Hill-Rom A-80400 Bariatric Nissen Strap/Thigh Retractors Instruction Manual
- June 5, 2024
- Hill-Rom
Table of Contents
Hill-Rom A-80400 Bariatric Nissen Strap/Thigh Retractors
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.
- The 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.
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.
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
Safety Considerations
Safety hazard symbol notice
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.
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.
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
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.
Operating the system
Applicable Symbols
| Symbol used | Description | Reference |
|---|---|---|
| **** | 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. 1 18 WWSSSSSSS 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 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
****| 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
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)
EMC considerations
This is not an electromechanical device. Therefore, EMC Declarations are not applicable.
EC authorized representative:
HILL-ROM SAS
B.P. 14 – Z.I. DU TALHOUET 56330 PLUVIGNER FRANCE
TEL: +33 (0)2 97 50 92 12
Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC. 100 DISCOVERY WAY ACTON, MA 01720 USA 800-433-5774 (NORTH AMERICA) 978-266-4200 (INTERNATIONAL)
EU Importer Information:
TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss Straße 7-9 07318 Saalfeld/Saale Germany
Australian sponsor Information:
Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083
System
System components Identification
Product Code and Description
- A-80400 – Bariat Nissen Straps / Thigh Retrac, US
- A-80400E – Bariat Nissen Straps/Thigh Retrac, EU
- A-80400UK – Bariatric Nissen Straps/Thigh Retrac, UK
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 |
|---|---|
| Accessory Cart | A-30010 (US), A-30013E (EU), |
A-30010UK (UK), A-30010J (Japan)
| Name of Consumable | Product Number |
|---|---|
| Not Applicable | Not Applicable |
Note: Consult the corresponding IFU for the products mentioned in the above table.
Indication for use
The Nissen strap is used in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery during Reverse Trendelenburg positioning. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Intended use
The Nissen strap is designed to position and support the patient’s upper leg in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery during Reverse Trendelenburg positioning. These devices are intended to be used by healthcare professionals within the Operating Room setting.
Equipment Setup and Use
Prior to use
- Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.
- Make sure product has been properly cleaned and disinfected and wiped dry prior to each use.
Setup
- Position the Strap Mount on the table rail adjacent to the patient’s thigh. Tighten.
- Pull the strap under and around the patient’s thigh. The pad must be between the thigh and the strap encircling the thigh.
- Position the buckle mount 150mm (6”) from the strap mount on the table railtoward the head end of the table. Tighten.
- Pull the strap through the buckle until it is taut, and the patient is held on the table. Lock by pressing the buckle latch to the closed position.
- Repeat steps a. through d. for the other strap.
Device controls and indicators
Controls and indicators of this device are described within the Setup instructions.
Storage, Handling and Removal Instructions
-
Storage and Handling
The product should be stored in a clean and safe environment to prevent product damage. See storage Specifications under Product Specification section. -
Removal Instruction
- Loosen the strap from the buckle.
- Loosen the buckle section mount knob and remove mount.
- Release the patient thigh and remove the strap section mount.
Troubleshooting Guide
This device does not have a troubleshooting guide. For technical support user of the device shall first contact Hill-Rom Technical Support.
Device Maintenance
Periodic Maintenance is not required for this device.
Safety Precautions and General Information
General Safety Warnings and Cautions
WARNING
- Do not use if product shows visible damage.
- Prior to using this device, please read the instructions for equipment set up and use. Familiarize yourself with the product before application on a patient.
- To prevent patient and/or user injury and/or equipment damage, examine the device and surgical-table side rails for potential damage or wear prior to use. Do not use the device if damage is visible, if parts are missing or if it does not function as expected.
- Do not attach strap to any type of table width extender as patient injury could result
CAUTION
- Do not over-tighten straps around patient’s legs as injury may result.
- Do not exceed safe working load shown in the product specification table.
Product Specifications
| Mechanical Specifications | Description |
|---|---|
| Product Dimensions | Pad Dimension 79 cm x 18 cm (31” x 7”) |
(L x W)
Material
| Aluminum, Conductive strap, Viscoelastic Foam, Fusion 3, Black, Lectrolite
Fusion 3HP, Black, Lectrolite Duotone, Black, Vinyl-nitrile rubber
Safe Working Load on the device| 1.000 lbs. (453.5 kg)
Overall Weight of Complete Device| 3.6 lbs. (1.63 kg)
Storage Specifications| Description
Storage temperature| -29ᵒ C to +60ᵒ C
Storage Relative humidity range| 15% to 85%
Operating temperature| This device is intended to be used in a controlled
Operating Room environment.
Operating Relative humidity range
Electrical Specifications| Description
Not Applicable.| Not Applicable.
Software Specifications| Description
Not Applicable.| Not Applicable.
Compatibility Specifications| Description
Operating Room Table Compatibility
| The Bariatric Nissen Thigh Strap is compatible with the following surgical
table rail styles: US, UK, EU
Note: Consult the corresponding IFU for the products mentioned in the
above table.
Sterilization Instruction
This device is not intended to be sterilized.
Cleaning and Disinfection Instruction
WARNING
- Do not use bleach or products that contain bleach to clean the device. Injury or equipment damage can occur.
- After each use, clean the device with alcohol-based wipes.
- Do not put the device into water. Equipment damage can occur.
- Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean and disinfect the device.
- Read and follow the manufacturer’s recommendation for low-level disinfection.
- Read and follow the cleaning product’s instructions. Use caution in areas where liquid can get into the mechanism.
- Wipe the device with a clean, dry cloth.
- Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
List of Applicable Standards
| Sl. no | Standards | Description |
|---|
1
| ****
EN 62366-1
| Medical devices – Part 1: Application of usability engineering to medical devices
2
| ****
EN ISO 14971
| Medical devices- Application of risk management to medical devices.
3
| ****
EN 1041
| Information supplied by the manufacturer of medical devices
4
| ****
EN ISO 15223-1
| Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
5
| ****
EN ISO 10993-1
| Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
6
| ****
IEC 60601-2-46
| Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
7
| ****
ISTA
| International Safe Transit Association standards for package testing
---|---|---
References
- allenmedical.com - allenmedical Resources and Information.
- allenmedical.com - allenmedical Resources and Information.
- Patents | Hillrom
- Hillrom Locations by Country | Hillrom
- allenmedical.com - allenmedical Resources and Information.
- Patents | Hillrom
- Hillrom Locations by Country | Hillrom