BIOMEDICAL GUIDE

Laparoscopic Insufflators
Procedure Number 466-20210319

Adapt Procedure for

Insufflators, Laparoscopic [16-849]

Scope
Applies to pneumatically and electronically controlled insufflators intended for introduction of CO 2 gas into the peritoneal
space.

Interval
12 Months

Time Required
0.5 Hour

Questions?
Please contact BiomedicalGuide@ecri.org
Adapt Procedure For
Insufflators, Laparoscopic [16-849]

Scope
Applies to pneumatically and electronically controlled insufflators intended for introduction of CO 2 gas into the peritoneal
space.

Interval
12 Months

Time Required
0.5 Hour

Overview
Insufflators are used to establish and maintain the pneumoperitoneum during laparoscopic procedures. Gas, typically CO 2, is
used to inflate the peritoneal cavity to provide a viewing and working space within the abdomen.
The primary function of the insufflator is to act as a pressure-controlled gas flow regulator. The insufflator uses compressed
gas from a supply cylinder (700 to 850 psi) or wall outlet (50 to 100 psi) and delivers it into the patient’s peritoneal cavity,
typically at 10 to 15 mm Hg (0.2 to 0.3 psi). In pneumatic insufflators, abdominal pressure control is accomplished by limiting
the delivery pressure of the gas to the desired abdominal pressure. Electronic insufflators typically deliver gas at a pressure
higher than that desired in the pneumoperitoneum; these units limit abdominal pressure by slowing and then suspending flow
when the abdominal pressure reaches the user-selected pressure.
Pneumatic and electronic insufflators have controls for setting the pressure and maximum flow rate. For example, they feature
displays, gauges, or other indicators for set and detected abdominal pressure and flow, volume of gas consumed, and external
gas cylinder pressure or volume remaining. With pneumatic insufflators, flow is typically specified as high or low. With
electronic insufflators, flow rates are specified either as a time-averaged flow or as an instantaneous flow. The maximum flow
possible from a given insufflator varies depending on flow resistance introduced by in-line tubing filters and by the stopcock
connection through which the insufflator is connected to the patient.

Test Apparatus and Supplies

Electrical safety analyzer [Acceptance]
Pressure meter or gauge (range 0 to 75 mm Hg)
Empty 500 mL and 3L IV solution bags
Insufflator tubing set
Trocar sleeve with stopcock

Special Precautions
If there is evidence of blood or body fluid contamination, submit the device for cleaning and decontamination before
inspecting it. (See IPM Safety in Biomedical Guide HTM Resources, Technical Documents for additional precautions and
guidelines.)
When testing insufflators that employ nitrous oxide or helium, any exhausted gas should be scavenged to protect personnel.

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Procedure Number: 466-20210319
Procedure
Be sure that you understand how to operate the equipment and the purpose of each control, indicator, and alarm. Before
beginning an inspection, carefully read this procedure and the inspection and preventive maintenance procedure
recommended by the manufacturer (typically included in the service manual). Use Biomedical Guide’s Support Assessment
Form to document a scheduled maintenance interval and procedure that reflects past experience with this model and type of
equipment and the environment where it is used. Also consider BiomedicalBenchmark Maintenance Data for this model and
type of equipment.

The following procedure contains tasks for Acceptance and Scheduled inspections; tasks not labeled [ Acceptance] or
[Scheduled] apply to both types of inspections. The form provided for the General Devices IPM procedure can be used to
develop a form for documenting performance of this procedure.

Qualitative Tasks
Chassis/Housing [Acceptance]
Check for shipping damage; report any damage to the manufacturer, shipper, or service organization, and arrange for repair
or replacement.
Check that the insufflator is suitably constructed to withstand normal hospital use and abuse. For instance, a unit with venting
on the top of the housing or poorly protected or sealed controls and indicators may be prone to fluid entry. If not correctable,
warn users or take other preventive measures.)
Examine the exterior of the insufflator for cleanliness and general physical condition. Ensure that plastic housings are intact,
that all assembly hardware (e.g., screws, fasteners) is present and tight.

Chassis/Housing [Scheduled]
Examine the exterior of the insufflator for cleanliness and general physical condition. Ensure that plastic housings are intact,
that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Inspect the gas
outlet port for evidence of fluid entry, which can indicate contamination by body fluids.

Mount/Fasteners [Acceptance]
If the insufflator is mounted on a stand or cart, ensure that the assembly and weight distribution is stable and that the
insufflator will not tip over during transport. If it is attached to a wall, check the security of this attachment. If the insufflator
is designed to rest on a shelf, ensure that it has nonslip legs or supports.

Mount/Fasteners [Scheduled]
If the insufflator is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall, check the
security of this attachment.

AC Plug [Acceptance]
A solidly constructed, good quality plug with adequate strain relief is acceptable, but the use of a Hospital Grade plug
(identifiable by a green dot and/or labeling) will eliminate guesswork and ensure a plug of acceptable construction quality.
Right-angle plugs are unacceptable for devices that are moved frequently. A good quality two-prong plug is acceptable for
double-insulated devices. Replace the plug or have the supplier replace it if it is not Hospital Grade or otherwise suitable.
Hospital Grade molded plugs are acceptable.
Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect
it.

AC Plug [Scheduled]
Examine the AC power plug for damage. If any damage is suspected, open the plug and inspect it.

Line Cord [Acceptance]
Ensure that the line cord is long enough for the incubator's intended application; an extension cord should not be required. (A
length of 10 ft [3 m] is suitable for most applications.)

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Procedure Number: 466-20210319
Equipment having a detachable power cord should also have adequate capture devices, cleats, or channels to hold the cord in
place. If these are absent, request that the supplier provide suitable means of securing the cord. Verify that the incubator has
adequate alarms or indicators for line-power loss and battery depletion and an adequate battery-charging indicator.

Line Cord [Scheduled]

Inspect the cord for signs of damage. If damaged, repair or replace the cord.

Strain Reliefs [Acceptance]

Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable
(by the user), affix the cord to the insufflator so that it cannot be removed by the operator.

Strain Reliefs [Scheduled]

Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely.

Circuit Breaker/Fuse [Acceptance]

If the insufflator has a circuit breaker, check that it moves freely. If the insufflator is protected by a fuse, verify that the fuse
type is labeled and that all fuses and spares are the properly rated. If the value and type are not labeled, check the manual
for the proper current rating and type and permanently mark this information on the insufflator housing near the fuse holder.

Tubes/Hoses
Check the condition of gas-supply hoses. They should be clean and without cracks, particularly at the hose fittings.

Pneumatic Connectors [Acceptance]

Verify appropriate connectors are supplied if connection to other hospital equipment or systems is required. Insufflators that
connect to the piped medical gas system should have the matching DISS or quick-connect fitting for the appropriate gas.
Verify that suitable connectors are supplied with the insufflator so that adapters are not required.
Verify that the high-pressure hose connector is pin-indexed for a CO 2 gas (or alternative gas) tank yoke. Examine all external
gas fittings and connectors, for general condition. Gas fittings should be tight and should not leak.

Pneumatic Connectors [Scheduled]

Verify that the high-pressure hose fitting is in good condition. Examine all external gas fittings and connectors for general
condition. Gas fittings should be tight and should not leak.

Filters [Acceptance]
Check for the presence and condition of internal gas filters. Record the manufacturer's recommended interval for service of
internal filters (typically 2 years).

Filters [Scheduled]
Check the condition of internal gas filters. Clean or replace as appropriate. Follow the manufacturer's recommended interval
for service of internal filters (typically 2 years) and instructions for replacement.

Controls/Switches [Acceptance]
Verify that software setup parameters accessible through hidden or service menus are correctly set for the appropriate
application and are consistent for all insufflators. Instruction and service manuals may contain instructions regarding such
modes. If they do not, contact the manufacturer. Discuss appropriate settings with the department head and users. If alarm
capabilities are included, see the Acceptance test for Alarms.
Examine all controls and switches for physical condition, secure mounting, and correct motion. If a control has fixed-limit
stops, check for proper alignment, as well as positive stopping.
For the model configured with a touch screen, check every available key on the screen, ensure the screen is working properly
and execute right operation. Ensure the screen is normal with no missing characters or any bright spots and dark shadows on
the screen.

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Procedure Number: 466-20210319
Controls/Switches [Scheduled]
Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have
not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as
positive stopping. During the course of the inspection, check that each control and switch performs its proper function.

Indicators/Displays
Confirm the operation of all lamps, indicators, meters, gauges, and visual displays on the insufflator. Observe that all
segments of a digital display function.

User Calibration
Verify that any pre-use calibration function operates.

Alarms
Induce alarm conditions to activate audible and visual alarms. Check that all associated interlocks or features function. If the
insufflator has an alarm-silence feature, check the method of reset (i.e., manual or automatic) against the manufacturer's
specifications.
Note the bag pressures at which intermittent or continuous audible alarms and visual indicators are activated during the
Pressure Setting Accuracy and Pressure Relief Mechanism quantitative inspection tasks. Confirm appropriate volume, as well
as the operation of a volume control if so equipped.

Labeling
Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible.

Manuals [Acceptance] 
An operators and service manual (electronic or hard copy), including schematics, should be provided with the monitor.

Software
Ensure all the software are up to date.

Reusable Tube Set

For the unit with reusable tube set, clean and disinfect the reusable tube set according to manufacturer’s instruction. Ensure
the number of sterilization cycles for the tube set does not exceed the number of uses indicated by the manufacturer.

Accessories
Verify that all necessary accessories have been supplied with the unit.

Quantitative Tasks
Grounding Resistance [Acceptance] 0.5 
Measure the resistance between the grounding pin of the power cord (if so equipped) and exposed (unpainted and not
anodized) metal on the chassis. Grounding resistance should not exceed 0.5 . Grounding resistance measurement is not
applicable to double insulated devices.
Depending upon circumstances, including prior history of grounding failures or power cord damage, frequency of use, and
environmental factors, this task should be considered for inclusion in scheduled inspections.

Touch Current [Acceptance] 500 µA

Touch (chassis leakage) current must be measured with the device powered by a conventional (grounded) power system,
even if it is normally used in an area with isolated power. ECRI does not recommend touch current tests of double-insulated
devices.
With the polarity of the power line normal and the equipment ground wire disconnected, measure touch current with the
device operating in all normal modes, including on, standby, and off. Maximum touch current should not exceed 500 A.

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Procedure Number: 466-20210319
Inspect AC adapters used to power (or recharge) certain devices for CE mark or UL (or other testing laboratory) listing and to
verify that it is labeled to identify the device with which it is to be used. ECRI recommends testing of adapters, particularly
those that are not listed, by measuring the leakage current from each secondary (low voltage) connection to ground. The
leakage current should not exceed the limit for the device touch current.

Pressure Setting Accuracy ±3 mm Hg

Connect the insufflator to the stopcock of a trocar sleeve inserted into an empty 3 L solution bag as illustrated in Figure 1.
Introduce a large-bore hypodermic needle through an injection port on the bag. Connect the pressure meter or gauge to the
hypodermic needle, and measure the gas pressure in the bag after it has stabilized.
Measurements should be taken at maximum, minimum, and a pressure setting in the range of 12 to 15 mm Hg and should be
within 3 mm Hg of the pressure setting. At any pressure setting, the displayed pressure should be within 3 mm of the
measured pressure.

Figure 1. Setup for pressure and flow testing

Pressure Relief Mechanism mfr max

pressure spec
An insufflator should limit delivered pressure to a
manufacturer-specified maximum possible value. In
addition to a pressure-relief valve, some insufflators also
have vents that are electronically opened if the detected
pressure exceeds a threshold value (e.g., 30 mm Hg) or if
the detected pressure exceeds the selected pressure by a
certain value. In many cases, these vents activate after a
delay of several seconds.
With the insufflator connected to a filled 3 L solution bag
bag as illustrated in Figure 1, manually compress the bag
so that pressure is increased in 5 mm Hg increments until
pressure relief is activated. Note the bag pressure at which
pressure relief starts to occur as indicated by the pressure
meter or gauge also connected to the bag.

Maximum Flow [Acceptance] mfr spec

Refer to figure 1. It is important to minimize flow resistance in the connection between the insufflator tubing set and the
reservoir bag (e.g., do not use a Veress or hypodermic needle for this connection). The trocar cannula or IV stopcock used to
connect the insufflator to the solution bag should be maintained as a permanent test device because flow resistance of
stopcocks and cannulae may vary.
With the insufflator set to its maximum flow setting, measure the time required to fill an empty 3 L solution bag to a typical
pressure setting (e.g., 15 mm Hg) through the tubing/filter set intended for use with the insufflator, and record it. Calculate
the flow using the following formula:

Flow (L/min)=(3 L) x (60 sec/min) / Fill Time (sec)

Compare this calculated flow to manufacturer specifications and retain it as a comparison value for future inspections.
Insufflators typically have a maximum flow of 10 to 15 L/min. (Calculated flow may differ markedly from the manufacturer's
specified maximum flow rate if it is specified as an instantaneous flow or is not adjusted for flow resistance of the tubing set
and filter.)

Maximum Flow [Scheduled] Compare to calculated value from Acceptance inspection

Refer to figure 1. It is important to minimize flow resistance in the connection between the insufflator tubing set and the
reservoir bag [e.g., do not use a Veress or hypodermic needle for this connection]. The trocar cannula or IV stopcock used to
connect the insufflator to the solution bag should be the same as used for Acceptance testing because flow resistance of
stopcocks and cannulae may vary.

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Procedure Number: 466-20210319
With the insufflator set to its maximum flow setting, measure the time required to fill an empty 3 L solution bag to a typical
pressure setting (e.g., 15 mm Hg) through the tubing/filter set intended for use with the insufflator, and record it. Calculate
the flow using the following formula:

Flow (L/min)=(3 L) x (60 sec/min) / Fill Time (sec)

Compare the calculated flow to the value calculated during acceptance testing. Insufflators typically have a maximum flow of
10 to 15 L/min. (Calculated flow may differ markedly from the manufacturer's specified maximum flow rate if it is specified as
an instantaneous flow or is not adjusted for flow resistance of the tubing set and filter.)

Low Flow [Acceptance] mfr spec

Refer to Figure 1. With the insufflator set to minimum flow setting, measure the time required to fill an empty 500 mL IV
solution bag to a typical pressure setting (e.g., 15 mm Hg) through the tubing/filter set intended for use with the insufflator,
and record it. Calculate the flow using the following formula:

Flow (L/min)=(0.5 L) x (60 sec/min) / Fill Time (sec)

Compare this calculated flow to manufacturer specifications and retain it as a comparison value for future inspections.
Insufflators should have a setting that delivers flow in the range of 1 to 2 L/min.

Low Flow [Scheduled] Compare to calculated value from Acceptance inspection

Refer to Figure 1. With the insufflator set to minimum flow setting, measure the time required to fill an empty 500 mL IV
solution bag to a typical pressure setting (e.g., 15 mm Hg) through the tubing/filter set intended for use with the insufflator,
and record it. Calculate the flow using the following formula:

Flow (L/min)=(0.5 L) x (60 sec/min) / Fill Time (sec)

Compare this calculated flow to the value calculated during Acceptance testing. Insufflators should have a setting that delivers
flow in the range of 1 to 2 L/min.

Preventive Maintenance [Does not apply to Acceptance procedure]

Clean
Clean the exterior (interior, if required). Wipe the surface of the device with a moistened soft cloth with the surface
disinfectant and make sure no water gets into the device. Do not attempt to sterilize the device.

Lubricate
Lubricate per the manufacturer's instructions.

Calibrate
Calibrate pressure settings, if required.

Replace
Replace filters, if required.

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Procedure Number: 466-20210319