Precision Medical PM5900 User Manual

USER MANUAL

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 ....................... 2

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 ELEVATION/BAROMETRIC PRESSURE CHANGE ...... 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

1

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

Symbol indicates the device complies with the requirements
of Directive 93/42/EEC concerning medical devices and all
applicable International Standards.

2

Follow instructions for use

General Mandatory Action Sign

Calibration

Calibration Failed

Audio Alarm Paused

Low Battery

Check

Locked

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.

Liquid ingress protection - Dripping water (vertically
falling drops) shall have no harmful effect on the device
when mounted in an upright position.

3

DANGER

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

WARNING

• Only trained, qualied 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 qualied 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 ame or ammable/ 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.

• Never install the sensor in a location that will expose the sensor to patient’s

exhaled breath or secretions, unless you intend to dispose of the sensor, ow

diverter and tee adapter.

• Improper use of this device can cause inaccurate oxygen measurements

• Device intended for use with dry gas only.

• Before use, all individuals who will be using the Oxygen Monitor must become
thoroughly familiar with the information contained in this Operation Manual.
Strict adherence to the operating instructions is necessary for safe, effective
product performance. This product will perform only as designed if installed
and operated in accordance with the manufacturer’s operating instructions.

• Use only genuine Precision Medical Inc. accessories and replacement parts.
Failure to do so may seriously impair the analyzer’s performance. Repair of

this equipment must be performed by a qualied service technician.

• Calibrate the Oxygen Monitor weekly when in operation, or if environmental

conditions change signicantly. (i.e., Elevation, Temperature, Pressure,

Humidity.

• Use of the Oxygen Monitor near devices that generate electrical elds may

cause erratic readings.

• Although the sensor of this device has been tested with various anesthesia

gases including nitrous oxide, Halothane, Isourane, Enurane, Sevourane
and Desurane and found to have acceptably low interference, the device

in entirety (including electronics) is not suitable for use in the presence of a

ammable anesthetic mixture with air or with oxygen or nitrous oxide. Only the
threaded sensor face, ow diverter, and “T” adapter may be allowed to contact

such a gas mixture.

• No modication of this equipment is allowed.

4

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.

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

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: ± 3.0% 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

5