Cadi Scientific SMB800 Users Manual
CCaaddii SScciieennttiiffiicc PPttee LLttdd
SSMMBB--880000 SSmmaarrttBBrriiddggee
IInnssttrruuccttiioonnss FFoorr UUssee
Document No.:
Established Date:
Revision:
B
28 October 2009
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Revision:
Issue
Date:
Document No.:
Date Revision Contents of Revision Revised by Reviewed by Approved by
28 October
2009
22
September
A New Ng Ken
Wee
B Update
Ng Ken
Wee
2010
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Revision:
Issue
Date:
Document No.:
Notices
Copyright © 2010 Cadi Scientific Pte Ltd.
No part of this manual may be reproduced in any form or by any means (including electronic
storage and retrieval or translation into a foreign language) without prior agreement and
written consent from Cadi Scientific Pte Ltd as governed by international copyright laws.
Regulatory Information
For customer in the U.S.A and Canada
The SMB-800 SmartBRIDGE (FCC ID: VPE-SMB800) has been tested and found to comply
with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These
limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may
cause undesired operation.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users must follow the specific operating instructions for satisfying RF exposure
compliance. This transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter.
The lithium battery inside this product contains Perchlorate. The following statement is required
by the State of California, USA:
Perchlorate Material – special handling may apply.
Changes or modifications not expressly approved by the manufacturer could void the user’s
authority to operate the equipment.
For customer in Europe
This equipment has been tested and found to comply with the limits set out in the R&TTE
Directive.
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Quality Objectives and Quality Planning Control
Procedures
Management
Representative
Revision:
B01
Issue
Date:
Document No.:
28 Oct 2009
MDDQP-001-A2
Page 4 of
Annex II
29
Where you see this symbol on any of our electrical products/packaging in Europe, it means that
at end of life the product/battery must be disposed of in accordance with any applicable laws or
requirements for the separate disposal of electrical equipment/batteries.
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Quality Objectives and Quality Planning Control
Procedures
Management
Representative
Revision:
B01
Issue
Date:
Document No.:
28 Oct 2009
MDDQP-001-A2
Page 5 of
Annex II
29
Product Information
Product model: CADI SMB-800
Product name: SmartBridge
Manufacturing site: 31 Ubi Road 1, #03-00 Aztech Building, Singapore 408694
Version Information
This version is subject to change or upgrade without notice
Version: A01
Issue date: xxxxxxxx
Declaration
Cadi Scientific Pte Ltd reserves the right to change the product described in this
Operating Manual. All information contained in this Operating Manual is subject to
change without prior notice.
Manufacturer’s Responsibility
Cadi Scientific is responsible for the safety, reliability and performance of the device
under the following conditions:
Assembling, upgrading, resetting and repairing are performed by Cadi’s authorized
personnel.
Operating this device following this manual.
Product serial number and labels are intact to verify the product identity as manufactured
by Cadi Scientific Pte Ltd.
Product storing environment, operating environment and electrical environment are as
described in this manual.
Damages not by misuse of accidental dropping.
Free services apply to products with applicable items within warranty period. For
products beyond the description of warranty conditions, service charge applies.
Customers are required to pay for any transportation and applicable customs fees of
returned goods to Cadi Scientific.
Return Proceedures
If return is necessary, take the following steps:
1. Obtain return goods authorization from Cadi Scientific Customer Service
Department. Inform Cadi Scientific of the serial number and mark this serial
number on the cartons. If the serial number cannot be recognized, the return
cannot be accepted. Describe briefly the reasons for return.
2. Frieght Charge: customer is responsible for freight charges (including customs) for
any returns.
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Quality Objectives and Quality Planning Control
Procedures
Management
Representative
Revision:
B01
Standards Compliance
This SmartBridge meets the following standards
Issue
Date:
Document No.:
28 Oct 2009
MDDQP-001-A2
Page 6 of
Annex II
29
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Quality Objectives and Quality Planning Control
Procedures
Management
Representative
Revision:
B01
Issue
Date:
Document No.:
28 Oct 2009
MDDQP-001-A2
Page 7 of
Annex II
1. Safety
1.1 Safety Information
This chapter lists all warnings, attentions and basic safety information when using
CADI SMB-800 SmartBridge. Other safety information can be found in appropriate
chapters.
29
1.1.1 Danger
There is no safety information on levels of danger.
1.1.2 Warning
Only professional doctors and nurses can use this CADI SMB-800 for clinical monitoring
under certain conditions.
Before using CADI SMB-800, users must check the device and its accessories to ensure
its proper function and safety.
Disposable accessories should be disposed according to the regulations of the hospital.
Do not use CADI SMB-800 in an environment where flammable substances are present.
Users should set alarm settings according to patient types and conditions.
Do not open CADI SMB-800 case. Otherwise, it may cause serious injuries or death.
Do not use on patients during defibrillation. Otherwise, it may cause serious injuries or
death.
Ensure patient safety when using CADI SMB-800 with other electrical surgical devices.
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Quality Objectives and Quality Planning Control
Procedures
Management
Representative
Revision:
B01
Issue
Date:
Document No.:
28 Oct 2009
MDDQP-001-A2
Page 8 of
Annex II
29
The packaging material should be disposed according to local regulations and should be
kept in a place where no children can reach.
Connect CADI SMB-800 only with the provided power adapter. Use with any other
adapters may cause serious injuries or death.
1.1.3 Caution
Use accessories recommended in this manual to ensure patient safety.
Magnetic fields may affect the performance of CADI SMB-800. Any equipment in use
near CADI SMB-800 must be in compliance with EMC standards. Cell phones, X-ray or
MRI devices are possible interference sources, as they emit high electro-magnetism
radiation.
Before connecting CADI SMB-800 to power, ensure the voltage and frequency are in
accordance with the requirements on the adapter label or in the manual.
Install and transport CADI SMB-800 properly to prevent any damages caused by
dropping, impact, shakes or other mechanical forces.
This equipment should be installed and operated with minimum distance 20cm between
the radiator & your body.
1.1.4 Note
Note
Place this manual next to the CADI SMB-800 for convenience when needed.
The software for the CADI SMB-800 is developed in accordance with IEC60601-1-4
standards to minimize any risks caused by program errors.
Up to 1000 trend data storage.
Place CADI SMB-800 where easy observation, operation and maintenance can be
obtained.
CCaaddii SScciieennttiiffiicc PPttee LLttdd
Document:
Dept. of
preparation:
Quality Objectives and Quality Planning Control
Procedures
Management
Representative
1.2 Symbols
Revision:
B01
Issue
Date:
Document No.:
28 Oct 2009
MDDQP-001-A2
Page 9 of
Annex II
29
Loading...