• Object ID: 00000018WIA3072FD20GYZ
  • Topic ID: id_13106631 Version: 3.0
  • Date: Aug 29, 2019 1:57:12 AM

1.5T 8ch Breast Array Coil P Port Introduction

The performance of any modifications and/or repairs that have not been evaluated and approved by GEHC Coils Engineering may cause the device to be adulterated within the meaning of section 501(h) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 351(h) and is strictly prohibited.

Specifically, unapproved modifications may impact the safety claims of the device pertaining to the patient/user in relation to shock, biocompatibility, flammability, biological, and thermal regulations. Any changes to materials outside of those within the products service documentation may be considered adulterated and can be in violation of good manufacturing practice requirements.

Overview

This document describes the 1.5T Breast Array Coil made by GE Healthcare. To identify the 1.5T GEM Breast Array Coil, refer to the illustrations below.

Figure 1. 1.5T Breast Array Coil Label
Figure 2. Coil with Headrest and Pads

Shipping Lists

Table 1. Shipping Contents and packing list for Breast Coil
Description Part Number Quantity
Box 1
1.5T Breast Array 53963451
Headrest Assembly53963461
Operator Manual2422019-2991
Lateral Biopsy Assembly53805662
Breast Chamber Cover24143411
Plate, Lateral Compression24145432
Plate, Medial Compression24145442
Phantom Positioner53434321
3T Kizuna Breast Coil Positioner55009322
M4 X .7 X 12MM Brass ScrewsU1-53024310
1.5T HD FLAT GEM TABLE BREAST ARRAY TRANSLATION LABEL5490496-151
Coil Name Language Translation Label Instruction Sheet54926581
Box 2
BREAST COIL PATIENT PAD54016601
Transition Pad54016611
U-Shaped Headrest Pad54049191
Armrest Pad54016621
Footrest Pad54016631
Breast Chamber Cover Pad54049231
Compression Pad54093791
Box 3
The following items are provided only when the coil is ordered with the biopsy option.
Breast Coil Lateral Biopsy Plate24240042
Breast Coil Medical Biopsy Plate24240062
Biopsy Operator Manual2418208-2991

Environmental Requirements

Storage Requirements: Coil should be stored in the scanner room.

Dimensions: 521 mm (L) x 541 mm (W) x 244 mm (H)

Weight: 7.4 kg (16.3 lb)