Model note · Oesophageal Manometry

Diversatek (formerly Sandhill Scientific) inSIGHT Ultima high resolution manometry system

Name: Diversatek (formerly Sandhill Scientific) inSIGHT Ultima high resolution manometry system
Brand: Diversatek (formerly Sandhill Scientific)

The inSIGHT Ultima is Diversatek's gastrointestinal motility system for oesophageal and anorectal studies, sold as a cart or desktop set. A small central unit provides patient isolation and signal conditioning for high resolution solid state probes and passes the data over USB to a PC running Zvu software. The usual oesophageal probe is the Zvu HRiM probe, which combines circumferential pressure sensors with impedance rings so clinicians can see both contraction pressure and bolus movement. Sandhill Scientific was bought by Diversatek in December 2013.

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The model

Maker, model and type.

Maker: Diversatek Healthcare, Inc. (Highlands Ranch, Colorado)
Model: inSIGHT Ultima high resolution manometry system
Device type: Oesophageal Manometry
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Central unit	Part H12R-2000; 5.1 x 12.7 x 20.3 cm (H x W x D); 0.9 kg	Source
Channels	Up to 48, all displayable at once; pressure and impedance via signal conditioning; 16 bit A/D conversion	Source
Power	5/12 Vdc, 30 W from a medical grade external supply, fed from a medical grade isolation transformer (ISO-MED-3, 600 VA)	Source
Patient connection and PC link	Isolated type BF patient connection on Port 1; USB link to PC software	Source
Operating environment	10 to 40 C; 0 to 80% RH at 31 C falling linearly to 50% RH at 40 C; up to 2,000 m	Source
Cart (CART5R)	167.6 cm high, 48.3 cm wide, 61 cm deep; 54.4 kg; height adjustable work area	Source
HRiM probe (HRIM-201)	12 Fr, 34 circumferential pressure sensors and 18 impedance channels	Source
HRiM probe life (510(k) testing)	Tested to 200 reprocessing and use cycles plus 2 years accelerated ageing; adult use only	Source
Regulatory basis	System under K012232; HRiM probe cleared as K190208, product code FFX, 21 CFR 876.1725, Class II	Source

Recalls

Known FDA recalls.

Z-2521-20232023-07-25
Zvu Functional GI software (ZVU-3) labelled as revision 3.3.0 was actually revision 3.2.0.
FDA record
Z-1487-20122009-02-23
InSIGHT Suite revision H and BioVIEW 5.5.1 software could give incorrect oesophageal contraction readings; free replacement software was supplied.
FDA record

Safety

Safety warnings from the record.

Impedance catheters can interfere with pacemakers and implanted defibrillators, so implanted devices should be monitored during studies. Source
The system is not waterproof, must not be used near MRI or in oxygen rich settings, and is not for emergency use or patient monitoring. Source
Connect only to an earthed supply; on desktop systems use the medical grade isolation transformer and keep other devices and power strips off its outlets. Source
Probe applied parts use 304 stainless steel with 8 to 11% nickel, a risk for nickel allergic patients. Source
The probe is supplied non-sterile and needs enzymatic cleaning and high level disinfection before first use and after every patient; sterilisation by any method is not allowed. Source

Sources

Where this note comes from.

Not covered: The public user guides list no numbered error codes, so the errorCodes array is empty; LED states are covered in first checks. No service manual or internal calibration tolerances are public, and repair is by return to Diversatek. MAUDE holds only about a dozen Diversatek motility reports (single counts of failure to calibrate, failure to power up, torn material and others), far too few to show a trend. Diversatek now also sells the PriZm central unit, and current Ultima base systems are listed as not compatible with MiVu; check which platform a site actually has.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

Oesophageal Manometry