Ama Tech F-70300 User manual

Prone Head Positioner
Instructions for Use
Product No. F-70300
D-720741
VERSION C

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 2 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
IMPORTANT NOTICES
•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.
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.

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 3 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Table of Contents
Prone Head Positioner (F-70300)
1General Information............................................................................................................ 5
Copyright Notice:........................................................................................................ 5
Trademarks:............................................................................................................... 5
Contact Details:.......................................................................................................... 6
Safety Considerations:............................................................................................... 6
1.4.1 Safety hazard symbol notice:........................................................................... 6
1.4.2 Equipment misuse notice:................................................................................ 6
1.4.3 Notice to users and/or patients:........................................................................ 6
1.4.4 Safe disposal: .................................................................................................. 6
Operating the system:................................................................................................ 7
1.5.1 Applicable Symbols:......................................................................................... 7
1.5.2 Intended User and Patient Population:............................................................. 8
1.5.3 Compliance with medical device regulations:................................................... 8
EMC considerations:.................................................................................................. 8
EC authorized representative:.................................................................................... 8
Manufacturing Information:......................................................................................... 9
2System ................................................................................................................................... 9
System components Identification:............................................................................. 9
Product Code and Description:................................................................................... 9
List of Accessories and Consumable Components Table:.........................................10
Indication for use:......................................................................................................10
Intended use:............................................................................................................10
Residual risk: ............................................................................................................10
3Equipment Setup and Use:............................................................................................... 11
Prior to use:...............................................................................................................11
Setup: .......................................................................................................................11
Device controls and indicators:..................................................................................14
Storage, Handling and Removal Instructions:............................................................14
3.4.1 Storage and Handling: ....................................................................................14
3.4.2 Removal Instruction: .......................................................................................14
Troubleshooting Guide:.............................................................................................14

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 4 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Device Maintenance:.................................................................................................15
4Safety Precautions and General Information:............................................................... 15
General Safety Warnings and Cautions: ...................................................................15
Product Specifications:..............................................................................................16
Sterilization Instruction:.............................................................................................16
Cleaning and Disinfection Instruction: .......................................................................17
5List of Applicable Standards: ........................................................................................... 17

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 5 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
1General Information
AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which 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.
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.
Trademarks:
Trademark information can be found in www.allenmedical.com/pages/terms-
conditions.
Product may be covered by one or more patents. Please consult listing at
www.hill-rom.com/patents for any patent(s).

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 6 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Contact Details:
For complains or ordering information, please contact your supplier and refer to
the catalog. All modifications, upgrades, or repairs must be performed by an
authorized specialist.
Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL
DEGRADATION.
1.4.2 Equipment misuse notice:
Do not use 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
using the contact details provided in section 1.3 of this Instruction for Use and to 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:
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 your supplier for guidance on safe
disposal protocols.

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 7 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Operating the system:
1.5.1 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.
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
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

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 8 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
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
Intended to show when the IFU should be
referenced for use
EN ISO 15223-1
1.5.2 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
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)
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: [phone]

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 9 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
2System
System components Identification:
Product Code and Description:
F-70300 -Prone Head Positioner
Head Positioner Lock Knob
Tethered to Mount Task
Head Positioner Mask
Mirror
Mount Mask
Mount
Mask Lever

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 10 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
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
F-30010 (US), F-30010E (EU), F30010UK (UK)
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.
Indication for use:
The Head Positioner is used in a variety of surgical procedures including, but not
limited to spine surgery. These devices are capable of being used with a broad
patient population as determined appropriate by the caregiver or institution.
Intended use:
The Head Positioner is designed to position and support the patient’s head in a
variety of surgical procedures including, but not limited to spine surgery. These
devices are intended to be used by healthcare professionals within the
Operating Room setting.
Residual risk:
This product complies with relevant performance, safety standards. However,
patient or device harm from misuse, device damage, device, function or
mechanical hazards cannot be completely excluded.
Name of Consumable
Product number
Comfort Mask
F-70310

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 11 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
3Equipment Setup and Use:
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.
Setup:
Step 1: Place head
positioner on Spine System
approximately 12” from
chest supports.
Step 2: Push down firmly on
the clamp latch to lock the
Supine Top into place. Pull
outward on the clamp
latch to ensure the clamp
is locked.
Step 3: Place disposable
mask.

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 12 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Step 4: Ensure lateral slide is
locked.
Step 5: Adjust height to
same level as Wing Set
pads.
Step 6: Lock ball joint
securely.
Step 7: Remove handle.
Patient Transfer
Step 8: Place the disposable mask
on the patient, while in the supine
position on a stretcher.
Step 9: Guide intubation tubes into
the chin cradle during patient
transfer.

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 13 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Operational Adjustment
Step 10: Rotate mirror up to visualize
patient’s face.
Step 11:
Adjust position on patient’s face.
•Unlatch and slide Head Positioner
along frame.
•Ensure patient’s eyes are free
from any contact and chin is
adequately supported.
•Press down latch after
repositioning.
Step 12:
Adjust lateral shift.
•Unlock Lever.
•Support head and adjust slide block.
•Lock lever.
Eyes Free
Chin
Supported

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 14 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Step 13:
Adjust neck to neutral position
(2-person operation)
a. First person must support patient’s
head while second person releases
ball joint.
b. Position as desired.
c. Lock ball joint securely.
Step 14:
Intraoperative adjustments
a. Disconnect intubation tube and feed through opening in mask and Head
Positioner.
b. Fold mirror down for suction.
c. Release latches and shift Head Positioner after Spine System articulations.
Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.
Storage, Handling and Removal Instructions:
3.4.1 Storage and Handling:
The product should be stored in a clean and safe environment to prevent product
damage.
3.4.2 Removal Instruction:
1. Push the white clamp locks down to unlock.
2. Pull up firmly on the clamp latches to release.
3. Ensure both latches are released during removal.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of
the device shall first contact his or her supplier.

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 15 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Device Maintenance:
Make sure that all labels are installed and can be read. Replace labels as
necessary by using a plastic scraper to remove the label. Use an alcohol wipe to
remove any adhesive residue.
Contact Allen Medical Systems, Inc. if you need to repair or replace the device
contact us using the information from the contact details section (1.3).
4Safety Precautions and General Information:
General Safety Warnings and Cautions:
WARNING:
a. Do not use if product shows visible damage.
b. 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.
c. 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.
d. Not intended for rigid fixation, Head positioner to be used as a support surface
only.
e. Lock ball joint securely to avoid patient injury.
f. Remove handle after tightening ball joint to avoid unintended release. (See
step 6&7)
g. Do not use if product shows visible damage
h. Do not exceed 500lb patient weight limit.
i. To avoid injury to patient, ensure head positioner is properly latched and locked
prior to loading a patient.
CAUTION:
Do not exceed safe working load shown in the product specification table

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 16 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
Mechanical Specifications
Description
Product Dimensions
Length 18 ½” (47cm)
Width 12 1/8” (30.8cm)
Height 10” (25.4cm)
Material
•Engineering Polymers
•Stainless Steel
•Aluminum
Safe Working Load on the device
500 lbs. (226 kg)
Overall Weight of Complete Device
20 lbs. (9 kg)
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC
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
The Prone Head Positioner is compatible
with:
1. Spine System (F-70100)
2. Jackson Table
3. Other spinal frame with 17” spaced
1¼”W x 1 ½”H
4. Comfort Mask Disposable
Operating Room Table Compatibility
The Prone Head Positioner is compatible
with the following surgical table rail styles:
US, UK, EU, DEN, JP, SWISS.

INSTRUCTIONS FOR USE
Document Number: D-720741 Page 17 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Cleaning and Disinfection Instruction:
•Clean the device after Each use.
•Clean and disinfect using a quaternary ammonium disinfecting/cleaning
solution following the manufacturers recommendation for achieving low-
level disinfection.
•Read the cleaning product’s directions and follow the instructions on the
label. Use caution in areas where fluid migration may occur.
•After use of disinfectant, clean the device with alcohol-based wipes.
•Dry product with a dry, absorbent and lint free cloth.
•Make certain the product is dry prior to reinstalling or storing to avoid
damage.
WARNING: Damage may result if product is cleaned with bleach.
CAUTION: DO NOT IMMERSE IN ANY LIQUID.
CAUTION: DO NOT USE BLEACH OR PHENOLICS.
5List 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

Prone Head Positioner
Instructions d'utilisation
N° de produit F-70300
D-720741
VERSION C

INSTRUCTIONS D'UTILISATION
Document Number: D-720741 Page 19 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
INFORMATIONS IMPORTANTES
•Lisez et assimilez tous les avertissements présents dans ce manuel et sur le
dispositif avant de l'utiliser avec un patient.
•Le symbole sert à alerter l'utilisateur à propos de procédures importantes
ou d'instructions de sécurité concernant l'utilisation de ce dispositif.
Le symbole sur les étiquettes sert à indiquer quand il est nécessaire
de se reporter aux instructions d'utilisation.
•Les techniques détaillées dans ce manuel sont uniquement des suggestions
du fabricant. La responsabilité finale des soins au patient en ce qui
concerne ce dispositif incombe au médecin traitant.
•Le fonctionnement du dispositif doit être contrôlé avant chaque utilisation.
•Le dispositif doit être utilisé uniquement par du personnel qualifié.
•Toutes les modifications, mises à jour ou réparations doivent être effectuées
par un spécialiste agréé.
•Gardez ce manuel pour référence future.
•Tout incident grave qui survient en lien avec le dispositif doit être signalé au
fabricant et à l'autorité compétente figurant dans le présent document.
Avant d'utiliser ce dispositif ou tout autre dispositif médical avec un
patient, il est recommandé de lire les Instructions d'utilisation et de
se familiariser avec le produit.

INSTRUCTIONS D'UTILISATION
Document Number: D-720741 Page 20 Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
Table des matières
Prone Head Positioner (F-70300)
1Informations générales ..................................................................................................... 22
Avis de droits d'auteur :.............................................................................................22
Marques de commerce :............................................................................................22
Coordonnées : ..........................................................................................................23
Consignes de sécurité :.............................................................................................23
1.4.1 Avis relatif au symbole de danger pour la sécurité :........................................23
1.4.2 Avis de mauvaise utilisation de l'équipement : ................................................23
1.4.3 Avis aux utilisateurs et/ou aux patients :..........................................................23
1.4.4 Mise au rebut en toute sécurité :.....................................................................23
Utilisation du système : .............................................................................................24
1.5.1 Symboles applicables : ...................................................................................24
1.5.2 Population de patients et utilisateurs prévus : .................................................25
1.5.3 Conformité au règlement relatif aux dispositifs médicaux :..............................25
Considérations relatives à la CEM : ..........................................................................25
Représentant autorisé dans la CE :...........................................................................25
Informations de fabrication :......................................................................................26
2Système............................................................................................................................... 26
Identification des composants du système :..............................................................26
Code produit et description : .....................................................................................26
Liste des accessoires et tableau des consommables :..............................................27
Indication d'utilisation :..............................................................................................27
Usage prévu :............................................................................................................27
Risque résiduel :.......................................................................................................28
3Mise en place et utilisation du dispositif :....................................................................... 28
Avant l'utilisation : .....................................................................................................28
Mise en place :..........................................................................................................28
Commandes et indicateurs du dispositif :..................................................................31
Instructions de stockage, de manipulation et de dépose : .........................................31
3.4.1 Stockage et manipulation :..............................................................................31
3.4.2 Instructions de dépose :..................................................................................32
Guide de dépannage :...............................................................................................32