KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203

Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 21002410743

Nama Dagang / Merek : BRAINLAB Stereotaxic System

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B

Kategori Produk : Peralatan Neurologi

Sub Kategori : Peralatan Neurologi Bedah

Jenis Produk : Stereotaxic instrument.

Tipe / Ukuran : BUZZ

Kemasan : Unit

Nama Produsen / Pabrikan : BRAINLAB AG., Germany

Nama Pendaftar : PT. PENDAR ANDHIKA PARAMARTHA, DKI Jakarta

Atas dasar lisensi dari : -

Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 30 September 2022.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Izin edar ini merupakan persetujuan perpanjangan dari Nomor Izin Edar Alat Kesehatan
KEMENKES RI AKL 21002410743 tanggal 04 Februari 2019. Dengan demikian izin edar
sebelumnya dinyatakan tidak berlaku.
4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.

Jakarta, 18 Maret 2021

Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
 KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203

LAMPIRAN
NOMOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 21002410743

No. Deskripsi Tipe / Kode

1 MONITORCAMERATIANG BUZZ

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini

Jakarta, 18 Maret 2021

Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
LABELING PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

This document requires an approval signature by

 Project Manager
 Reviewer
 Regulatory Affairs AG

Stereotaxic System
BUZZ

PAGE 1 OF 13
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-195 Rev.012 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

1 PRODUCT LABEL(S)

1.1 MONITOR CART

Article number & name Label(s)

BUZZ
BUZZ Monitor Cart

PL-17712 Product Label Buzz

Navigation1 Monitor Cart

PF1054-2034
PSU Box Label Anthrazit

symbol ISO 7010-M002

WIL-0117
Warning Label - No pushing
ISO 7010-M002
size 15mm

On power button (Part of PF1054-

2521)
IEC 60417-5009

Ground Terminals
WIL-0119
IEC 60417-5019
Size 10mm

PAGE 2 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

Part of 17711-68
Fuse Labels

size 25x8 mm each

Part of 17711-68
Inlet Polarity
size 25x8 mm

Part of 17711-68
Terminal Block

size 25x8 mm each

1.2 CAMERA CART

Article number & name Label(s)

17711-01 – BuzzCamera Cart

PL-17711 Product Label Buzz

Navigation 17700 Camera Cart

PAGE 3 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

PF1051-4002
Transport Position

ISO 7010-M002 (left)

ISO 7010-P017 (right)

WIL-0117
Warning Label - No pushing
ISO 7010-M002

PF1051-2027
Electronic Box Label

W024
Trapping Zone Hands
ISO 7010-W024

17711-79, Laser Warning Label for

Vega English

PAGE 4 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

Ground Terminals
WIL-0119
IEC 60417-5019

Fuse Labels
Part of 17711-68

Battery Marking
Part of 17711-68

1.3 EM TRACKING DEVICE

Article number & name Label(s)

18092-02 – EM Base Station

Label – 0000019701 EM Base Station

ISO 7000-1641

IEC 60417-5333

PAGE 5 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

18092-01 EM Field Generator

PL-18092-01-EN

ISO 7000-1641

ISO 7010-W006

18092-08A – EM FG ASM

0000019702, EM Field Generator

 Article number
18092-30 – EM Field Generator Arm  Serial number
 CE symbol
 “Do not sterilize”
 “Manual clean only”
NE1022-0201, EM FG Arm Labelling  “Close clamp to clean”

NE1022-2_275-0061, Fisso Articulated Arm (engraved on the article)

6600-56 M10/M12x1
 Brainlab logo

(engraved on the article)

PAGE 6 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

18098-01 and 18098-01A

EM On site Packaging

NE1018-PELI-1610-PRINT-TOP-EPS

NE1018-PELI-1610-PRINT-LOGO-EPS

PAGE 7 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

2 PACKAGING LABEL(S)

The below packaging label specifications have been entered into the ERP system:

Article number & name Label(s)

17700 - Buzz Navigation 17700

(Medical device packaging label)

0000024561-LBL, Packaging Label

Buzz Navigation 17700

17710 – Buzz Navigation System

(SAP packaging label)

17717 – Buzz Navigation System EM

(SAP packaging label)

17712 – Buzz Navigation – Extension

Display Cart

(SAP packaging label)

PAGE 8 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

Curve Camera Cart packaging Label:

- Brainlab logo
- “BRAINLAB”

Part of Brainlab Art. No.: 17711-52 CC

Packaging Accessory and Cardboard
Camera Cart Packaging Label:

- Label showing “Sensitive

Medical Equipment”
- Symbol "this way up" (ISO
7000-0623)
- Symbol "fragile item, handle
carefully", ISO 7000-0621
- Symbol "protect from rain
(Keep dry)", ISO 7000-0626
- Symbol "temperature
limitation", ISO 7000-0632
- Symbol "humidity limitation",
ISO 7000-2506
- Symbol "atmospheric pressure
limitation", ISO 7000-2521
- Symbol "do not stack", ISO
7000-2402

Part of Brainlab Art. No.: 17711-52 CC

Packaging Accessory and Cardboard
Monitor Cart Packaging Label:

- Brainlab logo
- “BRAINLAB”

Part of Brainlab Art. No.: 17712-42 MC

Packaging Cardboard

PAGE 9 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.011 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Article number & name Label(s)

Monitor Cart Packaging Label:

- Label showing “Sensitive

Medical Equipment”
- Symbol "this way up" (ISO
7000-0623)
- Symbol "fragile item, handle
carefully", ISO 7000-0621
- Symbol "protect from rain
(Keep dry)", ISO 7000-0626
- Symbol "temperature
limitation", ISO 7000-0632
- Symbol "humidity limitation",
ISO 7000-2506
- Symbol "atmospheric pressure
limitation", ISO 7000-2521
- Symbol "do not stack", ISO
7000-2402

Part of Brainlab Art. No.: 17712-42 MC

Packaging Cardboard
18098-02 EM Disposable Packaging
Label:

- Label showing “Sensitive

Medical Equipment”
- Symbol "fragile item, handle
carefully", ISO 7000-0621
- Symbol "protect from rain
(Keep dry)", ISO 7000-0626
- Symbol "recyclable", ISO
7000-1135
- Symbol "temperature
limitation", ISO 7000-0632
- Symbol "humidity limitation",
ISO 7000-2506
- Symbol "atmospheric pressure
limitation", ISO 7000-2521

PAGE 10 OF 10
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.0111 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

3 MANDATORY SYMBOLS AND INFORMATION

This section applies to all medical devices manufactured at Brainlab to ensure the labelling contains all
mandatory information and symbols as required by 93/42/EEC Annex I art. 13.3. and/or 2017/745
Annex I art. 23.2.

Product About Packaging

Symbol/text Additional information
label box label
Medical Name as per Declaration of
device/component/acces Conformity, version up to  N/A 
sory name 2nd digit (if applicable)

 N/A 

Symbol and UDI consisting

of UDI-DI and UDI-PI
(software: GTIN and Build
number; hardware: GTIN,  N/A 
production date and serial
number in both human and
machine readable code)

or
 N/A 
Symbol and legal
manufacturer name +
address + date of
 N/A 
manufacture
N/A N/A
Symbol and, if available
online, link and support N/A
ISO 7010-P017 is ISO 7010-P017 is used
contact details
used instead instead

 N/A 

Symbol and article number  N/A 

Symbol and batch code or

serial number
 N/A 

PAGE 1 OF 3
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.0111 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

4 ADDITIONAL SYMBOLS AND INFORMATION

Other than the mandatory symbols and information defined in the previous section, additional labelling
requirements based on international standards and regulations may apply to your product (such as
ISO 15223-1, IEC 60601-1, China RoHS, WEEE, FDA regulations, etc).

Complete the following checklist by adding all additional content required on the product and packing
labels.

Product Packaging
Symbol/text Standard/Regulation
label label

a   IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  WEEE

PAGE 2 OF 3
LABELING: PRODUCT &
PACKAGING LABEL
Template ID: FORM 04-190 Rev.0111 CONFIDENTIAL

Product Data Management Record number: 0000208070

Record version: 002.9 Record status: APPROVED

Product Packaging
Symbol/text Standard/Regulation
label label

  NRTL certification

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

  IEC 60601-1

PAGE 3 OF 3
BU Z Z ON -WALL T e c hnic a l Spe c ific a t ions

● 42” Full HD Touch Display and optional

additional display same size mounted on the
wall

● Up to six viewing displays, thereof up to four

touch displays, can be connected to the Buzz
while simultaneously operated

ELECTRICAL REQUIREMENTS
Power Input: 100-240V; 50/60Hz
Power Consumption:
Touch Display max. 186W
(incl. Transfer Lines and Feature Panel)
Computer (incl. Transfer lines) max. 700W

Power supply for Transfer lines: 10x 5VDC

OPERATING, STORAGE AND TRANSPORT REQUIREMENTS

Temperature:
Operation 10°C to 35°C [50°F to 95°F]
Storage -10°C to 45°C [14°F to 113°F]
Humidity:
Operation 30% to 75% (non condensing)
Storage 10% to 90% (non condensing)
Pressure:
Operation/Storage 700 hPa to 1060 hPa
MR conditional: No (no installation in MR scanner room)
INGRESS PROTECTION (IP)

On-Wall Display: IP 21

Computer: IP 20

Display front (USB/Power/Microphone): Designed according IP44

IP2x= protection against medium foreign bodies (e.g. finger), IPx1= protection against dripping
water
IP2x= protection against medium foreign bodies (e.g. finger), IPx0= no water protection
IP4x=protection against foreign grains >1mm (tools, wires), IPx4=protection against splash water

TOUCH DISPLAY AND FEATURE PANEL

Panel Size: 42”

Resolution: Full HD (1920x1080)

Technology: LCD panel (IPS panel with Edge-LED

backlight)

Touch Screen: P-cap based multi-touch (10 touch inputs)

White Luminance: 450cd/m²

Viewing Angle: 178° horizontal, 178° vertical

Contrast Ratio: Type 1300:1

Color Depth: 8bit, 1.07 Billion colors

DICOM: DICOM preset

Glass: Tempered safety glass with antireflection

I/O connections: 2x USB 2.0

Audio Control: Volume control via software/audio device

Speaker/Camera/Microphone: Integrated in Feature Panel (main display)

COMPUTER
Processor:

Type Intel Xeon E5-1650v3

Base Frequency/ Turbo Frequency 3.5 GHz / 3.8 GHz

Cores/ Cache 6 / 15MB

RAM Type/ Capacity: DDR4 / 16GB

Secondary Storage Type/ Capacity: SSD / 256 GB

Optical Disc Drive: CD/DVD writer

Operating System: Windows 10 64-bit IoT Enterprise 2015 LTSB

Graphics:

Type 2x Nvidia Quadro K2200

Frequency 1124 MHz
GPU RAM 4x4 GB
I/O Connections:

LAN 4x LAN 10/100/1000

USB 8x USB 2.0, 4x USB 3.0

Video Output (incl. Main display): 4x UHD DisplayPort, 2x FullHD DVI-I

Video Input: 1x S-Video, 1x Composite, 2x HD-SDI, 2x

DVI-I
All six video signals can be displayed
simultaneously

Mounting options: Copper cable: 2,5m or fiber cable up to

……………………………………………………………100m between display and computer

Audio: Line-Out / Line-In / Microphone-In

Power Supply for Transfer Lines: 10x 5VDC

TRANSFER LINE BOX (from Computer to Touch Display)

Type of transmission: Fiber Optic Transfer Lines and Ethernet

cable
Transmission Distance: 100 m (3937 inch)

Signal Type: Display Port, USB

Mounting: On display backside or behind computer

cover

CLEANABILITY

DISINFECTANT TYPE EXAMPLE

Alcohol-based Meliseptol, Mikrozid AF Liquid

Alkylamine-based Incidin Plus 2%
Active oxygen-based Perform

Aldehyde/ chloride-based Antiseptica Combi

CERTIFICATION AND CLASSIFICATION

 ETL (Intertek)
 IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 (Ed. 3.1)
 AAMI ANSI IEC 60601-1-2:2007/(R)2012
 CSA C22.2#60601-1 Issued: 2008/02/01 Ed:2
 EN 60601-1-2:2007 + AC:2010
 IEC 60601-1-2: 2014 (Edition 4.0)
 Included in: IEC 60601-1-2: 2014 (Edition 4.0), no separate certificate required for Japan
 CE, RoHS, REACH, WEEE, POP
DIMENSIONS

BUZZ ON-WALL SYSTEM

Height: 667 mm (26.26 inch)
Width: 1866 mm (73.43 inch)
Depth total: 183 mm (7.2 inch)
Weight total: 60 kg (132.27 lbs)
(34 kg Display + 26 kg
Computer)
Weight w/o
holder wall: 51,77 kg (114.13 lbs)

MAIN DISPLAY WITH FEATURE PANEL

Height: 667 mm (26.26 inch)
Width: 1189 mm (46.81
inch)
Depth total: 103 mm (4.06 inch)
Weight total: 34 kg (75 lbs)

COMPUTER WALL MOUNTED WITH COVER

Width: 677 mm (26.65 inch)
Height: 667 mm (26.26 inch)
Depth total: 183 mm (7.2 inch)
Weight total: 26 kg (57.3 lbs)