembly.
14. Raise table to convenient working height for surgeon.

lllustration 5-5
Right / Left Pinning(Bi-Lateral Traction)

Telescopic Bar:2
Sacral Rest with Pad:1
Perineal Post with Pad:1
Traction Unit Assembly:2
Foot Traction Boot:2
Universal Leg Holder:1
Armboard(PA26):2
Traction Accessory Clamp:2
Tibia Countertraction Support :1
Multitask Armboard(PA14):1
Clark Socket(PA24):2
Screen(PA03):1

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-8 Right / Left I.M. Nailing-supine W/Skeletal Traction


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check the table
and accessories for damage or wear prior to each use. Do not use
if any damage is apparent or device cannot be securely tightened.
Procedure as follows:
1. Attach PA900 Orthopedic Extension. Refer to the section 5-3.
2. Loosen the locking knob. Then, position and lock abductor bars. Refer to the
Illustration 5-6 for reference.
3. Insert sacral rest into affected side slot of pelvic bracket.
4. Apply traction accessory clamp for unaffected universal leg holder.
5. Loosen the locking knob. Then, move abductor bars. Refer to the Illustration 5-6 for
reference.
6. Insert patient transfer board.
7. Transfer patient.
8. Add armboard to unaffected side.
9. Insert the perineal post and make sure the patient is snug against it.
10. Place the universal leg holder in traction accessory clamp and position unaffected leg.
11. Support affected leg and remove patient transfer board.
12. Reposition abductor bar while supporting affected leg.
13. Insert traction bow into boot plate and secure.
14. Place foot in traction unit assembly and secure.
15. Raise table to convenient working height for surgeon.

lllustration 5-6
Right / Left I.M. Nailing-Supine W/Skeletal Traction

Telescopic Bar :2
Sacral Rest with Pad :1
Perineal Post with Pad :1
Traction Unit Assembly :2
Foot Traction Boot :2
Traction Accessory Clamp :2
Traction Bow :1
Universal Leg Holder :1
Armboard(PA26):2
Multitask Armboard(PA14):1
Clark Socket(PA24):1
Screen(PA03):1

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-9 Right / Left I.M. Nailing Lateral Procedure(Alternate Setup)


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check the table
and accessories for damage or wear prior to each use. Do not use
if any damage is apparent or device cannot be securely tightened.
Procedure as follows:
1. Attach the PA900 Orthopedic Extension. Refer to the section 5-3.
2. Loosen the locking knob. Then, position and lock abductor bars. Refer to the
Illustration 5-7 for reference.
3. Insert hip rest into affected side slot of pelvic bracket.
4. Add traction accessory clamps and position traction unit assembly.Refer to
illustration 5-7.
5. Transfer patient onto the table (supine).
6. After anesthetizing, roll patient onto unaffected side.
7. Insert the elevator and Pelvic Crest Supoort into the middle slot of pelvic bracket and
support affected leg, rotate the Pelvic Crest Support between legs.
8. Adjust height of the lateral countertraction support to compensate for patient size.
9. Insert the lateral support to the pelvic crest support.
10. Remove the patient transfer board.
11. Secure patient’s feet in foot traction boot.
12. Adjust lateral countertraction support to assure patient is snug against it.
13. Adjust table height to the convenient working height for surgeon.
14. Position the C-Arm. Refer to the illustration 5-7.

lllustration 5-7
Right / Left I.M. Nailing-Supine W/Skeletal Traction

Telescopic Bar :2
Sacral Rest with Pad :1
Hip Rest with Pad :1
Elevator:1
Pelvic Crest Support:1
Lateral Support:1
Traction Unit Assembly:2
Fot Traction Boot:2
Armboard(PA26):1
Multitask Armboard(PA14):1
Clark Socket(PA24):2
Screen(PA03):1

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-10 Myelograms Position


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check the table
and accessories for damage or wear prior to each use. Do not use
if any damage is apparent or device cannot be securely tightened.
Procedure as follows:
1. Attach PA900 Orthopedic Extension. Refer to the section 5-3.
2. Remove alll the accessories from the abductor bars. Refer to the Illustration 5-8 for
reference.
3. Insert the patient transfer board.
4. Transfer patient.
5. Insert the Dorsal Operation Pad onto the table.
6. Raise the table to the convenient working area for surgeon.
7. Position the C-Arm. Refer to the illustration 5-8.

lllustration 5-8
Myelograms Position

Spine Pad(PA27):1
Patient Transfer Board with Pad(A104):1

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-11 Accessories

A102 A103 A104


Sacral Rest with Pad Perineal Post Patient Transfer Board with Pad

A105 A106 A107

Suspension Arm Assembly Traction Accessory Clamp Universal Leg Holder

A108 A109 A110/A148


Tibia Counteraction Support Telescopic Bar Traction Unit Assembly

A111
A112 A113
Boot Plate End Stand Support Elevator

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

Accessories

A116
A117 A118
Hip Rest with Pad Traction Bow Storage Trolley

PA14 PA24 PA27


Multitask Armboard Clark Socket Spine Pad

0003348 A147 A434


Foot Traction Boot Shoulder Balance Block Pelvic Bracket

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

5-12 Attachment Of Accessories


▲ WARNING! PREVENT POSSIBLE PATIENT OR USER INJURY: Check if the
table and accessories for damage or wear prior to each use. Do
not use table and accessories if any damage is apparent or device
cannot be securely tightened.
▲ NOTE! Do not use Mediland accessories with the other brand device.
That may damage the equipment or injure the user.
▲ NOTE! If adjustment is needed in clamp position, loosen knob on clamp
and slide along abductor to the desired position.

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Mediland Enterprise Corporation PA900 Orthopedic Extension
Rev 2 DIRECTION SM-PA900E

SECTION 6 MAINTENANCE
6-1 Maintenance Procedure
Use the following materials to perform the cleaning procedures described in this section:
Several clean, dry lint-free cloths.
Container of clean water.
Materials for different situations.

SOIL OR STAINS :
Use neutral soap suds and lukewarm water. Rinse with water and allow to dry. Do
not use harsh cleansers, solvents, or detergents.

HARD TO CLEAN SPOTS :


Use standard household/viny
l cleansers and/or a soft bristle brush on troublesome spots or stains. Pre-soak
heavy, dried-on soil.

DISINFECTION :
Dilute disinfectants and/or germicides as specified on the product label.l Do not use
in concentrations that exceed those that are recommended by the manufacturer.
Contact Mediland for a list of recommended disinfectants.

※ Note : When using disinfectants, manufacturer’s label recommendations must be


followed.

※ Caution : Use only recommended cleaners/disinfectants on Mediland tables. Do not use


phenoilcs, which may cause patient skin burns if inadequately rinsed off, or
alcohol, which does not have sufficient cleaning/disinfecting properties.
6-2 Service Maintenance
The service maintenance should be executed by the Mediland Service People or the
authorized service people. Any unauthorized service maintenance happened that may
cause the device damage or uer injury. Any futher service question, please contact to
Mediland at

Tel : 886-3-3280688
Fax : 886-3-3289458
E-mail : international@mediland.com.tw

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