Instructions for Use
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Allen® Advance Table Instructions for Use Product Code A-71100-SCH
80028190 Version G English
LANGUAGES ENGLISH...1 中文简体... 71 中文繁體... 135 DANSK...199 NEDERLANDS...269 FRANÇAIS...345 DEUTSCH...421 BAHASA INDONESIA...497 ITALIANO...571 日本語版... 647 한국어... 715 LATVISKI...783 POLSKI...853 PORTUGUÊS...931 ROMÂNESC...1005 SRPSKI...1075 SLOVENSKY...1147 SLOVENŠČINA...1219 ESPAÑOL...1289 SVENSKA...1367 TÜRK...1437 TIẾNG VIỆT...1507
Document Number: 80028190 Version: G
Page 2 English
Issue Date: 03 FEB 2023 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 instructions and warnings in this manual and on the device itself prior to use with a patient. Keep this manual available to train new users. • 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. • Routine maintenance should be performed by facility-authorized personnel. Injury or equipment damage can occur. • 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. • Any reference to a side of the Allen Advance Table is from the patient’s view lying on an installed patient support top on his or her back. • When we discuss the installation of the Prone Support Set, any position reference is with the patient lying face down on the patient support top. • This manual includes the different features and options for the Allen Advance Table, some of which may not apply to your unit. To identify the model that you have, look at the model number label that is on the inside of the head-end base, near the power outlet.
Document Number: 80028190 Version: G
Page 3 English
Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE
Table of Contents Allen® Advance Table 1.
General Information:... 7 1.1
Copyright Notice:... 7
1.2
Trademarks:... 8
1.3
Contact Details:... 8
1.4
Safety Considerations:... 8
1.5
1.4.1
Safety hazard symbol notice:... 8
1.4.2
Equipment misuse notice:... 8
1.4.3
Notice to users and/or patients:... 9
1.4.4
Safe disposal:... 9
Operating the system:... 10 1.5.1
Applicable Symbols:... 10
1.5.2
Intended User and Patient Population:... 12
1.5.3
Compliance with medical device regulations:... 12
1.6
EMC considerations:... 13
1.7
EC authorized representative:... 19
1.8
Manufacturing Information:... 19
1.9
EU Importer Information:... 19
1.10 Authorised Australian sponsor:... 19 2.
3.
System... 20 2.1
System components Identification:... 20
2.2
Product Code and Description:... 22
2.3
List of Accessories and Consumable Components Table:... 22
2.4
Indication for use:... 25
2.5
Intended use:... 25
Equipment Setup and Use:... 26 3.1
Prior to use:... 26
3.2
Setup:... 26 3.2.1
Controls and Indicators... 26
3.2.2
Turn the Unit On and Off... 28
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INSTRUCTIONS FOR USE 3.2.3
Lock and Unlock the Brakes... 29
3.2.4
Adjust the Length of the Allen Advance Table... 31
3.2.5
Install the H-Brackets and a Patient Support Top... 31
3.2.6
Install the Prone Support Set (A-71300) on the Rail Top... 35
3.2.7
Pre-Use Check... 38
3.2.8
Adjust the Height of the Allen Advance Table... 39
3.2.9
Put the Allen Advance Table in a Trendelenburg Position... 40
3.2.10 Tilt the Support Top... 41 3.2.11 Level the Allen Advance Table and the Support Top... 42 3.2.12 Rotate the Support Top 180°... 43 3.2.13 Transfer a Patient... 47 3.2.14 Access the Cervical Traction Assembly... 48 3.2.15 Shut Down the Allen Advance Table... 50 3.3
Device controls and indicators:... 51
3.4
Storage, Handling and Removal Instructions:... 54
3.5
3.6
3.4.1
Storage and Handling:... 54
3.4.2
Removal Instruction:... 54
Troubleshooting Guide:... 54 3.5.1
The Allen Advance Table will not go into Pendant Control Mode from the Manual Flip Mode... 55
3.5.2
The Pendant Control and Manual Flip Indicators are Flashing... 55
3.5.3
The Brakes Locked and Unlocked Indicators are Flashing... 55
3.5.4
The Allen Advance Table “Beeps” when a Pendant Control is Pressed... 55
3.5.5
Service Calls... 55
Device Maintenance:... 56 3.6.1
3.7
4.
Maintenance Checks... 56
Parts Replacement... 57 3.7.1
Pendant... 59
3.7.2
Fuses... 60
Safety Precautions and General Information:... 61 4.1
General Safety Warnings and Cautions:... 61
4.2
Product Specifications:... 64
Document Number: 80028190 Version: G
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Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE
5.
4.3
Declarations:... 66
4.4
Sterilization Instruction:... 66
4.5
Cleaning and Disinfection Instruction:... 67 4.5.1
Clean... 68
4.5.2
Clean Difficult Spots... 68
4.5.3
Steam Clean... 68
4.5.4
Disinfect... 68
List of Applicable Standards:... 69
Document Number: 80028190 Version: G
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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 on-site product demonstrations.
1.1
Copyright Notice:
Revision © 2022 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.
Document Number: 80028190 Version: G
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INSTRUCTIONS FOR USE 1.2
Trademarks:
Trademark information can be found at Allenmedical.com/pages/terms-conditions. Products may be covered by one or more patents. Please consult listing at Hill-rom.com/patents for any patent(s). Mizuho OSI® is a registered trademark of Mizuho Orthopedic Systems, Inc. Velcro® is a registered trademark of Velcro Industries, BV. Ultra Comfort™ is a trademark of Allen Medical Systems, Inc. Allen®, Bow®, C-Flex®, and Easy Lock® are registered trademarks of Allen Medical Systems, Inc. Quick View™ is a trademark of Hill-Rom Services, Inc.
1.3
Contact Details:
For ordering information please see catalog. Allen Customer Service Contact Information: North America
International
(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.
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INSTRUCTIONS FOR USE 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
1.4.4
Safe disposal:
When the Allen Advance Table has reached the end of its useful life, discard it in accordance with local standards. Recycle as much as possible. 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.
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INSTRUCTIONS FOR USE 1.5
Operating the system:
1.5.1
Applicable Symbols:
Symbol used
Description
Reference
Table Frame Symbols 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.
EN ISO 15223-1
• 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. Indicates the medical device Global Trade Item Number
21 CFR 830 MDR 2017/745
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 date when the medical device was manufactured
EN ISO 15223-1
Indicates the manufacturer’s catalogue number
EN ISO 15223-1
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INSTRUCTIONS FOR USE Symbol used
Description
Reference
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
Medical Electrical Equipment Evaluated
UL60601-1, EN 60601-1, IEC 60601-1, IEC 60601-2-46, IEC 60601-1-2
Type B applied part
N/A
Degree of protection against the ingress of water
N/A
Equipotential
N/A
Failure to Follow the Operating Instructions Could Put the Patient or Operator at Risk.
IEC 60601-1
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INSTRUCTIONS FOR USE Symbol used
1.5.2
Description
Reference
Shows the maximum patient weight for the Allen Advance Table.
N/A
The Allen Advance Table is not suitable for use in oxygen enriched environments or where there is a flammable anesthetics mixture with air, oxygen, or nitrous oxide.
N/A
Shows that tape should not be used.
N/A
Shows that a crushing hazard is present. Make sure that your body is not in an area where a crushing hazard is present.
N/A
Intended User and Patient Population:
The intended users of the Allen® Advance Table are healthcare employees who have been trained to use the product, and who have the physical strength and cognitive skills to operate and control the product. Follow facility safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the product safely. 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. 1.5.3
Compliance with medical device regulations: This Product is a non-invasive, Class I Medical Device. This system is CE-marked according to Annex VIII, Rule 1, of the Medical Device Regulations (REGULATION (EU) 2017/745).
Document Number: 80028190 Version: G
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INSTRUCTIONS FOR USE 1.6
EMC considerations:
WARNING: If the Allen Advance Table is to be used near high-frequency surgical equipment, cardiac defibrillators, and cardiac defibrillator-monitors, refer to the product manufacturer’s instructions to make sure the equipment will operate as intended. This device meets all requirements for electromagnetic compatibility per IEC 60601-1-2. Other products that are used near the Allen Advance Table should comply with this standard also. Otherwise, electromagnetic interference between the products could cause the products to operate incorrectly. If problems do occur, contact the product manufacturer(s).
WARNING: The A-71100-XX/A-71101-XX should not be used adjacent to other electrical equipment. If adjacent use is necessary, observe the A-71100-XX/A-71101-XX and the other electrical equipment to make sure they operate as intended.
WARNING: This device meets all requirements for electromagnetic compatibility per IEC 60601-1-2. It is unlikely that the user will encounter problems with this device because of inadequate electromagnetic immunity. However, electromagnetic immunity is always relative, and standards are based on anticipated environments of use. If the user observes unusual device behavior, particularly if such behavior is intermittent and associated with nearby use of radio or TV transmitters, cell phones, or electro-surgical equipment, this could be an indication of electromagnetic interference. If such behavior occurs, the user should try to move the interfering equipment further from this device. Make sure the A-71100-XX/A-71101-XX operate correctly when they are used near other electronic devices. Portable and mobile radio frequency (RF) communications equipment can affect electrical equipment. Medical equipment needs special precautions in regard to electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information supplied in the tables that follow.
Document Number: 80028190 Version: G
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Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE Guidance and Manufacturer's Declaration - Electromagnetic Emissions The A-71100-XX/A-71101-XX are intended for use in the electromagnetic environment specified below. The customer or the user of the A-71100-XX/A-71101-XX should make sure it is used in such an environment. Emissions Test
Compliance
Electromagnetic Environment-Guidance
RF Emissions
Group 1
The A-71100-XX/A-71101-XX use RF energy only for its internal functions. Therefore, its RF emissions are low and are not likely to cause any interference in nearby electronic equipment.
Class B
The A-71100-XX/A-71101-XX are suitable for use in all establishments, other than domestic, and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
CISPR 11 RF Emissions
CISPR 11 Harmonic Emissions
Class A
IEC 61000-3-2 Voltage Fluctuations/ Flicker Emissions
Complies
IEC 61000-3-3
Document Number: 80028190 Version: G
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INSTRUCTIONS FOR USE Guidance and Manufacturer's Declaration - Electromagnetic Immunity The A-71100-XX/A-71101-XX are intended for use in the electromagnetic environment specified below. The customer or the user of the A-71100-XX/A-71101-XX should make sure it is used in such an environment. Immunity Test Electrostatic Discharge (ESD)
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment- Guidance
± 6 kV Contact
± 6 kV Contact
± 8 kV Air
± 8 kV Air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
± 2 kV for Power Supply Lines
± 2 kV for Power Supply Lines
± 1 kV for Input/ Output Lines
± 1 kV for Input/ Output Lines
± 1 kV Line(s) to Line(s)
± 1 kV Line(s) to Line(s)
± 2 kV Line(s) to Earth
± 2 kV Line(s) to Earth
< 5% UT (> 95% dip in UT) for 0.5 cycles
< 5% UT (> 95% dip in UT) for 0.5 cycles
40% UT (60% dip in UT) for 5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
70% UT (30% dip in UT) for 25 cycles
< 5% UT (> 95% dip in UT) for 5 seconds
< 5% UT (> 95% dip in UT) for 5 seconds
IEC 61000-4-2 Electrical Fast Transient/Burst
IEC 61000-4-4 Surge
IEC 61000-4-5 Voltage Dips, Short Interruptions, and Voltage Variations On Power Supply Input Lines
IEC 61000-4-11
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Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be of a typical commercial or hospital environment. If the user of the A-71100-XX/A-71101-XX requires continued operation during power mains interruption, it is recommended that the A-71100-XX/ A-71101-XX be powered from an uninterruptedly power supply or a battery.
Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE Guidance and Manufacturer's Declaration - Electromagnetic Immunity The A-71100-XX/A-71101-XX are intended for use in the electromagnetic environment specified below. The customer or the user of the A-71100-XX/A-71101-XX should make sure it is used in such an environment. Immunity Test Power Frequency (50/60Hz) Magnetic Field
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment- Guidance
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
Document Number: 80028190 Version: G
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Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE Guidance and Manufacturer's Declaration - Electromagnetic Immunity The A-71100-XX/A-71101-XX are intended for use in the electromagnetic environment specified below. The customer or the user of the A-71100-XX/A-71101-XX should make sure it is used in such an environment. Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment- Guidance Portable and mobile RF communications equipment should be used no closer to any part of the A-71100-XX/A-71101-XX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 Vrms
3 V/m
d = 1.17√ P
150 kHz to 80 MHz
d = 1.17√ P
80 MHz to 800 MHz
d = 2.33√ P
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher the frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Document Number: 80028190 Version: G
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Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the A-71100-XX/A-71101-XX is used exceeds the applicable RF compliance level above, the A-71100-XX/A-71101-XX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the A-71100-XX/A-71101-XX. b. Over the frequency range of 150 kHz to 80 MHz, field strength should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the A-71100-XX/A-71101-XX The A-71100-XX/A-71101-XX are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the A-71100-XX/A-71101-XX1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the A-71100-XX/A-71101-XX as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter, W
Separation distance according to frequency of transmitter, m 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.17√ P
d = 1.17√ P
d = 2.33√ P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Document Number: 80028190 Version: G
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Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE 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:
Baxter Medical Systems GmbH + Co. KG Carl-Zeiss Straße 7-9 07318 Saalfeld/Saale Germany
1.10
Authorised Australian sponsor:
Welch Allyn Australia Pty. Ltd. 1 Baxter Drive Old Toongabbie, NSW 2146 Australia
Document Number: 80028190 Version: G
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Issue Date: 03 FEB 2023 Ref Blank Template: 80025117 Ver. F
INSTRUCTIONS FOR USE 2.
System
2.1
System components Identification:
VIEW 1
Item
Feature
Page
Item
Feature
Page
A
Flip handle
43
F
On/Off switch
28
B
Cervical traction rope insertion
48
G
Power cord outlet
28
C
Patient support top with pad
31
H
Pendant
27
D
Cross pin and H-bracket storage
35
I
Pendant holder
50
E
Collapsible cross tube
31
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