Precision Medical Oxygen Monitor User Manual

USER MANUAL

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Model: PM5900

SAVE THESE INSTRUCTIONS

(For latest revision, go to www.precisionmedical.com)

Federal (USA) law restricts this device to sale
by or on the order of a physician.

Tel: [phone]

Fax: [phone]
300 Held Drive Toll Free Tel: [phone]
Northampton Pa 18067 (USA) Toll Free Fax: [phone]

ISO 13485 Certied www.precisionmedical.com

CONTENTS

RECEIVING/INSPECTION ....................................................................... 2

INTENDED USE ....................................................................................... 2

OPERATOR PROFILE ............................................................................. 2

READ ALL INSTRUCTIONS BEFORE USING ........................................ 2

SAFETY INFORMATION - WARNINGS AND CAUTIONS ....................... 3

SPECIFICATIONS .................................................................................... 5

COMPONENT DESCRIPTION ................................................................. 6

OXYGEN MONITOR IDENTIFICATION .............................................. 6

OXYGEN MONITOR LCD DISPLAY IDENTIFICATION ...................... 8

OXYGEN SENSOR COMPONENT IDENTIFICATION ....................... 9

BATTERY INSTALLATION .....................................................................10

BATTERY INSTALLATION DIAGRAM ..............................................10

OPERATING INSTRUCTIONS ............................................................... 10

QUICK SETUP GUIDE .......................................................................11

SENSOR INSTALLATION ..................................................................11

CALIBRATION ....................................................................................12

EFFECTS OF TEMPERATURE: ..............................................................12

EFFECTS OF HUMIDITY: .......................................................................13

EFFECT OF PRESSURE: .......................................................................13

EFFECTS OF ANESTHETIC GASES: ...................................................13

ALARMS ................................................................................................. 14

TO SET ALARM: ............................................................................... 14

ALARM SITUATION: ......................................................................... 15

CLEANING ............................................................................................. 15

MAINTENANCE ..................................................................................... 16

SENSOR REPLACEMENT ............................................................... 16

BATTERY REPLACEMENT ..............................................................16

RETURNS .............................................................................................. 16

DISPOSAL INSTRUCTIONS ..................................................................16

TROUBLESHOOTING ........................................................................... 17

ALARM CONDITIONS ............................................................................ 18

REPLACEMENT PARTS ........................................................................ 18

ACCESSORIES...................................................................................... 18

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RECEIVING/INSPECTION

Remove the Precision Medical Oxygen Monitor from the packaging
and inspect for damage. If there is any damage, DO NOT USE and
contact your Provider.

INTENDED USE

Precision Medical, Inc. Oxygen Monitor provides continuous,
direct monitoring of oxygen mixtures in a wide variety of medical
applications such as anesthesiology (e.g., anesthesia machines),
respiratory devices (e.g., respirators, ventilators, pediatric incubators),
and oxygen therapy (e.g., oxygen tents).

OPERATOR PROFILE

The oxygen monitor is to be used by trained healthcare professionals
under the supervision, or on the order, of a physician in a hospital (or
other clinical setting). The Precision Medical, Inc. Oxygen Monitor is not
intended for transport use. This device is not an oxygen supply source.

READ ALL INSTRUCTIONS BEFORE USING

This manual instructs a Professional to install and operate the Oxygen
Monitor. This is provided for your safety and to prevent damage to the
Oxygen Monitor. If you do not understand this manual, DO NOT USE
the Oxygen Monitor and contact your Provider.

SAFETY INFORMATION - WARNINGS AND CAUTIONS

DANGER

WARNING

CAUTION

CAUTION

Indicates an imminently hazardous situation which, if
not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury.

Used without the safety alert symbol indicates a
potentially hazardous situation which, if not avoided,
may result in property damage.

Direct current.

PM5900 WITH RESPECT TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL60601-1, IEC60601-1,
CAN/CSA C22.2 NO. 601.1

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Follow instructions for use

General Mandatory Action Sign

Calibration

Calibration Failed

Audio Alarm Paused

Low Battery

Check

Locked

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Oxygen Sensor

Pass

This device may contain electrical components that
are hazardous to the environment. DO NOT dispose
device into standard trash. Contact your local waste
management for disposal of Electronic Equipment.

Caution! U.S. Federal Law restricts this device to sale
by or on the order of a physician.

Symbol indicates the device complies with the
requirements of Directive 93/42/EEC concerning
medical devices and all applicable International
Standards. (On CE marked devices ONLY)

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DANGER

This product is not intended as a life-sustaining or life­supporting device.

WARNING

• Only trained, qualified medical personnel under the direct
supervision of a licensed physician should operate the Oxygen
Monitor.

• Use this Oxygen Monitor only for its intended use as described
in this manual.

• Medical Oxygen should meet the requirements of USP.

• Always follow ANSI and CGA standards for Medical Gas
Products, Flowmeters, and Oxygen Handling.

• The Oxygen Monitor should be serviced by a qualified hospital/
dealer service technician, or by Precision Medical, Inc.

• DO NOT obstruct the alarm grill on the back of the Oxygen
Monitor.

• DO NOT use near any type of flame or flammable/ explosive
substances, vapors or atmosphere.

• DO NOT allow an excess length of cable near the patient’s
head or neck, this could result in strangulation. Secure excess
cable to bed rail or suitable object.

• DO NOT use Oxygen Monitor with a cable that appears worn,
cracked or has damaged insulation.

CAUTION

• The Oxygen Monitor contains magnetic, ferrous material that
may affect the results of an MRI.

• Store the Oxygen Monitor in a clean, dry area when not in use.

• DO NOT use if dirt or contaminants are present on or around
this Oxygen Monitor or connecting devices.

• DO NOT smoke in an area where oxygen is being
administered.

• DO NOT clean with aromatic hydrocarbons.

• DO NOT steam autoclave.

• DO NOT gas sterilize with (EtO) Ethylene Oxide.

• DO NOT immerse Oxygen Monitor or Sensor in liquid.

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SPECIFICATIONS

Base Device Specications

Dimensions (Monitor without cable and sensor attached):

Length: 1.72” (4.36 cm)

Width: 3.56” (9.04 cm)

Height: 5.44” (13.82 cm)

Cable Length: 10 ft. (3.05m) (fully extended)

Weight:

Device Weight: 1.11 lbs (0.50 kg)

(includes: monitor, sensor, batteries and cable)

Shipping Weight: 1.64 lbs (0.75 kg)

Operating Conditions:

Temperature: 50ºF- 113ºF (10ºC - 45ºC)

Altitude: Sea Level to 8000 feet

Storage Conditions:

Temperature: 5°F - 122°F (-15°C- 50°C)

Humidity: 0 - 95% non-condensing

Mode of Operation: Continuous

Electrical Classication: Internally powered Medical Electrical equipment

Power Requirements: 4, AA Alkaline Batteries (4 x 1.5 Volts) 6 VDC
Battery Life: approximately 2000 hours

(continuous use non-alarm condition)

Diverter Fitting: ts industry standard, 15 mm “T” adapter
Measurement Range: 0.0 - 100%
Resolution: 0.1 Increments
Accuracy & Linearity: ± 1% of full scale at constant temperature, R.H. and

pressure when calibrated at full scale

Total Accuracy: ± 2.5% Actual Oxygen Level over full operating

temperature range

Response Time: 90% of nal value in less than 12 seconds at

77°F (25ºC)

Warm-up Time: none required

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