Flex Frame System A-70100 Instructions for Use Rev C March 2020

INSTRUCTIONS FOR USE ENGLISH ... 3 中文简体 ... 35 HRVATSKI ... 67 NEDERLANDS ... 99 SUOMI ... 136 FRANÇAIS ... 168 DEUTSCH ... 202 ΕΛΛΗΝΙΚΑ ... 234 ITALIANO ... 269 LATVISKI ... 302 NORSK ... 335 POLSKI ... 369 PORTUGUÊS ... 402 ROMÂNESC ... 435 SRPSKI ... 470 SLOVENSKY ... 504 SLOVENŠČINA ... 538 ESPAÑOL ... 571 SVENSKA ... 603

Document Number: 80028177 Version: C

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Issue Date: 26 MAR 2020 Ref Blank Template: 80025117 Ver. F

INSTRUCTIONS FOR USE IMPORTANT NOTICES Prior to using this or any other type of medical apparatus with a patient, it is recommended that you read the Instructions for Use and familiarize yourself with the product.

•

Read and understand all warnings in this manual and on the device itself prior to use with a patient.

•

The symbol is intended to alert the user to important procedures or safety instructions regarding the use of this device. The symbol on the labels is intended to show when the IFU should be referenced for use.

•

• • • • •

The techniques detailed in this manual are only manufacturer’s suggestions. The final responsibility for patient care with respect to this device remains with the attending physician. Device function should be checked prior to each usage. This device should only be operated by trained personnel. All modifications, upgrades, or repairs must be performed by an authorized specialist. Keep this manual available for future reference. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority listed in this document.

Document Number: 80028177 Version: C

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INSTRUCTIONS FOR USE

Table of Contents Allen® Flex Frame System (A-70100) 1

General Information: ... 6 1.1 Copyright Notice: ... 6 1.2 Trademarks:... 6 1.3 Contact Details: ... 7 1.4 Safety Considerations:... 7 1.4.1 Safety hazard symbol notice: ... 7 1.4.2 Equipment misuse notice: ... 7 1.4.3 Notice to users and/or patients: ... 7 1.4.4 Safe disposal: ... 8 1.5 Operating the system: ... 8 1.5.1 Applicable Symbols:... 8 1.5.2 Intended User and Patient Population: ... 9 1.5.3 Compliance with medical device regulations: ... Error! Bookmark not defined. 1.6 EMC considerations: ... 10 1.7 EC authorized representative: ... 10 1.8 Manufacturing Information: ... 10 1.9 EU Importer Information: ... 10 1.10 Australian sponsor Information: ... 10

2

System ... 11 2.1 System components Identification: ... 11 2.2 Product Code and Description:... 13 2.3 List of Accessories and Consumable Components Table:... 14 2.4 Indication for use: ... 15 2.5 Intended use:... 15 2.6 Residual Risk: ... 15

3

Equipment Setup and Use:... 16 3.1 Prior to use: ... 16 3.2 Setup: ... 17 3.3 Device controls and indicators: ... 21

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INSTRUCTIONS FOR USE 3.4 Storage, Handling and Removal Instructions:... 27 3.4.1 Storage and Handling: ... 27 3.4.2 Removal Instruction: ... 27 3.5 Troubleshooting Guide: ... 28 3.6 Device Maintenance: ... 29 4

Safety Precautions and General Information:... 30 4.1 General Safety Warnings and Cautions: ... 30 4.2 Product Specifications: ... 31 4.3 Sterilization Instruction: ... 32 4.4 Cleaning and Disinfection Instruction: ... 32

5

List of Applicable Standards: ... 32

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INSTRUCTIONS FOR USE 1

General Information: Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc., (NYSE: HRC), a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry. As an industry leader in patient positioning, our passion is improving patient outcomes and caregiver safety, while enhancing our customers' efficiency. Our inspiration comes from providing innovative solutions to address our customers' most pressing needs. We immerse ourselves in our customers' world, to better address these needs and the daily challenges of their environment. Whether developing a solution to address patient positioning challenges or creating a system to offer safe and effective surgical site access for the surgical team, we are committed to providing products of exceptional value and quality. Allen products are backed by responsive and reliable service and complimentary onsite product demonstrations.

1.1 Copyright Notice: Revision © 2019 Allen Medical Systems Inc. ALL RIGHTS RESERVED. No part of this text shall be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information or retrieval system without written permission from Allen Medical Systems, Inc. (Allen Medical). The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Allen Medical.

1.2 Trademarks: Trademark information conditions.

can

be

found

at

Allenmedical.com/pages/terms-

Products may be covered by one or more patents. Please consult listing at Hill-rom.com/patents for any patent(s).

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INSTRUCTIONS FOR USE 1.3 Contact Details: For ordering information please see catalog. Allen Customer Service Contact Information:

International

North America (800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

1.4 Safety Considerations: 1.4.1

Safety hazard symbol notice: DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.

1.4.2

Equipment misuse notice:

Do not use the product if package is damaged or unintentionally opened before use. All modifications, upgrades, or repairs must be performed by an authorized specialist. 1.4.3

Notice to users and/or patients:

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Note: Refer to the surgical table manufacturer's user guide for instructions on use. Always refer to the surgical table manufacturer’s weight limits.

NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE

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INSTRUCTIONS FOR USE 1.4.4

Safe disposal:

Customers should adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hill-Rom Technical Support for guidance on safe disposal protocols.

1.5 Operating the system: 1.5.1

Applicable Symbols:

Symbol used

Description Indicates the device is a medical device

MDR 2017/745

Indicates the medical device manufacturer

EN ISO 15223-1

Indicates the manufacturer’s serial number. The device serial number is encoded as 1YYWWSSSSSSS.  YY indicates the year of manufacture. i.e. 118WWSSSSSSS where 18 represents the year 2018.  WW indicates the number of the manufacturing week per a standard shop calendar. (Leading zeros included.)  SSSSSSS is a sequential unique number.

EN ISO 15223-1

Indicates the medical device Global Trade Item Number

21 CFR 830 MDR 2017/745

Indicates the date when the medical device was manufactured

EN ISO 15223-1

Document Number: 80028177 Version: C

Reference

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INSTRUCTIONS FOR USE

1.5.2

Indicates the manufacturer’s lot code using the Julian Date yyddd, where yy indicates the last two digits of the year and ddd indicates the day of the year. i.e. April 4th, 2019 would be represented as 19094.

EN ISO 15223-1

Indicates the manufacturer’s catalogue number

EN ISO 15223-1

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions.

EN ISO 15223-1

Indicates the device do not contain natural rubber or dry natural rubber latex

EN ISO 15223-1

Indicates the authorized representative in the European Community

EN ISO 15223-1

Indicates the Medical Device complies to REGULATION (EU) 2017/745

MDR 2017/745

Indicates a Warning

IEC 60601-1

Indicates the need for the user to consult the instruction for use

EN ISO 15223-1

Intended User and Patient Population:

Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare professionals involved in the device intended procedure. Not intended for Lay persons. Intended Populations: This device is intended to be used with patients that do not exceed the weight in the safe working load field specified in the product specification section 4.2

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INSTRUCTIONS FOR USE 1.6 EMC considerations: This is not an electromechanical device. Therefore, EMC Declarations are not applicable.

1.7 EC authorized representative: HILL-ROM SAS B.P. 14 - Z.I. DU TALHOUET 56330 PLUVIGNER FRANCE TEL: +33 (0)2 97 50 92 12

1.8 Manufacturing Information: ALLEN MEDICAL SYSTEMS, INC. 100 DISCOVERY WAY ACTON, MA 01720 USA 800-433-5774 (NORTH AMERICA) 978-266-4200 (INTERNATIONAL)

1.9

EU Importer Information: TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss Straße 7-9 07318 Saalfeld/Saale Germany

1.10 Australian sponsor Information: Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 - Phone 1800 650 083.

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INSTRUCTIONS FOR USE 2 2.1

System System components Identification: Spine System:

Supine Tops

C-Prone Wingsets

C-Flex

Armboard Rail

*Patient supports shown here are part of the Allen Spine System. They are not included with A-70100, but are shown for reference.

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INSTRUCTIONS FOR USE Flex Frame:

Rail Clamp Carbon Fiber Handle Crank

Rails

Tilt Pin

Handlebar

Corner Connector Floor Lock Pads End Cap

Leg

Foot Lock

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INSTRUCTIONS FOR USE Flex Frame Labels:

Table Attach Height Adjustment

Base Lock

Lock Location

Warning Labels

2.2 Product Code and Description: A-70100 - Allen Flex Frame

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INSTRUCTIONS FOR USE 2.3 List of Accessories and Consumable Components Table: The following list are accessories and components that may be used with this device. Name of Accessory

Product number

Allen Flex Frame OR Table Clamps

A-70510-US, A-70510-UK, A-70510-EU, A-70510-DEN, A-70510-JP A-70501-US, A-70501-UK, A-70501-EU, A-70501-DEN, A-70501-JP. A-70502-US, A-70502-UK, A-70502-EU, A-70502-DEN, A-70502-JP A-70502-US, A-70502-UK, A-70502-EU, A-70502-DEN, A-70502-JP.

Allen Flex Frame Accessory Rail

Allen Arm board Rail

A-70500-US, A-70500-UK, A-70500-EU, A-70500-DEN, A-70500-JP

Allen Wing Set System

A-70200, A-70201, A-70202, A-70270

Allen Supine

A-70400, A-70403, A-70404

Allen Contour

A-70270

Name of Consumable

Product number

Comfort covers

A-70260

Allen Comfort Mask Disposable

A-70310

Note: Consult the corresponding IFU for the products mentioned in the above table.

CAUTION: Reuse of disposables will lead to patient cross contamination and/or device failure.

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INSTRUCTIONS FOR USE 2.4 Indication for use: The Flex Frame is used in a variety of surgical procedures including, but not limited to spine, cranial, cervical surgery and/or surgery that requires prone, lateral and supine positioning. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

2.5 Intended use: The Flex frame is designed to position and support the patient’s head, chest, arms, abdomen and hip in a variety of surgical procedures including, but not limited to spine, cranial, cervical surgery and/or surgery that requires prone, lateral and supine positioning. These devices are intended to be used by healthcare professionals within the Operating Room setting.

2.6 Residual Risk: This product complies with relevant performance, safety standards. However, device harm from misuse, device damage or mechanical hazards cannot be completely excluded.

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INSTRUCTIONS FOR USE 3

Equipment Setup and Use:

3.1 Prior to use: a. Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage. b. Make sure product has been properly cleaned and disinfected and wiped dry prior to each use. c. Position and orient table in the room. Flex 5’ (1525 mm) Frame will extend approximately 5’ (1525 mm) from end of OR table.

d. Remove head section if attaching to back section. OR Remove lower leg section if attaching to seat section.

e. Place floor lock pads under table, then engage floor locks. Verify floor locks are engaged by tugging on floor lock pads.

Ensure OR table is rated for patient weight at connection (If this information is not available it should be tested prior to loading a patient).

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INSTRUCTIONS FOR USE 3.2 Setup:

1. Position Flex Frame’s wheels 5’ (1525 mm) from end of table section and remove Rail 5’

Clamps from Handlebar.

(1525 mm)

2. Attach Rail Clamps to OR table. Clip on near open area on table rail.

3. Slide to end of rail as shown and tighten knob securely.

Make sure that the rail clamps are fully locked onto the accessory rails prior to loading a patient.

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INSTRUCTIONS FOR USE 4. Raise leg to its maximum height using the Crank Handle.

5. Step on base as shown. 6. Push top of frame forward as shown.

7. "Rock" frame off 1st hook. 8. "Rock" frame off 2nd hook and lower to ground.

9. Pull End Caps.

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INSTRUCTIONS FOR USE 10. Lift end of Flex Frame and place into table clamps. Verify OR table’s leg section is clear of contact with frame if attached to seat section.

11. Push End Caps flush to OR

1” Min Gap (25 mm)

table clamps. Insure Flex Frame is centered on OR table.

OR Table

Verify there is a 1” (25 mm) minimum gap between the OR table and Flex Frame.

12. Tighten handles on underside of frame. a. Tighten one handle. b. Verify End Caps are flush and tighten second side.

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INSTRUCTIONS FOR USE 13. Verify

frame

is

securely

attached to OR table. A. Grasp Carbon Fiber Rail as shown. B. Push and pull Flex Frame to verify it is locked.

14. Lower

frame

to

desired

height. 15. Verify leg is vertical and insure the base is flush to floor. The indicator level should be set to 0° during setup.

Indicator Level

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