SOUTHEASTERN MEDICAL Supply CMS 50-E User Manual

Pulse Oximeter

SOUTHEASTERN MEDICAL SUPPLY, INC

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This Manual is written and complied in accordance with the council directive MDD 93/42/EEC for
medical devices and corresponding standards. This Manual is written in accordance with standards
for the Fingertip Pulse Oximeter. In case of modifications and software upgrades, you will be
advised in due time with a Modification Notice.

The Manual includes the Fingertip Pulse Oximeter’s features, main structure, functions,
specifications, correct methods for transportation, installation, usage, operation, repair, maintenance
and storage, etc. as well as the safety procedures to protect both the user and equipment. Refer to
the respective chapters for details.

This manual is designed to be used by experienced personnel who are familiar with the
measurements of blood oxygen saturation and the us e of this type of instrument. This manual is
compiled by our company in cooperation with Southeastern Medical Supply, Inc. and the copyright
is possessed by our company.

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Instructions to User

Dear Users, thank you very much for purchasing The CMS 50-E Fingertip Pulse Oximeter.

Please read these instructions carefully before using this equipment. These instructions describing
the operating procedures should be followed strictly. Failure to follow these instructions can cause
measuring abnormality, equipment damage and personal injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring abnormality,
personal injury and equipment damage due to user’s negligence of the operation instructions. The
manufacturer’s warranty service does not cover such faults.

This product is a medical device, and can be used repeatedly. Its assumed useful life is 3 years.

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WARNING:
0 For the special patients with pulmonary disorders such as COPD and other respiratory

and circulatory problems, more prudent placing of the device must be used. The device
can not be clipped on any edema or tender tissue.

0 The red laser light (the infrared is invisible) emitted from the device is harmful to the

eyes, so do not stare at the light or shine it into anyone’s eyes.

0 Testee can not use heavy thick enamel or acrylic fake fingernails.
0 Testee’s fingernail can not be too long as to prohibit the proper placement of the finger

into the device.

0 Please refer to the correlative literature about the clinical restrictions and caution.
0 This device is not intended for treatment. Please consult your physician prior to use.

Pulse Oximeter Proper Use Tips:

 PLACE FINGER INSIDE UNIT BEFORE TURNING ON
 SLIDE FINGER TO BACK OF UNIT AND VERIFY SENSOR IS UNDER FINGER PAD
 TURN DEVICE ON AND VERIFY SIGNAL QUALITY WITH PLETHYSMOGRAPH

BAR WAVEFORM AND/OR PULSE SIGNAL STRENGTH BAR.

 Please Note

: Turning the device on before finger is properly positioned will cause erratic

readings and affect the operation of the device

 A flexible circuit wire connects the two parts of the device. Do not twist or pull on the

connection. Attaching the Lanyard Cord to this wire will damage the device and is not
covered under warranty. USE THE LANYARD PORT HOLES ON THE END OF THE
DEVICE TO ATTACH THE LANYARD CORD.

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Table of Contents

1.

SAFETY ............................................................................................................................................. 1

1.1. INSTRUCTIONS FOR SAFE OPERATION ...................................................................................... 1

1.2.

WARNINGS .............................................................................................................................. 1

1.3.

HAZARDS ................................................................................................................................ 1

2.

OVERVIEW ...................................................................................................................................... 2

2.1. FEATURES ............................................................................................................................... 2

2.2.

DESIGNED DEVICE APPLICA TION ............................................................................................ 2

2.3.

ENVIRONMENTAL REQUI REMENTS .......................................................................................... 2

3. PRINCIPLE AND CAUTION ........................................................................................................... 3

3.1. PRINCIPLE OF SPO2 MEASUREMENT ....................................................................................... 3

3.2.

PRIOR TO OPERATION ............................................................................................................. 3

3.3.

CLINICAL RESTRICTIONS ......................................................................................................... 4

4. TECHNICAL SPECIFICATIONS ................................................................................................... 4

5. ACCESSORIES ................................................................................................................................ 5

6. INSTALLATION .............................................................................................................................. 5

6.1. VIEW OF THE FRONT PANEL ..................................................................................................... 5

6.2.

MOUNTING OF THE LANYARD CORD .................................................................................. 6

7. OPERATING GUIDE ...................................................................................................................... 6

8. CLEANING AND DISINFECTING ............................................................................................... 10

9. REP AIRING AND MAINTENANCE ............................................................................................. 10

10. TROUBLESHOOTING ................................................................................................................. 11

11. KEY OF SYMBOLS ....................................................................................................................... 11

12.

FUNCTIONAL SPECIFICATIONS ............................................................................................. 12

1. Safety

1.1 Instructions for safe operation

◇

Check the main unit and all accessories periodically to make sure that there is no visible damage

that may affect patient’s safety and monitoring performance. It is recommended that the device
should be inspected at least once a week. Please stop using the monitor if there is obvious
damage to the device.

◇

Necessary maintenance must be performed by qualified service engineers ONLY. There are no

user serviceable parts and users are not permitted to service the device by themselves.

◇

The oximeter cannot be used together with devices not specified in User’s Manual. Please use

the device as recommended by the Manufacturer.

1.2 Warnings

0 Explosive hazard—DO NOT use the oximeter in environment with flammable gas such as

some ignitable anesthetic agents.

0 DO NOT use the oximeter while the testee is under measurement of an MRI or CT.
0 Be careful with the use of the lanyard cord. Improper use of the lanyard cord will cause

device damage not covered under the manufacturer’s warranty. Swinging the device by the
lanyard cord will void the warranty. Please do not use lanyard cord if allergic to lany ard cord.

0 Please do not use this product if allergic to rubber latex finger cushion cushion.
0 Please dispose of the device, accessories and packing materials (including plastic bag, foam

and carton) according to local laws.

1.3 Hazards

 Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high

temperature and moisture.

 If the oximeter gets wet, please stop using it immediately.
 When it is carried from cold environment to warm and humid environment, please do not use

it as condensation formed by use could cause damage to the device. Allow the device to
resume room temperature before use.

 DO NOT operate button on front panel with any sharp objects.
 High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to

User’s Manual for instructions of cleaning and disinfection.

 Do not immerse the oximeter in liquid. When it needs cleaning, please wipe its surface with

disinfectant solution using a soft cloth. Do not spray any liquid directly onto the device.

 When cleaning the device with water, the temperature should be less than 60℃ (140

o

F).

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