Mallinckrodt Nellcor N-395

The Mallinckrodt Nellcor N-395 is a pulse oximeter made by Mallinckrodt Pharmaceuticals. Pulse oximeters are non-invasive devices used to monitor a patient’s oxygen saturation. Mallinckrodt is a manufacturer of specialty pharmaceuticals, imaging agents, and generic drugs. The company also acquires, manufactures, and sells products for diagnostic procedures and pain treatment.

The Nellcor N-395 is designed as a portable pulse oximeter that measures pulse rate and functional oxygen saturation. This model can be used for adult, pediatric, and neonatal patients in hospitals, hospital-like facilities, and intra-hospital transport.

The N-395 model features four soft keys that allow the operator to access recorded trend information, choose the language, adjust the internal clock, change alarm limits, and change communication processes. This pulse oximeter can be powered either by AC power or on its internal battery, which is rechargeable. On a fully charged battery, the device can run for up to two hours. This model takes 18 hours to fully charge while in use.

When pulse rate or saturated oxygen levels move above or below a preset value, the pulse oximeter will produce audible and visual alarms.

The Mallinckrodt Nellcor N-395 typically includes a grey plastic housing. The model number, “N-395,” is printed in the upper right-hand corner of the device’s front face.

Troubleshooting and repair information for the Mallinckrodt Nellcor N-395 pulse oximeter can be found in the device’s service manual.

GENERAL:

• Designed to meet safety requirements of: UL 2601-1 CSA-C22.2 No. 601-1-M90, IEC 601-1 (Class I, type BF), ISO 9919, EMC per EN 60601-1-2.

ELECTRICAL:

• Protection Class: Class I: per IEC 601-1, clause 2.2.4
• Degree of Protection: Type BF: per IEC 601-1, clause 2.2.26
• Mode of Operation: Continuous
• Battery Type: Rechargeable, sealed lead-acid, internal
• Operating time: 2 hours minimum on new, fully charged battery under the following conditions: no alarms, no analog or serial output devices attached, no RS-232 level nurse call output and backlight on.
• Recharge period:
  • 14 hours for full charge (in standby)
  • 18 hours for full charge (in use)
• Fuses:
  • 2 each 5 x 20 mm
  • Slow Blow: 0.5 Amp 250 volts
• AC Power: Selectable by switch
  • 100-120 VAC, 50/60 Hz or
  • 200-240 VAC, 50/60 Hz
  • 20 VA
• Sensor: The wavelength of the light emitted is within the range of 250 nm to 1,000 nm with the energy not exceeding 10 mw.

PHYSICAL CHARACTERISTICS:

Dimensions

• 3.3 in. H x 10.4 in. W x 6.8 in. D
• 8.4 cm H x 26.4 cm W x 17.3 cm D

Weight

• 5.7 lbs.
• 2.6 kg

ENVIRONMENTAL:

• Operating Temperature: 5 C to 40 C (+41 F to +104 F)
• Storage Temperature: -20 C to +70 C (-4 F to +158 F)
• Operating Altitude: -390 m to +3,658 m (-1,280 ft. to +12,000 ft.)
• Relative Humidity: 15 %RH to 95 %RH, noncondensing

ALARMS:

Alarm Limit Range

• % Saturation: 20-100%
• Pulse: 30-250 bpm

PERFORMANCE:

Measurement Range

• SpO2: 1-100%
• Pulse/Heart Rate: 20-250 bpm
• Accuracy
• Saturation (%SpO2 ±1 SD):
• Without Motion:

** Adults: 70 to 100% ±2 digits

** Neonates: 70 to 100% ±3 digits

• 1 to 69% unspecified

* With Motion:

• Adults and Neonates: 70 to 100% ±3 digits
  • 1 to 69% unspecified
• Pulse Rate
  • Without Motion: 20 to 250 ±3 digits
  • With Motion: Normal physiologic range (e.g., 55 ñ 125 bpm) ±5 digits

Mallinckrodt Nellcor N-395 Operator’s Manual

Mallinckrodt Nellcor N-395 Product Page

Mallinckrodt Nellcor N-395 Service Manual

Wikipedia: Mallinckrodt