Hillrom Affinity 4 Birthing Bed User Guide

User Guide for Hillrom models including: Affinity 4 Birthing Bed, Affinity, 4 Birthing Bed, Birthing Bed, Bed
Affinity 4 Birthing Bed Instructions for Use Ver 16

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Affinity 4 Birthing Bed Instructions for Use Ver 16 - Hillrom

Nov 6, 2024 — Replace this manual (USR025) if it is damaged and/or can not be read. Reference . Hillrom Affinity 4 Birthing Bed Service Manual (195826). Hillrom ...
2024-11-06 — ... F. Central brake and steer pedal. N. Siderail lighting control (optional). G. Storable labor grips. O. Air support system (optional). H. CPR feature. P.
[PDF] Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16) i

Warning—If the integrity of the external protective earth conductor is in doubt, operate the bed from its internal electrical power source. ... tray (lift ...
File Info : application/pdf, 66 Pages, 12.00MB
u025 16
Hillrom Affinity 4
BIRTHING BED
Instructions for Use
Product No. P3700
USR025 REV 16

QUICK VIEW LIST OF BED FEATURES

Caregiver-Side Control

Patient-Side Control

Item A B
C D E F G H

Description
V-cut or straight-cut mattress Lift-off, Stow and Go Foot Section or Slide off foot sectiona EasyGlide Calf Supports OneStep Foot Supports Fluid basin Central brake and steer pedal Storable labor grips CPR feature

a. Slide off foot section no longer available.

Item I J

Description 8° trend-like position One-handle siderail release

K

Removable headboard

L

Lockout indicator

M

Battery indicator

N

Siderail lighting control (optional)

O

Air support system (optional)

P

Siderail communications package,

(optional)

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

i

PATENTS / PATENT hillrom.com/patents
May be covered by one or more patents. See the above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications.

Legal Manufacturers: HILL-ROM, INC. 1069 STATE ROUTE 46 E BATESVILLE, IN 47006 USA
Authorized Brazilian Representative: VR MEDICAL - MEDICAL DEVICES IMPORTER & DISTRIBUTOR, LTDA. 391 BATATAES STREET CJ 11-13, 8TH FLOOR SÃO PAULO, SP - BRAZIL CNPJ: 04.718.143/0001-94
Authorized Representative for Kazakhstan:
Kazakh LLP "MITEK ALMATY" (MITEK ALMATY) KAZAKHSTAN, ALMATY CITY, ZHETYSU DISTRICT, STREET LOBACHEVSKY, HOUSE 78
Authorized Representative in Ukraine: STALMED LLC KAZIMIRA MALEVICHA STR. 31, OFFICE 353 03150, KYIV, UKRAINE M: +38-044-451-50-52

Authorized Australian Sponsor: HILL-ROM PTY LTD 1 BAXTER DRIVE OLD TOONGABBIE NSW 2146 AUSTRALIA
Authorized European Union Representative and EU Importer: HILL-ROM SAS B.P. 14 - Z.I. DU TALHOUËT 56330 PLUVIGNER FRANCE Tel: +33 (0)2 97 50 92 12
Russian LLP "ALMATY" (ALMATY) KAZAKHSTAN, ALMATY CITY, ZHETYSU DISTRICT, STREET LOBACHEVSKY, HOUSE 78

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 Hill-Rom Services, Inc. (Hill-Rom).

The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill-Rom.
The information in this manual is subject to change without notice. Hill-Rom makes no commitment to update or keep current the information in this manual.
Hill-Rom reserves the right to make changes without notice in design, specifications, and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products.
Notice to Users and/or Patients in EU--Any serious incident that has occurred in relation to this device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

This manual (USR025) was originally released and supplied in English. For a list of available translations, contact Baxter Technical Support.

Product images and labels are for illustrative purposes only. Actual product and label may vary.

Sixteenth Edition, 2024-10 First Printing, 2000

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Baxter, Affinity 4, EasyGlide, Hillrom, OneStep, Point-of-Care, SideCom and Stow and Go are trademarks of Baxter International Inc. or its subsidiaries.
Any other trademarks, product names or brand images appearing herein are the property of their respective owners.
For product support or to order additional copies of this manual (USR025), contact your distributor, local Baxter representative, or go to www.hillrom.com.
Replace this manual (USR025) if it is damaged and/or can not be read.
Reference Documents
Hillrom Affinity 4 Birthing Bed Service Manual (195826)
Hillrom Affinity 4 Birthing Bed--Unpacking Instructions (180987)

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

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NOTES:

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Table of Contents
Quick View List of Bed Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Product Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 All AFFINITY 4 Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 B through D Model Beds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 E Model and Newer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
POINT-OF-CARE Bed Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Caregiver Bed Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Bed Up/Down (Hilow) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Lockout Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Caregiver and Patient Bed Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Back Section Lumbar Mattress Control (Optional) . . . . . . . . . . . . . . . . . . . . . . . 11 Foot Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Head Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Nurse Call (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Seat Section Mattress Control (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Patient Bed Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 TV On/Off (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Bed Frame Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Central Brake and Steer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Automatic Tilt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 CPR Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Fluid Basin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Foot Section (Lift-Off or Slide-Off). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 STOW AND GO Foot Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 ONESTEP Foot Supports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Headboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Labor Grips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

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Table of Contents

Night Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Battery Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Battery Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Siderails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Trend-Like Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Optional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Air Support System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Seat Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Lumbar Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Siderail Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Built-In SIDECOM Communication System Controls (Optional) . . . . . . . . . . . . . . . . 21

Built-In Siderail Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Casters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Calf Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Mattresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Mattress Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Non-Air Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Wood Headboards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Patient Positioning--Labor and Birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Upright Position/Voiding Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Lateral Position (Sims) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Kneeling Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Legs Elevated With Foot Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Squatting With The Labor Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Pushing With The Labor Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Pushing With The Labor Bar (With Foot Supports) . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Pushing with Calf Supports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Epidural/Spinal (Lateral Approach) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Epidural (Sitting Approach) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Straight Line Trend-Like Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

General Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Throne Position (Chair) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Birthing Bed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Delivery Table Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

With Calf Supports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Table of Contents

With Full Leg Supports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

High Modified Trend-Like Position (Birth And Repair) . . . . . . . . . . . . . . . . . . . . . . . 28

Transport the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Transport Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Anesthesia Screen--P9625 (No Longer Available) . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Arm Board--P9620 (No Longer Available) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Calf Supports--P3705A and P35745 (No Longer Available) . . . . . . . . . . . . . . . . . . . 31

Comfort Pad--P3612TPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Disposable Funnel Drape--P7834 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Foley Hook Kit--P3623 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Foot Rest Bar--P451 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Full Leg Supports--P7625 (No Longer Available) and P7634C . . . . . . . . . . . . . . . . 32

Headboards--P3617 and P3629 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Infusion Support System (ISS)--P158A and P159 . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Labor Bar--P3613B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Oxygen Tank Holder--P27605 (No Longer Available) . . . . . . . . . . . . . . . . . . . . . . . . 34

Oxygen Tank Holder--P276A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Pendant Control Kit with Holder--P5362 and P3618 (No Longer Available) . . . . . 35

Permanent IV Pole--P222101 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Rail and Hanger--P53120120 and P17073001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Slipcovers (Head and Foot)--140562, P3628C, P3630B and P3631B . . . . . . . . . . 36

Slipcover Upgrade Kits--P3730A and P3731A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Push Handles--P015378 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Line Manager -- P3733 (No Longer Available) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Permanent IV Pole--P3732A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Prepare the Bed for Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . 41

STEP 1: Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

STEP 2: Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Prepare the Bed for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Laundry Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Care of Wood Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

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Table of Contents
Mattress Care and Draping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Decommissioning and Disposal Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Expected Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Electromagnetic Emissions Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Intended Use
INTENDED USE
The Hillrom Affinity 4 Birthing Bed is intended to be used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. It is not intended for use as a general hospital bed.
The intended users of this product 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. There are some controls and features on the bed intended to be used by the patients and family members upon appropriate orientation by the caregiver. Follow facility safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the product safely.
The maximum patient weight is 470 lb (213 kg).
The bed safe working load is 500 lb (227 kg).
Safe working load: includes mattresses, headboard, patient weight, any accessories or equipment on the bed, caregiver weight, and any visitors sharing the bed.
There are no known Contraindications for this product.
INTRODUCTION
This document provides the information required for normal operation of the Affinity 4 Birthing Bed from Baxter. Before operating the Affinity 4 Birthing Bed, be sure that you have read and understood in detail the contents of this document. It is important that you read and strictly adhere to the aspects of safety contained in this document. Any reference to a side of the bed is from the patient's view lying in the bed on their back.
In this document, there are references to different bed models. To identify which model of bed you have, look at the serial number label. The label is located on the main frame at the head end. For example, P3700BXXXX identifies a B model bed.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

1

Safety Information

SAFETY INFORMATION

WARNING: Obey all warnings throughout this document. Failure to do so could cause injury and/or equipment damage:
· Warning--Read and understand all warnings in this document and on the unit itself prior to use with a patient.
· Warning--Follow the product manufacturer's instructions.
· Warning--To help prevent the risk of hospital bed fires, make sure facility persons follow the safety tips in the FDA Public Health Notification: Safety Tips for Preventing Hospital Bed Fires. (US only)
· Warning--Evaluate patients for entrapment and fall risk according to facility protocol, and monitor patients appropriately.
· Warning--The bed should be left in the lowest position when the patient is unattended.
· Warning--Make sure that you position tubes, lines, and linens away from moving parts.
· Warning--Make sure patient hands are kept away from moving parts while operating the bed.
· Warning--Stay clear of pinch and contact points while adjusting the foot support.
· Warning--Make sure the position of the unit is such that you can quickly, without obstruction, unplug the power cord from the main power supply if necessary.
· Warning--The potential for electrical shock exists with electrical equipment. Failure to follow facility protocols may cause death or serious injury.
· Warning--Establish policies and procedures to train and educate your staff on the risks associated with electrical equipment.
· Warning--Incorrect use or handling of the power cord may cause damage to the power cord. If damage has occurred to the power cord or any of its components, immediately remove the Base from service, and contact the applicable maintenance persons.
· Warning--To reduce the risk of electric shock, the bed should only be connected to supply mains with a protective earth.
· Warning--If the integrity of the external protective earth conductor is in doubt, operate the bed from its internal electrical power source.
· Warning--Only use Hillrom or Baxter power cords as a replacement. Other power cords have not been investigated for compliance with electrical safety standards for this product.
· Warning--Only use Hillrom or Baxter specified mattresses, parts, and accessories. Do not modify the bed system without authorization from Baxter.
· Warning--The included power cord set and Li-ion battery may not be used with any other equipment other than Affinity 4 Birthing Bed models they are packaged with.
· Warning--Do not operate the bed in the presence of flammable gas or vapors.
· Warning--Young children should be supervised around the bed.
· Warning--Visitors should not sit on the bed.
· Warning--Use oxygen administering equipment of the nasal, mask, or ventilator type only. Do not use the bed with oxygen tents.
· Warning--Deactivate the bed functions using the lockout control. Movement of a patient or inadvertent activation of the bed functions by anyone else could result in personal injury.
· Warning--Do not use the bed if a malfunction occurs. Contact the applicable maintenance persons.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Symbols
CAUTION: Obey all cautions throughout this document and also the safety information below. Failure to do so could cause equipment damage:
· Caution--Do not sore anything under the bed. · Caution--Use only parts and accessories from Baxter. Do not modify or change the bed system
without approval from Baxter.
California Proposition 65 Warning
WARNING: Warning--This product can expose you to chemicals including Lead and Di (2-ethylhexyl) phthalate (DEHP), which are known to the State of California to cause cancer, and Lead and Di (2-ethylhexyl) phthalate (DEHP), which are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
SYMBOLS
This document contains different typefaces and symbols to make the content easier to read and understand: · Standard text--used for regular data. · Boldface text--emphasizes a word, phrase, or trademark. · NOTE:--sets apart special data or important instruction clarification. · WARNING or CAUTION
Warning-- identifies situations or actions that may have an effect on patient or user safety. To ignore a warning could cause patient or user injury. Caution--identifies special procedures or precautions that persons must obey to help prevent equipment damage.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

3

Symbols

PRODUCT SYMBOLS

These symbols are on the product and may or may not be on your model of the Affinity 4 Birthing Bed:

Symbol

Description

All AFFINITY 4 Models

Symbol

Description

Catalog number

Serial Number

Manufacturer

Date of manufacture

Warning--Do Not Use with Oxygen Tents-- Must consult accompanying documentation--indicates the use of oxygen administering equipment of the nasal, mask, or ventilator type only or oxygen tents that can be contained inside the siderails. Can be green or blue.
Type B applied part according to IEC 606011 (UL 60601-1).

Conforms to European requirements for class I medical devices in accordance with Regulation (EU) 2017/745
Medical Device

Bed Up/Bed Down control.

Do not step--do not step on the Stow and Go Foot Section.

Foot and head sections Up/Down controls.
Battery charge status (refer to the section titled "Battery Backup" on page 19 for battery status information).

Blue and black is for B through D model beds. Red and black is for E model and newer beds.
Warning--Do not step (located on the base frame). Blue and black is for A through D model beds. Red and black is for E model and newer beds.
Shows that you should not hang power cords on the Line Managers.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Symbol

Description
Nurse call (refer to the section titled "Nurse Call (Optional)" on page 12 for nurse call switch information).

Symbol

Lockout control status--when the lockout control status light is on, the lockout function is activated.
Identifying mains fuse.

Do not throw away--

indicates the need to

recycle the item in

accordance with local

Pb

regulations.

B through D Model Beds

According to IEC 60529, rating for protection against fluid ingress and identified as equipment that is protected against vertically falling water when tilted up to 15°.

Caution--Consult accompanying documents.

Certified by Underwriters Laboratories, Inc. (Serial Numbers after H297AA4665 and up to Serial Numbers beginning with M170AA; as being in accordance with that which is shown in the Classification and Standards table (see page 49)

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Symbols
Description Do Not Push--do not use the headboard to push the bed. On wood headboards without integrated push handles. Equipotentiality. Beds with grounding post only.
Alternating current
Manufacturer or distributer complies with the Waste Electric and Electronic Equipment Directive 2002/96/EC. Room Light On/Off control.
Back section mattress (lumbar) control.
Seat section mattress control (optional).
5

Symbols
Symbol

= kg

Description

Symbol

CPR function--Identifies the release lever that can be used to manually drop the inclined head section, in order that cardiopulmonary resuscitation can be performed without delay.
Safe working load.

Electric shock hazard.
Calf support release lever.
Trend-Like function.

Description TV On/Off/Audio control (optional).
Lockout control label-- The switch in the up position indicates the lockout control is on. The switch in the down position indicates the lockout control is off (refer to the section titled "Lockout Controls" on page 11 for lockout status information). Keep feet clear of this area. do not step on the Stow and Go Foot Section. Potential for injury. Lock and unlock position of the calf support.
Transport label.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Symbol E Model and Newer

Description

Symbol

According to IEC 60529, rating for protection against fluid ingress and identified as equipment that is protected against vertically falling water when tilted up to 15°.

Certified by Underwriters Laboratories, Inc. (P3700E Serial Numbers that begin with M171AA and up to Serial Numbers beginning with O218AA; as being in accordance with that which is shown in the Classification and Standards table (see page 49) Certified by Underwriters Laboratories, LLC (P3700E Serial Numbers that begin with O219AA and higher); as being in accordance with that which is shown in the Classification and Standards table (see page 49) Complies with the requirements of California prop 65
Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Symbols
Description
Total bed weight, including the rated safe working load (SWL), is 470 kg (1036 lb); and where the rated SWL for the bed-frame includes maximum patient weight. This label is only applicable to the P3700E Serial Numbers after those that begin with S361AA (and in accordance with the standards shown in the Classification and Standards table on page 49). Note: Affinity 4 bed weight, excluding rated SWL, is 244 kg (536 lb) minimum. Warning--Consult accompanying documents. Yellow and black.
Caution--Consult accompanying documents. White and black.
7

Symbols
Symbol
8

Description

Symbol

Medical Bed for Adults. (P3700E Serial Numbers after those that begin with S361AA)

Back section mattress (lumbar) control.
Room Light On/Off control.
Seat section mattress control (optional).

Description
Lockout control label-- The switch in the up position indicates the lockout control is on. The switch in the down position indicates the lockout control is off (refer to the section titled "Lockout Controls" on page 11 for lockout status information).
Caution--Identifying power inlet fuse or a battery power inlet fuse. Consult accompanying documentation.
Warning--Protective earth ground--Must consult accompanying documentation. Beds with grounding post only.
Lock and unlock position of the calf support.

TV On/Off/Audio control (optional).

Calf support release lever.

CPR function--Identifies the release lever that can be used to manually drop the inclined head section, in order that cardiopulmonary resuscitation can be performed without delay.

Warning--Transport label. Must consult accompanying documents.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Symbol

Description
Warning--Bed safe working load.

Symbol

Warning--Maximum patient weight.

Symbols
Description
Warning--Engage foot section latch-- Stow and Go Beds. Must consult accompanying documents. Warning--Lift-off foot section--engagement advisory. Must consult accompanying documents.

Warning--Safe working load--foot section only. Must consult accompanying documents.
Warning--Electrical shock hazard. Must consult accompanying documents.
Warning--Use hospital grade receptacle only. Must consult accompanying documents. Beds without grounding post only.

Caution: Connect to approved communication system only. Consult accompanying documents.
Warning--Must consult accompanying documents. On the pendant and calf support.
Trend-Like function.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

9

POINT-OF-CARE Bed Controls
POINT-OF-CARE BED CONTROLS
The Affinity 4 is electrically operated using siderail or pendant controls. The hilow, head, and foot functions can be operated by battery backup, if necessary.
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Before you press a bed articulation control, make sure that objects and devices are away from the bed's articulating sections.
· Warning--Make sure to monitor the patient and all patient interface lines during articulation. · Warning--Keep hands and feet away from openings between the bed sections during
articulation.
Affinity 4 Birthing Bed (B through D model beds)

Caregiver Control Panel Affinity 4 Birthing Bed (E model beds)

Patient Control Panel

Caregiver Control Panel
CAREGIVER BED CONTROLS
Bed Up/Down (Hilow)

Patient Control Panel

CAUTION: Caution--Make sure the bed does not touch the wall at the head end. When the bed is raised, it moves slightly towards the head end. If the bed is too close to the wall, damage could occur.
The Bed Up/Down controls located on both siderails allow you to raise or lower the bed 16" (41 cm). The low position is for general use and to assist with patient egress, while the high position is used for patient procedures.
To raise--press and hold the Bed Up control until the bed is at the desired height.
To lower--press and hold the Bed Down control until the bed is at the desired height.

WARNING:
Warning--Leave the bed in the low position when the patient is unattended. This can reduce the possibility of patient falls and the severity of any resultant injuries.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

POINT-OF-CARE Bed Controls
NOTES: · If the foot section is at its lowest position when the bed is lowered, the bed will stop at a higher position to ensure that the foot section does not interfere with the base. · If the bed is in the low position and the Trend-Like function is activated, the bed will rise to the appropriate height to allow the bed to move to the full Trend-Like position.
Lockout Controls The Lockout controls deactivate the hilow, head, and foot functions on the bed. When a lockout is activated, both the patient and caregiver controls for motor functions are locked out. To lock--press the Lockout control switch to deactivate the motors. The lockout LED indicator on the siderail will light. Activating the lockout function does not affect the operation of the emergency CPR Release.
CAREGIVER AND PATIENT BED CONTROLS
Back Section Lumbar Mattress Control (Optional) The Back Section Mattress (Lumbar) control enables you to inflate or deflate the back section lumbar mattress in order to attain a degree of firmness or softness. To inflate-- press and hold the Back Firm control (plus sign) until the desired firmness is attained. To deflate-- press and hold the Back Deflate control (minus sign) until the desired softness is attained.
Foot Section The Foot Up/Down controls located on both siderails enable you to raise or lower the foot section of the bed 9" (23 cm) of travel from its lowest position.
WARNING: Warning--When the labor grips and calf supports are in position for use, be careful when you lower the foot section. Failure to do so could cause the patient's hands to become trapped between the labor grip and calf support. To raise--press and hold the Foot Up control to raise the foot section of the bed. To lower--press and hold the Foot Down control to lower the foot section of the bed. NOTE: If the foot section is at its lowest position when the bed is lowered, the bed will stop at a higher position to ensure that the foot section does not interfere with the base.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

11

POINT-OF-CARE Bed Controls
Head Section
The Head Up/Down controls located on both siderails enable you to raise or lower the head section of the bed. The head section can be raised to any angle of inclination up to 63°.
To raise--press and hold the Head Up control to raise the head section of the bed.
To lower--press and hold the Head Down control to lower the head section of the bed. NOTE: The Head Up/Down and Bed Up/Down functions will not work at the same time. If you press the Head Up and Bed Up control, the bed will raise until you release the Bed Up control.
Nurse Call (Optional)
On beds equipped with the optional nurse call feature, use the Nurse Call control to place a call to the nurse call system. Above the Nurse Call control, the Call indicator light illuminates and flashes on the patient's siderail controls, indicating a call has been made.
To Activate 1. Press and release the Nurse Call control. 2. The LED indicator above the switch will flash indicating that the patient placed
a nurse call. When the nurse answers, the LED indicator will turn on solid. The nurse may then talk to you and you may speak into the speaker /microphone.
WARNING: Warning--If the Nurse Call control does not operate, make sure the patient knows that pressing the control will not call the nurse. Patient injury may occur.
CAUTION: Caution--If power to the bed is lost, the nurse call function can still operate up to 4 hours depending on the charge of the battery. Before becoming completely non-functional, the system will place a noncancellable nurse call. NOTE: The Nurse Call controls cannot be locked out.
Seat Section Mattress Control (Optional)
The Seat Section Mattress Control enables you to inflate or deflate the seat section mattress in order to attain a degree of firmness or softness.
To auto-inflate the seat section--press the Caregiver Seat Inflate control (plus sign). To cancel the auto-inflate function, press the Caregiver Seat Inflate control (plus sign) again.
To auto-deflate the seat section--press the Caregiver Seat Deflate control (minus sign). To cancel the auto-deflate function, press the Caregiver Seat Deflate control (minus sign) again.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Bed Frame Features
To inflate or deflate the seat section from the patient controls--press and hold the Patient Seat Inflate control (plus sign) or the Patient Seat Deflate control (minus sign). NOTE: The auto-inflate function runs for 20 to 25 seconds before shutting off.
PATIENT BED CONTROLS
TV On/Off (Optional) The TV on/off control turns on and off the audio for the television and radio. To activate--press and release the TV control. The television and radio audio come on. The television and radio volume controls on the patient siderail control panels are now operational. To deactivate--press and release the TV control. The green indicator light goes off, and the television and radio audio are muted.
BED FRAME FEATURES
CENTRAL BRAKE AND STEER
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Unless you are to transport a patient, always set the brakes when the unit is occupied. Make sure the brakes are set before any patient transfer on to or off the bed.
· Warning--Keep feet out from under the brake/steer pedal when you engage it.
CAUTION: Caution--Make sure the bed does not touch the wall at the head end. When the bed is raised, it moves slightly towards the head end. If the bed is too close to the wall, damage could occur. The Affinity 4 Birthing Bed is equipped with 4-wheel braking and 1-wheel steering. To brake--step down firmly on the Brake Pedal. Casters will immediately lock into place. Push and pull on the bed to ensure the brakes are set. To release, press firmly on the Steer Pedal until both pedals are level (neutral position). To steer--step down firmly on the Steer Pedal. To release, press firmly on the Brake Pedal until both pedals are level (neutral position).

To Brake

To Steer

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

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Bed Frame Features
AUTOMATIC TILT
· As the head section is raised, the seat section gradually tilts up from 0° to 15°.
· As the head section is lowered, the seat section gradually returns to a flat position.

CPR RELEASE
The CPR Release enables the caregiver to save valuable time in an emergency. When activated, the CPR Release automatically lowers the head and seat section to the flat position, which creates a firm surface to support a CPR board.
To activate--Pull the emergency CPR Release handle on either side of the bed. Release your hand when the head section is down to the lowest position.

FLUID BASIN
The fluid basin is removable. and easily removed for cleaning.
To Remove/Replace the lift-off or slide-off foot section fluid basin 1. Pull the fluid basin straight out. 2. Slide the basin straight into the holding devices. 3. Shake the basin gently to ensure it is securely seated.
To Remove/Replace the STOW AND GO Foot Section fluid basin 1. Pull the basin up and out of the foot section. 2. Put the basin down in to the opening in the foot section.
FOOT SECTION (LIFT-OFF OR SLIDE-OFF)
To Remove The foot section can be removed by using the following methods: If the foot section height can be adjusted: 1. Adjust the foot section so that the top of the mattress is about
waist high. 2. Turn the mattress wings inward. 3. Pivot the foot supports laterally.

Lift-off Fluid Basin
Stow and Go Foot Section Fluid Basin

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Bed Frame Features
· Grasp the handles, and hold the foot section as close to the body as possible.
· Lift-Off Foot Section: Lift and slide the foot section toward you (bending your knees) while taking a step backward.
· Slide-Off Foot Section: Squeeze the release levers to disengage the foot section, and slide the section toward you (bending your knees) while taking a step backward.
· Lift-Off Foot Section: With the knees bent, place it on the floor with the perineal stand down to hold it upright.
If the foot section is well below the waist and cannot be adjusted:
· Turn the mattress wings inward.
· Pivot the foot supports laterally.
· Approach the foot section from an angle (side or front).
· Place one leg forward and one leg back, bending the knees slightly.
· Grasp the handles, and hold the foot section as close to the body as possible.
· Lift-Off Foot Section: Lift and slide the foot section toward you while taking a step backward.
· Slide-Off Foot Section: Squeeze the release levers to disengage it, and slide the foot section toward you while taking a step backward.
· Turn the foot section so the stand is down and, with the knees bent, place it on the floor.
To Install
1. Grasp the foot section with both hands.
2. Position the foot section onto the mounting brackets located on the bed frame.
3. Lift-Off Foot Section: While holding the foot section level, lift and slide it until the latches securely engage and a level surface is achieved.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

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Bed Frame Features
4. Slide-Off Foot Section: While holding the foot section level, push it until the latches securely engage and a level surface is achieved.
5. Pull on the foot section to ensure that it is locked into position. NOTE: If the foot section is not level, this is an indication that it is not locked into position.
6. Lift the foot section to the level position and push until the latches securely engage.
WARNING: Warning--The foot section must be fully secured under the mattress to provide safe support. Possible personal injury or equipment damage could occur.
The foot section must be locked into place. Pull to ensure that the latch is engaged.
STOW AND GO FOOT SECTION
To Remove 1. Adjust the foot section so that
the top of the mattress is about waist high. 2. Pivot the foot supports laterally. 3. Fold up the sides of the foot section mattress. 4. Grasp the handles on the side of the foot section mattress, and lift the mattress off the foot section. Or grasp the pull strap at the end of the mattress and pull the mattress away from the bed. 5. Put the mattress in an applicable location off of the bed. 6. Grasp the foot section by the handle. 7. Raise the end of the foot section up. The foot section will start to slide down under the bed. 8. Lower the back edge of the foot section until it stops. 9. Push the foot section under the bed until it stops.
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Make sure the foot section is securely locked in place when you install the mattress. · Warning--Do not force the Stow and Go Foot Section into the stow position.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Bed Frame Features
To Install 1. Grasp the handle on the foot section. 2. Pull up on the foot section until it locks into
position. 3. Put the mattress on the foot section. 4. Make sure the mattress catch goes into the
foot section catch. 5. Push the foot end of the mattress down in
front of the handle. 6. Unfold the mattress. 7. Put the foot supports in the applicable position.
ONESTEP FOOT SUPPORTS
The OneStep Foot Supports can be simultaneously positioned up or down, through use of the motor powered foot section yoke. This foot section yoke controls the overall height up and down. Each support can be independently positioned by using the mechanical release latches at the end of the foot supports.
WARNING: To help prevent injury and/or equipment damage, obey the following warnings:
· Warning--When you adjust the foot supports, stay clear of pinch and contact points.
· Warning--Make sure the foot supports are securely locked in place before use.
To Adjust the Foot Supports · To position the patient's legs, squeeze the release lever and rotate the foot support. The foot support rotates upward and outward from 0° to 85°. · To return to the storage position, squeeze the release latch again, and return the supports to the desired position.
The maximum safe working load is 150 lb (68 kg).
HEADBOARD
The headboard includes built-in handles which aid in steering control and increase mobility. The headboard assembly is removable.
To remove--grasp the hand holds firmly, and lift up.
To install--align the headboard sockets with the posts on the bed frame, and lower the headboard until it rest on the bed frame.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

17

Bed Frame Features
IV POLE
The bed comes equipped with one IV pole, stored at the head end of the bed on the headboard. The IV pole sockets are located at each corner of the bed at the head end.
WARNING: To help prevent injury or equipment damage, obey these warnings:
· Warning--Do not exceed the 40 lb (18 kg) load capacity of the IV pole.
· Warning--Do not exceed the 2.5 lb (1.1 kg) load capacity of the hook. To install--remove the IV pole from the holders. Insert the pole into the desired socket, and turn clockwise until it drops fully into the socket and locks into place. The maximum safe working load is 25 lb (11 kg).
LABOR GRIPS
Ergonomically correct labor grips comfortably accommodate patients of all sizes. The handles are covered with a non-porous, fluid resistant foam that is comfortable for mothers to squeeze.
To Activate 1. To raise the labor grip, grasp the grip, and rotate it from under the bed
until it clicks in place. 2. To lower, pull the release latch, and lower the grip under the bed.
NIGHT LIGHT
Whenever the bed is plugged in, the night light may be always on, or may only come on when the room darkens, depending on the bed's manufacture date. It does not function when the bed is powered by the battery. On beds with serial number R298AA9413 and higher, the night light will be on when the bed is powered by the battery in Battery Backup operation and not in Battery Sleep mode. For more information, see "Battery Backup" on page 19 or "Battery Sleep" on page 19.
Location The night light is located on the bottom center of the bed frame.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Bed Frame Features

BATTERY BACKUP
The Affinity 4 Birthing Bed is designed with battery backup as a standard feature. The battery allows the hilow, foot, and head motors to be activated from the siderail controls without power being supplied to the bed. In addition, the battery backup powers the nurse call function, but it does not power any other bed functions, such as the optional air support system.
Location
The battery backup indicator is located on the siderail to indicate the battery condition.
Battery Backup LED Indicators (while connected to AC power): · ON = Battery is charging.
Battery Backup LED Indicators (while on battery power): · ON = Battery status is operational. · FLASHING = Battery needs charging. · OFF = Battery is discharged below the level required to run the motors or battery is in Battery Sleep mode.
NOTE: If the battery has been completely discharged, it may take up to 36 hours to recharge to operational status.

WARNING:
Warning--Make sure that the battery is always charged. Plug the bed into AC power whenever possible. Otherwise, patient injury, patient discomfort, and/or equipment damage may occur.

CAUTION:
Caution--Remove the battery if the bed will not be in service for extended periods of time. Failure to do so could result in damage to the life of the battery, or damage to the bed. Contact the appropriate maintenance personnel, and refer to the Hillrom Affinity 4 Birthing Bed Service Manual (195826).

BATTERY SLEEP
For Affinity 4 Birthing Beds with serial number R298AA9413 and higher, the battery sleep feature will significantly reduce battery power consumption and extend battery life when the bed is not connected to a wall power source.
To Activate
The battery sleep feature will engage as soon as the bed is unplugged from a wall power source or after 3 minutes and 42 seconds of inactivity while in Battery Backup operation.
To Deactivate
While the bed is not plugged in to a wall power source: 1. Press any caregiver motor function (see "Bed Up/Down (Hilow)" on page 10, "Foot Section" on
page 11, or "Head Section" on page 12). 2. Press any nurse call control, if equipped. 3. Quickly press the trend-like position handle (see "Trend-Like Function" on page 20).
After the battery sleep function is canceled, the bed will operate normally in Battery Backup for 3 minutes and 42 seconds after the last control is pressed.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

19

Bed Frame Features
SIDERAILS
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Evaluate patients for entrapment risk in accordance with facility protocol and/or healthcare provider directives, and monitor patients appropriately.
· Warning--Make sure the patient is clear of the siderails when you raise or lower them.
· Warning--When you raise or lower the siderail, stay clear of pinch and contact points.
· Warning--Make sure all siderails are fully latched when in the raised position. Failure to do either of these could cause serious injury or death.
NOTE: Siderails are intended to be a reminder to the patient of the unit's edges, not a patient-restraining device. When appropriate, Baxter recommends that medical persons determine the correct methods necessary to make sure a patient remains safely in bed.
Siderails in the raised position are intended to make the patient aware of the proximity of the edge of the mattress and to assist in the patient entry and exit.
CAUTION: Caution--Before you raise or lower a siderail, make sure that the area around the siderail is free of objects and devices. Failure to do so could cause equipment damage.
The bed has two siderails, one located on each side. The siderails contain caregiver and patient siderail controls, and can be adjusted between the upright and lowered positions.
To Adjust · To raise or lower the siderails, pull the Siderail Release Latch on the siderail, and swing the siderail into the desired position. When raising the siderails, you will hear a click when the siderail is securely in place. · To store a siderail, lower it completely and push it in under the bed surface.
TREND-LIKE FUNCTION
The bed can achieve up to 8° of Trend-Like positioning. You can activate the Trend-Like controls at any bed height. When the bed is in its lowest position and the Trend-Like function is activated, the bed will rise to the appropriate height in order to go into the full Trend-Like (8°) position.
To Activate 1. To position the sleep surface in a Trend-Like position, push down on the handle and guide the bed
to the desired degree, up to 8°. 2. To level the sleep surface, pull up on the handle and guide the bed to a level position.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Optional Features

OPTIONAL FEATURES
AIR SUPPORT SYSTEM
The Affinity 4 Birthing Bed features air surface controls (located on both the outside and inside of the siderail) for both seat and lumbar support. These controls provide improved patient comfort during labor, recovery, and postpartum while minimizing the cost, maintenance, and labor concerns associated with the use of overlays.
SEAT SUPPORT
Enables the patient to tailor her own comfort level. Provides pelvic support to improve practictioner access and visibility during deliveries and repairs. The firmness or softness of the surface is controlled by increasing or decreasing the amount of air contained in the air bladder. Patient and staff controls are embedded in both siderails.
LUMBAR SUPPORT
Adds varying degrees of back support in the lumbar region to improve patient comfort both before and after delivery. Fully inflated, the lumbar support allows positioning of the patient's perineum out the VCut for examination and delivery. The maximum lumbar inflation from a flat position to a full position is 4" (10 cm).

SIDERAIL CONTROLS

BUILT-IN SIDECOM COMMUNICATION SYSTEM CONTROLS (OPTIONAL)
Every Affinity 4 Birthing Bed with siderail controls is pre-wired to accommodate the SideCom Communication System now or in the future. The SideCom Communication System enables integration of the backlit nurse call, entertainment (radio and TV), and lighting in the siderails. The optional Universal TV is also available.

BUILT-IN SIDERAIL CONTROLS
Patient and staff controls are embedded in the siderails on both sides of the bed.
The patient controls are always in full view of the patient, and the international graphic symbols provide easy orientation. Patient head and foot section controls are embedded in the inside panel of the siderails (on both sides of the bed) for the patient's convenience. Powered operation allows the patient to respond to her body signals and reduces her dependence on staff assistance for positioning, support, and comfort. These controls include Head Up/Head Down and Foot Up/Foot Down.
Staff controls are embedded in the outside panel of both siderails. In addition to head and foot section controls, the outside panel contains controls for the hilow operation.

CASTERS
Five inch casters are the standard for the Affinity 4 Birthing Bed. Six inch casters are an available option for the Affinity 4 birthing bed. Eight inch casters are no longer available. The eight inch casters were available for the Affinity 4 Birthing Bed (not available for Stow and Go foot section).

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

21

Mattresses
CALF SUPPORT
The standard calf support is included with the Affinity 4 Birthing Bed. Additional calf supports are available as optional features and are identified in the Accessories section of this document (see "Accessories" on page 30).
MATTRESSES
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Replace the mattress or cushions if the cover becomes torn or cut. · Warning--Some safety features of the bed may not function or may not operate as intended
with mattresses that are not designed specifically for this bed. Check with the mattress manufacturer to make sure that the safety features of the bed have been tested and verified to operate correctly with the replacement mattress. Failure to do so could cause serious personal injury or equipment damage. NOTE: Baxter recommends the use of Hillrom or Baxter mattresses that have been designed and tested specifically for the Affinity 4 Birthing Bed. If you purchase a replacement mattress from Baxter or another manufacturer, make sure that the safety features of the bed have been tested and verified to operate correctly with the replacement mattress. The replacement mattress should meet the applicable regulations and technical standards to minimize the risk of injury to patients and caregivers. For the latest list of mattresses recommended for use, contact Baxter Customer Service.
MATTRESS MODELS
The bed is available in two options: the V-Cut or Straight-Cut.

V-Cut
Non-Air Mattress A pressure redistribution foam mattress is available.

Straight-Cut

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Patient Positioning--Labor and Birth
WOOD HEADBOARDS
The wood headboards include built-in handles which aid in steering control and increase mobility. The headboard assembly is removable. Beds with the push handle option will not have handles on the headboard.
To remove--grasp the hand holds firmly, and lift up.
To install--align the headboard sockets with the posts on the bed frame, and lower the headboard until it rest on the bed frame.
PATIENT POSITIONING--LABOR AND BIRTH
NOTE: The Labor and Delivery Drape should be placed over the bottom sheet before the patient gets into the bed.
To allow the patient to participate, show her how to operate the controls.
UPRIGHT POSITION/VOIDING POSITION
1. Raise the head of the bed to a comfortable position by pressing the Head Up control.
2. Lower the foot section by pressing the Foot Down control.
3. Place the patient in an upright position.
4. Place the bed pan backward into the V-Cut on the foot section.
5. A specimen container may also be used. Slide it between the mattress and bed frame.
6. Position the patient out and over the V-Cut having her hold the labor grips for support. 7. If the patient's legs are unstable, position her feet with the soles together to prevent sliding.
LATERAL POSITION (SIMS)
1. With the bed in the lowest position and the head of the bed adjusted for the patient's comfort, position the attached calf support with the foot end pointed toward the head of the bed.
2. With the patient lying on her left side, place her right leg in the support and lower the foot section for comfort.
3. Adjust the support, and tighten the joint.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

23

Patient Positioning--Labor and Birth
KNEELING POSITION
1. Raise the head section of the bed to the full upright position. 2. Have the patient kneel on the seat section and use the head
section of the bed for support.
LEGS ELEVATED WITH FOOT MATTRESS
This position is useful for various clinical reasons during antepartum care, postpartum care, and anesthesia administration when a patient's legs require elevation. It may also be used for patient comfort. To Adjust 1. Raise the foot section to its highest position. 2. Fold in the hinged part of the foot section mattress. 3. Place the patient's legs on the elevated mattress section.
SQUATTING WITH THE LABOR BAR
1. With the bed in the lowest position, raise the head by pressing the Head Up control, and lower the foot section by pressing the Foot Down control.
2. Insert the labor bar into the leg support sockets, so it angles away from the head of the bed.
3. The patient may squat on the seat section, holding the Labor Bar, or sit with her feet on the foot section leaning forward onto the bar.

24

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Patient Positioning--Labor and Birth
PUSHING WITH THE LABOR BAR
1. Raise the head of the bed to a comfortable position by pressing the Head Up control.
2. Insert the labor bar into the support sockets, so it angles away from the head of the bed.
3. Lower the foot section, if needed, by pressing the Foot Down control.
4. Place the patient's feet on either side of the Labor Bar. 5. The patient may grip the labor grips or pull back on her knees.
PUSHING WITH THE LABOR BAR (WITH FOOT SUPPORTS)
1. Raise the head of the bed to a comfortable position by pressing the Head Up control.
2. Remove the foot section. 3. Place the patient's feet on the foot supports and adjust for
comfort. 4. Insert the labor bar into the support sockets, so it angles away
from the head of the bed. 5. The patient may grasp the labor bar where it's comfortable for
her.
PUSHING WITH CALF SUPPORTS
WARNING: Warning--Make sure the calf supports are securely locked in place before use. Injury and/or equipment damage may occur. To Adjust 1. Adjust the head of the bed to approximately 30°, by pressing the
Head Up control. 2. Place the patient's legs on the calf supports. 3. The patient may pull back on her knees without the need for the
staff to assist her. 4. Lower the foot section if desired.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

25

Patient Positioning--Labor and Birth
EPIDURAL/SPINAL (LATERAL APPROACH)
1. Lower and tuck away one siderail. 2. Position the bed to a comfortable height, and lower the head of
the bed. 3. Place the patient in a lateral recumbent position at the mattress
edge.
EPIDURAL (SITTING APPROACH)
1. Raise or lower the bed to a comfortable height for the staff, and flatten the bed.
2. Have the patient dangle her legs over the opposite side of the bed.
STRAIGHT LINE TREND-LIKE POSITIONING
1. Pull the CPR Release to lower the head of the bed to a full flat position.
2. Push down on the Trend-Like handles (located on either side of the bed) and guide the bed to the desired degree, up to 8°.
3. To level the sleep surface, pull up on the handle and guide the bed to a flat position.
General Anesthesia 1. In an emergency, position the bed to a comfortable height. 2. Remove the headboard. 3. Position the patient for intubation.

26

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Patient Positioning--Labor and Birth
THRONE POSITION (CHAIR)
1. Raise the head of the bed to place the patient in a sitting position.
2. Pull up the labor grips. 3. Position the patient's feet in the foot supports. 4. Remove the foot section. 5. Use the Foot control to raise or lower the Foot Supports. 6. Tuck the end of the drape into the drainage pan and raise the
bed to a comfortable height by pressing the Bed Up control.
WARNING: Warning--To avoid injury, make sure the patient's hands are clear of the labor grips when they are raised.
BIRTHING BED MODE
1. Position the patient's feet in the foot supports. Raise the supports to a comfortable position. 2. Pull up the labor grips. 3. Remove the foot section, and tuck the drape into the drainage pan. 4. Tilt up the foot support. 5. Raise the bed to a comfortable height by pressing the Bed Up control, and position the patient's
perineum out and over the edge of the seat section.
DELIVERY TABLE MODE
1. Slide the patient down so that her buttocks are at the division in the mattress.
2. Lower the foot section to its lowest position.
With Calf Supports 1. Position the attached calf supports, and place the patient's legs
in the supports. 2. Adjust the angle of the supports, and tighten the ball joints.
With Full Leg Supports 1. Adjust the angle of the leg supports, and tighten the black-
winged knob. 2. Push the Foot Up control to raise the leg supports, so that they
securely support the patient's perineum over the cut-out space. 3. Remove the foot section, and raise the bed to a comfortable
working height. The drainage pan can also be removed for extra exposure.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

27

Transport the Patient
NOTE: Check pressure points.
· Press the Foot Up control to raise the supports so that they securely support the patient's perineum over the edge of the seat section.
· Remove the foot section, and raise the bed to a comfortable working height. The drainage pan can also be removed for extra exposure.
HIGH MODIFIED TREND-LIKE POSITION (BIRTH AND REPAIR)
1. Raise the bed to the desired height using the Hilow control. 2. Raise the head section to the desired position by using the
Head Up control. 3. Position the patient's legs in calf supports. 4. Push down on the Trend-Like handle to place the patient in
modified Trend-Like position and to raise the perineum.

TRANSPORT THE PATIENT
The bed is intended to be used to transport patients with the foot end of the system forward. Before transport, store the power cords to prevent tripping. Take care to prevent damage to AC power cords. An electrical shock hazard exists. Use only the headboard, headboard push handles (wood headboards), or the integrated push handles (D model and newer beds) to move the bed.
Transport the bed with the head-end lift arms (A) parallel to the ground or lower.
Make sure the patient, equipment, and all lines are placed within the perimeter of the bed for intrahospital transport.
Fully extended IV poles could damage doorways or ceiling fixtures. Lower poles before patient transport.
Make sure that the Nurse Call system cables are correctly connected after transport.
Generally, as the load increases, the risk of instability goes up.
Lower the foot section and head section to increase stability.
Lower the bed deck height to increase stability.
Use and position of accessories may affect stability. Do not overextend IV poles or similar accessories and do not overload accessories. If multiple accessories are in use, distribute them evenly from side to side or head to foot.
For inclines or thresholds, only approach them as you move forward or backwards.
To help prevent overbalance or collision with hidden objects or people, do not make sharp corners and do not turn the bed at high speeds.
Use two or more caregivers to transport the bed if it is occupied.

28

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Transport the Patient
TRANSPORT SAFETY INFORMATION
WARNING: To help prevent injury and/or equipment damage, obey these warnings when you transport a patient in the bed:
· Warning--Unless you are transporting a patient, always set the brakes when the unit is occupied. Make sure the brakes are set before any patient transfer on to or off the bed.
· Warning--Make sure to have appropriate assistance when you transport a patient. · Warning--The bed is intended to be used to transport patients with the foot end of the bed
forward. Prior to transport, properly store the power cord to help prevent tripping. · Warning--Use only the integrated headboard transport handles or integrated push handles to
move the bed during transport. · Warning--Do not use the line manager or IV poles to move the bed. · Warning--Make sure that the patient, equipment, Foley bags, and all lines are securely placed
within the perimeter of the bed for intra-hospital transport. · Warning--Before transporting the bed, ensure that the unplugged and wrapped power cord is
stored on the power cord wrap holder provided on the headboard. · Warning--Fully extended IV poles and any attached equipment could impact doorways or
ceiling fixtures. Lower the poles prior to patient transport and make sure all attached equipment does not impact doorways. · Warning--Be sure to connect the nurse call SideCom Communication System cables after transport is complete. · Warning--Do not leave the bed exposed to extreme environmental conditions for extended periods of time. · Warning--Make sure the bed is not transported over a side inclination of more than 5°. · Warning--Remove the arm board, and store the calf support and foot supports before transporting. · Warning--During transport, use caution so the bed does not tip or overbalance. · Warning--Transport of the bed may cause a buildup of static electricity.
CAUTION: To help prevent equipment damage, obey these cautions when you transport a patient in the bed:
· Caution--Use caution when you move the bed through doorways. · Caution--Before transporting the bed, ensure that the power cord is stored on the power cord
wrap holder provided on the headboard.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

29

Accessories
ACCESSORIES
Product Number P9625 P9620 P35745 P3705 P3612TPA P7834 P3623 P451 P7625 P7634C P3617 P3629 P278B P159 P158A P3613B P276A P5362 P222101 P2217 P7925D120 P53120120 P17073001 SA1528 SA4585 SA1529 SA4586 P3627 P3628 P3630 P3631 P3730 P3731 P3574A P3616 P3618 P3619 P015378 P3733A P3732A
30

Description
Anesthesia screen (no longer available) Arm board (no longer available) Calf supports, telescoping (detachable) Calf support and arm Comfort pad Drapes, Medline/Proxima Foley hook kit Foot rest bar - lift off only Full leg supports, attached (no longer available) Full leg supports, telescoping Headboard - wood (contemporary) Headboard (blow molded) Instrument tray (lift off version only) ISS offset bar ISS transfer pole Labor bar Oxygen tank holder Pendant kit with holder (no longer available) Permanent IV Pole (B through C model beds) Standard IV Pole Procedural light Rail - Stow and Go foot section Hanger - Stow and Go foot section Sheets, V-cut, complete Sheets, V-cut, two-piece Sheets, straight edge, complete Sheets, straight edge, two-piece Slipcover, head section, straight edge Slipcover, head section, V-cut Slipcover, foot section, V-cut Slipcover, foot section, straight edge Slipcover, foot section upgrade kit, U-cut Slipcover, foot section upgrade kit, V-cut Calf support, detach (telescoping) Calf supports, attached (no longer available) Pendant (no longer available) Mattress, wedge (no longer available) Push handles Line manager Permanent IV Pole

Weight
3.2 lb (1.45 kg) 7.1 lb (3.22 kg) 7.3 lb (3.31 kg) 6.4 lb (2.90 kg) 9.8 lb (4.45 kg) 0.4 lb (.17 kg) 0.8 lb (.37 kg) 5.3 lb (2.40 kg) 4.2 lb (1.90 kg) 8.0 lb (3.63 kg) 18.3 lb (8.30 kg) 8.8 lb (3.99 kg) 5.0 lb (2.27 kg) 1.0 lb (.45 kg) 2.6 lb (1.2 kg) 8.7 lb (3.95 kg) 3.8 lb (1.74 kg) 0.9 lb (0.41 kg) 4.4 lb (1.8 kg) 2.4 lb (1.09 kg) N/A N/A N/A 1.0 lb (.45 kg) 1.0 lb (.45 kg) 1.0 lb (.45 kg) 1.0 lb (.45 kg) 1.7 lb (0.77 kg) 1.7 lb (0.77 kg) 1.1 lb (0.50 kg) 1.1 lb (0.50 kg) 45.0 lb (20.4 kg) 45.0 lb (20.4 kg) 3.2 lb (1.5 kg) 9.0 lb (4.1 kg) 0.8 lb (0.36 kg) 3.0 lb (1.36 kg) 2.2 lb (0.99 kg) 0.8 lb (0.36 kg) 3.5 lb (1.59 kg)

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Accessories
ANESTHESIA SCREEN--P9625 (NO LONGER AVAILABLE)
The base of the frame slides between the mattress and the frame. The screen can be positioned on either side of the bed. The maximum safe working load is 5 lb (2.3 kg).
WARNING: To help prevent personal injury or equipment damage, obey these warnings:
· Warning--Make sure the patient does not grab the anesthesia screen. · Warning--Do not attach anything to the anesthesia screen.
ARM BOARD--P9620 (NO LONGER AVAILABLE)
The arm board is held in place between the frame and mattress. The padding is removable for cleaning. The maximum safe working load is 30 lb (14 kg).

CALF SUPPORTS--P3705A AND P35745 (NO LONGER AVAILABLE)

The P3705 calf supports are permanently attached to the foot support for easy access. The removable P35745 calf support (not shown) is fully padded with telescoping height adjustment; it is installed the same as the P7625C and P7634C full leg supports (see page 32).

Release Handle (P3705A shown)

WARNING:
To help prevent personal injury or equipment damage, obey these warnings:

Unlocked

Locked

· Warning--Make sure the calf supports are securely locked in place before use.

· Warning--Keep hands clear of pinch and contact points while adjusting the calf supports.

To Adjust for Use
1. Fold in the hinged mattress.
2. Rotate the foot supports all the way upward, and outward.
3. Pull the release latch, and rotate the calf support to the upright position. The calf supports lock when in the upright position.
4. Adjust the calf support using the release handle.
· To unlock the calf support, pull the release handle a 1/4 turn toward the foot end. To lock it, push the release handle a 1/4 turn toward the head end.
NOTE: Check for pressure points, and make appropriate adjustments. For TALL PATIENTS, angle the support downward. For SHORT PATIENTS, angle the support upward.

The maximum safe working load is 60 lb (27 kg).

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

31

Accessories
COMFORT PAD--P3612TPA
The comfort pad is placed on top of the mattress and fitted securely around the mattress corners. It rolls up into a compact bundle for storage. This pad provides 1" (25.4 mm) of high density viscoelastic foam and fits 5" mattresses on all Affinity models.
DISPOSABLE FUNNEL DRAPE--P7834
The funnel drape tucks into the fluid basin when the end of the bed is removed. The drape should be placed over the bottom sheet before the patient gets into bed, with the soft, absorbent surface next to the patient, waterproof side down.
FOLEY HOOK KIT--P3623
This kit can be mounted to either side of the bed frame near the labor grip. The maximum safe working load is 10 lb (4.5 kg).

FOOT REST BAR--P451
This bar provides a convenient foot rest for the physician (or obstetrician) and is for lift off versions only.
The maximum safe working load is 150 lb (68 kg).
NOTE: The Foot Rest Bar is not available on the Affinity 4 Birthing Bed that has the Stow and Go Foot Section option.

FULL LEG SUPPORTS--P7625 (NO LONGER AVAILABLE) AND P7634C
Both leg supports are padded with ball joint and pull handles. The P7634 is telescoping.
To Adjust for Use 1. Electrically lower the foot section to the lowest position, with
the patient's legs on the foot section, before placing her legs into the supports. 2. Both full-leg supports are interchangeable right and left. 3. For leg support installation, place the rod into the steel sockets located at the point where the foot section attaches to the yoke. 4. Drop them into the sockets, and rotate until you hear the support lock. 5. Rotate the supports so that the black knob faces inboard, toward the patient, and leave the knob loose. 6. For large patients, rotate the black knob outboard, away from the patient. 7. Place the patient's legs into the supports.

32

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Accessories
8. Adjust the position by rotating her knees out. 9. Tighten the black knob. 10. Raise the foot section electrically to fill in the popliteal space by pushing the Foot Up control. The
patient's legs should be completely supported. 11. Remove the foot section. 12. Rotate the foot supports up and away from the center of the bed. NOTE: Check for pressure points, and make appropriate adjustments. For TALL PATIENTS, angle the support downward. For SHORT PATIENTS, angle the support upward. The maximum safe working load is 60 lb (27 kg).
HEADBOARDS--P3617 AND P3629
The P3617 contemporary wood headboard and the P3629 blow-molded headboard are available in a choice of wood grain laminate and color stain panel options.
INSTRUMENT TRAY--P278
The instrument tray is designed to optimize the process of performing obstetrical postpartum procedures. This instrument tray is compatible with lift-off and slide-off foot sections.
Location The instrument tray is located at the foot section of the bed, in the foot section yoke.
WARNING: Warning--The instrument tray is for medical equipment only. Do not stand or sit on the instrument tray. Do not place an infant on the instrument tray. Personal injury can occur. The maximum safe working load is 25 lb (11 kg). NOTE: The Instrument Tray is not available on the Affinity 4 Birthing Bed that has the Stow and Go Foot Section option.
INFUSION SUPPORT SYSTEM (ISS)--P158A AND P159
The P158 transfer pole and the P159 offset bar provide placement of infusion support devices and may be located at either side of the head section. The maximum safe working load is 40 lb (18 kg).

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

33

Accessories
LABOR BAR--P3613B
For extra support, the labor bar fits into the leg support sockets between the seat and foot cushions.
To Adjust · To raise or lower the bar, use the Foot controls. The bar can be used in either direction for different positions and purposes.
The maximum safe working load is 100 lb (45 kg).
OXYGEN TANK HOLDER--P27605 (NO LONGER AVAILABLE)
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Failure to correctly attach the oxygen tank holder could cause it to drop. Injury or equipment damage could occur.
· Warning--If the oxygen tank holder is placed at the foot end of the bed, make sure the Foot and Knee Up/Down controls are locked out. Failure to do so can result in caregiver, patient, or visitor injury if the foot section fully lowers and the holder becomes dislodged from the bed.
· Warning--When the bed is articulated and the oxygen tank holder is placed at the foot end of the bed, make sure the extremities of the caregiver, patient, or visitor are clear of the area around and underneath the oxygen tank holder.
The oxygen tank holder attaches to the frame in a vertical position. It holds one standard (E size) oxygen tank. Only use E size oxygen tank for P27605.
The maximum safe working load is 30 lb (14 kg).
OXYGEN TANK HOLDER--P276A
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Failure to correctly attach the oxygen tank holder could cause it to fall. Injury or equipment damage could occur.
· Warning--If the oxygen tank holder is placed at the foot end of the bed, make sure the Foot and Knee Up/Down controls are locked out. Failure to do so can result in caregiver, patient, or visitor injury if the foot section fully lowers and the holder becomes dislodged from the bed.
· Warning--When the bed is articulated and the oxygen tank holder is placed at the foot end of the bed, make sure the extremities of the caregiver, patient, or visitor are clear of the area around and underneath the oxygen tank holder.
The oxygen tank holder attaches to the frame in a vertical position. It holds one standard D or E size oxygen tank.
Insert the oxygen tank holder into one of the equipment sockets to mount it on the bed.
The maximum safe working load is 30 lb (14 kg). NOTE: Lowering the product height (including use of Trendelenburg and Reverse Trendelenburg) may cause the oxygen tank holder (P276A) to touch the floor.

34

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Accessories
PENDANT CONTROL KIT WITH HOLDER--P5362 AND P3618 (NO LONGER AVAILABLE)
This kit contains a pendant control and holder to control the bed high/low, head up/down and foot up/down functions. The holder clamps to the bed side rail. Make sure you stow the pendant and pendant cable when it is not in use or when you transport the bed. To activate--push the appropriate control(s).
PERMANENT IV POLE--P222101
The Permanent IV Pole mounts to the head section frame. The pole slides to either side of the bed and enables additional IV bags and pumps to be mounted. The P222101 can not be used on D model beds. The maximum safe working load is 25 lb (11 kg). To Deploy 1. Lift the IV pole from its stored position behind the headboard, and
position it straight up. 2. Make sure that the pole drops and locks into position. 3. Raise the upper section of the pole to the desired height. The IV pole is ready for use. To Store 1. Grasp and hold the upper section of the IV pole. Push the upper collar down, and lower the upper
pole section into the lower pole section. 2. Lift the lower section of the IV pole up, and lower the pole down to the stored position behind the
headboard. The poles should rest in the storage slots provided on the bed frame.
CAUTION: Caution--Make sure any IV pole mounted infusion pumps are not in the direct path of the moving head section. Interference with head section articulation could result.
RAIL AND HANGER--P53120120 AND P17073001
The equipment rail (P53120120) and hanger with bracket (P17073001) are for the Affinity 4 Birthing Bed, Stow and Go foot section.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

35

Accessories

SLIPCOVERS (HEAD AND FOOT)--140562, P3628C, P3630B AND P3631B

Head Section Slipcover
The head section slipcover is simply placed over the head section mattress for protection from normal wear and tear and from fluids.
Foot Section Slipcover
The foot section slipcover is simply placed over the foot section mattress for protection from normal wear and tear and from fluids.

Number
140562 P3628C P3630B P3631B

Description
Slipcover, head section, straight edge Slipcover, head section, V-cut Slipcover, foot section, straight edge Slipcover, foot section, V-cut

SLIPCOVER UPGRADE KITS--P3730A AND P3731A
These upgrade kits enables upgrade from Affinity 4 Birthing Bed lift off to Stow and Go foot section. The P3730A is for the U-cut slipcover and the P3731A is for the V-cut slipcover.

PUSH HANDLES--P015378
The push handles are located on the head end of the bed and are used to move the bed.
Remove from the Stowed Position
Pull the push handles upward until they lock in position.

To Stow
WARNING: Warning--Make sure the patient or caregiver hands are not in the path of travel while you lower the transport handles. Injury could occur.
1. Lift up on the push handles to unlock them. 2. Move the push handles in toward the
center of bed to the stowed position.

36

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Accessories
LINE MANAGER -- P3733 (NO LONGER AVAILABLE)
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Do not use the Line Manager for ventilator circuits.
· Warning--Failure to keep aseptic lines separate from non-aseptic lines may cause cross contamination.
· Warning--Do not hang cords on the Line Manager.
· Warning--When you use the Line Manager, monitor the lines to make sure they are not pinched or kinked and there is sufficient slack for bed articulations and patient movement.
· Warning--Failure to remove lines from the Line Manager before you transfer the patient could cause patient injury or equipment damage.
· Warning--Do not use the line manager to move the bed. · Warning--Do not use tape to hold lines inside the line manager. · Warning--Do not hang cords on the Line Manager.
A Line Manager is on each side of the head end of the bed. The Line Manager helps to keep lines (such as IV infusion lines, suction lines, oxygen lines, etc.) together and away from the articulating frame. The flexibility of the Line Manager lets you bend it in any direction.
The line manager can hold one set of the following: · 4 monitor lines of 1/8" diameter · 2 suction lines of 1/2" diameter · 2 oxygen lines of 3/8" diameter · 8 IV infusion lines of 1/4" diameter · 1 feeding tube of 3/8" diameter

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

37

Accessories
PERMANENT IV POLE--P3732A
The Permanent IV Pole option consists of one IV pole that supports up to two IV pumps plus bags. The IV pole is attached to the bed frame near the corner of the headboard. The IV pole can support up to 40 lb (18 kg). The hooks can support 2.5 lb (1.1 kg).
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Do not exceed the 40 lb (18 kg) IV pole or 2.5 lb (1.1 kg) hook weight capacity.
· Warning--Only attach medical equipment to the lower section of the IV pole.
CAUTION: Caution--Make sure any IV pole mounted infusion pumps are not in the direct path of the moving head section. Equipment damage could occur.
Make sure you mount infusion pumps on the lower part of the IV pole.
To Deploy 1. Lift the IV pole from its stored position behind the headboard and put it straight up. 2. Make sure that the pole drops and locks into position. 3. Raise the upper section of the pole to the desired height. The IV pole is ready for use.
To Store:
WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--Make sure the patient hands are not in the path of travel while you lower the IV pole. · Warning--When lowering the upper section of an IV pole, always grasp and hold the upper
section of the pole before pulling the release knob. 1. Grasp and hold the upper section of the IV pole. Push the upper collar down, and lower the upper
pole section into the lower pole section. 2. Lift the lower section of the IV pole up, and lower the pole down to the stored position behind the
headboard. The pole should rest in the storage slot provided on the bed frame. 3. Make sure you hold the top section of the IV pole when you extend or retract it.
CAUTION: Caution--Only use the headboard handles or push handles to move the bed. Equipment damage could occur. Do not use the IV poles to move the bed; only use the headboard or push handles.

38

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Cleaning and Disinfecting

CLEANING AND DISINFECTING

WARNING: To help prevent injury and/or equipment damage, obey these warnings:
· Warning--The potential for electrical shock exists with electrical equipment. Failure to follow facility protocol could cause death or serious injury.
· Warning--Unplug the bed from its power source, and activate the lockout switches before cleaning or service.
· Warning--Do not reuse wiping material for multiple steps or on multiple products. · Warning--Harmful cleaning solutions may cause skin rash and/or irritation upon contact.
Follow the manufacturer's instructions found on the product label and Safety Data Sheet (SDS). · Warning--Inadequate cleaning procedures may result in harm to patients or caregivers. · Warning--Lift and move items correctly. Do not twist, and seek assistance when necessary.
Make sure the bed is at a correct height to lift items off the bed. · Warning--If the mattress cover becomes torn or cut, replace the surface. · Warning--The use of non-approved cleaning solutions may cause product damage that could
result in patient harm. · Warning--Fluid spills on to the bed electronics could cause a hazard. If such a spill occurs,
unplug the bed, and remove it from service. When fluid spills occur outside of what is seen in normal use, immediately do as follows: a. Unplug the bed from its power source. b. Remove the patient from the bed. c. Clean the fluid spill from the bed system. d. Have maintenance examine the system completely. e. Do not put the bed back into service until it is completely dry, tested, and found to be safe
to operate.
CAUTION: To help prevent equipment damage, obey these cautions:
· Caution--Do not steam clean or power wash the bed. Pressure and excessive moisture can damage the protective surfaces of the bed and its electrical components.
· Caution--Do not use harsh cleansers/detergents, heavy duty grease removers, solvents such as toluene, xylene, or acetone, and do not use scouring pads (you may use a soft bristle brush).
· Caution--Do not use bleach as your primary everyday cleaner/disinfectant. · Caution--Fully extend the foot section prior to the cleaning and disinfection process.
RECOMMENDATIONS
For proper cleaning and disinfection, staff members should be trained.
The trainer should carefully read the instructions and follow them when the trainee is being trained. The trainee should:
· Be given time to read the instructions and to ask any questions. · Clean and disinfect the product while the trainer supervises. During, and/or after this process,
the trainer should correct the trainee of any differences from the instructions for use.

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

39

Cleaning and Disinfecting

The trainer should supervise the trainee until the trainee can clean and disinfect the bed as instructed.
Baxter recommends to clean and disinfect the bed and mattress before first patient use, between patient uses, and regularly during extended patient stays.
Some fluids used in the hospital environment, such as iodophor and zinc oxide creams, can cause permanent stains. Remove temporary stains by wiping vigorously with a lightly-dampened wiping cloth.

CLEANING AND DISINFECTION

Cleaning and disinfection are distinctly different processes. Cleaning is the physical removal of visible and non-visible soil and contaminants. Disinfection is intended to kill microorganisms.
Table 1 below summarizes the approved cleaners/disinfectants for use along with the associated contact time for disinfection.
Table 1: Approved Cleaners/Disinfectants

Cleaner/Disinfectant
Wex-Cide Germicidal Detergent ready-to-use Virex II 256 Disinfectant Cleaner OxyCide Daily Disinfectant Cleaner Oxivir Tb Disinfectant Cleaner CaviCide Disinfectant Cleaner Clorox HealthCare Bleach Germicidal Cleaner ready-to-use Clorox HealthCare Bleach Germicidal Wipes

Recommended for Routine Cleaning and Disinfection
Yes

Recommended for Disinfection against Clostridium Difficile (C.Diff )

Maintain Wetness (Disinfection Contact Time)

No

10 minutes

Yes

No

Yes

Yes

10 minutes 3 minutes

Yes

No

Yes

No

No*

Yes

10 minutes 3 minutes 5 minutes

No*

Yes

3 minutes

*Bleach is not recommended as the primary cleaner/disinfectant.

Remove any disinfectant residue prior to and after the use of bleach with a new or clean cloth/wipe soaked in tap water.
NOTE: Not all cleaners and disinfectants listed in Table 1 may be approved for sale in your country. Always refer to the local regulations for applicable approved, listed in Table 1, cleaners and disinfectants. For questions, contact your Baxter representative.

When you perform the detailed cleaning steps, please note the following:
· A reusable or disposable microfiber cloth or a Clorox HealthCare Bleach Germicidal Wipe is recommended as the wiping cloth.
· Always replace the wiping cloth when visibly soiled.
· Always replace the wiping cloth between steps (spot clean, clean, and disinfect).
· Always use Personal Protective Equipment (PPE).
· Adjust the bed position, siderails, headboard and footboard as needed for ease of cleaning and disinfection.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Cleaning and Disinfecting
Prepare the Bed for Cleaning and Disinfecting a. Fully extend the foot section as applicable. b. Unplug the bed.
STEP 1: Cleaning a. As necessary, first remove visible soil from the bed and the mattress using a wiping cloth soaked with an approved cleaner/disinfectant (see "Table 1: Approved Cleaners/Disinfectants" on page 40). · Give special attention to seams and other areas where soil may accumulate. · A soft bristle brush may be used to loosen hardened soil. · Use as many wiping cloths as needed to remove the soil.
NOTE: If desired, the head and foot slipcovers may be laundered to remove visible soil. See "Laundry Guidelines" on page 42.
It is important to remove all visible soil from all areas before continuing to remove non-visible soil. b. With a new or clean wiping cloth soaked in an approved cleaner/disinfectant, use firm pressure to wipe all surfaces of the bed and mattress. Use a new or clean wiping cloth as often as necessary. Make sure the following items are cleaned: · Siderails · Headboard · Areas between the headboard and mattress, and siderails and mattress · Upper frame · Base frame · Power cord · Patient pendant (handheld remote) and pendant cord · Accessories · Mattress - top and bottom c. Examine the following for damage: · Top mattress cover · Bottom mattress cover and mattress retaining snaps · Zipper closure d. Damaged items may require the mattress to be replaced.
STEP 2: Disinfection a. With a new or clean wiping cloth soaked in an approved cleaner/disinfectant, use light pressure to wipe all exterior surfaces of the bed previously cleaned. b. Make sure all surfaces remain wet with the cleaner/disinfectant for the specified contact time. Re-wet surfaces with a new or clean wiping cloth as necessary. See "Table 1: Approved Cleaners/Disinfectants" on page 40 for the contact time.
NOTE: If bleach is used with another cleaner/disinfectant, use a new or clean cloth/wipe soaked in tap water to remove any disinfectant residue prior to and after the bleach application. c. Always allow the cleaned/disinfected surfaces to air-dry prior to putting bed back in service.

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41

Cleaning and Disinfecting
Prepare the Bed for Use a. If the mattress has air bladders, connect the two hoses that are beneath the seat section. b. Fasten the two mattress retaining snaps that are beneath the seat section. c. Plug the bed into an applicable power outlet.
Laundry Guidelines
Laundry can be used as a pre-cleaning step for the Affinity 4 head and foot slipcovers. Launder the slipcovers, then follow the Cleaning and Disinfection instructions. Machine wash the slipcovers as follows: 1. Remove the head and foot slipcovers from the mattress. 2. Machine wash the slipcovers per facility protocol. 3. Rinse the slipcovers thoroughly in clean water. 4. Use the lowest temperature setting of the dryer to dry the slipcovers. Do not use high
temperatures. 5. Follow the Cleaning and Disinfecting instructions. See "Cleaning and Disinfection" on page 40.
CARE OF WOOD COMPONENTS
Wood is selected for use on beds because of its beauty and warmth. All Baxter wood products are treated with a resin-based sealer and finish that provide resistance to abrasion, staining, fluids, and fire. Many disinfectant/cleansers have a "softening" effect on any painted or finished surface if used in high concentrations. Diluted ammonia, mild detergents, and diluted bleach solutions may be used. Clean by wiping a soft dampened cloth over the surface, followed by wiping with a dry cloth. At no time should a wet cloth be allowed to lay on the surface. Any liquid spilled on the surface should be wiped up immediately. Any liquid allowed to lay on the surface unattended may damage the finish. For protection of the finish we recommend using a liquid-type furniture polish. Polish about once a month, and wipe off any excess with a soft dry cloth. Have any nicks or scrapes repaired to prevent water damage.
MATTRESS CARE AND DRAPING
Correct draping technique is essential in preserving the life of the mattress. Drapes must be fluid repellent. The Baxter labor and delivery drape effectively covers the lower three quarters of the bedding throughout labor. Additional pads or towels placed under the patient will help prevent fluid from reaching the edges of the drape. This safeguard keeps the sheets clean and dry while preventing fluid exposure to the mattress.
NOTES: · Standard OB packs and paper drapes will not keep the sheets dry. · Repeated soaking of mattress materials will accelerate wear and eventually destroy mattress seals, causing fluids to leak into the cushions. · Baxter slipcovers are recommended to help extend the life of the mattress. · Mattress damage caused by improper draping and cleaning procedures is not covered by warranty. · Sheets must always be placed over the mattress before the bed is used by a patient.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Preventive Maintenance

The following products have been tested by the Herculite Laboratory and have been found not to have a harmful effect on Dartex fabrics when used in accordance with manufacturer's recommended
dilution.

Trade Name
A33 Absolute Beaucoup Blue Chip Coverage 256 El Dorado Plus Elimstaph Forward DC Frenklin Sentine Galahad Hi-Tor Insurance

Type Quartenary Quartenary Phenolic Quartenary Quartenary Quartenary Quartenary Quartenary Quartenary
Phenolic Quartenary Quartenary

Manufacturer Airwick Walton-March Huntington S.C. Johnson Vestal Puritan/Churchill Walter G. Legge S.C. Johnson Purex
Puritan/Churchill Huntington Vestal

Trade Name
LPH Matar Omega Quanto Sanikleen Sanmaster III Surfacide Tri-Quat Vesphene II

Type
Phenolic Phenolic Quartenary Quartenary Quartenary Quartenary Quartenary Quartenary Phenolic

Manufacturer
Vestal Huntington Airwick Huntington West Chemical Service Master Walton-March Vestal Vestal

Virex Deep Purple Betagone

Quartenary N/A N/A

S.C. Johnson N/A N/A

PREVENTIVE MAINTENANCE

WARNING: Warning--Only facility-authorized persons should service the Affinity 4 Birthing Bed. Service done by unauthorized persons could cause injury or equipment damage.
The Affinity 4 Birthing Bed requires an effective maintenance program. We recommend that you do annual preventive maintenance (PM) for Joint Commission certification. PM not only meets Joint Commission requirements but can help make sure of a long, operative life for the Affinity 4 Birthing Bed. Two effective ways to reduce downtime and make sure the patient remains comfortable are to keep accurate records and maintain the Affinity 4 Birthing Bed. For the preventive maintenance schedule, refer to the Hillrom Affinity 4 Birthing Bed Service Manual (195826).
For service and/or technical information other than that specified in this document, refer to the Hillrom Affinity 4 Birthing Bed Service Manual (195826).

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43

Decommissioning and Disposal Instructions
DECOMMISSIONING AND DISPOSAL INSTRUCTIONS
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 Baxter Technical Support for guidance on safe disposal protocols. · In order to ensure the safe handling and disposal of this product, follow all relevant warnings
provided in the service manual regarding possible causes of injury when decommissioning a bed. · Always ensure that the bed is unplugged before decommissioning. · The bed and its accessories should be cleaned and disinfected, as described in the instructions for use, before any other decommissioning activities. · If the decommissioned bed or accessory is still fit for use, Baxter recommends donating the decommissioned bed and accessories to a charitable organization so that they can be reused. · If the decommissioned bed or accessory is not fit for use, Baxter recommends dismantling the bed in accordance with the instructions provided in the service manual. Baxter recommends that all oil and hydraulic fluids are removed from the product before recycling or disposal, if applicable. · Always check and comply with all local and national regulations and facility protocols when decommissioning a product.
Batteries should be recycled. Never dispose of batteries which contain substances that can be dangerous for the environment and health.
Other components, such as electronic components, plastics and metals, are recyclable in many local jurisdictions. Baxter recommends recycling all components that can be recycled locally.
Components which cannot be recycled can be disposed of via standard waste disposal procedures.
EXPECTED LIFE
The expected life of the Affinity 4 Birthing Bed is 8 years of normal use provided that recommended preventive maintenance is performed. However, certain components have a shorter life cycle and will need to be replaced in order for the bed to meet its expected life. They are listed below: · Bed batteries have a minimum 2 years life expectancy. · Mattresses have a 5 year life expectancy.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Troubleshooting
TROUBLESHOOTING
WARNING: Warning--Only facility-authorized personnel should troubleshoot the Affinity 4 Birthing Bed. Troubleshooting by unauthorized personnel could result in personal injury or equipment damage.
POWER LOSS
A power loss can occur under these conditions: · The bed power cord has been unplugged from the AC power outlet. · A power outage has occurred. · A bed fuse has blown.
During a power loss, the bed can operate on battery backup. See "Battery Backup" on page 19. Always check the battery charge status on the siderail. The bed may not be functioning due to the battery being drained, and the bed needing to be plugged into its appropriate power source.

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45

Specifications

SPECIFICATIONS

Product Identification

Product Number Description

P3700B P3700C P3700D P3700E P3700E1

Affinity 4 Birthing Bed, introduces Stow and Go Retractable Foot Section Affinity 4 Birthing Bed, updated foot section Affinity 4 Birthing Bed, introduces transport handles Affinity 4 Birthing Bed, EN 60601-1 and IEC 60601-2-52 compliant Affinity 4 Birthing Bed, EN 60601-1 and IEC 60601-2-52, Redesigned Base Module, Lift Arms and Intermediate frame from Phase 1 Affinity refresh.

Specifications

Feature

Dimension

Overall Length (maximum)

90" (229 cm) (B through C model beds) 92" (234 cm) (D model and newer beds)

Length from roller bumpers to break in seat section 61 7/8" (157 cm)

Length from break in the seat section to end of bed 28 1/8" (71 cm)

Maximum Width (siderails stored)

36" (91 cm)

Maximum Width (siderails up)

39" (99 cm)

Maximum Headboard Height

52" (132 cm)

Maximum Siderail Height (without mattress)

14¾" (37.47 cm)

Minimum Under-Bed Clearance

5" (13 cm), 3" (7.62 cm) for Stow and Go foot sections

Wheel Base

50" (127 cm) x 29" (74 cm)

Mattress Width

35" (89 cm)

Mattress Length

78" (198 cm)

Mattress Thickness (head/seat)

5" (12.7 cm)

Mattress Thickness (foot)

3.5" (8.9 cm)

Detachable Power Cord, IEC 320/interface

US, 84" (213 cm)/international, 98" (248.9 cm)

Caster Size

5" (12.7cm) standard on bed 6" (15 cm) option available

Head Section Inclination (maximum)

63°

Seat Section Inclination (maximum)

15°

Bed Height Range (Lift-off foot section)

19.0-33.75" (48.3-85.7 cm)

Bed Height Range Stow and Go foot section

19.5-33.75" (49.5-85.7 cm)

Bed Height Range (Lift-off with mattress)

24.0-38.75" (60.9-98.4 cm)

Bed Height Range Stow and Go with mattress

24.5-38.75" (62.2-98.4 cm)

Trend-Like position (maximum)

8°

Bed Lift capacity (safe working load)a

500 lb (227 kg)

Maximum patient weight

470 lb (213 kg)

Foot Section Lift capacity (maximum)

400 lb (181 kg)

Head Section Lift capacity (maximum)

200 lb (91 kg)

Max Height of Seat Section (in Trend-Like position) 40" (102 cm)

a. Bed lift capacity (safe working load) includes mattresses, headboard, patient weight, any accessories or equipment on the bed, caregiver weight, and any visitors sharing the bed.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Bed Dimensions (see "Specifications" on page 46)

Specifications

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47

Specifications

Environmental Conditions for Transport and Storage

Condition Temperature Relative humidity Pressure

Range -40°F (-40°C) to 158°F (70°C) 10% to 95% non-condensing 500 hPa to 1060 hPa

Environmental Conditions for Use

Condition Temperature Relative humidity range Altitude

Range
59°F (15°C) to 104°F (40°C) ambient temperature 10% to 85% non-condensing Medical electric equipment rated to operate at an altitude of less than 9842.5' (3000 m)

Mains Power Requirements

Condition
Rated voltage Power/input Frequency

Range
100V AC/120V AC/230V AC 5A /4A/ 2A 50/60 Hz

Fuse Specifications

Condition
Air system (optional) fuse (beds with Serial Numbers below R298AA9413) Battery fuse Mains fuse (100 V bed model) Mains fuse (120 V bed model) Mains fuse (230 V bed model)

Range 2 A, 250 V~, 5 x 20 mm, UL 198G Fast Acting
10 A, 32 V~, ATO 5 A, 125 V~, 5 x 20 mm, UL 198G Slo-Blo or equivalent 4 A, 125 V~, 5 x 20 mm, UL 198G Slo-Blo or equivalent 2 A, 250 V~, 5 x 20 mm, IEC127 Sheet III, Time Delay, high breaking capacity

Bed Weight

Condition
Bed weight--includes frame and plastic headboard only
Mattress--seat section and main mattress

B and C Model Beds 464 lb (210 kg) (Lift off ) 485 lb (220 kg) Stow and Go
25 lb (11 kg) (foam mattress) 26 lb (12 kg) (air mattress)

D and E Model Beds 480 lb (217 kg) (Lift off ) 511 lb (232 kg) Stow and Go
25 lb (11 kg) (foam mattress) 26 lb (12 kg) (air mattress)

Applied Parts (in accordance with IEC 60601-1)

Siderails Foot section--lift-off and Stow and Go Mattress Attached calf support Detachable non-telescopic calf support Detachable non-telescopic leg support

Headboard Labor grips Labor bar Detachable telescopic calf support Detachable telescopic leg support Armboard

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Specifications

Nurse Call Connection Requirements

For information about the Nurse Call connection requirements, refer to the SideCom Communication System Design and Application Manual (DS059).

Classification and Standards
The P3700 Affinity 4 Birthing Bed is designed and manufactured according to equipment classifications and the following standards.

Technical and Quality Assurance Standards
Serial Numbers after H297AA4665 and up to Serial Numbers beginning with O218AA
 Serial Numbers before O079AA  Serial Numbers after O078AA P3700E beds with Serial Numbers between those beginning with O219AA and S360AA
P3700E beds with Serial Numbers after those that begin with S361AA
 Up to Serial Numbers beginning with T242AA

Directive 93/42/EEC until May 25, 2020 Regulation (EU) 2017/745 regulation from May 26, 2020 WEEE Directive 2012/19/EU RoHS Directive 2011/65/EU ISO and EN ISO 13485 ISO and EN ISO 14971 REACH Directive 1907/2006 RoHS Directive 2011/65/EU as amended by (EU) 2015/863
IEC and EN 60601-1 (2nd Edition) UL 60601-1: 2006 IEC and EN 60601-2-38 + A1 CAN/CSA C22.2 No. 601.1-M90 + A1 and A2
IEC and EN 60601-1-2 (2nd Edition) CAN/CSA-C22.2 No. 60601-1-2:03 + A1
IEC and EN 60601-1-2 (3rd Edition) CAN/CSA-C22.2 No. 60601-1-2:2007
IEC and EN 60601-1 (Edition 3.0) IEC and EN 60601-2-52 IEC and EN 60601-1-2 (3rd Edition) IEC and EN 60601-1-6: 2010 IEC and EN 62366 CAN/CSA C22.2 No. 60601.1: 2008
IEC and EN 60601-1 (Edition 3.1) IEC and EN 60601-2-52 + Amendment 1 IEC and EN 60601-1-6: 2010 + Amendment 1 IEC and EN 62366 + Amendment 1 CAN/CSA C22.2 No. 60601.1-14
IEC and EN 60601-1-2 (3rd Edition) CAN/CSA-C22.2 No. 60601-1-2-08

 After Serial Numbers beginning with T242AA
Equipment Classifications per EN 60601-1
Degree of Protection Against Electric Shock of the Applied Part
Classification according to Directive 93/42/EEC
Degree of Protection Against Ingress of Water

IEC and EN 60601-1-2 (Edition 4.1) CAN/CSA-C22.2 No. 60601-1-2:16 Class I equipment, internally powered equipment Type B
Class I IPX2--P3700 model versions B through D IPX4-- P3700E Affinity 4 beds

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49

Specifications

Degree of Protection Against the Presence of Flammable Anesthetic Mixtures Mode of Operation Sound Pressure Level(s)
Application Environments
Flammability Codes
ELECTROMAGNETIC EMISSIONS GUIDANCE

Not for use with flammable anesthetics
Continuous operation with intermittent loading, 3 minutes ON/27 minutes OFF  52 dBA--highest time-weighted sound level (excluding transport, articulation, and surface inflation/deflation modes)
 65 dBA--highest time-weighted sound level (excluding transport, articulation, and surface inflation/deflation modes). Acute Care, LDR (Labor, Delivery, Recovery), or LDRP (Labor, Delivery, Recovery, Postpartum) application settings. Not intended for use as a general hospital bed. All recommended support surfaces meet the applicable United States, Canadian, and European flammability specifications.

CAUTION:
Caution--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 notes unusual device behavior, particularly if such behavior is intermittent and associated with nearby usage of radio or TV transmitters, cell phones, or electrosurgical equipment, this could be an indication of electromagnetic interference. If such behavior occurs, the user should try moving the interfering equipment further from this device.

WARNING: Warning--The P3700 Affinity 4 Birthing Bed should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the P3700 and the other electrical equipment to make sure they operate as intended.
Make sure the P3700 bed operates correctly when it is used near other electronic devices. Portable and mobile radio frequency (RF) communications equipment can affect electrical equipment.

WARNING: Warning--Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the P3700 Affinity 4 Birthing bed, including cables specified by the manufacturer. Equipment performance may be impacted.
The use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of this device as replacement parts for internal components, may result in increased emissions or decreased Immunity of the P3700 bed.
Medical electrical 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 following tables.

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Specifications

Guidance and Manufacturer's Declaration--Electromagnetic Emissions

The P3700 AFFINITY 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The customer or the user should make sure that they are used in such an environment.

Emissions Test
RF Emissions CISPR 11
RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Compliance Group 1
Class A Class A Complies

Electromagnetic Environment--Guidance
The P3700 Affinity 4 Birthing Bed uses RF energy only for its internal functions. Therefore, the RF emissions are low and are not likely to cause any interference in nearby electronic equipment.
The P3700 Affinity 4 Birthing Bed is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electromagnetic Immunity Guidance

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The P3700 AFFINITY 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The customer or the user should make sure that it is used in such an environment.

Immunity Test
Electrostatic Discharge (ESD) IEC 61000-4-2

EN and IEC 60601-1-2 Test Level
± 6 kV Contact ± 8 kV Air (see Note 1)
± 8 kV Contact ± 15 kV Air (see Note 2)

EMC Compliance Level
± 6 kV Contact ± 8 kV Air (see Note 1)
± 8 kV Contact ± 15 kV Air (see Note 2)

Electromagnetic Environment-- Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient/Burst IEC 61000-4-4
Surge IEC 61000-4-5

± 2 kV for Power Supply Lines (see Note 1) 5 kHz Repetition Frequency
± 2 kV for Power Supply Lines (see Note 2) 100 kHz Repetition Frequency
± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

Power Frequency Magnetic Fields IEC 61000-4-8

3 A/m (see Note 1) 30 A/m (see Note 2)

± 2 kV for Power Supply Lines (see Note 1) 5 kHz Repetition Frequency
± 2 kV for Power Supply Lines (see Note 2) 100 kHz Repetition Frequency ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth
3 A/m (see Note 1)
30 A/m (see Note 2)

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 that of a typical commercial or hospital environment. When the inputs are greater than 5.5 Vrms, it may damage the speaker system.

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51

Specifications

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The P3700 AFFINITY 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The customer or the user should make sure that it is used in such an environment.

Immunity Test
Voltage Dips, Short Interrupts, & Variations On Power Supply Lines IEC 61000-4-11 (see Notes 1 and Note 3)
Voltage Dips IEC 61000-4-11 (see Notes 2 and Note 3)
Voltage Interruptions IEC 61000-4-11 (see Notes 2 and 3)

EN and IEC 60601-1-2 Test Level
< 5% UT (>95% dip in UT for 0.5 cycle) < 40% UT (60% dip in UT for 5 cycles) < 70% UT (30% dip in UT for 25 cycles) < 5% UT (95% dip in UT for 5 seconds)
0% UT for 0.5 cycle at 0°, 45°, 90°, 135°, 180, 225°, 270°, and 315° (for singlephase mains equipment); 0% UT for 1 cycle 70% UT for 25/50 Hz, and 30/60 Hz cycles
0% UT for 250/50 Hz and 300/60 Hz cycles

EMC Compliance Level
< 5% UT (>95% dip in UT for 0.5 cycle) < 40% UT (60% dip in UT for 5 cycles) < 70% UT (30% dip in UT for 25 cycles) < 5% UT (95% dip in UT for 5 seconds)
0% UT for 0.5 cycle at 0°, 45°, 90°, 135°, 180, 225°, 270°, and 315° (for singlephase mains equipment); 0% UT for 1 cycle 70% UT for 25/50 Hz, and 30/60 Hz cycles
0% UT for 250/50 Hz and 300/60 Hz cycles

Electromagnetic Environment-- Guidance
Mains power quality should be that of a typical commercial or hospital environment. If the user of the P3700 Affinity 4 Birthing Bed requires continued operation during power mains interruptions, it is recommended that the Affinity 4 Birthing Bed be powered from an uninterruptible power supply or battery.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity - Continued

The P3700 AFFINITY 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The customer or the user should make sure it is used in such an environment.

Immunity Test

EN and IEC 60601-1-2 Test Level

EMC Compliance Level

Electromagnetic Environment--Guidance

Conducted-RF IEC 61000-4-6

3 Vrms (80% AM) 150 KHz to 80 MHz (see Note 1)

3 Vrms (80% AM) 150 KHz to 80 MHz (see Note 1)

3 Vrms (80% AM) 150 KHz to 80 MHz(6 Vrms in ISM Bands per CISPR-11) see Note 2)

3 Vrms (80% AM) 150 KHz to 80 MHz(6 Vrms in ISM Bands per CISPR-11) see Note 2)

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (see Note 5), should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with this symbol.

Radiated-RF IEC 61000-4-3

3 V/m 80 MHz to 2500 MHz (see Note 1)

3 V/m 80 MHz to 2500 MHz (see Note 1)

3 V/m 80 MHz to 2700 MHz (see Note 2)

3 V/m 80 MHz to 2700 MHz (see Note 2)

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Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

Specifications

Guidance and Manufacturer's Declaration - Electromagnetic Immunity - Continued

The P3700 AFFINITY 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The customer or the user should make sure it is used in such an environment.

Immunity Test

EN and IEC 60601-1-2 Test Level

EMC Compliance Level

Electromagnetic Environment--Guidance

Note 1: Corresponding information shown is with respect to the 3rd Edition of EN/IEC 60601-1-2 and is relevant for all P3700 Affinity 4 units having serial numbers beginning with and up to T242AA. Note 2: Corresponding information shown is with respect to EN/IEC 60601-1-2 and is relevant for all P3700E Affinity 4 units having serial numbers beginning with and after T242AA. Note 3: UT is the AC mains voltage prior to application of the test level. Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, object, and people. Note 5: 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 can not 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 P3700 Affinity 4 bed is used exceeds the applicable RF compliance level above, the P3700 Affinity 4 bed should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the P3700 Affinity 4 bed.

IMMUNITY to Proximity Fields from Radio Frequency Wireless Communications Equipment

In addition to the Radiated RF IEC 61000-4-3 as shown in the table above, the P3700E Affinity 4 Birthing Bed with serial numbers after T242AA have been tested as specified in the table below.

Test Frequency (MHz)

Band (MHz)

Service

Modulation

Maximum Power (W)

Distance (m)

Immunity Test Level (V/m)

385

380-390

TETRA 400

Pulse

1,8

0,3

27

modulation

18 Hz

450

430-470

GMRS 460,

FM + 5 kHz

2

0,3

28

FRS460

deviation

1 kHz sine

710

Pulse

745

704-787

LTE Band 13, 17 modulation

0,2

0,3

9

780

217 Hz

810

GSM 800/900

870

TETRA 800,

Pulse

800-960

iDEN 820,

modulation

2

0,3

28

930

CDMA 850,

18 Hz

LTE Band 5

1720

GSM 1800;

1845 1970

1700-1990

CDMA 1900; GSM 1900; DECT; LTE Band 1,3, 4,

Pulse modulation 217 Hz

2

0,3

28

25; UMTS

2450

2400-2570 Bluetooth

Pulse

2

0,3

28

WLAN, 802.11 modulation

b/g/n,

217 Hz

RFID

5240

WLAN

Pulse

5500

5100-5800 802.11

modulation

0,2

0,3

9

5785

a/n

217 Hz

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)

53

Specifications

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the P3700 AFFINITY 4 Birthing Bed
The P3700 Affinity 4 Birthing Bed is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the P3700 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the P3700 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 d = 1.2 P

80 MHz to 800 MHz d = 1.2 P

800 MHz to 2.5 GHz d = 1.2 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

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.

54

Hillrom Affinity 4 Birthing Bed Instructions for Use (USR025 REV 16)
References

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